Search results with tag "Microbiological examination of non sterile"
4.05 Microbiological Examination of Non-sterile Products
www.pmda.go.jp4.05 Microbiological Examination of Non-sterile Products Change to read as follows: This chapter includes microbial enumeration tests and tests for specified micro-organisms. For the test, use a mixture of several portions selected at random from the bulk or from the contents of a sufficient number of containers.
Quality Control: Microbial Limit Tests for Nonsterile ...
www.arlok.commicrobiological quality established in Pharmacopeial monographs. • The major contaminants of nonsterile pharmaceutical products and ingredi-ents are bacteria, yeast, and molds.1,2 Also, the following excerpt from part 1 of this topic stated1: United States Pharmacopeia (USP) Chapters <61> Microbiological Examination of Non-Sterile Products:
2.6.13. MICROBIOLOGICAL EXAMINATION OF NON-STERILE ...
uk.vwr-cmd.comWhen an acceptance criterion for microbiological quality is prescribed it is interpreted as follows: ... —103 CFU:maximumacceptablecount=2000,andsoforth. The recommended solutions and media are described in general chapter 2.6.13 (under section B, Harmonised method). 01/2007:20613 2.6.13. MICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS ...
2.6.12. MICROBIOLOGICAL EXAMINATION OF NON …
uspbpep.comMICROBIOLOGICAL EXAMINATION OF NON-STERILE PRODUCTS (TOTAL VIABLE AEROBIC COUNT) The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi which may grow under aerobic conditions. The tests are designed primarily to determine whether
2.6.12. MICROBIOLOGICAL EXAMINATION OF NON-STERILE ...
www.uspbpep.com2.6.11. Depressor substances EUROPEAN PHARMACOPOEIA 6.0 monograph and note whether the contractions produced by the preparation with the added histamine correspond to the amount of histamine added.