Water For Injection
Continuous Sterile Filtration System
The on-demand WFI production system represents a breakthrough in water purification. With its state-of-the-art design, it adheres to the stringent requirements of ASSE/IAPMO ICG 376-2023 for the production of Water for Injection. The endless loop technology ensures continuous sterile filtration, significantly reducing the risk of contamination typically associated with tank storage.
BioProcess Container (BPC) Features:
The WFI Quality Water is stored and shipped in BioProcess Containers (BPCs). BPCs are utilized to meet single-use upstream and downstream bioprocessing needs. The containers utilize films that are engineered to meet the most demanding requirements of bioproduction processes. The standard 200L container utilizes CX5-14 film and the 20L utilizes ASI 28 EVA film. These containers/films are developed specifically for liquid handling, storage, and transportation. Other types or brands of BPC can be utilized to meet specific requirements.
- Meets or exceeds USP standards and monograph requirements
- FDA-registered cGMP manufacturing facility
- U.S. Pharmacopeia (USP<1231>) and ISO 13485:2016 compliant
- The only water treatment system that has been tested and certified to the new IGC376 standard
| Classification | WFI Quality Water Grades | Options | |||
|---|---|---|---|---|---|
| Test | Test Method | Water for Injection, USP** | Water for Injection, USP-Sterile | Water for Injection, USP- Sterile/DNase/RNase Free | Size |
| Conductivity @25 C (µs/cm) | USP <645> | ≤ 1.3 | ≤ 1.3** | ≤ 1.3** | 20L / 200L Bag |
| TOC (mg/L) | USP <643> | ≤ 0.5 | ≤ 0.5 | ≤ 0.5 | 20L / 200L Bag |
| Endotoxins (EU/mL) | USP <85> | < 0.25 | < 0.25 | < 0.25 | 20L / 200L Bag |
| Sterility | USP <71> | * | No Growth | No Growth | 20L / 200L Bag |
| DNase/RNase Free | Fluorometric Assay | * | * | No Detected | 20L |
Meets USP monograph for Water for Injection at point of fill. Not intended for parenteral administration. WFI QUALITY WATER IS INTENDED FOR FURTHER
MANUFACTURING OR RESEARCH USE. NOT FOR DIAGNOSTIC USE OR DIRECT ADMINISTRATION INTO HUMANS OR ANIMALS.
*Not Specified, Not Required, Not Applicable or No Limit
**Meets USP Monograph at Point of Fill
Additional Information
Download the HANS™ Scientific WFI brochure for more information.
