Total Laboratory Services Ltd Total Laboratory Services Ltd are the official Distributor for all Erweka products in the UK, With more than 25 years experience in the Pharmaceutical Industry. Erweka is an internationally recognized, leading developer of Dissolution and Laboratory Equipment. Founded in 1951, Erweka is sold and serviced in more than 80 countries worldwide. Above all, Erweka has a reputation for supplying high quality products, with reliability and excellent customer service. Total Laboratory Services Ltd are proud to be the Erweka distributor and offer the full sales and service programme for both new and used machines as well as spare parts throughout the UK.
Products • Tablet Dissolution Testers (USP 1,2,5,6) • BioDis (USP3,7) • Flow-Through Cell (USP4) • Offline Dissolution Systems • Online Dissolution Systems • On-/Offline Dissolution Systems • Fully Automated Dissolution Systems • Media Preparation – Degassing • Friability Testers
Services Total Laboratory Services Ltd has experienced and trained staff who can also offer the following services for new and existing equipment. These services also apply to equipment manufactured by other companies. • Installation and Operational Qualification • Mechanical Calibration • Performance Verification Test (PVT – Prednisone Tablets)
• Disintegration Testers
• Preventative Maintenance
• Tablet Hardness Testers
• Maintenance Contracts
• Multicheck – Fully Automated Tablet &
• Service and Repair
Hardness Tester
• Spare Parts Department
• Granulate Testers
• Instrument and Software Training
• Suppository Testers
• Dissolution Training
• Blister Density Testers • Tapped Density Testers
• Demonstrations arranged at customer site or our purpose built Laboratory.
• Erweka All Purpose Equipment
• Instrument Rental and Leasing
(Small Scale Production for R&D and Formulation)
• Tablet Press • Chewing Gum Testers
• Part Exchange Welcome • Telephone Support We will be more than happy to answer any questions you may have about the Erweka product range.
Laboratory Equipment Range Simply select your equipment of choice from the categories below, and read more about each model. It couldn’t be simpler! All links are fully interactive at the click of a mouse or tap of a finger.
Disintegration Testers Type A and Type B baskets, multiple stations and automated features Hardness & Friability Testers Automated and manual insertion and a host of test parameters
Intelligent Design
Dissolution Testers Standalone, auto-sampling, online / offline and flow-through
Superior Quality
CHOOSE
Adaptable Technology
Total Laboratory Services can provide a large, all-encompassing range of laboratory machinery directly from ERWEKA, the world-class manufacturer of high quality lab equipment.
R&D / All-purpose Unit A truly versatile machine with multiple attachments
USP/FDA Compliant
. We also supply suppository testers, tapped density testers, granulate flow testers and vacuum leak testers too!
The new
DT 126 light
Manual dissolution testing simple and compact
DT 126 light The new ERWEKA light DT 126 delivers the proven ERWEKA quality in a comprehensive package for a budget for simple dissolution testing with USP method 1, 2 and 5 (USP method 2 paddles included). The DT 126 is equipped with 6 test stations and a fixed drive head (high-hea), allowing easy access to each vessel. The shafts can be replaced easily and the unique water bath of moulded PET is equipped with the time-proven ERWEKA water outlet for easy cleaning. The external flow through heater reduces the influence of external vibrations and ensures a constant temperature. All these features make sure that the ERWEKA light DT 126 is the perfect entry-level device for the world of dissolution testing.
DT 126 Light Highlights ■ ■ ■ ■ ■ ■ ■ ■
100% USP/EP/JP compliant Compact design saving lab space High-head mode for easy access to the vessels Universal shafts with attachments for Method 1, 2 (paddles included) and 5 Easy cleaning of the water bath and the set-up area External flow through heater reduces influence of external vibrations and ensures constant temperature Simple control using symbol keypad with LED display for temperature, RPM and runtime Manual sampling using height adjustable holder for USP sampling points
LED-display and symbol keypad for easy control
Technical Data Dissolution tester for USP methods 1 (Basket), 2 (Paddle), 5 (Paddle over Disk) and 6 (Rotating Cylinder) with 6 test stations – USP method 2 included
External PT 100 temperature sensor
100% USP/EP/JP compliant
Heating range: 30-50 °C (± 0,2 °C)
Fulfills all specifications in accordance with FDA “Mechanical Calibration”
Dimensions (width / depth/ height): 510 mm / 450 mm / 660 mm / 30 kg (weight)
Rotational speed 20-220 rpm ± 1 rpm
USB-A printer interface (for selected printers) USB-B interface for firmware updates RS 232 interface for heater control
Low-evaporation vessel covers are included
ERWEKA GmbH
Technical specifications of products described are stated without
Ottostr. 20-22
Email: sales@erweka.com
63150 Heusenstamm
Tel.:
+49 6104 6903-0
Germany
Fax:
+49 6104 6903-40
warranty and subject to change any time without further notice. v.1.0.6.15
Dissolution Tester DT 720 Series Dissolution Tester USP Apparatus 1, 2, 5 and 6
DT 720 Highlights: ■■ Dissolution tester with 6, 7 or 8 test stations. ■■ Can be operated either in High-Head or Low-Head position of the drive heads. ■■ In Low-Head mode the vessels are sealed to offer the lowest possible evaporation with V-shaped vessel covers. ■■ Easy and fast lifting of the drive head by manual lifter with gas strut support. ■■ 3 different locking positions for High-Head, Low-Head or cleaning position of test head. ■■ Drop magazines operated manually, simultaneously or staggered.
One-piece moulded PET water bath with outlet valve
■■ Superior one-piece moulded water bath made of PET, non-leaking, easy to clean with outlet valve. ■■ Easy programming using symbol keypad. ■■ External flow-through heater to reduce influence of vibrations. ■■ Optimal access to vessels and bath for easy cleaning. ■■ USP compliant sample withdrawal. ■■ Non-corrosive design using plastics, alloys and fluoropolymers.
Easy to clean without moving the bath
USP Apparatus 1,2,5,6
It combines state-of-the-art technology with excellent and userfriendly design. The High-Head and Low-Head operating modes offer highest flexibility. The tester can be used as a stand-alone tester as well as a dissolution system equipped with an automated sampling station and operated via the ERWEKA Disso.net software.
Dissolution
The ERWEKA dissolution tester DT 720 series has been designed in accordance with USP/EP/JP requirements for testing tablet and other dosage forms.
DT 720 Series Specifications Dissolution tester for USP methods 1 (basket), 2 (paddle), 5 (paddle- over- disk) and 6 (rotating cylinder) with 6, 7 or 8 test stations (726, 727, 728) 100% USP/EP/JP compliant Fulfills all specifications in accordance with FDA “Mechanical Calibration” LE display for each test parameter with up/down buttons Evaporation less than 1% (50 rpm / 1000 ml / 37 °C / 24 h) Lifter column with gas strut support for effortless lifting and lowering of the drive head Automatic vessel centring via centring rings External high-power heater, heating range: 30 - 40 °C, even distribution of temperature Wobble less than 0.2 mm (paddles) Standard manual tablet drop magazine for 8 samples Height adjustment feet for quick levelling
Options üü External PT 100 temperature sensor for water bath or media temperature display üü Automatic tablet drop with control of temperature tolerance (USP) üü USB-A printer interface for documentation of test run parameters (time, date, rpm, temperatures etc.) üü Low evaporation vessel cover for High-Head operation üü External cooling device with autonomous operation üü Video monitoring/recording of dissolution test in time lapse mode üü Vessels 1000 ml, 2000 ml, glass or amber glass (UV protected), 250 ml mini glass vessels üü Paddles, baskets, discs for paddle-over-disc, rotating cylinders, enhancer cell, intrinsic dissolution, felodipine baskets, suppository baskets, extraction cell üü Dissolution qualification tool kit üü Upgrade to work as online dissolution system üü USP compliant automated sampling station with automatic height adjustment of sampling points üü IQ/OQ/PV documents, IQ/OQ/PV service üü Maintenance service
RS 232 interface for PC connection, USB-B interface for firmware updates Dimensions: 830 mm (width incl. heater) / 640 mm (depth) / 940 mm (height) / 47 kg (weight)
DT 728 in Low-Head mode to minimise evaporation
Effortless lifting and lowering of the drive head with gas strut support Membrane sealed sampling - manual or automated with added sampling station Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 6104 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Dissolution Tester DT 820 Series
Dissolution Tester USP Apparatus 1, 2, 5 and 6
line sampling system. It allows storage of up to 60 product test-run parameters. The DT 820 series can be equipped with 6, 7 or 8 test stations and
The DT 820 Series Highlights: ■ Three locking positions for High-Head, Low-Head and cleaning position o er highest flexibility ■ Easy and fast handling of the drive head height by manual lifter with gas strut support ■ Easy programming by alpha-numeric touch-sensitive foil keypad ■ Integrated system suitability test menu with documentation print out of temperature and rotational speed ■ Automatic self-check of the temperature in the bath/ vessel before test start ■ External high power flow through heater with no vibration to the dissolution tester
Easy to clean one-piece moulded water bath with outlet valve
■ Pre-heating function, programmable for each weekday ■ Calibration routine for temperature sensor and heater ■ Quick exchange of stirring methods using same shafts ■ One-piece moulded non-leaking PET water bath with outlet valve ■ Non-corrosive construction (plastics, alloys, fluoropolymers) ■ pH change routines, menu guided ■ Print out of documentation ■ User management, password protected ■ Optimal vessel access and easy cleaning ■ Independent external PT 100 temperature sensor
The DT 820 series comes with built-in intelligence like large memory and system suitability tests
USP Apparatus 1,2,5,6
The water bath is designed for easy access and cleaning and is made of non-leaking PET.
Dissolution
temperature sensor for checking the water bath.
DT 820 Series Specifications Dissolution tester for USP methods 1 (Basket), 2 (Paddle), 5 (Paddle over Disk) and 6 (Rotating Cylinder) with 6, 7 or 8 test stations (826, 827, 828) 100% USP/EP/JP compliant Fulfils all specifications in accordance with FDA “Mechanical Calibration” Evaporation less than 1% during 24 h (37 °C / 50 rpm / 1000 ml) USB-A printer interface (for selected printers) Product memory for storage of up to 60 monographs Rotational speed 20-220 rpm ± 2 rpm Heating range: 30-50 °C (± 0,2 °C), cooling optional 5.7“ display, alpha-numeric touch-sensitive foil keypad
Options
Automatic tablet drop magazine with control of temperature tolerance (USP) before drop USP compliant sampling station with automatic height adjustment of the USP sampling points Illumination of bath (white LEDs) for better visibility of the samples External cooling device with independent operation Upgrade for control of o ine sampling dissolution system O ine components (pump, fraction collector) Video monitoring and recording Clear or amber glass vessels, various sizes Paddles, baskets, disks, rotating cylinders, enhancer cell, intrinsic dissolution, felodipine baskets, suppository baskets, extraction cell Dissolution qualification tool kit IQ/OQ/PV documents IQ/OQ/PV service Maintenance service
OQ traffic light for display of USP / EP compliance of the unit Acoustic and optic reminder of manual sampling (29 intervals) Dimensions: 830 mm (width incl. heater) / 640 mm (depth) / 940 mm (height) / 47 kg (weight)
Electronic temperature sensor for permanent check of bath temparature
Technical specifications of products described are stated without warranty and subject to change any time without futher notice.
The DT 828 with optional automated sampling station controls offline system
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Dissolution Tester DT 1410 Series Dissolution Tester USP Apparatus 1, 2, 5 and 6 The DT 1410 Series is based on the DT 720 and can be configured for 12, 13 or 14 test stations arranged in 2 rows.
DT 1410 Series Highlights: ■ Dissolution tester with 12,13 or 14 test stations ■ 3 different locking positions for High-Head, Low-Head and cleaning position of test head ■ Low-Head mode for quick and convenient closing of the vessel ■ High-Head mode for maximum access to each vessel ■ Optimized cover design for lowest evaporation ■ Easy and fast lifting of the drive head by manual lifter with gas strut support ■ 3 different locking positions for High-Head, Low-Head and cleaning position of test head
Easy to clean acrylic water bath with outlet valve
■ Drop magazines operated manually allows simultaneous or staggered drop of the tablets ■ Easy to clean water bath with outlet valve ■ Easy programming using symbol keypad ■ External, independent flow-through heater ■ Calibration routine for temperature sensor and heater ■ Optimal access to vessels and bath for easy cleaning
Low-Head, High-Head and cleaning positions possible
USP Apparatus 1,2,5,6
The DT 1410 series are made with high throughput in mind. Due to the configuration the unit offers to run 2 different batches of the same product or 2 different products with the same dissolution parameters at the same time.
Dissolution
It offers the possibility for one test with 12 / 13 / 14 tablets or two tests with 6/7 tablets. The advantage is that two USP tests can be carried out with one bath at equal test conditions. Various vessel capacities (400 ml, 1000 ml, 2000 ml) are available as well as High-Head or LowHead design are available.
DT 1410 Series Specifications Dissolution tester for USP methods 1 (basket), 2 (paddle), 5 (paddle-over-disk) and 6 (rotating cylinder) with 12, 13 or 14 test stations (DT 1412, DT 1413, DT 1414) 100% USP/EP/JP compliant Fulfills all specifications in accordance with FDA “Mechanical Calibration” LE display for each test parameter with up/down buttons Evaporation less than 1% (50 rpm / 1000 ml / 37 °C / 24 h) Lifter column with gas strut support for effortless lifting and lowering of the drive head Automatic vessel centring via centring rings External, independent high-power heater, heating range: 30 - 50 °C, even distribution of temperature Wobble less than 0.5 mm (paddles) Standard manual tablet drop magazine for max. 14 samples Height adjustment stand for quick levelling
Options + External PT 100 temperature sensor for water bath or media temperature display + Automatic tablet drop magazine with temperature check (according USP) before drop + USB-A printer interface for documentation of test run parameters (time, date, rpm, temperatures etc.) + Low evaporation vessel cover for High-Head operation + Vessels 1000 ml, 2000 ml, glass or amber glass (UV protected), 400 ml glass vessels + Paddles, baskets, discs for paddle-over-disk, rotating cylinders, enhancer cell, intrinsic dissolution, felodipine baskets, suppository baskets, extraction cell, USP “japanese sinker“ + Dissolution qualification tool kit for mechanical calibration according FDA + Upgrade to work as online dissolution system + USP compliant automated sampling station with automatic height adjustment according method and volume + USB printer interface + IQ/OQ/PV documents, IQ/OQ/PV service + Maintenance service
RS 232 interface for PC connection, USB-B interface for firmware updates
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 6104 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Dissolution Tester DT 1610 Series
Dissolution Tester USP Apparatus 1, 2, 5 and 6
The DT 1610 Series Highlights: ■ 3 different locking positions for High-Head, LowHead and cleaning position of test head ■ Low-Head mode for quick and convenient closing of the vessel ■ High-Head mode for maximum access to each vessel ■ Optimized cover design for lowest evaporation ■ Easy and fast lifting of the drive head by manual lifter with gas strut support ■ Easy programming by alpha-numeric touch-sensitive foil keypad ■ Integrated system suitability test with documentation print out of temperature and rotational speed ■ Automatic check of the temperature in the bath / vessel before test start
Easy to clean acrylic water bath with outlet valve
■ ■ ■ ■ ■ ■ ■ ■ ■
External, independent flow-through heater Pre-heating function, programmable for each weekday Calibration routine for temperature sensor and heater Quick exchange of stirring methods using same shafts pH change routines, menu guided Print out of test protocol User management, password protected Optimal vessel access and easy cleaning Independent external PT 100 temperature sensor
The DT 1610 Series comes with built-in intelligence for system control
USP Apparatus 1,2,5,6
It offers an OQ traffic light to show USP/EP compliance as well as an external temperature sensor for checking the water bath. The water bath is designed for easy access and cleaning. Due to the configuration the unit offers to run 2 different batches of the same product or 2 different products with the same dissolution parameters at the same time.
Dissolution
The ERWEKA DT 1610 Series offers advanced intelligence and features for stand-alone operation or control of complete dissolution offline systems. It allows storage of up to 60 product test-run parameters. The DT 1610 series is based on the DT 820 Series and can be equipped with 12, 13 or 14 test-stations arranged in 2 rows. It can be operated in High-Head and Low-Head mode.
DT 1610 Series Options Dissolution tester for USP methods 1 (Basket), 2 (Paddle), 5 (Paddle over Disk) and 6 (Rotating Cylinder) with 6, 7 or 8 test stations (DT 1612, DT 1613, DT 1614) 100% USP/EP/JP compliant nical Calibration” 5.7“ display, alpha-numeric touch-sensitive foil keypad Evaporation less than 1% (50 rpm / 1000 ml / 37 °C / 24 h) Lifter column with gas strut support for effortless lifting and lowering of the drive head USB-A printer converter parallel - USB
+ Automatic tablet drop magazine with temperature check (according USP) before drop + USP compliant sampling station with automatic height adjustment of the USP sampling points + Upgrade for control of offline sampling dissolution system + Offline components (pump, sample collector) + Vessels 1000 ml, 2000 ml, glass or amber glass (UV protected), 400 ml glass vessels + Paddles, baskets, discs for paddle-over-disk, rotating cylinders, enhancer cell, intrinsic dissolution, felodipine baskets, suppository baskets, extraction cell, USP “japanese sinker“ + Dissolution qualification tool kit for mechanical calibration according FDA + IQ/OQ/PV documents, IQ/OQ/PV service + Maintenance service
Product memory for storage of up to 60 methods Rotational speed 20-220 rpm ± 4 % External, independent high-power heater, heating range: 30 - 50 °C, even distribution of temperature Wobble less than 0.5 mm (paddles) Standard manual tablet drop magazine for max. 14 samples
unit Acoustic and optic reminder of manual sampling (29 intervals) RS 232 interface for PC connection
Technical specifications of products described are stated without warranty and subject to change any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Dissolution Offline System
Semi-automated Dissolution System USP Apparatus 1, 2, 5 and 6
The offline system is the combination of instruments for automatic dissolution sampling and fraction collection. The ERWEKA offline system are 100 % USP compliant. The basic configuration consists of a dissolution tester DT 828 (i-Version) with installed automatic sampling station, a peristaltic pump IPC 8 and a fraction collector FRL 824.
Another configuration is to connect a DT 161x via the IPC 16 to the sample collector FRL 624-2 / 724-2. Up to 14 samples can be withdrawn in parallel.
Dissolution
on system for high 840 and 10/25 ml tion of the sample sign.
Offline
The system is also also available availableas asaadilutidilutidossage testing with a syringe pump SP glass tubes which allow automated dilu-
in 1:1, 1:2, 1:5 or 1:10 relations or, in its high-end configuration, with the piston pump for almost maintenance free usage and filtration down to 0.22 μm for flat membrane filters.
Highlights Dissolution Highlights ■ Fully automated sampling ■ Integrated intelligence of DT 82x series for controlling the offline system without PC (i-version) ■ Automatic adjustment dependant on method ■ Optional measuring of temperature in each vessel ■ 100% USP compliant offline system ■ Easy to program ■ Automated tablet drop ■ Different permissions for each user possible ■ Sampling station with automatic USP height adjustment ■ Pre-heating function, programmable for each weekday ■ Cleaning of the complete system guided by the cleaning menu of the DT 820 dissolution tester
Sample Collector FRL Highlights ■ ■ ■ ■ ■ ■ ■ ■ ■ ■
Easy access to sample tubes Easy to clean Up to 26 rows for extended release formulation testing Integrated cleaning procedure Needles available in stainless steel or titanium for sensitive APIs, HPLC vials and glass tubes Special procedure for foaming medias handling Automated flush routine between sampling intervals Gentle and precise spindle drive of the sample collector FRL Movable trays provide easy exchange of different racks Different racks available for glass tubes or HPLC vials
Pump Highlights ■ IPC pump – reasonable price and easy to handle, innert material, 8 channel and 16 channels possible ■ SP syringe pump – high precision syringe pump for automated dilution of the sample in ratio up to 1:10 ■ PVP piston pump – for double filtration down to 0.22 μm for flat membrane filters, high precision, innert keramik material pump heads, almost maintenace free FRL sample collector can be equipped with different racks for different glass tubes or HPLC vials.
Recommended Configurations Standard Offline System with IPC Pump Standard configuration offline sample collector system with peristaltic pump, 6 to 8 channels depending on DT configuration. Media replacement only when no double filtration. Double filtration (option) possible when first filtration with Poroplast filters.
Dissolution Tester
Automatic Sampling Station
Peristaltic Pump
Sample Collector
DT 826 i-Version
ASS-8
IPC 8
FRL 624
DT 827 i-Version
ASS-8
IPC 8
FRL 724
DT 828 i-Version
ASS-8
IPC 8
FRL 824
Offline Diluting System with SP Syringe Pump Configuration for dilution and high dosage accuracy, for 6 or 8 channels only. Media replacement possible. No double filtration possible.
Dissolution Tester
Automatic Sampling Station
Syringe Pump
Sample Collector
DT 826 i-Version
ASS-8
SP 640
FRL 620
DT 828 i-Version
ASS-8
SP 840
FRL 820
High-End Offline System with PVP Piston Pump Configuration with piston pump is nearly maintenance free and allows filtration down to 0.22 Îźm for flat membrane filters, 6, 7 or 8 channels possible. Media replacement only when no double filtration. Double filtration (option) possible.
Dissolution Tester
Automatic Sampling Station
PIston Pump
Sample Collector
DT 826 i-Version
ASS-8
PVP 620
FRL 624
DT 827 i-Version
ASS-8
PVP 720
FRL 724
DT 828 i-Version
ASS-8
PVP 820
FRL 824
Recommended configurations DT 161x
Dissolution Tester
Automatic Sampling Station
Pump
Sample Collector
DT 1612 i-Version
ASS-14
IPC 16
FRL 624-2
DT 1614 i-Version
ASS-14
IPC 16
FRL 724-2
Technical Specifications Sample Collector FRL 624 / 724 / 824
System Control
Auto sample collector with 6 to 8 channels for sampling up to 26 intervals; 1 driven dosing arm with 8 stainless steel (optional Titanium) dosing tubes, RS 232 interface for external control by the ERWEKA dissolution tester (DT 82x i-version series)
DT 82x i-version dissolution testers are an upgraded version of the standard 82x series to control a complete offline system including ERWEKA sample transfer pump and sample collector FRL. Dilution
Sampling tubes and HPLC vials
Possible with syringe pump SP 640/840, ratios of 1:1, 1:2, 1:6´5, 1:10 (only with sample collector FRL 620/820).
26x 8 glass tubes of 12 ml capacity 18x 8 glass tubes of 25 ml capacity 26x 8 HPLC vials of 1.5 ml capacity 26x 8 HPLC vials of 4.0technology ml capacity in a modern deThe RoboDis II offers state-of-the-art See a video at www.erweka.com
Pump type
Peristaltic pump
Piston pump
Syringe pump
Pump
IPC 8 / 16
PVP 620 / 720 / 820
SP 640 / 840 25ml
Channels
8 or 16
6, 7 or 8
6 or 8
Valves
-
-
Accuracy
+/- 0.5ml
+/- 0,5 ml
+/- 0,2 ml
Dilution
-
-
(1:1, 1:2, 1:5, 1:10)
Media replacement
standard
standard
standard
Double filtration (option)
but only when first filtration
not possible
with Poroplast filters. No media replacement possible
No media replacement possible when double filtration
when double filtration. Required type of sample collector
FRL 624 / 724 / 824
FRL 624 / 724 / 824
FRL 620 / 820
System compatibility
DT Offline/ DT Online/ DT On-/Offline
DT Offline/ DT Online/ DT On-/ Offline
DT Offline
Advantage
■
Basic pump
■
possible with DT 14x/16x
■ ■
Filtration down to 0.22 μm for flat
■
Dilution possiible
membrane filters
■
High dosage accuracy
Low maintenance even at high throughput
■
Best choice for fully automated dissolution systems
Technical specifications for the products described are stated without warranty and subject to change at any time.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
When configuring an ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered seperately due to the vast variety of possible configurations.
Pump type
Peristaltic pump
Piston pump
Syringe pump
Pump
IPC 8 / 16
PVP 620 / 720 / 820
SP 640 / 840 25ml
Channels
8 or 16
6, 7 or 8
6 or 8
Valves
-
-
Accuracy
+/- 0.5ml
+/- 0,5 ml
+/- 0,2 ml
Dilution
-
-
(1:1, 1:2, 1:5, 1:10)
Media replacement
standard
standard
standard
Double filtration (option)
but only when first filtra-
not possible
tion with Poroplast filters. No
No media replacement possible
media replacement possible
when double filtration
Pumps
Dissolution
Dissolution Pumps Comparison Sheet
Important Note
when double filtration. Required type of sample collector
FRL 624 / 724 / 824
FRL 624 / 724 / 824
FRL 620 / 820
System compatibility
DT Offline/ DT Online/ DT
DT Offline/ DT Online/ DT On-/
DT Offline
On-/Offline
Offline
Advantage
■
Basic pump
■
possible with DT 14x/16x
■ ■
Filtration down to 0.22 μm for
■
Dilution possiible
flat membrane filters
■
High dosage accuracy
Low maintenance even at high throughput
■
Best choice for fully automated dissolution systems
1
Dissolution Offline Systems Configuration Chart
Important Note
Recommended configurations
Dissolution Tester
Automatic Sampling Station
Peristaltic Pump
Sample Collector
Article No. ( DT not included)
DT 826 i-Version
ASS-8
IPC 8
FRL 624
15-157-8624
DT 827 i-Version
ASS-8
IPC 8
FRL 724
15-157-8724
DT 828 i-Version
ASS-8
IPC 8
FRL 824
15-157-8824
Dissolution Tester
Automatic Sampling Station
Syringe Pump
Sample Collector
Article No. ( DT not included)
DT 826 i-Version
ASS-8
SP 640
FRL 620
15-158-8620
DT 828 i-Version
ASS-8
SP 840
FRL 820
15-158-8820
Standard configuration offline sample collector system with peristaltic pump, 6 to 8 channels depending on DT configuration. Media replacement only when no double filtration. Double filtration (option) possible when first filtration with Poroplast filters.
Offline
Standard Offline System with IPC
Dissolution
When configuring our ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered additionally due to the vast variety of configuration options. The i-Version upgrade for the DT 82x series is included in the system configuration.
Offline Diluting System with Syringe Pump SP Configuration for dilution and high dosage accuracy, for 6 or 8 channels only. Media replacement possible. No double filtration possible.
High-End Offline System with Piston Pump PVP Dissolution Tester
Sampling Station
Piston Pump
Sample Collector
Article No. ( DT not included)
DT 826 i-Version
ASS-8
PVP 620
FRL 624
15-159-8624
DT 827 i-Version
ASS-8
PVP 720
FRL 724
15-159-8724
DT 828 i-Version
ASS-8
PVP 820
FRL 824
15-159-8824
Configuration with piston pump is nearly maintenance free and allows filtration down to 0.22 Îźm for flat membrane filters, 6, 7 or 8 channels possible. Media replacement only when no double filtration. Double filtration (option) possible.
2
Important Note
Dissolution
Dissolution Offline System Configuration Chart
When configuring our ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered additionally due to the vast variety of configuration options. The i-Version upgrade for the DT 161x series is included in the system configuration.
Dissolution Tester
Sampling Station
Pump
Sample Collector
Article No. ( DT not included)
DT 1612 i-Version
ASS-14
IPC 16
FRL 624-2
16-x16-x624
DT 1614 i-Version
ASS-14
IPC 16
FRL 724-2
16-x16-x724
Offline
Recommended configurations DT 161x
3
Important Note hen configuring our ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered additionally due to the vast variety of configuration options.
Dissolution
Dissolution UV/VIS Online System Configuration Chart Recommended configurations
Standard Online System with UV/VIS Spectrophotometer Automatic Sampling Station
Peristaltic Pump
UV/VIS Spectrophotometer
DT 726 / 727 / 728
ASS-8
IPC 8
ERWKA SPM (Perkin Elmer Lambda 25 OEM) or Shimadzu 1800
PC + Disso. net software
ďƒź
Article No. ( DT not included)
UV/VIS Online
Dissolution Tester
72-203-2031 72-203-2033 72-203-2034
or Agilent 8453
DT 728 incl. auto sampling station ASS 8 + IPC 8 pump + ERWEKA SPM spectrophotometer + PC + Disso.net software
DT 1412 Online System with UV/VIS Spectrophotometer 12 channels Dissolution Tester
Automatic Sampling Station
Peristaltic Pump
UV/VIS Spectrophotometer
DT 1412
ASS-14
IPC 16
ERWEKA SPM-16 (special cuvettes needed) or Analytic Jena Specord 210/16 + 2 x Cuvette
PC + Disso.net software
ďƒź
Article No. ( DT not included)
72-x16-x412 72-x16-x512
changer
DT 1412 (Foto shows DT 1414) incl. auto sampling station ASS-14 + IPC 16 pump + ERWEKA SPM-16 spectrophotometer + PC + Disso.net software
4
Dissolution UV/VIS On-/Offline System = Dissolution system with UV/VIS online analysis plus sample collector for reference samples or later HPLC analysis
Dissolution UV/VIS On-/Offline System Configuration Chart
Dissolution
Important Note hen configuring our ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered additionally due to the vast variety of configuration options.
Recommended configurations Automatic Sampling Station
Peristaltic Pump
UV/VIS Spectrophotometer
Sample Collector
DT 726 (DT
ASS-8
IPC 8
ERWEKA SPM (Perkin Elmer Lambda
FRL 624
PC + Disso.net software
ďƒź
Article No. ( DT not included)
77-xx8-7624
727/728 pos-
25 OEM)
sible)
or Shimadzu 1800
77-xx8-7626
or Agilent 8453
77-xx8-7627
Dissolution Tester
Automatic Sampling Station
PeristalticPump
UV/VIS Spectrophotometer
Sample Collector
DT 1412
ASS-14
IPC 16
ERWEKA SPM 16 (special cuvettes
FRL 624-2
needed) or Analytic Jena Specord 210/16 + 2 x
PC + Disso.net software
ďƒź
UV/VIS On-/Offline
Dissolution Tester
Article No. ( DT not included)
77-x16-x624 77-x16-x626
cuvette changer
DT 728 incl. auto sampling station ASS 8 + IPC 8 pump + ERWEKA SPM spectrophotometer + FRL 624 sample collector+ PC + Disso.net software
DT 1412 incl. auto sampling station ASS 8 + IPC 8 pump + ERWEKA SPM spectrophotometer + FRL 624 sample collector+ PC + Disso.net software
5
Important Note
Dissolution HPLC On-/Offline System Configuration Chart
hen configuring our ERWEKA dissolution systems, the dissolution tester DT has to be configured first and ordered additionally due to the vast variety of configuration options.
Dissolution
HPLC analysis only with 6 or 2 x 6 channels possible.
Recommended configurations Automatic Sampling Station
Peristaltic Pump
Sample Collector
HPLC
PC + Disso.net software
DT 726 / 727 / 728
ASS-8
IPC 8
CTC sampler
For connection to 1 HPLC system (not included)
2 x DT 726/ 727/ 728
2 x ASS-8
2 x IPC 8
CTC sampler for
For connection to 1 HPLC
dual system with 2
system (not included)
Article No. ( DT not included)
ďƒź
72-230-0001
ďƒź
72-232-0001
HPLC On-/Offline
Dissolution Tester
PEEK blocks
DT 728 + HPLC On-/Offline System configuration
2 x DT 728 + HPLC On-/Offline System configuration for dual system
6
USP 4 Flow-Through Cell Systems
USP 4 Stand-Alone System
The Flow-Through-Cell Features DFZ 720 The ERWEKA Flow-Through cell dissolution tester is developed for products which require long term tests (i.e. implants) and / or need a high amount of media due to low solubilty. In configuration as a closed system the Flow-Through cell enables dissolution tests with a low amount of media in order to achieve the necessary testing environment as internationally required. Due to the possibility for easy pH changes, the Flow-Through cell is the perfect unit for IV/ IVC testing. It is controlled by a PC with the Disso.net USP 4 dissolution software.
Main System Components DFZ 720 Flow-Through cell DFZ 720 HKP 720 Pump PC with Disso.net USP 4 Software
Features DH 2000i Heater
Features HKP 720 Pump
100% USP conform valve-free piston pump Automatic setting of different flow rates 2 - 32 ml / min 7-channels High accuracy ≤ 5% Pump heads made of inert ceramic material
USP 4 Flow-Through Cell
Flow-Through cell with 7 test stations Each cell is equipped with an individual open/closing head with filters Heating of the cell by double-jacket holder Heating of the dissolution media by internal spiral made of stainless steel Support plate and cell holder made of chemical resistant material Integrated blockage controller Individual cellhead of the cells with independant closing mechanism Small footprint Controlled by Disso.net PC-Software Easy cleaning of water bath
Temperature measurement in each cell
1500 W flow-through-heater Low vibrations 2 independant temperature sensors
7x3-way-valve for individual control of each cell
Piston pump
DFZ 720
-
-
HKP 720
DFZ 720
PT 100
-
HKP 720
DFZ 720R (in-line version)
-
HKP 720
DFZ 720R (in-line version)
PT 100
HKP 720
Disso.net USP 4
Full dissolution software solution for Flow-Through-Cell
Disso.net helps you with standard USP 4 dissolution jobs, handles qualifying tasks and provides control over each single function and connected device (e.g. connected pump, Flow-Through cell, sample collector and/or UV/VIS spectrophotometer). Our audit trail generates a detailed protocol recording all events and time. The software includes an easy to handle method editor for highest safety in GMP
General Features Support for computer based ERWEKA Flow-Through structure
placement of the formulation Easy approach from top to bottom MS SQL database with local or network installation Global management of user, methods, reports, etc. Reliable backup and restore functions
senior operator, administrator) and single permissions Language support for English, German Multiple System Suitability Tests for highest reliability
Handling of the system with multitasking JobController Fully documented according to 21 CFR 820 Full audit trail according to 21 CFR Part 11 including date, time stamp, user ID GMP conform data correction with automatic rebatch of results before publishing (paperless lab) Report generation with custom logo Compact analytical report (default report with all relevant data) Method data Calibration data Raw data
USP 4 Software
support of all USP / EP dissolution cells used in our USP 4 systems. It also supports cells for special applications (e.g. dialyse cell) and visual guides for formulation placing in the respective cells.
Dissolution
The ERWEKA Disso.net software is the perfect 21 CFR Part 11
USP 4 Open Offline System
Infinite media testing and sample collection with the ERWEKA Open Offline Flow-Through System The Open System is the perfect solution for tests which require an unlimited supply of fresh media, e.g. low sulable drug substance. The sample collector FRL collects the complete or representative sample over a certain time for storage and later analysis. Due to integrated 3-way valves the system can automatically split for waste and sampling purposes.
Main System Components ■ ■ ■ ■
Flow-Through cell DFZ 720 + heater HKP 720 piston pump Sample Collector FRL 724 PC with Disso.net USP 4 Software
Features Piston Pump HKP 720
100% USP conform valve-free piston pump Automatic setting of different flow rates 2 - 32 ml / min. 7-channels High accuracy ≤ 5% Pump heads made of inert ceramic material
Features Sample Collector FRL 724 Up to 26 rows for extended release formulation testing Needles available in stainless steel or titanium for sensitive APIs Glass tubes (25 ml)
Features Automated Open Flow-Through System Handling of unlimited media for testing of low sulable drug substances Fully USP compliant Automated sampling collection Sampling of complete fractions into glass vials Sampling of representative fractions by splitting into waste and glass tubes
Features Flow-Through-Cell DFZ 720 Flow-Through cell with 7 test stations Each cell is equipped with an individual open/closing head with filters Heating of the cell by double-jacket holder Heating of the dissolution media by internal spiral made of stainless steel Support plate and cell holder made of chemical resistant material Integrated blockage controller Small footprint Controlled by Disso.net USP 4 Easy cleaning of water bath
Recommended configurations Optional Temperature Measurement PT 100
7x3-wayvalve for individual control of each cell
DFZ 720
-
-
HKP 720
FRL 724
PC with Disso.net USP 4
DFZ 720
-
HKP 720
FRL 724
PC with Disso.net USP 4
-
HKP 720
FRL 724
PC with Disso.net USP 4
HKP 720
FRL 724
PC with Disso.net
DFZ 720R in-line system DFZ 720R
Optional VS 480 media changer
Sample collector
System control
USP 4
USP 4 Open Offline
in-line system
Pump
Dissolution
USP 4 FlowThrough Cell
The DFZ 720R is used in combination with the 7x3-way-valve for individual control of each cell.
USP 4 Closed Offline System
Extensive long term testing with the independent Closed Flow-Through System The Closed System is the perfect solution for tests which requires low media volume for long term dissolution tests and / or to increase sensitivity of the analytical method, e.g. implants.
Main System Components ■ ■ ■ ■ ■ ■
DFZ 720 Flow-Through cell + heater HKP 720 piston pump Sample Collector FRL 724 Peristaltic pump IPC 8 or syring pump SP LMT 720 closed-loop unit PC with Disso.net USP 4 Software
Features Closed-Loop Unit LMT 7 flat-bottomed 1000 ml vessels Vessels placed in a thermostatically heated water bath Continuous media stirring by magnetic stirrers
Features Closed Flow-Through System Specific amount of minimum 2 ml to maximum 32 ml of media is pumped through the cell continually Media transfer station LMT with 7x 1000 ml vessels Fully USP compliant IPC 8 peristaltic pump or syringe pump SP for automated sampling Fraction collection with 3-way valves Long duration test runs with optimized media evaporation Media replacement possible
Features FRL 724 Easy access to sample tubes Easy to clean Up to 26 rows for extended release formulation testing Integrated cleaning procedure Needles available in stainless steel or titanium for sensitive APIs Glass tubes (25 ml) Automated flush routine between sampling intervals Gentle and precise spindle drive Movable trays provide easy exchange of different racks
Optional Temperature Measurement PT 100
Optional 7x3-way-valve for individual control of each cell
Pump
LMT unit
Sample collector
Pump for FRL
System control
DFZ 720
-
-
HKP 720
LMT
FRL 724
IPC 8
PC with Disso.net USP 4
DFZ 720
-
HKP 720
LMT
FRL 724
IPC 8
PC with Disso.net USP 4
DFZ 720R in-line system
HKP 720
LMT
FRL 724
IPC 8
PC with Disso.net USP 4
DFZ 720R in-line system
-
HKP 720
LMT
FRL 724
IPC 8
PC with Disso.net USP 4
The new USP4 version of our advanced Disso.NET software allows comfortable and easy use of our USP 4 systems.
USP 4 Closed Offline
USP 4 FlowThrough Cell
Dissolution
Recommended configurations
Flow-Through-Cells USP 4 Different cells for different purposes Accompanying our Flow-Through-Systems, we offer several different cells for different purposes – from the standard tablet cell to granulate & powder cells to cells for implants, suppositories and stents.
Tablet cell 12.00 mm
Tablet cell 22.6 mm
Granulate & Powder Cell
Implant cell
Tablet cell 22.6mm with dialiysis adapter
Tablet cell 22.6 mm with creme cell adapter
Tablet cell 22.6 mm with glass beads
Tablet cell 22.06 mm with glass beads
Suppository cell
Tablet holders type A 22,6 mm and type B 12mm
Technical specifications of products described are stated without warranty and subject to change any time without futher notice. V. 1.0.11.14.
ERWEKA GmbH sales@erweka.com +49 6104 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Stent cell
MediPrep 820 Series
Media Preparation
The MediPrep 820 series offers quick and easy preparation of up to 8 liters dissolution media in less than 15 minutes. In a single pass the media for dissolution tests can be precisely mixed, heated, degassed and filled gravimetrically into vessels. Foaming media like SDS (Sodium Dodecyl Sulfate) can also be used.
The MediPrep 820 offers one inlet for premixed media and one outlet for waste. The MediPrep 821 and 822 offer additional inlets for concentrates or premixed media. To prevent cross contamination an automated cleaning procedure is integrated.
The MediPrep 820 Highlights: ■■ Quick preparation and filling of up to 8 liter dissolution media conform with USP, EP in less than 15 minutes ■■ Documentation of the results according GLP/GMP ■■ Handling of up to 6 liters foaming media (tensides like SDS, max. 1% solution) ■■ Use of media concentrates mix ratio 1:9 to 1:1 with mixing accuracy ≤1% (only MediPrep 821 and 822) ■■ Gravimetric filling taking into account the media density ■■ Complete documentation of preparation and dosing volume including identification via batch ID
Filling with dosing hand directly into vessel
■■ Easy adjustment and calibration of all instrument parameters (temperature, pressure, volume) ■■ Optional printer for documentation ■■ Integrated automatic cleaning procedure of container and tubing ■■ Easy to use color touch panel and user guidance via menu and icons ■■ Memory capacity for 20 user profiles with three different access level ■■ Memory for 100 media preparation methods
Quick documentation via mobile thermal printer
Dissolution
Filling can be done at the integrated dosing port or with the optional remote filling hand directly into to dissolution tester’s vessels.
MediPrep 820 Series Optional dosing hand for remote filling
Specifications Product
MediPrep 820 / 821 / 822
Functions
Mixing, vacuum degassing, heating, gravimetric dosing
US Pharmacopeia conformance
ü
Inlet for premixed media
1 premixed media or DI-water for dilution of concentrates
Outlet for cleaning water
ü
Number of inlets for concentrates or premixed media
0/ 1/ 2
Remote dosing hand
Optional
Control
Touch panel 7“
Physiological media pH 1-12, at min. 2l
ü
Time needed for media preparation of 8l
≤ 15 min (dependent on degassing time)
Mixing accuracy
≤ 1% with a concentrate to water ratio 1:9 to 1:1 (only 821 and 822)
Handling of foaming media (SDS)
Max. 1% solution at max. 6 l
Dosing volume, accuracy
250 - 1000 ml , max. 1%
Weighing accuracy
≤ 0.1% at 2 kg
Heating temperature, accuracy
Max. 50° C, ± 0,5° C
Degassing pressure, accuracy
≤ 200 mbar, ± 2 mbar
Product memory
Max. 100
User memory
Max. 20 users, password-protected access
Interfaces
USB-A for specified printers, USB-B for firmware update
Dimensions (height x width x depth)
635 x 345 x 650 mm
Weight
35 kg
Power supply, safety fuses
115 or 230 50/60Hz, 2x16A
Power consumption
Max. 2000 Watt
Options üü MediPrep 821, as 820 with one additional inlet for concentrate/prepared media üü MediPrep 822, as 820 with two additional inlets for concentrates/prepared media üü Remote dosing hand for direct filling into dissolution tester üü Pressure reducing valve for direct connection of DI-water if > 5 bar üü MT 50l (50 l volume net) storage container for media
Technical specifications for the products described are stated without warranty and subject to change at any time without futher notice.
üü üü üü üü üü üü üü üü
MT 100l (100 l volume net) storage container for media Rack for 3 vessels Residual oxygen measuring device Calibration weights (2.0 kg,10.0 kg IQ/OQ documents Digital thermometer, certified Digital manometer, certified Pinters
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
RRT 10 BioDis USP Apparatus 3 and 7
The ERWEKA RRT10 is the perfect unit for multiple media pH changes for IV/IVC testing. It complies with USP apparatus 3 and screen procedure.
Highlights ■ Automated multiple pH-change e.g. for IV/IVC testing ■ Portable touchscreen with an easy-to-use, fully optimized operating system ■ Simple switch from USP apparatus 3 to USP appar■ Easy testing of enteric coated formulation testing ■ 50 ml, 100 ml, 300 ml, 1 l ■ Two reference positions for each row ■ Quick coupling for fast exchange of sample tools ■ Reduced evaporation losses due to automated covering system
Touch screen control
■ mesh screens ■ Water bath with 6 mm clear acrylic glass and outlet valve for easy cleaning ■ Formulation holder made of innert material e.g. 316 stainless steel, Fluoropolymer coated ■ USP 3 Cylinders automatically centred inside the vessels ■ PT 100 temperature sensor for checking temperature ■ USB printer and LAN interface
Formulation holder made of 316 stainless steel
USP 3 & USP 7
The ERWEKA RRT 10 BioDis is available with 6, 7* or 8 rows of vessels, 6 (or 7*) test stations and 2 reference positions. It sels. The acrylic glass water bath, which is equipped with an outlet valve for easy and convenient cleaning is heated duce evaporation, the RRT 10 comes with an automated covering system.
Dissolution
The unit is handled by a mobile touchscreen with an easy-to-use operating system, allowing operation of the the RRT 10 directly without the need of an external computer.
RRT 10 BioDis Test stations
6 rows with 6 stations (standard configuration) and 2 vials for reference purposes
Water bath
Water bath of 30 litres volume, 6 mm clear acrylic glass
Thermostat
Heating rate 1500w, 30째 C - 50째 C, accuracy +/- 0.2째 C
Temperature control
External PT 100 temperature sensor
Test vessels
300 ml USP-compliant cylindrical flat bottomed glass vessels (standard configuration)
Test cylinders (USP method 3)
USP-compliant glass reciprocating cylinders fitted with mesh screens (automated centring inside the vessel)
Formulation Holder (USP method 7)
Whole range of USP-compliant holders for non-eroding formulations made of stainless steel or polytetrafluoroethylene
Speed
Speed adjustable from 5 - 40 strokes/min., accuracy better than +/- 5%
Height of stroke
100 mm (USP method 3) 20 mm (USP method 7)
Evaporation
Vessels protected by automated covering system
Control of the unit
Operation by color-touchscreen, password protected access to firmware with OQ functions and product memory
Options + Option for USP 3/7 changable by user (no tools required) + 1000 ml conversion kit (4x 3 1000 ml vessel, adaptor for rack, 12x evaporation cover and 12 adaptors for vessel) for USP 3/7 + 100 ml conversion kit USP 7 + 50 ml conversion kit USP 7 + 7th row + 7th & 8th row + 6 stations (+2 reference stations) arranged in 7 or 8 rows + 7 stations arranged in 6, 7 or 8 rows + Various formulation holders + Cylindrical transdermal holders + IQ/OQ documents
* = optional
Technical specifications for described products stated without warranty and subject to change at any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Dissolution System RoboDis II Fully automated dissolution system
The RoboDis II is a 100% USP/EP compliant dissolution system for fully automated dissolution testing of up to 10 batches with USP method 1 (basket) or 2 (paddle).
RoboDis II Highlights: ■■ ■■ ■■ ■■ ■■ ■■ ■■ ■■ ■■
Fully automated dissolution testing for up to 10 batches USP method 1 and 2 – basket and paddle 100% USP/EP/JP compliant pH change in accordance with USP method A (half change), pH measuring in each vessel Parallel sampling approach Handling of Japanese sinkers Handling of up to 6 different media (concentrates and /or ready prepared) independently controlled by load cell Vacuum degassing of the pre-heated dissolution media in accordance with USP Filters precisely fitted by robot hand
■■ ■■ ■■ ■■ ■■
Filtration with flat membrane filtres (≥ 0,22 µm) supported Several analytical methods supported Support of several photometers and HPLC-systems Sampling time points independent of HPLC runtime Integrated system suitability tests for filling procedure, analytical method, system cleaning and test parameters (e.g. rotation speed, temperature) ■■ Video monitoring in time-lapse mode with overlaid real time dissolution curve ■■ Flexible bidirectional connection to various IT systems integrated
Analytical Methods: ■■ Fraction collection ■■ HPLC - online connection
■■ UV/VIS - online connection with flow-through cells ■■ Combination of all of the above
■■ Buffered HPLC – online connection
■■ Combined HPLC and UV/VIS online connection
Fully Automated
Integrated system suitability tests (SST) ensure reliability and easy control. Due to a parallel sampling approach, very short cycle times for measuring profiles can be realised.
Dissolution
The high-performance system is managed via the 21 CFR Part 11 compliant Disso.Net software. The software controls all functions including the precise robot arm movement as well as all analytical devices including data processing.
Dissolution System RoboDis II Tablet / Basket Storage ■■ Handling of up to 10 batches per robot start ■■ Containers/ baskets easily accessible at cabinet door ■■ No negative influences by temperature or humidity ■■ Handling of tablets, granulates, pellets ■■ Handling of USP Japanese sinkers supported
Medium Preparation and Supply ■■ Mobile tank for 120 litre media with optional stirrer ■■ Up to 6 (SUPAC) different media, media concentrates per start supported ■■ Preheating and vacuum degassing in accordance with USP ■■ Filling with precise piston pump, gravimetric controlled ■■ Parallel preparation of the next media during run ■■ Handling of foaming media supported
Easy placement of tablet containers in cabinet door
Precise basket mounting
Automatic media preparaton
Up to six different calibration standards
Filling hand
Handling of Japanese sinkers, parallel tablet drop
Tablet Handling (Paddle) ■■ Tablet transfer and parallel tablet drop by robot hand. ■■ Handling of Japanese sinkers ■■ High accuracy and reliability ■■ Pellets and granulates can be handled Tablet Handling (Basket) ■■ Basket mounted by robot hand ■■ Handling in accordance with USP/ EP and FDA Mechanical Calibration ■■ Used baskets are dropped into a container
Sampling System Basic ■■ USP compliant sampling station with 1 µm or 10 µm Poroplast inline filters ■■ Temperature measuring in each vessel ■■ Parallel sampling with peristaltic pump IPC 8 ■■ Closed loop system, no withdrawal of sample
Sampling System Advanced ■■ USP compliant sampling station with 1 µm or 10 µm Poroplast inline filters (pre filtration) ■■ Second filtration with 0.22µm, 0.45µm membrane filters with automatic filter changer AFC 825 ■■ Valve-free ceramic piston pump PVP 820 pH change ■■ pH change in accordance with method A (half change) ■■ Handling of the pH sensor by robot arm ■■ Automatic measuring of the pH value in one or each vessel ■■ Documentation of all data obtained including calibration of the pH meter UV/VIS online connection
pH change in accordance with USP method A (half change)
Vessel cleaning
Video recording
Automatic Cleaning ■■ Parallel cleaning performed automatically ■■ Number of cleaning steps can be chosen ■■ Result of the cleaning process is checked (SST) ■■ Contaminated media can be separated ■■ Integrated water stop
Video Recording in Time-Lapse Mode ■■ Video recording of the dissolution process in time-lapse mode ■■ Up to 6 cameras supported ■■ Overlapping real-time dissolution curve ■■ Support for formulation and dissolution method development
System Control ■■ 21 CFR Part 11 compliant Microsoft Windows based Disso. Net software package ■■ Interactive communication between RoboDis II and analytical method ■■ User defined reports via “Crystal Reports” ■■ Online control of rpm and temperature ■■ Bidirectional LIMS interface via XML ■■ Windows XP, Windows 7 and 8 compatible
The Disso.net software controls the system and transfers data
Chewing Gum Testing DRT Test equipment to masticate chewing gums, especially medicated ones, for the in vitro release of substances from the samples into a surrounding liquid medium. Up and down strokes (vertical) of the lower jaw in combination with a revolving movement of the upper jaw which provides mastication of the chewing gum and at the same time an agitation of the test medium.
As the DRT offers a modular design, any number of chewing gum can be testet at the same time, with the DRT-6 with 6 test stations the most commonly used. The cells can be equiped with accessories for measuring the pressure of chewing gum, torque at shear force (twisting motion), pH, temperature, etc. All measurements are logged into a data logger and can be printed.
Technical Details
Upper Jaw
Chewing gum tester DRT with 1 to 6 test stations (DRT-1 to DRT-6)
Revolving according to the revolving device, no up and down movements and mounted on a heat insulated holder
Revolving device for upper jaw:
Can be easily removed for cleaning or changing (recommended after each test)
Pneumatic drive unit, compressed air 6-8 bar, compressed air to be supplied by customer
Distance of upper and lower jaw in closed position adjustable between 0-10 mm
The angle of the revolving movement can be adjusted between 10° – 180°
Acid proofed stainless steel with blasted surface for a better grip
Test cell
Lower Jaw
Double-walled and made of glass which allows visual inspection during the test
Lifting according to the device for up and down movements
Volume for dissolution medium 20-70 ml
No sliding of the sample during mastication due to the design of the jaw and due to separate nets between the jaws
Temperature controlled by a water circulation system
Metal in contact with lower jaw tempered by the circulated water
In- and outlet nozzle for the water circulation system, Test Cell can be easily removed for cleaning or changing
Acid proofed stainless steel with blasted surface for a better grip Can be easily removed for cleaning or changing General Device for movements: Vertical pneumatic cylinder, compressed air 6-8 bar, compressed air supplied by the customer Movement frequency adjustable between 20 - 60 cycles per minute Temperature controlled water bath can be regulated between 25 – 45 °C. One water bath for up to 6 test cells, volume 25 litres, made of PMMA acrylic glass. Electronic pump for continuous circulation of the heated water Mobile carrier for easy transport of the whole equipment. Two level carrier with rubber wheels. Made of aluminium Electronic control of each test cell individually Control of movement frequencies, operation time, temperature and warming up period, no product memory, parallel and serial interface available currently
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Chewing Gum Tester
For manual sampling, emptying and cleaning process the lower jaw with the test cell can be lowered into the down position and the chewing process stops. The test cell, the upper and lower jaw can be easily removed. The temperature of the water in the test cell is controlled by a water circulation system. The test apparatus is used to chew gum and then analyzes the speed at which various substances leave a gum (release). The apparatus is also very helpful to develop candy chewing gums. Also a few odd applications are possible such as testing of snuff bags etc. and in a special design, controlled mort development of tablets.
Disintegration Tester ZT 220 Series The ERWEKA ZT 220 series is available with 1, 2, 3 or 4 test stations, driven by one synchronic motor. Each test station is operated in a separate glass vessel, which are placed in the PET moulded bath with cover to minimize evaporation. The unit comes with an integrated high-quality flow-through heating system.
Features ZT 220 ■ Easy and comfortable control by big and bright LE display clearly visual from a distance ■ Easy cleaning guarantee by the fast removal of the onepiece molded PET water bath ■ Continuous heating of the water bath by flow-through heater ■ 100% USP/EP/JP compliant ■ Acoustic signal selectable Options
Technical Data
1 to 4 test racks 30 ± 1 strokes/min. 55 ± 2 mm stroke height Function keys and 2x LE display for entering nominal bath temperature and required run-time Starts/stops to counting run-time automatically when basket rack is lowered Integrated flow-through heating system (accuracy ± 0.2°C)
Basket rack assambly type A (6 test station) or type B (3 test station) 100% USP compliant
Temperature range 20 - 50°C
External electronic temperature sensor
Run time up to 99 h, 59 s ± 1
Media pre-heat and disintegration rack storage container located in the water-bath (ZT 221 and 223 only)
Manual lift-in and -out of the baskets
Quick-Clean-Basket (100% USP/EP/JP compliant) for fast cleaning of the test stations. Water stabiliser with colour indicator, 1 bottle for 2 fillings Immersion thermometer with or without certified version certificate USB-A printer interface Qualification documents IQ/OQ/PV ERWEKA IQ/OQ/PV service at customer site Maintenance service
Technical specifications for the products described are stated without warranty and subject to change at any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Disintegration Tester
The run-time counter starts automatically as soon as the basket rack assembly is lowered into the test media. Lift-in and lift-out of the baskets is performed manually while the elapsed time of testing is automatically started/stopped.
Disintegration Tester ZT 320 Series The ZT 320 series comes with 1, 2, 3 or 4 individually operated test stations controlled by a dedicated keypad per station for easy setting of the required run-time parameters as well as start/stop operation. In standard configuration each test station offers manual liftin and -out of the basket rack assembly on start and completion of the pre-set run time. An alarm reminder can be selected.
Features ZT 320 ■ Individual start and stop function for each test station without influencing the test run of the other test-stations ■ Continuous heating of the water bath by a flow-through heater ■ External temperature sensor ■ Easy cleaning guarantee by the fast removal of the onepiece molded PET water bath ■ Tool free assembly and disassembly ■ One -point calibration for internal heater ■ 100% USP/EP/JP compliant ■ Acoustic signal selectable Options Automated lift-in and -out of the basket rack assembly/ ies on start/completion of the pre-set run-time of each test station.
Technical Data 1 to 4 test racks (ZT 321 to 324) 30 ± 1 strokes/min. 55 ± 2 mm stroke height LE display/s to show remaining run-time and actual bath temperature. Integrated flow-through heating system (accuracy ± 0.2°C) Temperature range 20 - 50°C Run time up to 99 h, 59 s ± 1 Manual lift- in and -out of the basket RS 232 interface
Basket rack assembly type A (6 test tubes) or type B (3 test tubes) 100% USP compliant mBasket for automated measuring, type A (6 test tubes) or type B (3 test tubes) 100% USP compliant Media pre-heat and disintegration rack storage container located in the water-bath (ZT 321 and 323 only) Quick-Clean-Basket (100% USP/EP/JP compliant) for fast cleaning of the test stations. USB-A printer interface for documentation print out Water stabiliser with colour indicator Qualification documents IQ/OQ/PV ERWEKA IQ/OQ/PV service at customer site
The optional mBasket for automated testing uses a magnetic guided disc and sensors under the USP/EP compliant sieves.
Maintenance service Technical specifications for products described are stated without warranty and subject to change at any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Disintegration Tester
The ZT 320 can be upgraded to the ZTm 320 for automated measurement of the disintegration time. The ZTm 320 comprises of an automated lift in- and -out function, the automated mBasket (type A or B) with magnetic sensor at the bottom and guided discs (100% USP conform) to determine the exact disintegration time.
Introducing
ZT 720 Series
The new generation of automated disintegration testing
ZT 720 Series for automated disintegration testing The ERWEKA ZT 720 series automatically determines the disintegration time of each sample by use of a unique system of magnets and sensors. It also tests whether or not a sample completely disintegrates. ZT 720 is available with 1 (ZT 721) or 2 (ZT 722) individually driven test stations, equipped with an integrated flow through heater. Its temperature sensor PT 100 allows constant control of the waterbath temperature. The ZT 720 series is controlled through an innovative 7” touch screen and is capable of storing and retrieving up to 100 products/methods with results and parameters. Select the basket type for your individual need: Basket type A comes with 6 test tubes for standard tablets, basket type B contains 3 test tubes for bigger tablets according to USP/EP standards. Effortless cleaning is easily possible due to the removable acrylic water bath equipped with an outlet. An USB and LAN interface ensures easy data export.
Touch display
NEW!
Intuitive navigation due to user-friendly menu structure
AutoBasket
NEW!
Automated determination of the disintegration time of each sample by built-in sensors
Highlights
■ ■ ■ ■ ■
ZT 720 Series: Main Features and Touch display
■ Automated determination of the disintegration time of each sample by built-in sensors within the new AutoBasket ■ Automated lift-in and lift–out of the basket rack at start/completion of the pre-set run-time ■ 7” integrated touchscreen display for convenient and easy operation Lift drive with stepper motor for direct speed control User friendly validation function through the lifter Quiet and gentle lifter movement 100% USP/EP conform Access is password protected
Intuitive menu operation via Touch display
The new ZT 720 series touch display During the development of the ZT 720 touch display we focused on the features which users find most important: Easy and fast creation of methods, quick launching of tests and documentation of test results. The intuitive touch display enables easy operation of all functions. ZT 720 is equipped with 4GB memory to store up to 100 products/ methods and about 1 million test results, which can be displayed and exported at any time, ensuring that no test results are lost. Comprehensive integrated calibration functions guarantee accurate results and document each calibration process: Maximum convenience combined with an extensive feature set.
Touch display Highlights ■ Intuitive navigation due to user-friendly menu structure ■ 4GB memory for methods and test results ■ Data export option: USB or LAN interface exports data in XML or CSV format ■ Interconnect your systems: Load data from one system to another via USB/SD interface ■ Automatic store function of test results after each test ■ Back-up function through USB/SD-Card ■ Customizable IQ/OQ/PV validation interval periods
Technical Data & Options Test stations
1 (ZT 721) or 2 (ZT 722)
Touch display
7“
Memory function
4 GB memory for 100 products/methods and approx. 1 million test results
Lift drive
Step motor
Speed mm/min
30 +/-1
Height of stroke (mm)
55 +/-2
Heating
Integrated flow through heating system
Temperature control
External PT 100 temperature sensor
Automatic determination of the disintegration time
AutoBasket type A (6 test tubes) or AutoBasket type B (3 test tubes plus discs)
Power consumption 230V/115V
■ ■ ■ ■ ■ ■ ■
AutoBasket type A (6 test tubes) & Type B (3 test tubes) Additional vessel for pre-heating (ZT 721 only) Disc remover for removal of type A discs from the basket Mesh 40 sieves for AutoBasket type A & B Printer IQ/OQ/PV documents IQ/OQ/PV validation service
1750 Watt
Voltage +/- 10%
230 VAC / 50 Hz - 60 Hz 115 VAC / 50 Hz 60 Hz
Interfaces
USB A, USB B and LAN
Printer interface for
Oki B430D and HP Laserjet Pro 400
Dimension width/depth/height weight
Options
397 mm / 365 mm / 667 mm 30 - 35 kg
ERWEKA GmbH
Technical specifications of products described are stated without
Ottostr. 20-22
E-mail: sales@erweka.com
63150 Heusenstamm
Tel.:
+49 6104 6903-0
Germany
Fax:
+49 6104 6903-40
warranty and are subject to change at any time without further notice. v.1.6.15
Tablet Hardness Tester TBH 125 Hardness & combination tester The TBH 125 is a basic dual-mode tablet hardness tester which offers accuracy, robust design and easy operation. It can test up to three parameters (hardness, diameter* and thickness*) using constant force or constant speed measurement principle. The TBH 125 is operated with a keypad for entering the number of samples required for testing. Sample results are shown on two bright LED displays and can be printed for documentation. The TBH 125 can be calibrated statically using weight stones or dynamically with AutoCal 2.0.
■ ■ ■ ■ ■ ■
Measurement of hardness, diameter* and thickness* Constant force or constant speed method selectable Quick and easy tablet placement in the jaws 99 tablets can be tested in one test run Adjustable breaks between the samples of test run Integrated menu for static calibration, settings and documentation printout ■ 100% USP/EP/JP compliant
Specifications ■ ■ ■ ■ ■ ■
Measuring range 10 – 300 Newton Tests samples up to 28 mm diameter 2 x 4-digit 16-segment LE display with function keys Electronic load cell Measuring units in Newton, Strong Cobb and Kilopond USB-A printer interface for documentation of time, date, results and statistics (specified printers) ■ USB-B interface for firmware updates
The TBH 125P with integrated printer and collection container*
*=optional Technical specifications of products described are stated without warranty and subject to change any time without futher notice.
Hardness / Diameter / Thickness
Options ■ Diameter measurement up to 28 mm diameter, accuracy ± 0.05 mm ■ Thickness measurement from 0.10 - 28 mm, accuracy ± 0.05 mm ■ Extended measuring range 10 - 500 N, accuracy ± 1N ■ Integrated printer for printing results, statistics and calibration protocol (TBH 125 P) ■ Collection container with splash guard ■ AutoCal 2.0 system, automated tool for calibrating the hardness test without weights
A ridge ensures perfect alignment of samples
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Hardness Testing
Features TBH 125
Tablet Hardness Tester TBH 325 Hardness & combination tester The TBH 325 is a compact manual hardness and combination tester for measuring up to 4 parameters - hardness, diameter*/length*, thickness* and weight* of tablets of all kinds.
options for all needs. The standard measuring range of 3 to 500 newton can be extended to 1000 Newton, and it measures in constant force or constant speed mode.
Features TBH 325 ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■ ■
Hardness
Precise hardness and combination* tester 100% USP/EP/JP compliant Constant force or constant speed method selectable Adjustable breaks between the samples of test run Collection container with splash guard Fast and easy menu guided calibration Numeric keypad with alpha-numeric sub function for entering test parameters, product name, batch number and remarks Memory function for 50 products with 3 tolerances Integrated menu (password protected) for static calibration, settings and documentation printout Measuring units in Newton, Strong Cobb and Kilopond Values in mm, inch, mg or g USB interface for USB memory stick Ethernet interface SD card slot USB printer interface for documentation of time, date, results and statistics
■ The tablet hardness can be measured in either constant speed or constant force principle
Diameter* (Length*) ■ A grooveway ensures that the tablet is perfectly aligned to measure the diameter/length
Thickness* ■ Thickness is measured manually
Weight* ■ The weight is measured manually via the externally connected balance, then data is transferred to the TBH 325 WTD *= option
PC USB LAN
SD-Card USB
Interfaces for USB, LAN, SD card
TBH 325 WTD offers weight measurement*
Hardness Testing
Up to 100 tablets can be precisely tested in one run. The TBH 325 o ers robust design that can be used directly within production environments and provides quick test results which are easily documented. Up to 50 products with three tolerances can be stored and recalled any time.
TBH 325 Options Diameter/length (for oblongs) measurement Thickness measurement
Measurement Range Hardness
3 - 500 N (±1 N)
extended*
3 - 1000 N (±1 N)
Extended measuring range 3 – 1.000 Newton
Diameter/Length*
2 - 28 mm (±0.05 mm)
Test jaws for sugar coated tablets
extended
2 - 70 mm (±0.05 mm)
Test jaws for oblong shaped tablets
Thickness*
0.10 - 12 mm (±0.05 mm)
AutoCal 2.0 System, automated tool for calibrating the hardness tester without weights
Weight*
20 mg - 64 g (±1 mg)
Win.print software to transfer measuring results to a PC
Constant Speed
0.05 - 3.00 mm/sec
Constant Force
10 - 200 N/sec
Weight measurement, different Sartorius and Mettler balances available
MC.net Software to operate TBH from PC RS 232 interface for standard data export Qualification ducuments IQ/OQ/PV ERWEKA IQ/OQ/PV service on customer site Maintenance service
Measurement Principles
Appliances details Power
100 - 240 V / 50-60 Hz
Width / depth / height
350 / 375 / 310 mm
Weight
10 kg
*= option
With MC.net software* the hardness tester can be operated from a PC
Technical specifications of products described are stated without warranty and subject to change any time without futher notice.
Optional thickness testing
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
A true All-rounder
MultiCheck 6
The new standard for fully automated tablet combination testing
New technologies for a quiet All-rounder The new MultiCheck 6 offers ease of operation, maximum efficiency and enhanced operator convenience. This fully automatic combination tester is packed with innovative technology: An intuitive touch display, the integrated functionality of the MC.net software, the capsule weight measurement system and the patented Oblong Navigator® are only some of the innovative new features. In addition the new MultiCheck 6 provides an unsurpassed low noise level and cleanest operation in its class. Proven features have been retained: MultiCheck 6 can test up to five tablet parameters - fully automated and 100% compliant with all pharmacopoeias around the world: A true all-rounder.
Weight ■ Weight is determined automatically by means of an integrated high-precision balance.
Thickness ■ Thickness is measured with the help of a linear potentiometer.
Diameter/Length ■ Diameter/Length is measured by means of a stepping motor.
Width ■ The Oblong Navigator® measures the width of even and odd-shaped oblongs aswell as other odd-shaped tablets.
Hardness testing ■ Hardness can be measured using either the „Constant Force“ or the „Constant Speed“ measuring principle.
Capsule weight measurement
NEW!
With its new empty capsule weight measurement system MultiCheck 6 is able to determine capsule weight and automatically deduct the weight of the empty capsule from the weight surement speeds up the measuring process.
Oblong Navigator速
NEW!
This patented turntable technology enables odd-shaped tablets to be aligned correctly and easily checked for diameter, width and length.
Electrical alignment threshold The alignment threshold ensures that tablets are correctly positioned and prevents tablets from being transported in an awkward position, for example on-edge.
Touchdisplay
NEW!
An intuitive touch display allows for easy operation of the unit.
Direct measurement
NEW!
Via the direct measurement menu, tests can be started quickly with results immediately stored.
Convenient operation – broad feature set
The new MultiCheck 6 touch display During the development of the MultiCheck 6 touch display we focused on the features which users will find most useful: Easy and fast creation of methods, launching of tests and documentation of test results. The intuitive touch display enables easy operation of offered functions. Thanks to the integrated MC.net software functions, measurements can be launched and results displayed directly on the unit. MultiCheck 6 can store up to 100 products / methods and 1 million test results, which can be displayed and exported at any time, ensuring that no test results are lost. Comprehensive integrated calibration functions guarantee accurate results and document each calibration process: Maximum convenience combined with an extensive feature set.
Benefits ■ Clearly structured home screen with direct access to measurements ■ Direct display of test results on the screen ■ Quick execution of measurements with direct measurement menu ■ Detailed documentation of tests and display of calibrations due and calibrations performed ■ Extensive calibration and adjustment capabilities ■ Red-yellow-green display for immediate recognition of the need for calibration ■ Easy integration of MultiCheck 6 into an existing network via Ethernet connection (RJ45) ■ Memory for up to 100 products / methods and 1 million test results ■ 7 inch touch display ■ USB A printer interface
MultiCheck 6: Convenient operation – broad feature set
Feature overview
Measurement functions ■ ■ ■ ■
Fully automatic testing of tablets for up to 5 parameters 100% USP/EP/JP compliant Constant Force und Constant Speed method selectable Measurement in Newton, Strong Cobb, Kilopond and lbf units ■ Values adjustable in mm, inch, mg or g Features ■ Touch display ■ Integrated data memory for re-calling the data of previously tested samples ■ Separation drum, with photocell for verification of tablet separation ■ Fixed or adjustable alignment threshold ■ Integrated capsule weight measurement ■ Oblong Navigator ® – patented turntable technology for perfect alignment of oblongs ■ Linear transport of the tablet to the individual test stations enables the permanent visual inspection of the testing procedure ■ Automatic cleaning of transport path and test jaws ■ Ethernet port for integration into existing networks ■ LAN, USB A, USB B and SD-Card slot ■ Memory for up to 100 products / methods ■ Data transfer by LAN in CSV fileformat ■ Backup using USB & SD-Card ■ Optional MC.net Software: audit trail according to FDA 21 CFR Part 11
The new Oblong Navigator ® with patented turntable ensures correct tablet alignment even in case of odd-shaped oblongs and tablets.
High-grade thickness measuring system for precise measurement.
Customer-oriented, Our configuration variants MultiCheck 6 is offered in three configuration variants: Basic, Standard and as All-rounder with Oblong Navaigator®. All three variants are fully focused on our customers‘ requirements.
We will be pleased to consult you as to which of these variants is best suited for your laboratory.
MultiCheck 6 „Basic“ enables testing of round tablets. MultiCheck 6 „Standard“ is designed for testing round tablets, dragées and evenly shaped oblongs and tablets. The MultiCheck 6 „All-rounder“ extends these features with the ability to perform measurements on odd-shaped oblongs and tablets as well as the fifth parameter width measurement.
Basic
Standard
All-rounder
Round tablets
Round tablets, dragées, evenly shaped oblongs
Round tablets, dragées, evenly shaped oblongs, odd-shaped oblongs
4 Values Weight, thickness, diameter, hardness
4 Values Weight, thickness, diameter, hardness
5 Values Weight, thickness, diameter, width, hardness
Touch display
Separation drum
Capsule measurement
Alignment threshold (fixed)
-
-
Alignment threshold (electronic, adjustable)
-
Slot for oblongs
-
not required
Positioning arm for oblongs
-
Oblong Navigator®
-
-
Main application
Measurement values
MultiCheck 6:
Customizable to suit your requirements In addition to the three equipment variants your MultiCheck 6 can be customized to your specific requirements. Please contact your local ERWEKA dealer for advice.
In addition our extensive range of services is at your disposal for installation, calibration and qualification of your system. Contact ERWEKA to arrange for a service visit at your site!
Our service portfolio
Options 12-chamber magazine for testing of large batches Extended hardness measurement range of up to 1000 N MC.net software PC with MC.net software Printer AutoCal 2.0 system for automatic calibration of hardness tester without weights + Dragée holder („Standard“ & „Allrounder“ versions only) + Sartorious OCE weighing system, suitable for trade weighing certification) + Customized data export + + + + + +
+ + + + +
Installation of MC.net software on customer‘s PC Initial setup of MultiCheck 6 Qualification documents (IQ/OQ/PV) ERWEKA on-site IQ/OQ/PV service Maintenance service
Technical Data Measurement Range Hardness
3 - 500 N (±1 N)
Diameter/Length
2 - 28 mm (±0.05 mm)
Thickness
0.10 - 10 mm (±0.05 mm)
Weight
0.02 g - 124g (±0,001 g)
Width
2 - 28 mm (±0.05 mm)
Measurement Principles Constant Speed
0.05 - 3.00 mm/sec
Constant Force
10 - 200 N/sec
Appliance details Power
100 - 240 V / 50-60 hz
Width/depth/height
643 / 627 / 613 mm
Weight
50 kg
Compliance MC.net-Software
21 CFR Part 11 compliant
Direct measurement menu for quick starting tests.
Friability/Abrasion Tester TAR The TAR series is a USP/ EP / JP compliant ERWEKA unit for testing friability and/or abrasion. Programming is easily performed by the symbol style keypad. The rotation speed can be set between 20 and 100 rpm and the test run duration can be set either in time or total number of revolutions. During the test run the actual rotation speed and the test run duration is shown on bright LE displays. The unit is available with 1 (TAR 120) or 2 (TAR 220) test drums.
Features TAR ■ Compatible with ERWEKA friability- and abrasion drums ■ Automatic removal of tablets after the friability test run ■ DC frequency motor with constant actual/nominal adjustment for adjustable speed ■ Built in timer ■ Switching leg for 10° adjustment ■ Membrane function keys for pre-selection of the test runtime in either number of turns or time and rotation spee ■ Available for 1 of 2 drums Options USB interface for print-out
Technical Data Instrument Operation
Touch foil keypad
Voltage
100 - 240 V / 50 - 60 Hz
Power consumption
40 N
Speed control
Yes
Speed range
20 - 100 +/- 1rpm
Test run timer
Infinitely adjustable up to 9 h., 59 min., 59 sec. +/-0,1
Revolution counter
Infinitely adjustable up to 9999
GTA 120
Friability drums left or right (with opening for automatic emptying) Abrasion drums left or right CoC (certificate of compliance), per drum Spare part kit for TAR 120/220 IQ/OQ/PV service, IQ/OQ/PV documents RS Tablets (75 pieces), certified
ERWEKA friability tester type GTA 120 designed for any form of tablets, granules and pellets according to the Pharm. Eur. For further information please contact our Sales department
Technical specifications for the products described are stated without warranty and subject to change at any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Friability / Abrasion
QuGTA 120
For larger samples the complete unit can be set to the USP / Pharm.Eur. required 10° position by a standard switching leg.
Suppository Testers ERWEKA offers suppository testers for hardness, melting point, penetration and disintegration testing. The ERWEKA SBT2 measures the hardness of suppository samples. The ERWEKA PM 30 measures the softening time of suppositories. The ERWEKA SSP measures the melting point of suppository samples.
SBT 2
Technical Details The suppository hardness tester, type SBT 2 consists of an electrically heated chamber containing a sample holder with a number of interchangeable plastic inserts to accept various sized suppositories. Once up to temperature, the hardness is checked by weights (included in the standard delivery range) which are added until the suppository collapses. The results are expressed in terms of total weight required to bring about the collapse of the suppository.
PM 30
Technical Details The ERWEKA PM 30 measures the softening time of suppositories. Suppositories must disintegrate, dissolve or melt at body temperature in order to release the active ingredients to the body. ERWEKA offers a version for USP method A and method B. The PM 30 Penetration Tester (compliant to EP, Apparatus A) and the PM 3 (acc. to EP, App. B) have been designed to carry out reproducible measurements to the softening time of suppositories at predetermined temperatures. The construction of the tester makes visual observation of the melting characteristics extremely simple. The unit comprises of 3 Test Stations. Options: Glass test tubes, 2g, with adaptor, for PM 30 acc. to EP App. B Glass test tubes, 3g, with adaptor, for PM 30 acc. to EP App. B Immersion thermometer with certificate (instead of non-certificated immersion thermometer) Water Stabiliser with colour indicator, 1 bottle for 2 filling
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Suppository Testers
The ERWEKA ST 35 measures disintegration, featuring 3 turning test stations (suppository holders) each located inside a 4 litre beaker glass.
Suppository Testers
SSP
Technical Details The ERWEKA SSP measures the melting point of suppository samples. It consists of a graduated tube like glass test chamber. The sample to be tested is placed in a spiral shaped glass test basket inside the test chamber which Itself is surrounded by a water jacket. The water inside the jacket can be heated by the optional circulation heater EST 2. Options: ERWEKA circulation heater EST 2 IQ/OQ documents
ST 35
Technical Details The suppository disintegration tester ST 35 comes with each test station located inside a 4 liter glass vessel with optional magnetic stirrer which are placed inside a thermostatically heated water bath which is non-leaking and double secured. The test stations are automatically turned 180° in adjustable intervals. The ST 35 features an integrated "high-power" flow-through heating system (accuracy ¹ 0.2°C) and internal temperature sensor for temperature display. Test time and nominal bath temperature is entered via the membrane keys. Current test time as well as actual water temperature are shown on clearly visible red LEDs. On request, an alarm may be selected to sound upon completion of the preset test time. Due to the width, at the ST 35 the test stations are separable to ease the cleaning process. Optional separately controllable magnetic stirrers can be placed in each test station (glass beaker) to get the required hydrodynamics Options: 3 magnetic stirrers, controlled by the membrane keys of the unit USB interface for print-out Water stabiliser with colour indicator, 1 bottle for 2 fillings
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
SVM Tapped Density Tester The ERWEKA SVM has been designed for measuring the tapped volume and tapped density of powders, granules and similar products. The ERWEKA SVM series is available with one or two glass cylinders and operates according USP method 1 (300 strokes/ min; stoke height 15 mm) or USP method 2 (250 strokes/min; stroke height 3 mm) which is equal to Pharm.Eur. and DIN ISO EN 787/11 requirements. As a special version the SVM 223 operates the first test station
SVM-121 / 221
SVM-122 / 222
ERWEKA Tapped Density Testers are available with one (SVM 121) and two test stations (SVM 221) for measuring the tapped volume and tapped density of powders, granules and similar products. Test parameters can be set in either time (hours/minutes/seconds) or number of strokes.
The SVM 122 (with one test station) and SVM 222 (with two test stations) operate according USP method 2 and Pharm.Eur. and DIN ISO EN 787/11 standards in respect of strokes/min. and height of stroke.
SVM 121/221 Technical Details
SVM 122/222 Technical Details
Number of test stations
1 (SVM 121) or 2 (SVM 221) glass cylinders
Number of test stations
1 (SVM 122) or 2 (SVM 222) glass cylinders
Stroke height Strokes / min
14 mm ± 2 mm, 300 strokes/min. ± 15 accoding to USP method 1
Stroke height Storkes / min
Keypad
Membrane function keypad
3.0 mm ± 0.2mm, 250 strokes/min ± 15. according to USP method 2, EP and DIN ISO EN 787/11
Display
Two illuminated LED displays
Keypad
Membrane function keypad
Pre-selection of testrun parameters
Time: 1 sec. to 9 hrs, 59 sec. Revolutions: 1 to 99.999
Display
Two illuminated LED displays
100 ml measuring cylinder Support plate
130 ± 16 g 240 ± 12 g
Pre-selection of test run time
Time: 1 sec. to 9 hrs., 59min., 59 sec. Revolutions: 1 to 99.999
100 ml measuring cylinder Support plate
130 ± 16 g 240 ± 12 g
Tapped Density Tester
according USP method 1 and the second station acording USP method 2. The test run time is selectable.
SVM 223 SVM 223
Options Glass cylinders, 100ml / 250ml / 500ml
cording to the USP method 1. The second test station operates at the same time according to the USP method 2/EP/DIN ISO EN 787, part 11.
USB printer interface Qualification tool kit IQ/OQ documents for SVM
SVM 223Technical Details Number of test stations
2, one for USP Method 1 and one for USP Method 2 (Pharm. Eur.)
Stroke height Strokes / min
14 mm ± 2 mm, 300 strokes/ min. ± 15 according to USP method 1 3.0 mm ± 0.2mm , 250 strokes/ min. ± 15 according to USP method 2, EP and DIN ISO EN 787/11
Keypad
Membrane function keypad
Display
Two LED displays
Pre-selection of test-run parameters
Time: 1 sec. to 9 hrs., 59min., 59 sec. Revolutions: 1 to 99.999
100 ml measuring cylinder Support plate
130 ± 16 g 240 ± 12 g
250 ml measuring cylinder Support plate
220 ± 44 g 450 ± 10 g
All ERWEKA glass cylinders with adapter kit according to USP or EP.
Technical specifications of products described are stated without warranty and subject to change any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Granulate Flow Tester GT The ERWEKA GT has been designed to determine flow properties of powders and granules according to four different measuring methods: • • • •
Qu
determination of flow time of the pre-defined sample weight (according to EP) determination of flow time of the pre-defined sample volume determination of weight of the sample which flows within a pre-defined time ratio of flow time and sample weight presented in the form of graphical curve with a subsequent calculation of the cotangents of the flow angle a = arctan (weight/time)
Where samples exhibit poor flowability, the hopper is available with a stirring device* with variable speed control. GT-B for automatic determination of the sample repose angle* and with optional stirring device*.
■ Flexible determination of flow properties with four different measuring methods ■ Special precise integrated balance can be detsched form the tester and used independly ■ Results are shown at the illuminated 320 digit 16-line fullgraphic LC display ■ Easy and fast exchangeable stainless steel nozzles (3 different size) by a quick coupling ■ Easy programming by the alpha-numeric touch-sensitive foil keypad ■ RS232C Interface for data output and firmware update ■ USB Interface for print out the results, graph and statistics
Options* + Stainless steel hoppers, 100 ml or 200 ml + Stainless Steel outlet nozzles, 6, 8, and 11.3 mm + automatic determination of the samle respose angle according to Pfrengle (GTB) + Stirring device for poor flowable samples + Qualification tool kit for GT + Calibration weights for readjustment of the integrated balance + IQ / OQ documents
Technical Data Keypad
Alpha-Numeric membrane keypad with additional function keys
Display
320 Digi 16-line graphic LC Display, illuminated
Hopper
Stainless steel,480 ml, quick-change System
Outlet nozzle
Stainless steel. 3 different diameters 10 / 15 / 25 mm
Interface(s)
RS232C USB
Balance Precisions balance
Mettler Toledo Panda 7/SG
Maximum load
7000 g
Accuracy
0,1 g
Dimensions
700mm (height) / 430mm (width) / 400mm (depth) / 25kg (weight)
Voltage
100-240V / 50-60Hz
ERWEKA GTB The GTB offers in addition to the standard flow properties the measurement of the angle of repose according to Pfrengle: the powder or granulate falls onto a plate with a specified surface and creates a cone. An integrated driven laser measures the side wall of the built-up cone and the actual angle is calculated and displayed and/or printed.
Technical specifications for the products described are stated without warranty and subject to change at any time without futher notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Granulate Tester
Features GT
Granulate Flow Tester GTL The basic ERWEKA granulate & powder flow tester offers to determine the knowledge of the flow properties to ensure that accurate dosing is maintained. Determination of the flow time of a pre-weight sample (DAB 10). Determination of the flow time of a pre-defined sample volume.
Technical Details Granulate and Powder Determination of the flow time of a pre-weight sample (DAB 10)
Options Stainless Steel Hoppers, 100 ml or 480 ml Stainless Steel Outlet Nozzles, 6.0, 8.0 and 11.3 mm
Flow Tester for Determination of the flow time of a pre-defined sample volume Keypad Numeric Membrane Keypad with additional Function keys
Qualification Handbook Validation Tools Serial RS 232 interface for data transfer
Hopper Stainless Steel, 200 ml, Quick-Change System Stainless Steel, 3 different diameters (5; 10; 15 mm), QuickChange System
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Granulate Flow Tester
GTL
The GTL is handled by numeric membrane keys, results are shown at the illuminated 4-line LC display. As standard the unit is delivered with a stainless steel hopper (200 ml) and three stainless steel outlet nozzles (10.0; 15.0; 25.0 mm) which can be exchanged by a quick coupling. Additional stainless steel hoppers (100; 480 ml) and outlet nozzles (6.0; 8.0; 11.3 mm) are available as option.
Vacuum Leak Tester VDT A vacuum leak tester for blisters and other packaging forms. The max. vacuum (absolute pressure range up to 300 mbar) and the vacuum hold time before release can be set easily via the symbol keypad. The actual vacuum is continuously displayed. Test-run parameters can be printed out via an printer interface/package. With the ERWEKA VDT/S, the blister pack is entered into a vacuum container (150, 200, 250 or 300 mm diameter), which is filled with a methylene blue solution. The vacuum pump is integrated into the control unit of the VDT/S and creates a vacuum in the container (absolute pressure range from 100 to 300 mbar). As the vacuum pump is switched off, air is sucked into the container and the methylene blue water is sucked into any imperfectly sealed packaging. Test-run parameters, such as actual/nominal vacuum, hold time etc. can be hard-copied by the printer interface/package.
Vacuum Tester
VDT
The integrated vacuum pump can be re-calibrated using the optional validation kit which includes a vacuummeter, type DVR.
Technical Details 150 mm diameter container 200 mm diameter container 250 mm diameter container 300 mm diameter container Validation Tool Kit, certified, for VDT/S comprising of: - Vacuummeter Type DVR - Stop Watch IQ/OQ Handbook Spare Part Kit
Technical specifications for the products described are stated without warranty and subject to change at any time without further notice.
ERWEKA GmbH sales@erweka.com +49 (6104) 6903-0
Ottostr. 20 - 22 63150 Heusenstamm Germany
Our All-Purpose Solution
AR 403
Ideal for R&D and small scale production in the pharmaceutical, chemical, cosmetic and food industry For pharmacy, university and laboratory applications Modular design – one drive unit and various attachments for different uses and needs
ERWEKA AR 403
The ERWEKA All-Purpose System is based on a powerful drive unit available in two versions. The various attachments can be easily and quickly connected by means of a coupling. The drive unit AR 403 is equipped with a three-phase AC motor. The sturdy ball bearing worm gear drive is completely maintenance-free and provides an output torque of max 23 Nm. The unit features electronic speed control variable between 20 and 400 rpm. A digital dial regulates the speed. Through permanent nominal/actual adjustment the preselected speed is kept, even under varying load. The AR 403-S is similar to the AR 403 but has a different drive train. This connection is designed for heavy use. Available options: ++ Foot switch ++ USB interface for printout ++ IQ / OQ / PV documents
Ideal for R&D and small scale production The All-Purpose equipment is ideal for small scale production in the pharmaceutical, chemical, cosmetic and food industries. It fits perfectly into Research & Development of tablets, ointments, creams and more. The modular design is compact, economical and offers a powerful motor drive with a wide range of easily interchangeable attachments for various purposes.
The different possibilities are as follows: ■■ ■■ ■■ ■■ ■■ ■■ ■■ ■■
Stirring Kneading Mixing Granulating Coating Polishing Grinding Sieving
■■ ■■ ■■ ■■
Homogenizing Filling Dosing Tablet production
Technical Specifications AR 403 / AR 403-S Torque
Robust / -S for heavy use
Voltage/frequency
230V 50/60 Hz 115 V/60 Hz 127V/60Hz
Width
450 mm
Length
400 mm
Height
440 mm
Weight
30 kg
Motor type
Three-phase AC motor
Power
750 W
Tropics insulation
Class F
RPM
20-400 rpm
Tolerance rpm (coasting)
+/- 1 rpm
Gear type
Worm gear
Output
20-400 rpm
Gear max. torque
23 Nm
Efficiency
89%
Timer Possible time setting
Hours/minutes
Set time (max)
9h 59min
Tolerance timer
+/- 1 sec
Main benefits of the modular ERWEKA method: ■■ Little lab space needed ■■ Constant product quality - improved production ■■ Economical capital cost - one drive, many attachments ■■ High quality - made in Germany
AR 403 Attachments ERWEKA UG (Universal Gear) The universal gear is required for adjusting the angle of operation (0-80°) and for speed reduction (1:6). The UG is required for the operation of ■■ Ball mills (KM 0) ■■ Cube mixer (KB 15/20/S) ■■ Double Cone Mixer (DKM) ■■ Pelletizer (GTE) ■■ Coating pan (DKE/S) ■■ Polishing drum (PT)
Grinding
ERWEKA KM (Ball Mill) Ball mill for grinding crystalline materials and for mixing dry, or under certain circumstances, moist materials.
available lengthened for the simultaneous use of two mixers oft he same size (KM 5 l or KM 10 l volume, working capacity max. 40%).
The balls are made of porcelain having a diameter from 30 to 50 mm. The drum is sealed airtight with a lid and is delivered including frame for drive unit. Drum and balls can be sterilized in water. For using the ball mill, a drive support is needed, which is optionally
The ball mill KM 0 (with 0,5 l volume, working capacity of max. 40% and made of stainless steel) is attached to the drive unit via the ERWEKA Universal Gear. The drum is available with 0.5, 5 or 10 l volume.
ERWEKA CM (Conical Mill) The Conical Mill is a product infeed system for application in developments in the pharmaceutical and food industries, which pulverizes powdery and free flowing products by a sieve with fixed maximum sizes of impurity-free granule (adjustable 0.3 – 3.0 mm; perforated round holes, grater holes or square holes).
Rotation speed (continuous 60 – 1200 rpm) and sieve crack (standard 1.5 mm, adjustable 0.5 – 3.0 mm in 0.25 mm steps) can be varied for detailed adjustment of process.
ERWEKA SM/SMS (Three Roller Mill) Three roller mill for the production of pastes, ointments, creams and similar products. The rollers are manufactured in porcelain (SM) or stainless steel (SM S). Each roller has a diameter of 50 mm.
Grinding
The mill has an output between 2 kg/h and 15 kg/h depending on the consistency of the product to be produced.
The rollers are spring loaded to prevent damage and the space between the rollers is adjustable by one screw.
ERWEKA KB (Cube Mixer) The cube mixer uses a tumbling motion to produce a homogenous blend within a short time. The mixing action is assisted by three stainless steel rods strategically positioned within the cube. The cube mixer is attached to the drive unit via the ERWEKA Universal Gear UG, which permits operation at various angles for optimum efficiency. Our cube mixers are available in the following versions:
ERWEKA DKM (Double Cone Mixer) Double cone mixer for the mixing of free flowing powders and granules.
The mixing vessel (11.9 liter volume, working capacity 50%) is made of stainless steel.
The arrangement of the mixer in combination with the angle adjustment of the universal gear allows a multi-dimensional mixing process.
The ERWEKA Universal Gear UG is needed for connection and allows operation at various angles for optimum efficiency.
Mixing
■■ (KB 15) Cube mixer made of acrylic glass with a volume of 3.5 l and 40% working capacity
■■ (KB 15 S) Cube mixer made of stainless steel, 3.5 l volume, 40% working capacity ■■ (KB 20) Cube mixer made of acrylicglass, 8 l volume, 40% working capacity ■■ (KB 20 S) Cube mixer made of stainless steel, 8 l volume, 40% working capacity ■■ (KB 30) Cube mixer made of acrylicglass, 11 l volume, 40 % working capacity ■■ (KB 30 S) Cube mixer made of stainless steel, 11 l volume, 40 % working capacity
AR 403 Attachments ERWEKA RM (Drum Hoop Mixer) Drum hoop mixer with diagonal placement of the drum within the hoop. The rotation of the hoop itself produces a uniform, three-dimensional displacement of the material to be processed and hence a tumbling mixing action. The mixer consists of two parts: the drive support and drum hoop with acrylic mixing drum. For using the drum hoop mixer a drive
support is needed, which is optionally available lengthened for the simultaneous use of two mixers of the same size (RM 5 or RM 10 liter volume, working capacity max. 40%). Mixing drums are available with 5 liter and 10 liter volumes. Ball mill drums are available as optional accessories.
ERWEKA SW 1/S (Laboratory High Speed Mixer) Laboratory high speed mixer operating on the plough-share principle for the mixing of powders, granules and other products of fibrous nature.
Mixing
Quantity ratios of 1:100,000 can be mixed homogeneously in only a few minutes. The mixing drum (5 liter volume, working capacity max. 70%) can be rotated through 180 degrees and offers a removable cover for charging
and emptying. An electro-mechanical cover switch ensures that the drive unit AR 403 is switched off when the cover is removed. All parts coming into contact with the product are made of stainless steel.
ERWEKA Y5 (Mixer Y5) Mixer Y5 with Y-shaped mixing vessel for the gentle mixture of solid, well flowing materials (bulk materials).
capacious openings. Volume of the mixing container: 5 liter, recommended working conditions: max. 1.5 liter (30%) and 0-40 RPM.
The rotary motion of the mixing vessel makes a particularly homogenous mixture possible and suitable for sensitive materials.
All parts coming into contact with the material are made of stainless steel.
For optimal filling, emptying and cleaning the mixing vessel is equipped with three
ERWEKA PRS (Planetary Stirrer) Planetary stirring unit for mixing of creams, ointments, pastes, moist powders and liquids. This powerful mixing attachment comes with various mixing/stirring accessories e.g. kneading hook, mixing paddle, whisk and a fluoropolymer scraper for removing any product adhering to the side of the bowl thus ensuring a homogenous mixing in the shortest possible time.
The stirring/mixing accessories and vessel (5 liter volume, working capacity 60%) are made of stainless steel. Optionally an electric heated bowl or a double jacket bowl for heating and cooling by water is available.
ERWEKA LK 5 (Laboratory Kneader)
The asynchronous mixing action intensifies and considerably accelerates the kneading process. The kneading vessel is fitted with a plexiglas cover to monitor the kneading
process. An electro-magnetic cover lock ensures that the power supply to the drive is disconnected immediately when the vessel cover is removed.
Mixing
Laboratory kneader with stainless steel kneading vessel (5 liter volume, working capacity 65%), housing, two z-shaped kneading blades running at different speeds in opposing directions.
A thermostatically controlled heating jacket for the kneading vessel is available as an optional extra.
ERWEKA FGS (Wet Granulator) Wet granulator with oscillating rotor for the production of wet granules. The granules can be produced in varying sizes depending on the sieve mesh employed.
The following mesh sizes are also available: 0.315; 0.63; 0.8; 1.0; 1.25; 1.6; 2.0; 2.5 and 3.15 mm. Other special sieves are available on request.
Granulating
All parts coming into contact with the product are made of stainless steel. Working capacity is max. 30 kg/h depending on the material
and mesh width of the sieve used. The unit is supplied as standard with two sieves 1.0 mm and 1.6 mm MW respectively.
ERWEKA TG 2000 (Dry Granulator) Dry granulator with two driven rollers running in opposing directions from the inside to the outside. The rollers are 70 mm long and made of stainless steel. They are equipped with teeth to produce a powerful grinding action by forcing the material against a series of braking combs. The ERWEKA TG 2000 fully conforms to the latest safety requirements.
All parts coming into contact with the product are made of stainless steel. Fines produced during granulation are very low (max. 25%) and can be reduced to 15% by careful adjustment of the process. The maximum capacity of the dry granulator is 20 kg/hour.
ERWEKA VT (Vibration Sieve Shaker) ■■ (PS/S) Sieves set with 4 stainless steel sieves 20 cm Ø according to DAB 1998, ISO 565/3310-1. Other sieve sets are available on request. ■■ (VS) Sieve set with 9 sieves 31 cm Ø, according to DAB and Pharm. Europe, made of phosphor bronze. ■■ (VS/S) ditto, sieves made of stainless steel.
Sieving
The Erweka VT operates on the reciprocating cam principle. The vibration intensity can be adjusted by changing the speed of the drive unit. Available sieve sets include:
AR 403 Attachments
Pelletisation
ERWEKA GTE (Pelletizer) The pelletizer GTE (300 mm o.d.) is attached to the AR 403 via the universal gear UG which enables the operator to adjust the operating angle to the optimum position during operation. The material can be fed in manually or continuously. The rotary movement of the pan carries the product to the top of the pan and then flows down the pan in an even stream to the base. By addition of the requisite amount
of liquid, this process can be converted into the formation of pellets. The angle of the pan and the amount of liquid added determines the pellet size. When the pan is full, the pellets will continuously roll over the edge of the pan into a waiting container. All parts coming into contact with the product are made of stainless steel.
Coating
ERWEKA DKE/DKS (Coating Pans) Coating pans are used for coating tablets. The universal gear is required to attach the coating pans to the motor drive. This allows adjusting the angle of the pan and getting an optimum result from the coating process.
■■ DKE, stainless steel pan, volume 9.5 l, max. capacity 30%, 275 mm outside diameter. ■■ DKS, stainless steel pan, volume 15 l, max capacity 30%, 350 mm outside diameter.
An infrared radiator with a fixing rod can be mounted above the pan to accelerate drying if required.
Polishing
ERWEKA PT (Polishing Drum) Polishing drum to polish coated tablets. The drum is covered with interchangeable felt parts. The cover has a 120 mm o.d. opening for observation of the polishing process and addition of the polishing agent during the production process.
Homogenizer
ERWEKA HO/HHO (Homogenizer) For oil-in-water or water-in-oil emulsions. Mixing is achieved by a stainless steel piston. The volume of the stainless steel hopper is 1.5 liters. The maximum output is 30 kg/hour. The HHO is equipped with a heated hopper whereas the HO/UA offers a circulation and filling unit.
The polishing drum (2 l volume, working capacity max. 40%) is designed for attachment to the drive AR 403 unit via the universal gear UG in a similar manner as the coating pan.
ERWEKA FDF (Filling and Dosing Liquids) The two-station dosing and filling unit is suitable for the drop-free filling of all types of liquids.
The FDF comes with one set of filing nozzles 6 mm and 8 mm o.d.. Filling nozzles with different diameters are available on request.
ERWEKA FDS (Filling and Dosing Ointments etc.) The dosing machine FDS is suitable for filling precise quantities of ointments, creams, emulsions and similar products into tubes, cans, bottles etc. The standard unit has a dosing range of 10 – 200 ml. All parts coming into contact with the product are made of stainless steel. Quick removal of the pump and hopper (19 liter volume, max. capacity 1000 fills / hour)
Filling and Dosing
The dispense volume is easy to adjust. Quick removal of the pumps and valves for cleaning and sterilisation. The receiving container holder can be easily adjusted to accommodate various sizes. All parts coming into contact with the product are made of stainless steel. Maximum output: 1200 fills/hour.
The EWEKA FDF comes without pumps. Optional dosing pumps for a filling volume of 5 to 30 ml (DP 30) and 20 to 150 ml (DP 150) are available.
for cleaning. Filling nozzles of 2, 4 and 8 mm are part of the standard package. An additional cylinder unit to accommodate the filling range from 0.5 to 25 ml together with dispense heads with different apertures and special heads for filling tubes are available on request.
ERWEKA SG 4/W (Suppository Moulding)
The mixing vessel (5 liter volume, working capacity max. 65%) is located in a warm oil bath fitted with a thermostatically controlled heater adjustable between 20°C and 100°C. Stirring, mixing and melting are achieved in
a single operation and are not interrupted during the filling process. The moulds to be filled are positioned on a platform below the dispensing nozzle. A hand wheel enables the operator to move the platform and hence the moulds in both axes. All parts coming into contact with the product are made of stainless steel. Casting moulds are available on customer’s request.
Suppository Moulding
The suppository moulding unit SG 4/W is intended for the production of moulded suppositories, lipsticks and similar moulded products.
Technical Data All-Purpose Equipment Unit
Type
Volume max.
Capacity
UG
Output max.
required
KM 0
0.5 l
40 %
KM 5
5l
40 %
KM D 5
10 l
40 %
KM 10
10 l
40 %
KM D 10
20 l
40 %
DKE
9.5 l
30 %
DKS
15 l
30 %
KB 15
3.5 l
40 %
KB 15 S
3.5 l
40 %
KB 20
8l
40 %
KB 20 S
8l
40 %
KB 30
11 l
40 %
KB 30 S
11 l
40 %
Double cone mixer
DKM
11.9 l
50 %
Drum hoop mixer
RM 5
5l
40 %
RM 10
10 l
40 %
Ball mill
Coating pan
Cube mixer
Dry granulator
TG 2000
20 kg/h
Homogenizer
HO
1.5 l
30 kg/h
Laboatory high speed mixer
SW 1/S
5l
70 %
Laboratory kneader
LK 5
5l
65 %
Liquid filler
FDF
Pelletizer
GTE
Planetary mixer
PRS
5l
60 %
Polishing drum
PT
2l
40 %
Salve filling machine
FDS
19 l
1000/h
Suppository moulding machine
SG 4W
5l
65 %
Three roller mill
SM
15 kg
SMS
15 kg
Wet granulator
FGS
30 kg
Conical mill
CM
30 kg
Y-mixer
YB 5
1200/h
1.5 l
40 RPM
Liquids
Salves / Creams
Powders
Granulates
Pellets
Tablets / Dragees
Tablet Press EP-1 The ERWEKA eccentric single-punch tablet press EP-1 is the ideal tool for R&D and small batch production of round and odd shaped tablets. The single punch eccentric tablet press EP-1 can manufacture tablets and odd shaped products with a diameter of up to 20mm.
The throughput is maximum 4,000 strokes per hour. All components are either covered with hard chrome, or made of stainless steel AISI 316 or acrylic glass for the front door. The EP-1 is compliant to GMP and safety regulations.
It operates automatically i.e. the tablets are filled, pressed and ejected continuously. The compression force of up to 3 tons and the filling depth of up to 15mm are easily adjusted.
Technical Data & Options ■■ ■■ ■■ ■■ ■■ ■■ ■■
Press speed infinitely variable Max. tablet diameter 20mm Max. filling depth 17mm Max. compression force 3t Max. tablet output 4000 tablets/hour Net weight 135kg Dimensions press L/W/H (mm) 425/385/640 ■■ Dimensions with attachment parts L/W/H (mm) 550/400/800 ■■ Power supply 230V/50-60Hz ■■ Electrical load 2.2 kVA
Options ++ Measurement and display of compression force ++ Data transfer option ++ Data logging software ++ Standard data export via RS232 interface ++ Support table in stainless steel ++ Single punch and die set for round tablets, 4.0 mm to 20.0 mm diameter
++ Single punch and die set for shaped tablets, 4.0 mm to 20.0 mm diameter ++ Development of STR 1 or STS 1 single punch and die set ++ IQ /OQ documents ++ Transformer for EP-1 (from 110V to 230V)
Total Laboratory Services Ltd 14C Sunrise Business Park Blandford Forum Dorset DT11 8ST UK
Tel: 01258 861817 Mob: 07977 863521 Fax: 08455 190273 sales@totallaboratoryservices.co.uk www.totallaboratoryservices.co.uk