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Microbial Limits for Nonsterile Pharmaceuticals
Contamination of pharmaceuticals with microorganisms may lead to deleterious effects on 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 in three major Pharmacopeias.
USP <61>
Microbiological Examination of Non-Sterile products: Microbial Enumeration provides tests used to determine bioburden present in raw materials, during production, and in the finished product. This microbiological test determines the total population of aerobic bacteria and yeast and molds that might be present in pharmaceutical ingredients and finished products.
USP <62>
Microbiological Examination of Non-Sterile products: Tests for Specified Organisms
provides tests used to check for the presence of objectionable microorganisms that could cause the patient harm based on variability in the route of administration. This microbiological test verifies the absence of objectionable microorganisms in drug products and raw materials based on route of administration.
USP <1111>
Microbiological Examination of Non-Sterile products: Acceptance criteria for Pharmaceutical Preparations and Substances for Pharmaceutical Use lists acceptance criteria for microbiological quality of nonsterile dosage forms including: route of administration, total aerobic microbial count, total yeast and mold count, and absence of specified microorganisms.
The microbial limit for nonsterile products must be within an acceptable range that does not pose health hazards to intended patient groups or diminish product stability.
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