- Using certified ready prepared media high effort for media testing can be much avoided in routine laboratory.
- A sterile product must be used to ensure successful suitability test of microbiological methods.
- The procedure of inoculation with test strains for suitability test varies for quantitative, qualitative and semi-quantitative methods.
- Method suitability test and quantitative determination of fungi in herbal medicines should always be carried out on agar with antibiotics.
- The general use of neutralising agents appears to be expedient when testing herbal medicinal products.
International harmonisierte Vorschriften zur mikrobiologischen Prüfung nicht-steriler Produkte Teil 1: Praktische Erfahrungen bei der Durchführung der Eignungsprüfungen an pflanzlichen Fertigarzneimitteln Robert Schmücker, Elke LenzerPhytoLab GmbH & Co. KG, Vestenbergsgreuth (Germany) Korrespondenz: Dr. Robert Schmücker, Dutendorfer Str. 5–7, 91487 Vestenbergsgreuth (Germany); e-mail: robert.schmuecker@phytolab.de Internationally Harmonised Methods for the Microbiological Examination of Non-sterile Products / Part 1: Practical experiences acquired while performing suitability tests on herbal medicinal products The following experiences can be made on the basis of knowledge acquired during the practical implementation of suitability tests on herbal medicinal products in accordance with the harmonised microbiological methods in 6th Supplement to the European Pharmacopeia 5th edition (Ph.Eur. 5.6): Key words Methodeneignungsprüfung • Methodenvalidierung • Mikroorganismen • Nährmedienprüfung • Phytopharmaka |
|
pharmind 2008, Nr. 6, Seite 775
