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10.11.2020 - Pharmacy
Culture medium controls according to the European Pharmacopoeia (Ph.Eur.)
In the Ph. Eur., the general chapters on the methods of biology also include requirements for microbiological testing. This includes, for example, the enumeration of viable microorganisms (Chap. 2.6.12) in the testing of non-sterile pharmaceuticals, the detection of specific microorganisms (Chap. 2.6.13), as well as the testing of herbal medicinal products (Chap. 2.6.31). In all these chapters, a verification of the suitability of the media used is always required.
The following tests are provided for in the context of media control:
- Verification of the suitability or growth-promoting properties of media
- Indicator properties
- For selective media: testing of growth-inhibiting properties and indicator properties
The required media controls must be performed on each batch of a medium, regardless of whether it is obtained in ready-to-use form or is self-manufactured.
Verification of the dilution solutions used is not yet provided for in the Ph. Eur.
We routinely perform these media controls for you as a service. We test according to the above-described specifications of the European Pharmacopoeia.
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