SimpleMix. 16 oz, 1 Gallon, and 200 L SimpleMix System

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Christian Murphy
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1 SimpleMix 16 oz, 1 Gallon, and 200 L SimpleMix System

2 SimpleMix Page 2 of 6 The Transfer of Disinfectants and Sporicides to ISO 5 Areas In review of compliant methods of transferring disinfectants and sporicides to the aseptic manufacturing area, a variety of industry practices exist. Common methods include: 1) Creating a use-dilution, filter sterilizing the solution into the aseptic area, 2) Using a unit dose sterile disinfectant or sporicide and sterile water to mix within the aseptic area 3) Using a 1-gallon container and a measuring cup to formulate with sterile water within the aseptic area. In each scenario, difficulty in true compliance is commonplace. In review of the obstacles associated with each system, we see the following problematic scenarios: Filter sterilizing agents to the aseptic area: In creation of a filtration process, firms must first assure the validated mixing of the agent with quality water in a tank located exterior to the classified area. The solution is then pumped to the aseptic area through pre-sterilized lines and a sterile, bubble point tested (before and after) 0.2 micron filter. Subsequently, the solution is required to be filled into presterilized containers, buckets or internal holding vessels. This system is very involved, expensive, time consuming and requires a complete documentation trail of processing. In the end, it may be questioned whether such solutions are actually sterile due to the handling process. Unit Dose or 1-gallon containers: When unit dose containers or 1-gallon containers (with measuring cup) are used, the problematic situation is always where to attain the sterile water for the dilution. Attaining sterile water requires a Water for Injection (WFI) line (drop) within the aseptic area or the purchase of an expensive Quick to use sterile water. As the mixing of the chemical agent should not occur exterior to the aseptic area, this becomes a challenge for most GMP operation. Incorporating a WFI water drop within the aseptic area is not recommended as water within the aseptic manufacturing environment may be a possible and continued source of contamination to the The SimpleMix System Technology Alternative As an innovative step to address this problematic situation, developed the SimpleMix System Technology. The system provides for the transfer of the sterile disinfectant and sterile water in a sealed container to the aseptic area. The system container is double bag packaged for easy transfer and eliminates all internal and external concerns for the use of a sterile, compliant disinfectant or sporicide. The Patent Pending SimpleMix System provides a sealed multi-chamber container that when activated mixes the two solutions. The top part contains the concentrate disinfectant or sporicide and the bottom part contains the USP WFI Quality Water. The system design permits the easy transfer of the sterile disinfectant or sporicide and sterile water to the aseptic manufacturing area without concern for the transfer of contamination.

SimpleMix Page 3 of 6 Advantages and Features Eliminates concerns by regulatory agencies for proper mixing and sterility of the solution. No more filtering solutions to aseptic manufacturing areas.

No more concerns for mixing and handling concentrate phenolics, quaternary ammoniums, peracetic acid & H202 or Cleaners with sterile water in aseptic manufacturing operations All chemical agents and

The contents of the double bag disinfectant and cleaners packaging are sterilized through a validated gamma radiation cycle that assures a 10-6 Sterility Assurance Level.

3 SimpleMix Page 3 of 6 Advantages and Features Eliminates concerns by regulatory agencies for proper mixing and sterility of the solution. No more filtering solutions to aseptic manufacturing areas. No more need to assure sterile USP Water for Injection is present in the aseptic area. No more concerns for mixing and handling concentrate phenolics, quaternary ammoniums, peracetic acid & H202 or Cleaners with sterile water in aseptic manufacturing operations All chemical agents and the WFI Quality Water in the SimpleMix System are filtered at 0.2 microns and manufactured in a ISO 5 (Grade A-B, former Class 100) filling operation. The contents of the double bag disinfectant and cleaners packaging are sterilized through a validated gamma radiation cycle that assures a 10-6 Sterility Assurance Level. The components of the sporicide package are aseptically filled into pre-sterilized containers. All product lots are sterility tested per current USP compendium. The system assures the appropriate dilution is made each time in a closed, sterile system. Dilutions are made safely as concentrate solutions are never handled. Available in DECON-PHENE, DECON-CYCLE, DECON-QUAT 100, DECON- QUAT 200C, DECON-CLEAN and DECON-SPORE 200 Plus. Also custom manufacturing is available. Available in 1-Gallon Containers, 16-ounce Trigger Sprayers and 200 Liter Drums

SimpleMix Page 4 of 6 The SimpleMix System Chemical Agents DECON-PHENE: a high ph phenolic at a 1:128 use dilution and a 2:128 use dilution DECON-CYCLE: a low ph phenolic at a 0.

5:128 use dilution DECON-CLEAN: a residue remover at a 1:128 use dilution DECON-SPORE 200 Plus: a peracetic acid and hydrogen peroxide at a disinfectant or sporicide dilution The 200 Liter Aseptic

4 SimpleMix Page 4 of 6 The SimpleMix System Chemical Agents DECON-PHENE: a high ph phenolic at a 1:128 use dilution and a 2:128 use dilution DECON-CYCLE: a low ph phenolic at a 0.5:128 use dilution and a 1:128 use dilution DECON-QUAT 100: a quaternary ammonium at a 2:128 use dilution DECON-QUAT 200: a fifth generation quaternary ammonium at a 0.5:128 use dilution DECON-CLEAN: a residue remover at a 1:128 use dilution DECON-SPORE 200 Plus: a peracetic acid and hydrogen peroxide at a disinfectant or sporicide dilution The 200 Liter Aseptic Mixing System The SimpleMix 200 Liter Mixing System is another innovative solution from VAI to assist large scale manufacturing operations with the difficult task of getting sterile disinfectants, cleaners and sporicides to their aseptic areas. The SimpleMix 200 Liter Aseptic Mixing System provides the ability to mix 200 liter solutions of disinfectants, cleaners and sporicides in a closed system for the users who require larger volumes of cleaning agents in their operations. The patented SimpleMix 200 Liter Closed Mixing System incorporates three integral parts a 200 liter container of 0.2 micron filtered sterile USP Water for Injection Quality Water (bottom container), a cubicontainer of 0.2 micron filtered sterile concentrate, disinfectant, cleaner or sporicide (top container) and a patented hose and value system. The 200 Liter container and the cubicontainer are connected via the sterile hose and valve system awaiting activation by the end user. The entire 200 Liter container, cubicontainer and hose and value system are double-bagged packaged and shipped to the end user on a skid ready for transportation to their required site.

5 SimpleMix Page 5 of 6 The method of attaining a sterile product by VAI is dependent upon the concentrate disinfectant, cleaner or sporicide s stability in varying sterilization methodologies. Two methods are employed by VAI. Products are either aseptically filled in a ISO 5 (Grade A, former Class 100) area utilizing pre-sterilized components (DECON-SPORE 200 Plus) or packaged in a, ISO 5 (Grade A, former Class 100) area and subsequently terminally sterilized through a validated 10-6 SAL gamma irradiation cycle (DECON-PHENE, DECON-CLEAN, DECON-QUAT 100, DECON-QUAT 200C & DECON-CYCLE ). The SimpleMix 200 Liter Aseptic Mixing System (WFI Quality Water and disinfectant, cleaner or sporicide) is subsequently tested per lot for sterility via current USP compendium. As received by the end user, the entire 200 Liter container is double-bagged packaged and skidded for ease of transfer via dolly, manual or automated lifting/transporting device to a ISO 8 (Grade C, former Class 100,000) area where one outer bag is removed. The 200 Liter container is then transferred to a ISO 7 (Grade B, former Class 10,000) area where the second outer bag is removed prior to entry into the ISO 5 (Grade A-B, former Class 100) area. Mixing Instructions for 200 Liter Containers One hose is inserted into the peristaltic pump. The pump can be located in any grade area as the SimpleMix 200 Liter container is a closed mixing system. This allows the container to be mixed in lower classifications and pumped to the desired end use point or mixed in the higher classification area as all the contents in the double-bagged packaging are delivered sterile from VAI. The peristaltic pump mixes the cubicontainer containing the concentrate with the Water for Injection Quality Water for approximately 3-5 minutes. The solution is contained in a closed sterile disposal system. By opening the dispense valve the sterile solution can be distributed through the sterile closed system to end use point. Once the end valve is closed, the system ensures its sterile integrity for the next use. Mixing Instructions for Gallon and 16 ounce Containers See primary label for use instructions and precautionary statements: 1. Remove the cap of the concentrate from the gallon container or 16oz container 2. Remove induction seal 3. Push inside plunger container completely down until bottom pops open and bellows are compressed 4. Allow all contents of the plunger container to mix into lower container 5. Replace the SimpleMix cap 6. In swirl motion, shake container for 15 seconds 7. Open side cap and pour or spray

6 SimpleMix Page 6 of 6 Ordering Information 16 ounce Containers Order Number Description Sterile/Non-Sterile Qty/Cs DC-06-16Z-01 DECON-Clean Sterile 12 DC-07-16Z-01 DECON-Clean Non-Sterile 12 DCY-06-16Z-01 DECON-CYCLE Sterile 12 DCY-07-16Z-01 DECON-CYCLE Non-Sterile 12 DCY-06-16Z-02 DECON-CYCLE Sterile 12 DCY-07-16Z-02 DECON-CYCLE Non-Sterile 12 DP-06-16Z-01 DECON-PHENE Sterile 12 DP-06-16Z-02 DECON-PHENE Sterile 12 DP-07-16Z-01 DECON-PHENE Non-Sterile 12 DP-07-16Z-02 DECON-PHENE Non-Sterile 12 DQ Z-01 DECON-QUAT 100 Sterile 12 DQ Z-01 DECON-QUAT 100 Non-Sterile 12 DQ200C-06-16Z-01 DECON-QUAT 200C Sterile 12 DS Z-01 DECON-SPORE 200 Plus (sporicide) Sterile 12 DS Z-01 DECON-SPORE 200 Plus (sporicide) Non-Sterile 12 DS Z-02 DECON-SPORE 200 Plus (disinfectant) Sterile 12 DS Z-02 DECON-SPORE 200 Plus (disinfectant) Non-Sterile 12 1 Gallon Containers Order Number Description Sterile/Non-Sterile Qty/Cs DC-04-1Z DECON-Clean Sterile 4 DC-05-1Z DECON-Clean Non-Sterile 4 DCY-04-1/2Z DECON-CYCLE Sterile 4 DCY-05-1/2Z DECON-CYCLE Non-Sterile 4 DCY-04-1Z DECON-CYCLE Sterile 4 DP-04-1Z DECON-PHENE Sterile 4 DP-04-2Z DECON-PHENE Sterile 4 DP-05-1Z DECON-PHENE Non-Sterile 4 DQ Z DECON-QUAT 100 Sterile 4 DQ Z DECON-QUAT 100 Non-Sterile 4 DQ200C-04-2Z DECON-QUAT 200C Sterile 4 DS /2ZA DECON-SPORE 200 Plus (disinfectant) Sterile 4 DS /2ZA DECON-SPORE 200 Plus (disinfectant) Non-Sterile 4 DS200-04A DECON-SPORE 200 Plus (sporicide) Sterile 4 DS200-05A DECON-SPORE 200 Plus (sporicide) Non-Sterile Liter Containers Order Number Description Sterile/Non-Sterile Qty/Cs DC L-CI DECON-Clean Sterile 1 DCY L-CI DECON-CYCLE Sterile 1 DP L-CI DECON-PHENE Sterile 1 DQ L-2XI DECON-QUAT 100 Sterile 1 DS L-SD-CI DECON-SPORE 200 Plus (sporicide) Sterile 1 DS L-SD-CI DECON-SPORE 200 Plus (disinfectant) Sterile 1 Patents:

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PRODUCT NO.: 7182-01 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