EP 2.6.12 Non-Sterile Microbiological Examination, Standard Test for Microbial Count Tests

EUROLAB laboratory provides testing and compliance services within the scope of EP 2.6.12 standard. The methods cannot be applied to products containing live microorganisms as active ingredients. Alternative microbiological procedures, including automated methods, may be used, provided their equivalence to the pharmacopoeial method is demonstrated.

Perform the detection under conditions designed to prevent exogenous microbial contamination of the product to be examined. The precautions taken to prevent contamination should be such that they do not affect any microorganisms that will appear in the test.

If the product to be examined has antimicrobial activity, this is removed or neutralized as much as possible. If inactivators are used for this purpose, their effectiveness and non-toxicity to microorganisms must be proven.

If surfactants are used for sample preparation, it must be demonstrated that they are not toxic to microorganisms and are compatible with the inactivators used.

Use the membrane filtration method or plate count methods as specified. The most likely number (MPN) method is generally the least accurate method for microbial counts, but may be most appropriate for some crop groups with very low bioburden.

EUROLAB assists manufacturers with EP 2.6.12 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.