USP 61 Microbial Enumeration Suitability – USP <61>
MicroMed tests devices for antimicrobial activity and sterile specifications using a neutralization format. The devices are exposed to an array of quantified microorganism indicators and a neutralization agent. The exposure of microorganisms and neutralization agent is filtered, plated and incubated to allow for enumeration. If enumeration does occur the device doesn’t contain antimicrobial activity and USP 62 can be tested without further modification.
USP 62 Testing for specified organisms – USP <62>
The devices are exposed to an array of quantified microorganism indicators and a neutralization agent if needed per USP 61. The exposure of microorganisms and neutralization agent, if needed, is filtered, plated and incubated to allow for enumeration. If enumeration doesn’t occur the device doesn’t contain bacteria pertaining to certain bacteria in the Enterobacteriaceae family.
MICROBIAL LIMITS TESTING
Microbial limits’ testing is performed to determine whether a product complies with compendial specifications for microbial quality. This testing consists of two parts. The quantitative phase, Microbial Enumeration, gives the total number of aerobic organisms as well as a total yeast and mold count on a product. The qualitative phase is known as the Test for Specified Microorganisms. This test is designed to determine the presence or absence of specific objectionable organisms in a product.
Prior to performing MLT testing on a product, the method must be validated to ensure that the product has no microbial inhibitory properties which could produce false negatives. This validation testing is known as the MLT Method Suitability Test.
The relevant standards for the Microbial Limits Test have been harmonized for the US, European, British, and Japanese markets. The relevant standards are USP <61> and <62>, EP Chapter 2.6.12 and 2.6.13, BP Chapter B1 and B2, and JP XV 1st Supplement.
Turn Around Time (TAT)
|BI-002||Microbial Enumeration – Aerobic Bacteria and Fungi – (TSA)||12 – 14 days|
|BI-002A||Microbial Enumeration – Aerobic Bacteria and Fungi – (SDA)||10 – 12 days|
USP – 62 Routine Testing
|BI-009||USP 62-Selective Media – (Escherichia coli)||3 – 4 days|
|BI-009||USP 62-Selective Media – (S. aureus)||3 – 4 days|
|BI-009||USP 62-Selective Media – (P.aeruginosa)||3 – 4 days|
|BI-009||USP 62-Selective Media – (Salmonella)||3 – 4 days|