This hands-on training includes USP <61> Microbial Enumeration Tests and USP <62> Tests for Specified Microorganisms.
USP <61> Microbial Enumeration Tests
USP <61> is often called a "Bioburden" or "Microbial Limits". This test determines how many microorganisms are present in nonsterile drug products.USP <61> is often called a "Bioburden" or "Microbial Limits". This test determines how many microorganisms are present in nonsterile drug products.
During a USP <61> test, the drug product is prepared and plated on two types of growth media, Soybean-Casein Digest Agar and Sabouraud Dextrose Agar. The plates are incubated at a defined temperature and duration. The number of colonies present on the plates are then counted and the results are calculated. To determine if the drug product passes the test, the number of colonies present in the drug product are compared to the acceptance criteria in USP <1111>.
USP <1111> provides acceptance limits for microorganisms present based on sample type (raw material or finished drug product) and route of administration.
USP <62> Tests for Specified Microorganisms
USP <62> test results determine if objectionable microorganisms that could cause patient harm based on the route of administration are present in non-sterile drug substances or products. The microorganisms of concern listed in USP <62> include:USP <62> test results determine if objectionable microorganisms that could cause patient harm based on the route of administration are present in non-sterile drug substances or products. The microorganisms of concern listed in USP <62> include:
A USP <62> test is initiated like USP <61> but uses microorganism specific growth media. At the conclusion of incubation, a result of "Pass" or "Fail" is generated. A passing result indicates the absence of the tested specified microorganism. USP <1111> provides absence of specified microorganism criteria based on sample type (raw material or finished drug product) and route of administration.