5th September 2023 Content supplied by: Condalab
Water Quality, A Critical Parameter in Pharma
One of the pillars in the pharmaceutical industry is the control and maintenance of water purification systems since this is one of the fundamental resources involved throughout the production processes.
Due to its many possible uses, this raw material will have different levels of quality and regulations, such as the Eur. Ph. in the EU, the USP in the USA, or the JP in Japan.
The Eur. Ph. categorizes water quality depending on its purity level:
- Water for injectables: for the preparation, dissolution, or dilution of substances and preparations via a parenteral route
- Purified water: for the preparation of medications that are not required to be sterile or non-pyrogenic
- Water for the preparation of extracts: for the preparation of herbal extracts
It is crucial to implement monitoring systems to control the water quality, given that certain microorganisms may survive and proliferate in aqueous environments and cause health risks. And unlike other samples, controls are not performed for specific parameters; instead, a general microbial load whose permitted limits depend on the quality level.
Monitoring the microbial count is required for injectable and highly purified water. First, the sample must be filtered with a membrane with a pore size of no more than 0.45 µm and then incubated in R2A Agar between 30ºC and 35ºC for at least five days.
It's the same workflow and incubation conditions for water used in extract preparation, except the medium used is TSA Agar.
Similarly, growth promotion tests of the culture media are required to confirm their performance and sterility.
Date Published: 5th September 2023
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