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QuantumTec WFI

QuantumTec 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.

Specifications

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

 

Features

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
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