ntended For Critical BioPharma Applications 

• Intended for use as a critical GMP Solution and Excipient for further parenteral manufacturing. *Intended for use in further parenteral manufacturing that requires terminal sterilization. Not intended for use as a sterile product.

General Product Description:

The manufacturing of Bio Excipient Grade GMP WFI, WAFI-3150 is performed at BioSpectra’s Bangor, PA, US FDA registered, GMP facility and is conducted in a dedicated processing area using only dedicated equipment.

• Molecular Formula: H2O
• Molecular Weight: 18.02 g/mol
• CAS #: 7732-18-5
• GMP WFI is a clear, colorless liquid.
• There are no known major food allergens (as defined by FDA and WHO) in the manufacture of this product.
• BioSpectra certifies that all GMP WFI, WAFI-3150 manufactured at BioSpectra and its raw materials are not derived from or come in contact with animal parts, products and/or byproducts.
• GMP WFI manufactured at BioSpectra and any raw materials used in the manufacture of GMP WFI at BioSpectra are not subject to genetic modification.

GMP Compliance:

• Bio Excipient Grade GMP WFI, WAFI-3150 is suitable for use as an excipient. It is manufactured in accordance with the ICH-Q7 Good Manufacturing Practice Guide. This grade of GMP WFI is not suitable to be used as an Active Pharmaceutical Ingredient, Drug Product or Household Item.

Retest Date:

• The recommended retest period for GMP WFI is two years from the date of manufacture.

Storage and Shipping Conditions:

• Ship and store at 5°C to 30°C

Package Sizes:

• Sterile, Single use 1000L totes, 200L drums, 4L and 1L bottles.