Cell culture performance is highly dependent on water purity. Irvine Scientific continuously monitors its Water for Injection (WFI) system for microbial levels, endotoxin, conductivity, and Total Organic Carbon (TOC). Irvine Scientific tests the final packaged product according to both USP and EP standards, and offers WFI Quality Water readily packaged in 1L bottles, 20L carboys, and 20L and 200L flexible packaging. Customized packaging and JP testing for WFI Quality Water is also available upon request.
Our WFI system incorporates a pre-treatment system, vapor compression still and WFI distribution loop. Water treatment steps include KDF filtration for chlorine/chloramines destruction, a polisher cation exchange system for the removal of ammonia, and a MECO® vapor compression pharmaceutical distillation unit for chemical and microbial purification. The entire system is designed for high-throughput production, ensuring this critical component’s availability.
WFI System Performance
|Parameter||Specification||IS Average Performance|
|Bioburden||10 cfu/100mL||0 cfu/100mL|
|Endotoxin||≤ 0.25 EU/mL||≤ 0.05 EU/mL|
|TOC||< 500 ppb||50.8 ± 21.3 ppb|
|Conductivity||≤ 2.1 µS/cm||0.71 ± 0.13 µS/cm|
WFI Quality Water meets both EP and USP grade specifications and can be readily purchased as either a 1L bottle, 20L plastic carboy, 20L sealed BioProcessing Container (BPC) shipped in an outer container, or 200L sealed BPC shipped inside a sealed drum. All flexible packaging is 0.1µm sterile filtered at time of fill into USP Class VI qualified BPCs. All BPCs are terminally sterilized at 25-40kGy with weldable tubing for our clients' bioprocessing needs.
Water meets the testing requirements for Sterile Water for Injection as stated in current USP and EP.
Every WFI lot is tested according to USP and EP Packaged Sterile Purified Water Standards and comes with a Certificate of Analysis. WFI is tested to JP standards — available upon request
|Part No.||Storage||Description||Testing||Product Uses|
|9309-20L||2°C to 30°C||WFI Quality Water; 20L BPC sealed in a box||
Multi-Compendial testing in accordance with Packaged Sterile Purified Water and Sterile Water for Injection Standards
|9309-200L||2°C to 30°C||WFI Quality Water; 200L BPC sealed in a drum|
|Appearance:||Clear colorless liquid|
|Endotoxin:||< 0.25 EU/mL|
|Acidity or Alkalinity:||Conforms|
|Nitrates:||NMT 0.2 ppm|
|Aluminum:||NMT 10 ppb|
|Ammonium:||NMT 0.2 ppm|
|Calcium and Magnesium:||Conforms|
|Heavy Metals:||NMT 0.1 ppm|
|Residue on Evaporation:||NMT 0.003%|