Water for injections
Water for injection ( latin water for injection or aqua ad injectionem ) abbreviated also WFI, is a hydrogen of a particularly pure quality, for the production of parenteral drugs (eg. Infusions - or injection solutions ) and aqueous ophthalmics according to the rules of the pharmacopoeia used becomes.
The production and specification of water for injection purposes is described in the monograph of the same name in the European Pharmacopoeia. In Europe, only distillation was allowed as a manufacturing process ; Since Ph. Eur. 9.1, reverse osmosis in combination with suitable processes such as electrodeionization, ultrafiltration or nanofiltration has also been permitted. Membrane processes such as reverse osmosis (USA) and ultrafiltration (Japan) are also permitted in other countries .
During the production and storage of water for injection purposes, strict sterility must be observed: normally a limit value of a maximum of 10 microorganisms per 100 ml for colony-forming, aerobic germs must be observed. If the water is to be used for medicinal preparations that are manufactured under aseptic conditions, stricter limit values may be necessary.
Water for injection purposes must correspond to the tests for purity prescribed in the pharmacopoeia monograph, with a distinction being made between water for injection purposes as bulk and sterilized water for injection purposes . The latter is contained in vessels and sterilized.
The limit values for conductivity , content of organic carbon , nitrate , heavy metals , aluminum and bacterial endotoxins must be observed. Sterilized water for injection purposes must also be checked for further ions as well as free of particles and sterility.
See also
literature
- Herbert Bendlin, Martin Eßmann: Reinstwasser: Planning, qualification and operation of ultrapure water systems , Maas & Peither AG - GMP-Verlag, ISBN 978-3934971097
Individual evidence
- ↑ European Pharmacopoeia , 6th edition, basic work 2008, monograph 6.0 / 0169
