Microbial Enumeration for Nonsterile Products
Microbial Enumeration tests for nonsterile products, following test procedures outlined in USP <61>, provides an evaluation of the microbial content of a product also known as bioburden testing. USP <62> is the method described for the screening of objectionable organisms or pathogens. The USP <61> and <62> test system requires validation/suitability testing and provides a rugged process for the detection of objectionable organisms. Product-specific objectionable organisms can be determined based on the product type, optimizing the testing process.
This test method has defined procedures for the detection of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, Salmonella species, and fungal organisms, and a quantitative for bile-tolerant gram-negative bacteria. USP <61/62> testing is recommended on all pharmaceutical raw materials, nonsterile products (such as liquids and powders), transdermal patches, and dietary supplements.
The advantage of using Nelson Labs is our rugged validation method for the test process, combined with a professional team of experts who provide individualized consultation. We’ll help you design the appropriate test plan for determining the objectionable organisms in your product.
- USP 61
- USP 62