ILS Water For Injection (WFI) is highly purified water rendered specifically for scientific applications. WFI is delivered in containers with universal connectors to improve our customers experience and protect the integrity of our product.
- Excellent choice for upstream and downstream media/buffer preparation for biopharmaceutical manufacturing applications.
- Widely used in medical device manufacturing/processing applications where a high quality, sterile water is required.
- Sterile, non-pyrogenic preparation which contains no bacteriostat, antimicromobial agent or added buffer.
- Complies with the United States Pharmacopoeia (USP) monograph for water for injection packaged in bulk for commercial use elsewhere.
- Multiple packaging sizes available, including 200L, 100L, 20L and 1L.
- Manufactured under cGMP and ISO 13485 guidelines in a FDA registered facility.
- The West Jordan Facility operates under current Good Manufacturing Practices (cGMP), and is capable of producing over 20,000L of USP high purity water daily. This capacity ensures short lead times for time sensitive orders.
ILS Sterile Water For Injection (WFI) quality water is rendered specifically for diverse manufacturing applications. Our cell culture grade sterile water is carefully produced through our nine-step proprietary system, following the closely regulated processes of primary filtration, deionization, UV treatment, multiple effect distillation and hot storage, culminating in passage through circulation systems before final filtration. The final filtration process is completed in a closed system to guarantee its scientific value. ILS’s USP Water for Injection Quality Water is meticulously quality controlled, offering the perfect solution for manufacturing uses like formulating, processing, rinsing, and diluting. ILS meets the United States Pharmacopoeia (USP) standards for Sterile Water for Injection.
Safe Sourced and Enhanced Manufacturing Processes
Sterile Water specific product test requirements and typical values are given below:
| Parameter | Method | Specification |
|---|---|---|
| Appearance | Visual | Clear liquid |
| Sterility | USP <71> | No growth |
| Endotoxin | <0.25 EU/mL | |
| TOC | USP <643> | <500 ppb |
| Conductivity | USP <645> | <5.0µS/cm |
