Microbial Enumeration and Test for Specified Organisms 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 and USP <60> is the method described for Burkholderia cepacia complex. The USP 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 Candida albicans, Burkholderia cepacia complex 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. USP 60 testing is recommended for inhalation use products or aqueous preparations for oral, oromucosal and nasal use.
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 60
- USP 61
- USP 62