Water for Injection, USP Grade*
Water for Injection (WFI) USP Grade*, is produced in ISO9001:2015 & ISO 13485: 2016 certified facilities. Meets specifications of ASTM (American Society for Testing and Materials) Type I Ultrapure water which is used for the most critical applications and advanced analytical procedures in the laboratory including cell and tissue culture, gas and liquid chromatography, further manufacturing, or research use. 50L, 100L and 200L (55gal) sizes are packaged in bioprocessing containers.
Water for Injection (WFI) USP Grade* is tested for Conductivity, Sterility, Total Organic Carbon (TOC) and Endotoxin to meet the following specifications.
|
Test name |
Specifications |
|
Conductivity |
<1.3 µS/cm at 25ºC |
|
Sterility (Bacterial count) |
<10 cfu/100ml |
|
Total Organic Carbon (TOC) |
<500 ppb |
|
Endotoxin |
<0.25 IU/ml |
* Endotoxin testing is done with the modified Limulus Amebocyte Lysate (LAL) Test. Sterility test is done with USP certified Tryptic Soy Broth (TSB) media with incubation at 37ºC for 14 days.