VAI WFI Quality Water® Water for Injection Quality Water Sterile Pharmaceutical Clean Room Formula VAI WF I -01-E Rev. 20 November 2014 File Data Technical
Veltek Associates, Inc., 15 Lee Boulevard, Malvern, PA 19355 USA T: 610-644-8335 F: 610-644-8336 www.sterile.com O V E R V I E W 1 of 4
VAI WFI Quality Water For Sterile Disinfectant Dilutions in Clean Room Operations
VAI has an innovative solution for those GMP facilities that demand the use of a high quality water grade in their daily operations. VAI’s WFI Quality Water is produced from our validated WFI water system. The system is routinely monitored and passes all of the USP test requirements for the monograph for “Water for Injection”.
Manufacturing of the final product into smaller container sizes is conducted in GMP, Class 100 (ISO 5, Grade A) conditions. All concerns are vested in maintaining the environmental conditions to an acceptable and compliant level. During manufacturing, VAI’s WFI Quality Water is filtered at 0.2 microns and filled into a 16 ounce trigger spray, 11oz aerosol, 1 gallon, 2 gallon or 200 liter containers. All containers are cleaned with 0.2 micron filtered air prior to filling. The 16 ounce, 1 and 2 gallon containers are then double bag packaged and sterilized through a validated gamma radiation cycle. The 16 ounce and 1 gallon containers are an excellent choice for dilution of disinfectant concentrates to a use-dilution mixture. The 200 liter container is manufactured through an aseptic manufacturing operation into the VAI Carboy Bag System. The system for manufacture of the 200 liter container is completely closed system. There is no exposure of the solution to the environment at any phase in the filling operation. The 200 liter container is a larger vessel and also intended for dilution of disinfectant concentrates to a use-dilution mixture.
VAI’s WFI Quality Water is in a class of its own. The intended use of the WFI Quality water is for disinfectant preparation and dilution and not for parenteral administration. Each lot of product is tested for sterility and endotoxin levels. Assay is conducted per the current compendium for Sterile USP Water for Injection. Sterility and endotoxin levels are done per the current USP compendium. The USP standard for endotoxin levels is < 0.25 EU/ml. and VAI’s WFI Quality Water consistently falls below 0.03 EU/ml. VAI has validated the expiration for the product at 2 years. Initial validation also tested for Calcium, Sulfate, Chloride, Ammonia, Carbon Dioxide, Silica, Heavy Metals, Total Solids and Coliforms all with not detectable results.
Order# Description Quan/cs. VAI-WFI-16Z VAI WFI Quality Water 16 oz Trigger Spray Container Sterile 12 VA-IWFI-1G VAI WFI Quality Water 1 Gallon Container Sterile 4 VAI-WFI-2G VAI WFI Quality Water 2 Gallon Container Sterile 2 VAI-WFI-200L VAI WFI Quality Water 200 Liter VAI-Carboy Bag Sterile 1 VAI-WFI-SP-11Z VAI WFI Quality Water 11oz Aerosol Can Sterile 24 VAI-WFI-200L-2B VAI WFI Quality Water 200 Liter Double-Bagged Sterile 1
Available Technical Data
VAIWFI-01 Technical Data PDF file
VAIWFI-02 Validation Report
Veltek Associates, Inc. 15 Lee Boulevard • Malvern, PA 19355-1234 Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] VAIWFI-01-E Rev. 20 Nov 2014
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Advantages Over Other Products in the Marketplace
® VAI WFI Quality Water is filled in Class 100 (ISO 5, Grade A) clean room conditions.
® VAI WFI Quality Water is filtered at 0.2 microns.
The 16 ounce trigger spray, 11ounce aerosol can, 1 and 2 gallon VAI WFI® Quality Water is sterilized via gamma radiation and validated at a SAL level of 10-6. This process guarantees sterility!
® The 200 Liter VAI WFI Quality Water is aseptically filled into pre- sterilized carboy bags in a drum. The manufacturing process is a completely closed system.
® VAI WFI Quality Water has been validated for sterility and shelf life for a period of 2 years.
® VAI WFI Quality Water is delivered with a lot specific Certificate of Analysis, Sterility Report and LAL Test Report. All testing per lot is done to current USP compendium.
® VAI WFI Quality Water is available in a 16 oz trigger spray, a 11 oz aerosol can, 1 and 2 gallon containers, and a 200 liter (55 gallon) lined drum.
® VAI WFI Quality Water container sizes mix with VAI’ sterile disinfectants to make a use dilution of DEC-PHENE®, DEC-CYCLE®, DEC-PHASE®, DEC-QUAT® 100, DEC-QUAT 200 and DEC-SPORE® 200 Plus.
® VAI WFI Quality Water is produced in VAI’s cGMP manufacturing facility.
® VAI WFI Quality Water is available in sufficient stocking quantities so you won’t have to wait for your order.
Veltek Associates, Inc. 15 Lee Boulevard • Malvern, PA 19355-1234 Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] VAIWFI-01-E Rev. 20 Nov 2014
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Testing and Manufacturing Specifications VAI is both an FDA and EPA Registered Manufacturing Operation
Test Specification Appearance Clear Liquid Endotoxin < 0.25 EEU/ml. Sterility per current USP No Growth Current USP Chemical Tests Conductivity Specifications
Component Sterilization 25.0 – 50.0 kGy
Lot Specific Sterile Documentation received with Certificate of Analysis each shipment. Certificate of Sterility Please contact VAI for a sample of this Certificate of Irradiation documentation. LAL Test Report
Veltek Associates, Inc. 15 Lee Boulevard • Malvern, PA 19355-1234 Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] VAIWFI-01-E Rev. 20 Nov 2014
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Veltek Associates, Inc. 15 Lee Boulevard • Malvern, PA 19355-1234 Tel: (610)644-8335 Fax: (610)644-8336 E-mail: [email protected] VAIWFI-01-E Rev. 20 Nov 2014