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Kathryn Carroll
5 years ago
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1 PRODUCT NO.: STARTER KIT (Germfree) For GermFree Glove Box DESCRIPTION: This convenient starter kit will allow the operator to jumpstart their cleaning with the GermFree Compounding Aseptic Isolator Glove Box. ADDITIONAL INFORMATION: Applicable Products: Included Parts: 1 x Sharps Container 1 x pk/30 IPA Saturated Wipes (9 x 11, Sterile, 70% USP Grade IPA, 30% DI Water) 20 pairs of Sterile Gloves, XL 1 x pk/25 Dry Wipes (9 x 9, Sterile, Non-pyrogenic, Non-woven) 1 x 32oz. Bottle of Accel TB Disinfectant/Cleaner Spray w/trigger 1 x Stainless Steel Mop w/12 Mop Heads 1 x 16oz. Bottle of Contec Sterile 70% Isopropanol Spray w/trigger 2 x Waste Port Disposable Bags, Yellow Note: The included parts are described in order as seen in the list above. Page 1 of 5

of polypropylene wipes saturated with a solution of 70% isopropanol alcohol and 30% deionized water in a resealable pouch. The pouch opens easily and the wipes are readily dispensed.

2 Sharps Container 5 gallon w/screw cap Dimensions: 10.5 W x 7.5 D x 18 H Handles designed for safe movement and transportation Hinge caps designed to provide temporary and final closure features IPA Saturated Wipes (Sterile, pk/30) The PROSAT PS-911EB consists of polypropylene wipes saturated with a solution of 70% isopropanol alcohol and 30% deionized water in a resealable pouch. The pouch opens easily and the wipes are readily dispensed. The PROSAT PS-911EB utilizes a meltblown polypropylene wipe which is exceptionally clean, being free from additives of any kind, and has a very low concentration of sodium. Increase solvent control and accountability and reduce VOC emissions with this sterile (per AAMI Guidelines) wipe. Compatible with ISO Class 5 cleanrooms. Wipe Material: Polypropylene Dimensions: 9 x 11 Wipe construction: Meltblown non-woven Solution of saturation; (blend ratio and constituents): 70% isopropanol alcohol/30& de-ionized water) Solvent grade: USP Page 2 of 5

A unique manufacturing process gives this wipe the greatest level of intrinsic sorbency, and quickest rate of sorbency, of any cleanroom compatible nonwoven wipe available.

3 Dry Wipes (Sterile, pk/25) The DuPont Sontara 9 x 9 non-pyrogenic wipe has been specially engineered as a cleanroom wipe. Made by DuPont, this Contamination Control Fabric incorporates maximum sorptive capacity, particle removal capability and low levels of particulate and extractable contaminants. A unique manufacturing process gives this wipe the greatest level of intrinsic sorbency, and quickest rate of sorbency, of any cleanroom compatible nonwoven wipe available. Nonwoven wipe, polyester/rayon blend Passes LAL test for endotoxins < 20 EU/device Validated sterile per AAMI Guidelines SAL of 10-6 Unique surface texture provides effective cleaning and particle removal 32oz Bottle of Accel TB Disinfectant/Cleaner Spray w/trigger TB is an EPA registered hospital disinfectant w/0.5% hydrogen peroxide for use on environmental surfaces in pharmaceutical cleanrooms, compounding pharmacies and animal labs where short contact time is beneficial. Accel TB is based on Accelerated Hydrogen Peroxide, (AHP), a synergistic blend of commonly used, ingredients that, when combined with low levels of hydrogen peroxide, dramatically increase its germicidal potency and cleaning performance. 30 Second Non Food Contact Broad-Spectrum Sanitizer giving a 3 Log (99.9%) reduction in Vegetative Bacteria Short contact times ensure effective decontamination No active residues as Hydrogen Peroxide breaks down into water and oxygen No disinfectant rotation required due to oxidizing mechanism of Accel TB User friendly and can be used daily Page 3 of 5

Easy Reach Mop EasyReach Cleaning Tool is a one piece handle/headframe used to gain access to hard to reach areas or confined spaces. Ideal to use inside isolators, fume hoods, glove boxes, RABS, etc.

4 Easy Reach Mop EasyReach Cleaning Tool is a one piece handle/headframe used to gain access to hard to reach areas or confined spaces. Ideal to use inside isolators, fume hoods, glove boxes, RABS, etc. This unit is 304 stainless steel and can be autoclaved or cold sterilized. 17 Length Stainless steel construction is lightweight, yet durable Use with all EasyReach cleaning pads; dry, presaturated, sterile and nonsterile Autoclavable at 121 C for 30 minutes Easy Reach Cleaning Pads Specially designed tab enables quick and easy fitting to the frame with gloved hands Presaturated EasyReach cleaning pads eliminate the need for 70% IPA spray, minimizing transfer of materials and simplifying cleaning procedures Well-fitted quilted polyester pad ensures effective, even surface coverage reducing the number of viable and non-viable contaminants and ensuring maximum residue removal Cleanroom laundered, validated sterile, single-use pads ensure no bioburden is added to the critical environment Package sizes are optimized for single session use minimizing waste; double bagged Page 4 of 5

16oz. Bottle of Contec Sterile 70% Isopropanol Spray w/trigger Contec Sterile 70% Isopropanol contains 70% by volume USP Grade Isopropanol (IPA) and 30% USP Grade Purified Water. Filtered to 0.

5 16oz. Bottle of Contec Sterile 70% Isopropanol Spray w/trigger Contec Sterile 70% Isopropanol contains 70% by volume USP Grade Isopropanol (IPA) and 30% USP Grade Purified Water. Filtered to 0.2μ and induction sealed to assure sterility, the bottles are doublebagged and gamma-irradiated. Each bottle has a lot code and expiration date for easy record keeping. Validated per the Association for the Advancement of Medical Instrumentation (AAMI) 11137:2006 Guidelines to a 10-6 Sterility Assurance Level (SAL). Note: Sterility validation is performed after trigger is installed. Appearance: Clear, colorless liquid Odor: Characteristic alcohol Water Quality: Meets the requirements of USP Grade Deionized Water % IPA Contents (+/-3%): 67.9% % Specific Gravity (20 C): Page 5 of 5

Cleaning & Disinfecting Products for Sterile Compounding

Cleaning & Disinfecting Products for Sterile Compounding Designed for: Compounding Pharmacies Pharmacy Cleanrooms Primary Engineering Controls Hazardous Drug Compounding Outsourcing Facilities www.contechealthcare.com