- Methods are included for bile-tolerant gram-negative bacteria (Enterobacteria and certain other gram-negative bacteria), Escherichia coli, Salmonella spp., Pseudomonas aeruginosa, Sta-phylococcus aureus, Clostridien and Candida albicans.
- Incubation regulations have been changed for most methods.
- In the test for Salmonella spp. and Staphylococcus aureus some other media are proposed.
- In the test for Clostridium spp. the areobic incubation on Columbia agar without Gentamycin is deleted. The method for Clostridium perfringens is also deleted.
- Reactions for confirmation are not regulated in detail. Only general requirements for confirmation are referred to.
- Control of nutrient media: The growth promoting properties, inhibitory properties and indicative properties must be tested.
Überprüfung der mikrobiologischen Qualität von nicht-sterilen Produkten nach den international harmonisierten Vorschriften Teil 2: Nachweis spezifizierter Mikroorganismen*) Hanfried Seyfarth Korrespondenz: Dr. Hanfried Seyfarth, Kirschenweg 12, 88400 Biberach/Riss (Germany) Microbiological Examination of Non-Sterile Products According to the International Harmonised Methods / Part 2: Test for specified micro-organisms The 6th Supplement to the Pharm. Eur. 5th edition contains the Test for specified micro-organisms in pharmaceutical preparations, harmonised with the regulations in the USA and Japan. This revised text of the test includes numerous modifications compared to the previous paragraph of the Pharm. Eur. 5th edition: Key words Mikrobiologische Qualität • Mikroorganismen • Nährmedienkontrolle |
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