á61ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: MICROBIAL ENUMERATION TESTS
ثبت نشده
چکیده
The tests described hereafter will allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, including the number of samples to be taken, and interpret the results as stated below. The methods are not applicable to products containing viable microorganisms as active ingredients. Alternative microbiological procedures, including automated methods, may be used, provided that their equivalence to the Pharmacopeial method has been demonstrated.
منابع مشابه
Quality Control: microbial limit tests for nonsterile pharmaceuticals, part 2.
Cases of contaminated nonsterile products have been reported in increasing numbers. Often, these contaminated products are associated with the presence of objectionable microorganisms. The major contaminants of nonsterile pharmaceutical products and ingredients are bacteria, yeasts, and molds. The combination of parts 1 and 2 of this series of articles provides a thorough examination of microbi...
متن کاملQuality control analytical methods: microbial limit tests for nonsterile pharmaceuticals, Part 1.
Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on the therapeutic properties of the drug, and may potentially cause injuries to intended recipients. Cases of contaminated nonsterile products have been reported in increasing numbers, and often associated with the presence of objectionable microorganisms. Methods for detection of these organisms are described...
متن کاملá62ñ MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS: TESTS FOR SPECIFIED MICROORGANISMS
The tests described hereafter will allow determination of the absence of, or limited occurrence of, specified microorganisms that may be detected under the conditions described. The tests are designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. When used for such purposes, follow the instructions given below, ...
متن کاملExamination of Nonsterile
EXAMINATION OF NONSTERILE Preparation of Test Strains PRODUCTS: MICROBIAL Use standardized stable suspensions of test strains or prepare as stated below. Seed-lot culture maintenance techENUMERATION TESTS niques (seed-lot systems) are used so that the viable microorganisms used for inoculation are not more than five passages removed from the original master seed-lot. Grow each of the bacterial ...
متن کاملWooden sticks as the source of a pseudoepidemic of infection with Rhizopus microsporus var. rhizopodiformis among immunocompromised patients.
Wooden sticks used to suspend feces obtained for surveillance cultures were found to be the source of Rhizopus microsporus var. rhizopodiformis causing a pseudo-outbreak among 17 immunocompromised patients cared for in three different wards. Nonsterile wooden products should therefore not be used for collecting, handling, and processing specimens for microbiological examination.
متن کامل