Aseptic Testing and Environmental Monitoring

ASEPTIC TESTING and ENVIRONMENTAL MONITORING

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

Media Test Kits & CSP Complexity Kits

Test Media - Contains Tryptic Soy Broth to encourage bacterial growth.

Note: Additional materials required to perform each test.

Media Test Kit, Low Complexity

Includes:

- (12) 5mL Vials containing test media

- (3) 50mL Sterile Vials (empty)

Media Test Kit, Medium Complexity

Includes:

- (3) 50mL Vials containing test media

- (6) 50mL Sterile Vials (empty)

- (3) 10mL Sterile Vials (empty)

Media Test Kit, High Complexity

Includes:

- (1) 3 gram Vial containing test media

- (9) 10mL Sterile Vials (empty)

CSP Low Complexity Kit

Includes:

- (1) 100mL TSB Serum Vial

- (3) 20mL Sterile Serum Vials (empty)

-

(1) Whirl-Pak® Bag

- (1) Results Log Sheet

CSP Medium Complexity Kit

Includes:

- (1) 1,000mL TSB Dual Port Bag (filled 700mL)

- (6) 100mL Sterile Dual Port Bags (empty)

- (6) 20mL Sterile Serum Vials (empty)

- (1) Whirl-Pak® Bag

- (1) Results Log Sheet

CSP High Complexity Kit

Includes:

-

Complexity matters!

-

(1) 125mL TSB Non-sterile Powder

(3 gram filled)

(9) 20mL Sterile Serum Vials (empty)

-

(1) Whirl-Pak® Bag

- (1) Results Log Sheet

USA HCL Item # Description

ü

A 17449 Media Test Kit, Low Complexity

ü

B 17450 Media Test Kit, Medium Complexity

ü

C 17451 Media Test Kit, High Complexity

ü

D 18242 CSP Low Complexity Kit

ü

E 18243 CSP Medium Complexity Kit

ü

F 18244 CSP High Complexity Kit

Media Test Kit, Multi-Tech

DIY Convenience - Create your own media fill challenge for up to 5 technicians by choosing the components that most closely represent your most complex procedure as required by USP <797>.

Includes:

- (5) 100mL TSB Media Bag

- (5) 3mL TSB Ampules (dyed red)

- (5) 20mL Serum Needle Port Septum Vials

USA HCL Item # Description

ü G 19873 Media Test Kit, Multi-Tech

hcl@GoHCL.com • Call: 1.800.848.1633 • Fax: 1.800.447.2923

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

A La Carte Media Test Supplies

DIY Convenience - Use a la carte items to create your own media fill challenge and match your most complex procedure as required by USP <797>. Tests allow users to document correct personnel technique and effective environmental control for the preparation of compounded sterile products.

TSB IV Bags for Media Test, 100mL & 700mL

Detect Microorganisms - IV bags contain TSB, which is a growth medium for bacteria and microbes and helps detect evidence of a wide variety of microorganisms. Each bag includes a needle port and spike port.

TSB Needle Port Septum Vials, 15mL & 100mL

High Quality Materials - Glass vials are filled with TSB and sealed with a chlorobutyl stoppers and blue plastic caps.

20101 - 20ml vials filled with 15ml of TSB

20201 - 100ml vials filled with 100ml of TSB

Empty Serum Vials

Sterile Container - Sterile empty vial with rubber stopper and aluminum ring. Vials are not FDA registered and are not appropriate for medication storage.

Red Dyed TSB Ampules, 3mL

Lifelike Simulation - Glass ampules are filled with red TSB to simulate commonly used chemotherapy agents. Protect against cuts and contamination with disposable ampule breakers, 10273.

Disposable Ampule Breakers

Safer Handling - Reduces the chance of finger cuts and cross contamination.

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

Irradiated SabDex Agar

Contact Plates, 65mm

Media - Irradiated Sabouraud Dextrose Agar with Lecithin and Tween 80 is recommended for the detection and enumeration of yeasts and fungi from environmental sources in a cleanroom setting.

Locking lid for safe transport!

Terminal Irradiation - Validated for a Sterility Assurance Level (SAL) of 10-6. Certificate of Analysis available upon request.

Room Temperature Storage - Terminally irradiated plates do not require refrigeration.

Molded Grid - Each plate has a molded grid to aid in counting microorganisms.

Note: Contact plates have a 30-day expiration.

This temperature sensitive product will ship via UPS or FedEx Next Day. Product ships Monday - Thursday only.

Quantity - 10 per package; triple bagged; 2 nylon inner bags; 1 outer Mylar® heat-sealed bag with easy-tear notch

Dimensions - 15mm H x 65mm Dia.

Item # Description Qty.

A 20940

Irradiated SabDex Agar 10 Contact Plates, 65mm

Irradiated Tryptic Soy Agar

Contact Plates, 65mm

Media - Irradiated Tryptic Soy Agar with Lecithin and Tween 80 is recommended for use as a general growth medium for establishing microbiological trends, alerts and action levels in biologically controlled environments.

Terminal Irradiation - Validated for a Sterility Assurance Level (SAL) of 10-6. Certificate of Analysis available upon request.

Room Temperature Storage - Terminally irradiated plates do not require refrigeration.

Molded Grid - Each plate has a molded grid to aid in counting microorganisms.

20939 Only - Media is tinted red for easy identification.

Note: Contact plates have a 30-day expiration.

This temperature sensitive product will ship via UPS or FedEx Next Day. Product ships Monday - Thursday only.

Quantity - 10 per package; triple bagged; 2 nylon inner bags; 1 outer Mylar® heat-sealed bag with easy-tear notch

Dimensions - 15mm H x 65mm Dia.

Locking Lid

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

Malt Extract Agar Contact Plate, 60mm

Detect Fungus - Quick, efficient method to test for mold and fungal growth in cleanroom areas. After compounding, swab surface and inoculate the plate, twist to lock, then incubate to gather results.

Ingredients - Plastic plate is filled with Malt Extract Agar (used to grow fungi, mold and yeast), Lecithin and Tween® (neutralizing agents that prevent growth interference from cleaning and disinfecting agents).

Expiration - Contact Plates have a 30-day expiration.

Dimensions - 15mm deep x 60mm Dia.

This temperature sensitive product will ship via UPS Next Day or FedEx Next Day. Product ships Monday-Thursday only. Refrigerate immediately upon arrival.

These plates can be used with air samplers!

USA HCL Item # Description Qty.

ü A 19860 Malt Extract Agar Contact Plate, 60mm 10

Surface Testing Contact Plate, 60mm

Fingertip Testing Contact Plate, 100mm

Monitor Bacterial Growth - Easily determine the efficiency of cleaning programs and aseptic techniques by monitoring the growth of bacterial colonies on incubated samples.

Ingredients - Plastic plate is filled with Malt Extract Agar (used to grow fungi, mold and yeast), Lecithin and Tween® (neutralizing agents that prevent growth interference from cleaning and disinfecting agents).

Expiration - Contact Plates have a 30-day expiration.

Dimensions - 15mm deep x 60mm Dia.

This temperature sensitive product will ship via UPS Next Day or FedEx Next Day. Product ships Monday-Thursday only. Refrigerate immediately upon arrival.

19373 Surface testing contact plates can be used with air samplers!

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

Chemo Training Kit

Hands-on Learning - Training and certification program educates participant(s) about the proper techniques and risks associated with handling cytotoxic drugs.

Multi-Use - 1 kit can be used to train 1 user multiple times or 5 separate users.

Kit Includes:

- 5 x 50mg Fluorescein Sodium Salt

- 5 x 3mL Fluorescein Solution 0.05%

- Recording log

Note - Chemo Training Kits have a 60-day expiration.

USA HCL Item # Description

ü A 20805 Chemo Training Kit

Nail Picks

Promote Proper Hygiene - Disposable plastic fingernail picks help achieve compliance with USP <797> requirements for proper hand hygiene. Designed for use prior to surgical hand antisepsis.

Quantity - 150 per pack, 6 packs per case; 900 picks total

USA HCL® Item # Description Qty.

B 20235 Nail Picks 1 20235-31 Nail Picks, case 6

Purell® LTX-12™ Surgical Scrub Dispenser

Convenient - Touchless dispenser encourages the use of hand scrub in medical facilities to help minimize the spread of infection. Designed for use with 19777 Waterless Surgical Scrub Gel. Side label provides instructions for proper cleaning technique.

Secure - LOCK OR NOT™ technology allows users to lock the dispenser and avoid tamper or gel refill removal using the included key.

Durable - Sturdy plastic housing features a clear viewing window and indicator light that signals when refill is required. Requires 4 D batteries, included.

Monitor Use - Works with GOJO® SMARTLINK™ Hand Hygiene Technology, which allows users to monitor staff compliance by turning real-time data into actionable information.

Purell Waterless Surgical Scrub Gel, Non-Sterile, 1,200mL

Active Ingredient - 70% Ethyl Alcohol

Follow Protocol - Pair with Nail Picks to meet proper hand hygiene protocol.

Persistent Activity - Alcohol-based surgical scrub formula kills microorganisms instantly and provides persistent activity to protect compounded sterile preparations from potentially harmful microbial exposure.

Compatible - Safe for use with latex, neoprene and polyisoprene gloves.

Eco-Friendly - Smart Flex™ PET bottle uses 30% less material than HDPE. Built-in technology prevents bottle from collapsing during use.

For more information about Purell persistent activity data, go to GoHCL.com

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

gohcl.com

ü

B 19522

Sterile DECON-AHOL® WFI Formula

Active Ingredient - 70% IPA

Alcohol cleaning solutions are made with 70% USP Isopropyl Alcohol and 30% Water For Injection (WFI).

Cleanroom Ready - Filtered to 0.2 microns and sterilized using gamma-irradiation and validated sterile to 10-6.

Double-bagged in easy tear bags and ready for introduction to the cleanroom.

EPA Registered: 19175 & 19175-31, 19522 & 19522-31, 19471 & 19471-31 -

Qty.

Sterile DECON-AHOL WFI Formula, Trigger Spray, 16 oz. 1

Sterile DECON-AHOL WFI Formula, Trigger Spray, 16 oz., case 12

Sterile DECON-AHOL WFI Formula, Squirt Bottle, 16 oz. 1

ü 19522-31 Sterile DECON-AHOL WFI Formula, Squirt Bottle, 16 oz., case 12

ü

C 19471 Sterile DECON-AHOL WFI Formula, 1-Gallon 1

ü 19471-31 Sterile DECON-AHOL WFI Formula, 1-Gallon, case 4

more brillaint cleaning options available at

SureTemp™ Digital Incubator, 40L

Operating Temperature Range - Ambient +5° to 75°C

Improve Accuracy - SureCheck™ technology allows users to set and monitor air temperature throughout incubation to determine that set points were met. User-set intervals allow users to record temperatures as often as every 60 seconds. Use a flash drive (not included) to download data points for easy record keeping.

Dual-Convection Technology - Allows users to choose between Mechanical Convection Mode for exceptional temperature uniformity or Gravity Convection Mode for longer incubations where airborne contamination or drying of samples may be an issue.

ASEPTIC TESTING & ENVIRONMENTAL MONITORING

MyTemp™ Mini Digital Incubators

Operating Temperature Range:

20910 - 15°C below ambient to 60°C 19702 - Ambient +1° to 60°C

Dual Functioning - Heats and cools (20910 only) to meet a wider range of regulations.

Easy to Use - Automatic operation and digital display allow users to confidently choose their desired temperature with peace-of-mind monitoring. Features a large LED control panel that displays chamber temperature.

Small Footprint - Compact unit has a generous interior with 2 adjustable shelves. An internal outlet powers small instruments and minimizes cord clutter outside the unit.

PO Box 25

Circleville, Ohio 43113-0025

EMBRACE COMPLIANCE