product
Colour | Colourless liquid |
Clarity | Clear |
Odour | Odourless |
pH | 4.0 – 7.5 |
Total Organic Carbon (APHA 5310B) | ≤ 500 µg/L |
Microbial limit test/Heterotrophic Plate Count (APHA 9215D 2005) | ≤ 10 CFU/100ml |
Conductivity | ≤ 1.3 µS/cm |
Produced in ISO 9001, ISO 13485 certified and FDA registered facility
Meets USP specifications for WFI
Low endotoxin levels
Lot specific COA and/or COS for each shipment
Gamma irradiated to SAL of 10-6 at 25-45 kGy
QT WFI is intended for use as a diluent for disinfectants, sanitizers or cleaners which are applied on hard non-porous surfaces in cleanrooms or other critical environments such as floors, walls, counters, tools, carts and other equipment
QT WFI can also be used for rinsing of hard non-porous surfaces
No. | Part No. | Description | Quantity | Dimension | Weight | HS Code | Shelf Life |
1 | QT9620-169 | Sterile WFI, 5L | 4 X 5L/case | 410mm (L) x 260mm (W) x 300mm (H) | 20.26 kg | 30049099 | 36 months |
2 | QT9620-10L | Sterile WFI, 10L | 1 X 10L/case | 220mm (L) x 260mm (W) x 320mm (H) | 10.80kg | 30049099 | 36 months |
Describe
QT Water for Injection (WFI) is produced in an ISO 9001, ISO 13485 certified and FDA registered facility using potable water which is subjected to extensive purification with 2 reverse osmosis passes and final filtration of 0.1μm. This process provides water quality that meets the United States Pharmacopeia (USP) specifications for WFI.
QT WFI is additionally filtered at 0.22 micron during filling then double-bagged in an ISO 7 classified environment, and terminally sterilized by gamma irradiation to a 10-6 Sterility Assurance Level (SAL).
QT WFI comes with a lot specific Certificate of Analysis (COA) and/or a Certificate of Irradiation (COI) making it convenient for facilities to obtain WFI-quality water, without the hassle of validation and costly maintenance of a WFI system.
Features
Colour | Colourless liquid |
Clarity | Clear |
Odour | Odourless |
pH | 4.0 – 7.5 |
Total Organic Carbon (APHA 5310B) | ≤ 500 µg/L |
Microbial limit test/Heterotrophic Plate Count (APHA 9215D 2005) | ≤ 10 CFU/100ml |
Conductivity | ≤ 1.3 µS/cm |
Applications
Produced in ISO 9001, ISO 13485 certified and FDA registered facility
Meets USP specifications for WFI
Low endotoxin levels
Lot specific COA and/or COS for each shipment
Gamma irradiated to SAL of 10-6 at 25-45 kGy
QT WFI is intended for use as a diluent for disinfectants, sanitizers or cleaners which are applied on hard non-porous surfaces in cleanrooms or other critical environments such as floors, walls, counters, tools, carts and other equipment
QT WFI can also be used for rinsing of hard non-porous surfaces
Packing
No. | Part No. | Description | Quantity | Dimension | Weight | HS Code | Shelf Life |
1 | QT9620-169 | Sterile WFI, 5L | 4 X 5L/case | 410mm (L) x 260mm (W) x 300mm (H) | 20.26 kg | 30049099 | 36 months |
2 | QT9620-10L | Sterile WFI, 10L | 1 X 10L/case | 220mm (L) x 260mm (W) x 320mm (H) | 10.80kg | 30049099 | 36 months |