DEC-AHOL WFI Formula
70% USP Isopropyl Alcohol formulated with 30% USP Water for Injection
DEC-AHOL WFI® Formula 70% - After years of development, Veltek Associates, Inc., has been able to produce DEC-AHOL WFI Formula, a USP Isopropyl Alcohol with USP Water for Injection formula that is not only sterile, but low in endotoxin levels. VAI was aware that simply filtering IPA might not result in acceptable endotoxin levels, therefore, creating a potential concern for cGMP/GLP operations. Addressing this concern, VAI formulated 70% USP IPA with 30% USP WFI that has very low levels of endotoxins, thus, making it an excellent choice for the critical ISO 5 (Grade A/B, Former Class 100) and ISO 7 (Grade C, Former class 10,000) aseptic manufacturing conditions. All assurances of environmental control during manufacture of DEC-AHOL WFI Formula were taken into account including: designing a closed system of manufacture, controlling endotoxin levels in elements such as tubing and final containers, formulation with low endotoxin WFI, and air washing raw material components with 0.2 micron filtered air.
DEC-AHOL WFI Formula 70% is an US-EPA registered hard surface disinfectant and sanitizer when used as directed. This USP IPA has been designed specifically for pharmaceutical, biotechnology, health care, and medical device cleaning rotations for use in both aseptic and non-aseptic environments. DEC-AHOL WFI Formula can be used for decontamination on numerous surfaces within any cleanroom operation while ensuring low endotoxin levels.
DEC-AHOL WFI Formula is 70% USP Isopropyl Alcohol with 30% Water for Injection filled in ISO 5 (Grade A/B, former Class 100), filtered at 0.2 microns, and subsequently terminally sterilized to 10-6 sterility assurance level. Each lot of DEC-AHOL WFI Formula is sterility tested according to current USP Compendium, is completely traceable, and has been completely validated for sterility and shelf life. DEC-AHOL WFI Formula is delivered each time with lot specific Certificate of Analysis, Certificate of Sterility, Certificate of Irradiation, and LAL Test Report.
DEC-AHOL WFI Formula is available in multiple container sizes including an 325 mL aerosol, 473 mL trigger spray, 473 mL squeeze bottle, 500 mL “bag in bottle” technology trigger spray, 946 mL trigger spray, 946 mL ASEPTI-CLEANSE (automatic touchless dispenser) bottle, 1000 mL “bag in bottle” technology trigger spray, 3.79 L container, 18.9 L container, and a 208 L container. Each sterile container is double bagged and packaged quadruple bagged using the ABCD Cleanroom Introduction System®. DEC-AHOL WFI Formula is packaged to comply with the requirements for transportation into a classified area.
Range of DEC-AHOL WFI Formula
Quality and Manufacturing
Formulated with endotoxin free Water for Injection
• Assayed according to current USP compendium
• Manufactured within a closed system where endotoxin levels are controlled
• Components are air washed with 0.2 micron filtered air before assembly
• Filled in an ISO 5 (Grade A/B, Former Class 100)
• Filtered at 0.2 microns
• Gamma irradiated at a 10-6 SAL
• Lot sterility tested according to current USP compendium
• Completely lot traceable from start to finish
• Completely validated for sterility and shelf life
STEEL-BRIGHT®
Stainless Steel Polish and Cleaner Sterile Cleanroom Formula
VAI manufactures a sterile stainless steel polish and cleaner that is processed to comply with the standards required by pharmaceutical, biotechnology, medical device, lab animal, and healthcare industries. STEEL-BRIGHT® has been developed for use in cleaning rotation cycles that demand a sterile stainless steel polish and cleaner to remove residue, spots, and stains in aseptic manufacturing areas and cleanroom operations. With sterile STEEL-BRIGHT, stainless steel can be restored to a residue free finish that will not rainbow or accumulate to a heavy build up. Surfaces will remain cleaner longer because there is no residue film to attract the soil. The gloss of the stainless steel is renewed and retained with wiping and buffing with no lasting powdery residue. STEEL-BRIGHT can also be used on chrome, brass, aluminum, and copper.
STEEL-BRIGHT is filled in ISO 5 (Grade A/B, former Class 100), filtered, and subsequently terminally sterilized to 10-6 sterility assurance level. Each lot of STEEL-BRIGHT is sterility tested according to current USP Compendium, is completely traceable, and has been completely validated for sterility and shelf life. STEEL-BRIGHT is delivered each time with a lot specific Certificate of Conformance,
Certificate of Sterility, and Certificate of Irradiation.
STEEL-BRIGHT is available in an 8 oz aerosol. This high quality, carbon dioxide propelled, aerosol spray can precipitates in a broad spray/mist without aspiration of the room’s air during use. Non-aspiration ensures that the master reservoir of STEEL-BRIGHT remains sterile from the first drop to the last drop. Each sterile container of STEEL-BRIGHT is individually double bagged and packaged in two
liner bags using the ABCD Cleanroom Introduction System®.
Quality and Manufacturing
• Each sterile container is double bagged packaged in easy tear bags
• Quadruple bagged in the ABCD Cleanroom Introduction System®
• Individually labeled with lot number and expiration
• Delivered with lot specific Certificate of Conformance, Certificate of Sterility, and Certificate of
Irradiation
• Available in an 8 oz aerosol that will not aspirate the room’s air
• Specifically formulated as a sterile cleanroom formula
• Professional strength stainless steel cleaner
• Emulsion based cleaner that will not rainbow or accumulate to a heavy build up
• Brightens and polishes without leaving a powdery residue
• Pleasantly lemon scented
• Contains no acids or abrasives
• Available in a saturated wipe, see: STEEL-BRIGHT® Wipe
DEC-GLASS®
Glass and Plexiglass Residue Remover and Cleaner
Sterile Cleanroom Pharmaceutical Formula
DEC-GLASS is designed for pharmaceutical and biotechnology cleaning cycles that demand a sterile glass and plexiglass cleaner capable of removing residues from disinfecting agents. DEC-GLASS is an effective one-step, ready-to-use, residue remover, glass and plexiglass cleaner that is formulated with USP Water for Injection. DEC-GLASS is an excellent cleaner designed for all washable, porous and non-porous environmental surfaces. Using DEC-GLASS, one can assure that noticeable and unnoticeable residues, smudges, oils and dirt build up are removed, thus returning the surface to its original form. Return of the surface to the original form assures that future decontamination operations will address surfaces and not the existing residues.
DEC-GLASS is available in a 16 oz. trigger spray bottle. Terminal sterilization is achieved by first filtering the solution at 0.2 microns, secondly, double bag packaging each container, and then subsequently sterilizing the entire contents via gamma irradiation. DEC-GLASS is delivered each time with the lot specific Certificate of Analysis, Certificate of Sterility and Certificate of Irradiation. DEC-GLASS is completely traceable and has been completely validated for sterility and shelf life.
Quality and Manufacturing
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Filled in an ISO 5 (Grade A/B, Former Class 100) operation
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Filtered at 0.2 microns
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Gamma irradiated to a sterility assurance level of 10-6
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Sterility tested according to current USP compendium
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Completely traceable from start to finish
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Completely validated for sterility and shelf life
DEC-CLEAN®
Residue Remover and Cleaner
Pharmaceutical Cleanroom Formula
DEC-CLEAN is designed for and processed to meet the standards required by pharmaceutical, biotechnology, healthcare, and lab animal research operations that demand a cleaning agent to remove residues left behind from disinfecting agents. DEC-CLEAN is an effective one-step residue remover when diluted at 1:128 (1 oz. per 1 gallon) of hard or soft water (400 ppm hard as CaCO3). Due to DEC-CLEAN’s formulation it is an excellent cleaner designed for all washable, non-porous environmental surfaces. Using DEC-CLEAN, one can assure that noticeable and unnoticeable residues are removed, thus returning the surface to its original form. Residues left behind from disinfectants, sanitizers, and sporicidies, including Sodium Hypochlorite can be easily removed using DEC-CLEAN. Returning the surface to its original form assures that future decontamination will be able to penetrate to the surface.
DEC-CLEAN is filled in ISO 5 (Grade A/B, Former Class 100), filtered, and then subsequently terminally sterilized to 10-6 sterility assurance level. Each lot of DEC-CLEAN is sterility tested according to current USP Compendium, is completely traceable, and has been completed validated for sterility and shelf life. DEC-CLEAN is delivered each time with a lot specific Certificate of Analysis, Certificate of Sterility, and Certificate of Irradiation.
DEC-CLEAN is available in multiple container sizes including a 1 gallon, 16 oz trigger spray, unit dose, and a 200 L drum. DEC-CLEAN 1 gallon, 16 oz, and 200 L containers come in our one-step, ready-to-use SimpleMix® System that allows for exact and fresh formulations each and every time without handling the concentrate. Each sterile container of DEC-CLEAN is individually double bagged and packaged in two liner bags using the ABCD Cleanroom Introduction System®.
Quality and Manufacturing
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Filled in an ISO 5 (Grade A/B, Former Class 100) operation
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Filtered
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Components are air washed with 0.2 micron filtered air before assembly
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Gamma irradiated at a 10-6 SAL
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Lot sterility tested according to current USP compendium
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Completely traceable from start to finish
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Completely validated for sterility and shelf life
DEC-SPORE 200 Plus
Peractic Acid & Hydrogen Peroxide Solution
Sterile Pharmaceutical Clean Room Formula
Dec-Spore 200 Plus is a peroxyacetic acid and hydrogen peroxide solution, and an effective Sterilant, Virucide, Disinfectant, Sanitizer and booster for alkaline detergents. This product disinfects as it cleans in one operation and is available in two concentrations. Dec-Spore 200 Plus is a broad-spectrum hard surface disinfectant that has been shown to be effective against (influenza A viruses – tested and listed on the label) and is expected to inactivate all influenza A viruses including Pandemic H1N1 (formerly called swine flu).
Dec-Spore 200 Plus is filled in ISO 5 (Grade A/B, former Class 100) and filtered at 0.2 microns into sterile components. It is available in several container sizes both sterile and non-sterile. Each lot is delivered with lot specific Certificate of Analysis and Certificate of Sterility. Dec-Spore 200 Plus products are completely traceable and have been completely validated for sterility and shelf life.
The SimpleMix® System Technology Alternative:
Veltek Associates, Inc. has developed the SimpleMix System Technology to eliminate measuring and additional containers. It provides for the transfer of the sterile concentrate 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 sterility concerns. It assures the accurate measurement of a concentrate. The Patented (US Patent 6851580, 7066354) SimpleMix System Gallon and 16oz Systems provide a sealed multi-chamber container that when activated mixes the solution to the use dilution. The opening on the top of the gallon size contains the concentrate and the bottom reservoir contains the USP WFI Quality Water. The 16 ounce side container houses the concentrate and the bottom reservoir houses the USP WFI Quality Water. Just open the small chamber cap, push the plunger container completely down until the bottom pops open and the bellows are compressed. The solution and water mix together. The system design permits the easy transfer of the product to the aseptic manufacturing area without concern for the transfer of contamination.
Product Features
VAI manufactures an EPA registered Peracetic Acid and Hydrogen Peroxide Solution that is for use as a bord spectrum sanitizer, Sporicides, fungicide cleaner and deodorizer. Decspore is the mixture work as a effective disinfectant and Sporicides. Dec-spore 200 plus has been developed for use in cleaning rotation cycles where hard surface disinfectant are essential to maintaining a clean environment.