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
Product 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 25-40Kgy
Suitable for:
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.
PRECAUTIONARY STATEMENT
Not to be used for Parenteral Administration. Not for use in sterile irrigation, injection, infusion, or as a potable product. QT WFI is intended for manufacturing and general laboratory use only.
Manufactured by: Quantum Tec Quantum Tec is a leading manufacturer in South East Asia in cleanroom Disinfectants, Sanitizers, and Cleaning Agent for the Life Science Industry with an ISO manufacturing facility based in Penang, Malaysia.
Water For Injection (WFI)
Description
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
Product Features:
Suitable for:
cleanrooms or other critical environments such as floors, walls, counters, tools, carts and other equipment.
PRECAUTIONARY STATEMENT
Not to be used for Parenteral Administration. Not for use in sterile irrigation, injection, infusion, or as a potable product. QT WFI is intended for manufacturing and general laboratory use only.
Manufactured by: Quantum Tec
Quantum Tec is a leading manufacturer in South East Asia in cleanroom Disinfectants, Sanitizers, and Cleaning Agent for the Life Science Industry with an ISO manufacturing facility based in Penang, Malaysia.
Additional information
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