Issuu

www.brinox.eu

Material Handling Systems

Pharmaceutical industry

Technology that delivers

Brinox solutions

Experience the joy of a complete and hassle-free service Brinox is an expert in designing, manufacturing, installing, automating and validating handling solutions for dosing, weighing, blending, mixing, sieving / milling, transporting, packaging and storing. It incorporates the cleaning process for components, units and systems as well. The entire process is managed with great precision, with safety being of the utmost importance. Brinox provides expert guidance for hazardous processes regarding containment including: ¬ ¬ ¬ ¬

assistance with the scale of the operation and the containment strategy, assistance with assessment of worst case material exposure limits, assistance with assessment of the dustiness and exposure potential, assistance and guidance with use of personal protective equipment.

Key advantages of Brinox solutions A WHOLESOME PARTNER – Brinox provides research and consultancy, development and process engineering, manufacturing, installation and automation and aftersales support and maintenance. AN UNDENIABLE EXPERT - Brinox is an expert in designing, manufacturing, installing, automating and validating material handling containment solutions for dosing, weighing, blending, mixing, sieving / milling, transporting, packaging and storing. UP TO ANY TASK – The modular approach allows Brinox to meet any customer and legislation demands or requirements, all the time meeting the highest requirements for reliability and longevity. EXTREMELY SUSTAINABLE – Brinox is able to fully integrate different process equipment with material handling, enabling it to achieve repeatable and validated operations. EASY TO CLEAN – Cross-contamination or product spillage is avoided with the use of well-engineered components and by the implementation of the CIP (cleaning in place) and DIP (drying in place) systems in combination with off-line cleaning. ALWAYS COMPLIANT - Brinox automation systems comply with all modern standards, including the ISA S88.01 standard and 21CFR part 11 guidelines.

Material handling systems

The expert you can count on Brinox’s design and implementation of a customisable material handling systems is based on a modular approach. Brinox excels in integrating new and existing processes, most notably the optimal division between clean and non-clean systems, mastering cleaning solutions (CIP and DIP) without the need for operator intervention and in accordance with the latest ATEX directive. The production system is fully automated, production optimization and minimization of production loss caused by assembly time and space being a driving force for Brinox engineers. Control and supervision, remote if needed, of the technological parameters and operations for all of the production lines and plants is a standard Brinox GMP-certified solution. An innovative computer control system allows centralised archiving and protection of data. Brinox strives to: ¬ obtain a flexible system for handling, with the possibility of upgrade, ¬ reduce the overall handling system dimensions, using a self-standing basement, ¬ take particular care in the external finishing to ease cleaning operations, ¬ guarantee a high degree of safety.

An entirely modular system Brinox offers a complete portfolio of flexible automation solutions, based on a wholesome and integrated approach. All components are compatible and scalable and meet the highest requirements for reliability and longevity. Brinox can produce a contained Occupational Exposure Band (OEB) 1â€“5 Material Handling System, depending on User Requirements Specification (URS) and risk assessment. Brinox offers either a horizontal (single level) or a vertical (multilevel) gravitational Material Handling System.

single level MATERIAL Handling System Brinox offers a single level facility using a modular Material Handling Systems, based on traditional principles where easy-to-clean solutions are used. The Single level Material Handling System, based on Brinox Lifting Hoists, complies with the specific needs of the pharmaceutical industry and is in full compliance with the latest GMP guidelines.

Production Islands

DRY GRANULATION

COATING

WET GRANULATION

INSPECTION

TABLETING

PACKAGING

Multilevel material Handling System Brinox offers multi-level facilities based on a modular Material Handling System which considers Dr W. Lhoestâ€™s principle of a vertical material handling system with a lot of potential for automation. The diagram below shows the five-level facility with two production floors, two technical floors and one utility floor. The container docking in the technical floor can reduce production floor surface by up to 50 %. Multi-level solutions are possible with a minimum of three floors. The maximum is limitless and is defined based on the clientâ€™s technology and agreed upon together with the client and Brinox experts.

TECHINACAL FLOOR Feeding Stations; HVAC; Material trasportation; CIP

TECHNICAL FLOOR Receiving stations; Blending; Feeding stations; Material transportation (containers); CIP

WAREHOUSE

PRODUCTION FLOOR Dispensing; Granulating Tableting; Coating; Inspection;

PACKAGING FLOOR Final Goods Storage UTILITIES FLOOR Clean utility, CIP; Wardrobe

Production Islands A production island consists of one or several connected docking stations intended to supply the production equipment or one specific technological operation with raw material. The production island is controlled by PLC/SCADA inside clean room. Brinox is creating production driven material handling with different main modules at different production phases.

WET GRANULATION

TABLETING

Technical area

Clean room

Technical area

COATING

INSPECTION

PACKAGING

Technical area

Clean room

Technical area

PROCESS AUTOMATION EXAMPLE OF PHARMACEUTICAL PRODUCTION WITH VERTICAL MATERIAL FLOW PROCESS ETHERNET LAN

PAS (MES)

SIEMENS PLC

PC cabinet

SCADA LCD in inox housing

Each docking station is an autonomous unit with PLC. Multiple stations of a specific production phase are connected into production island and are operated via single SCADA system. SCADA system is then connected to plant network and can access databases, servers, etc..

Historian/SQL

SIEMENS PLC

Main material handling system modules IBC’s - Intermediate bulk containers for tablets and powders CAPACITIES ¬ for powders and granulates: 20, 25, 50, 80, 100, 150, 200, 250, 300, 400, 800, 1200, 1400, 2400, 3500l ¬ for tablets: 20, 50, 100, 150, 250, 500, 800l ¬ for capsules: 20, 50, 100, 150, 250, 500l ¬ for tablets and capsules: 300, 500, 800l DIMENSIONS ¬ 800 x 1200 mm ¬ 1200 x 1200 mm INLET AND OUTLET ¬ for vertical gravitational flow: cone valves or butterfly valves ¬ for larger containment levels: split valves ¬ outlet and containers shape can be upgraded for cohesive powders due to specially developed vibration units. MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ internal surfaces: mechanically polished Ra<0.6µm (after polishing passivation is applied) ¬ external surface: cold rolled IIIc; Ra<0.8 µm, welds as laid, for frame profiles Ra<1.2 µm. (Frame profiles are continuously welded with no dead legs.)

Butterfly Valves DIMENSIONS ¬ tablets and capsules: 150 mm ¬ powders: 250 mm Other dimensions are available. Flaps are actuated manually or equipped with a clutch for pneumatic drive. INLET AND OUTLET ¬ for orbital welding ¬ for connection with standard clamps MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ silicone covered flap for tablets and capsules ¬ internal surfaces mechanically polished Ra<0.6µm (after polishing passivation is applied) ¬ external surface Ra<0.8 µm, welds as laid. 12

Split Butterfly Valves PERFORMANCES, DIMENSIONS ¬ manual handling: from DN50 to DN250 ¬ pneumatic closing/opening function: from DN100 to DN250 Split butterfly valves are developed and produced for chemicals hazard Group D (1.0 – 10 µgm-3 dust, 0.05 – 0.5 ppm vapour exposure limits) and E (0.01 – 1.0 µgm-3 dust, 0.005 – 0.05 ppm vapour exposure limits), based on HSG193 -1999, COSHH. INLET AND OUTLET ¬ for orbital welding ¬ for connection with standard clamps MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ internal surfaces mechanically polished Ra<0.6 µm (after polishing passivation is applied) ¬ external surface Ra<0.8 µm, welds as laid.

Cone Valve PERFORMANCES, DIMENSIONS ¬ all container sizes: 350 mm and 450 mm Cone valves for vertical material flow with good performances: ¬ precise dosing of the material, ¬ used mainly on large IBC’s - up to 3500l, ¬ used for sticky materials MATERIAL LOADING ¬ receiving container: lead covered Material (powder or tablets/capsules) is always loaded to the container on the upper side through the CTU (containment transfer unit). MATERIAL DISCHARGE For material discharge the container is placed on a feeding station connected to the receiving container or production machine. During powder or tablet/capsule transfer the cone valve is opened and pulsing and/or vibration is activated. The required quantity of material is transferred to the production machine or to the receiving container. MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ seals material: FDA approved rubber ¬ internal surfaces mechanically polished Ra<0.6 µm or according to buyer’s need (after polishing passivation is applied) ¬ external surface Ra<1.2 μm, welds as laid.

Receiving Stations PERFORMANCES Designed and produced to open the container lead to enable transfer of powder or tablets from the feeding station or production machine to the receiving container when performing automated material handling. INLET AND OUTLET The receiving container is lifted with the lifting table. The containment transfer unit enables the transfer of material from the production machine to the receiving container. MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ internal surfaces mechanically polished Ra<0.6 µm (after polishing passivation is applied) ¬ external surface Ra<1.2 μm, welds as laid.

Feeding Stations PERFORMANCES Powder feeding unit (PFU) and tablet/capsule feeding unit (TFU) designed for containment transfer of powder or tablets from the cone valve container to the production machine or Receiving Station. OUTLET ¬ for connection with standard clamps ¬ powder or tablets transfer is PLC controlled MATERIALS ¬ product contact parts: AISI 316 L ¬ non-product contact parts: AISI 304 L ¬ internal surfaces mechanically polished Ra<0.6 µm (after polishing passivation is applied) ¬ external surface Ra<1.2 μm µm, welds as laid.

Lifting Hoist USAGE ¬ enables manipulation of the pharma bin from its starting position (floor) to the position for dosing (machine inlet) MOVEMENT ¬ by two independent frequency controlled drives with continuous frequency regulation ¬ simultaneous vertical and circular movement enables short manipulation times ¬ both electrical motor drives have integrated brakes to prevent uncontrolled vertical and circular movements of the lifting hoist when those movements are not activated ¬ incremental encoders are also integrated into both drives for position feedback

A unique Cleaning and Drying in Place Method Brinox continues to optimise cleaning time, detergent consumption and strict control of the drying process. Cross-contamination is avoided by implementing the CIP (cleaning in place) and DIP (drying in place) systems in combination with off-line cleaning. The modular and standard approach allows: ¬ rapid and efficient on-site assembly, ¬ a large degree of flexibility in operation, ¬ optimal utilisation of the production building, ¬ efficient maintenance. Individual sub-modules are integrated into a single frame to perform CIP (cleaning in place), SIP (sterilisation in place when needed) and DIP (drying in place).

Brinox washing systems for cleaning and drying Brinox washing systems excel for a reason: ¬ complete package: development, production, montage, startup, installation qualification, operation qualification, site acceptance testing, ¬ small, medium and large cleaning systems, ¬ own mechanical, electrical development, ¬ innovative solutions adapted to users’ needs, ¬ economical use of water, energy and detergents, ¬ repetitive cleaning results, ¬ quality production, ¬ fully documented process, high quality systems and reliable management, ¬ and a flexible team with short delivery times.

Cleaning and drying in place modules

Cleaning Techniques Low pressure chemical cleaning This cleaning technique is used for most applications in solid dosage processes and for products with high containment requirements. Applications cleaned by this technique: ¬ ¬ ¬ ¬

fluid bed dryers mixers and granulators solution preparation vessels coating pans

¬ ¬ ¬ ¬

tableting machines mixer granulator and fluid bed dryer connection chutes pipes which come in contact with the product

High pressure (150 bar) chemical cleaning This cleaning technique is used for problematic non-soluble residues. The number of CIP skids depends on the frequency of product change – equipment contaminated with one product presents one work center – line. Applications cleaned by this technique: ¬ mixer granulator ¬ fluid bed dryer ¬ suspension preparation vessel

¬ cyclones ¬ connection chutes ¬ granulate and solution transport tubes

Off-line cleaning Brinox produces efficient cleaning machines of different sizes. The machine parts and tools are placed on a special washing racks where they are cleaned and dried. Applications cleaned by this technique: ¬ IBC containers ¬ stainless and plastic barrels ¬ internal pallets (alu or plastic)

Central CIP module Functions of the Central CIP module 1. In-line preparation of cleaning media: ¬ Cold drinking water ¬ Hot softened water ¬ Purified water (cold or hot) ¬ Detergents solution (2 to 4) + mobile detergent system connection when needed 2. Blowing the pipelines with clean compressed air

Nozzles The use of retractable nozzles makes possible an efficient and repetitive CIP/DIP process. The cleaning and drying of docking stations takes place over the retractable nozzle. The number of working nozzles is defined according to the CIP media supply capacity. Nozzle open

Nozzle closed

One nozzle needs the pressure of 2 bar and flow rate of 2.4 m3/h.

A System Compliant with all standards A team of Brinox Process Automation Experts are involved in all phases of development process, from the concept to the execution and everything in between. Brinox automation systems are designed to comply with the ISA S88.01 standard and 21CFR part 11 guidelines. Brinox uses: ¬ MES interface enables integration into customer execution systems and reporting ¬ open PLC-SCADA automation solutions ¬ project execution based on GAMP 5 guidelines ¬ SQL database as secure EBR archive (Siemens, GE and Microsoft) Brinox controls all production islands and all cleaning/drying in place systems through an open protocol communication interface to the Manufacturing Execution System (MES).

MES CIP order DIP order

CIP report DIP report

Central CIP/DIP

Weight RQ

CIP/DIP execution

Weight Station state

(docking station)

CIP/DIP execution

(docking station)

Process ethernet

Brinox process systems integration

(docking station)

Load/Unload Load/ Unload

Load/Unload

FD RC

FD RC FD RC

LAN

I/O optical

HB Warehouse

Central CIP/DIP

Transport finished

Transport (AGV/LMV)

(docking station)

Transport order PNT7124-> PNT7126

Partner profile “BRINOX is a partner that brings in more than 30 years of experience. Its excellent reputation in the pharmaceutical, biopharmaceutical, and food industries is a guarantee of its flawless process systems.” BRINOX is an innovative European company specialising in fast, efficient, cost-competitive, and personalised process systems. BRINOX is on the way to becoming Europe’s first-choice partner for customised process solutions. The company focuses on developing, producing,

and installing solutions that optimally address the complex challenges of automated processes. With its headquarters in Slovenia, partners in Europe and Russia and over 250 highly skilled employees, the company has adopted a system of ambitious corporate values based on the customer-centered approach.

Regulatory compliance Client support in the field of regulatory compliance, generating customised plans for increasing productivity in line with cGMP requirements R&D A rigorous approach, advanced tools and collaboration with leading experts and institutions Conceptual design Development of the optimal solution that is cost-effective, high-performing, and GMP compliant Testing Having our own testing facilities and strict test plans allow extensive FAT prior to delivery and successful SAT. Assembly On-site assembly is provided globally, regardless of the manufacturer’s location, ensuring proper installation and guaranteeing problem-free functioning. Automation Comprehensive automation solutions are based on the ISA S88.01 standard, 21CFR part 11 guidelines, PLC-SCADA open solutions, and GAMP 5 guidelines Engineering A precise definition of the functionality of process systems, of the links between them and development of the process flow chart (P&ID diagram). Designing of every process component, anticipating any possible process problems and ensuring high levels of efficiency and productivity. Manufacturing A high level of flexibility and adaptability to ever-changing demands, guaranteeing the highest possible quality control and respecting budgetary and time constraints Quality control and validation Monitoring quality within the manufacturing system, monitoring and addressing any errors or disruptions. Assistance during validation procedures, including complete documentation support. Maintenance Intervention, repair, and assembly. Spare parts for all equipment installed, engineer-supported interventions, online support and preventive check-ups.

Brinox d.o.o. Sora 21 SI-1215 Medvode, Slovenija T: +386 1 361 97 30 info@brinox.eu www.brinox.eu

Brinox Deutschland GmbH Maria-und-Georg-Dietrich Str. 2 77652 Offenburg Deutschland T: +49 (0) 781 970 678 10 info@brinox.de

Brinox Ireland & United Kingdom Chambers House, Ellison StreetCastlebar Co. Mayo, Ireland T: +353 94 9026821, + 353 87 6264360 info@brinox.eu

ООО «БРИНОКС РУС» Кутузовский пр-т 9/2, офис 98, 121248 Москва Российская Федерация T: +7 499 243 71 55 russia.office@brinox.eu