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Cell culture performance is highly dependent on water purity. FUJIFILM Irvine Scientific continuously monitors its Water for Injection (WFI) system for microbial levels, endotoxin, conductivity, and Total Organic Carbon (TOC). FUJIFILM 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.
WFI System
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 |
