- The number of samples is clearly defined.
- There are new regulations concerning the amount used for the test in case of a small amount of active substance or if the preparation contains only a small amount of active substance.
- Prescribed as obligatory are the nutritive media: Casein soya bean digest agar for the Total Aerobic Microbial Count and Sabouraud-dextrose agar (without addition of antibiotics) for the Total Combined Yeasts/Mould Count.
- Control of nutrient media: The growthpromotion qualities have to be tested on each batch of ready-prepared medium and each batch of medium, prepared either from dehydrated medium or from the ingredients described. The frequency of the test of media sterility is not clearly prescribed.
- Regulations for incubation: Casein soya bean digest agar 3 to 5 days at 30 to 35 °C and Sabouraud-dextrose agar 5 to 7 days at 20 to 25 °C.
- Evaluation: The limitation of the number of colonies in case of membrane filtration is missing (up to now max. 100 CFU/filter); the count in case of plate count method is limited to < 250 bacteria, < 50 fungi resp. (previously < 300 bacteria, < 100 fungi resp.).
- Interpretation of results: introduction of factor 2 instead of factor 5.
- The recovery rate during the method validation is fixed at 50 % (previously 20 %).
Überprüfung der mikrobiologischen Qualität von nicht-sterilen Produkten nach den international harmonisierten Vorschriften Teil 1: Zählung der gesamten vermehrungsfähigen Keime 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 1: Microbial Enumeration Tets The 6th Supplement to the Ph.Eur. 5th edition contains the methods for the total viable aerobic count 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 Ph.Eur. 5th edition: Key words Keimzahlbestimmung • Methodenvalidierung • Mikrobiologische Qualität • Nährmedienkontrolle • Sterilprodukte |
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pharmind 2006, Nr. 8, Seite 995
