ILS USP/EP Water for Injection Grade product is manufactured to meet both the USP and EP specifications.
- Tested against USP/EP specifications
- Clean in Place (CIP) and Steam in Place (SIP) systems
- Process Equipment Cleaning / Rinsing
ILS’ Water for Injection, multi-compendial United States Pharmacopeia (USP)/ European Pharmacopeia (EP) grade, is a sterile, non-pyrogenic preparation which contains no bacteriostat,antimicrobial agent or added buffer. It complies with both USP and EP monographs for water for injection packaged in bulk for commercial use elsewhere.
Manufactured under cGMP and ISO 13485 guidelines in an FDA registered facility.
ILS water is an excellent choice for upstream and downstream media/buffer preparation in biopharmaceutical manufacturing applications where EU requirements are necessary. It is also widely used in medical device manufacturing/processing applications where a high quality, sterile water is required.
Safe Sourced and Enhanced Manufacturing Processes
Sterile Water specific product test requirements and typical values are given below:
|Sterility||EP 8.6 2.6.1||No growth|
|Endotoxin||EP 8.6 2.6.14||<0.25 EU/mL|
|Particulate Matter||EP 8.6 2.9.19||Meets EP Requirements|
|Ammonium||EP 8.6||Maximum 0.2 ppm|
|Calcium and Magnesium||EP 8.6||A pure blue color is produced|
|Nitrate||EP 8.6||<0.2 ppm|
|Heavy Metals||EP 8.6||<0.1 ppm|
|Oxidizable Substances||EP 8.6||Solution remains faintly pink|
|Acidity||EP 8.6||Meets EP Requirements|