Media to Perform the Microbial Limit Test
For performing the microbial limit test (part of bioburden testing) in the pharmaceutical and cosmetics industries according to USP and EP, Merck provides a comprehensive range of granulated dehydrated culture media (DCM).
The microbial limit test (MLT) is performed to assess how many and which of certain viable microorganisms are present in non-sterile pharmaceutical, healthcare or cosmetics manufacturing samples that range from raw materials to finished products. The test provides information about the safety of the tested product by determining if quantitative limits for certain microorganisms are exceeded. It covers testing for bile tolerant gram-negative bacteria as well as for Escherichia coli, Salmonella, Pseudomonas aeruginosa, Staphylococcus aureus, clostridia and Candida albicans. The samples are prepared by mixing multiple portions taken randomly from the ingredient or product to be tested. If the samples contain antimicrobial substances, these have to be eliminated beforehand by dilution, neutralization, filtration, inactivation or other appropriate means. Great care must be taken to prevent microbial contamination from the outside.
Merck provides high quality media for performing the microbial limit test according to USP chapters 61 and 62 as well as EP chapters 2.6.12 and 2.6.13. These consistent culture media are available in a variety of formulations as dehydrated culture media in the form of granules.
Merck’s uniquely granulated culture media are not only convenient but also safe, meeting the highest industry performance standards as described in ISO 11133. Granulation causes significantly less dust than powdered media, leading to less inhalation of hazardous media components that cause allergic responses. In addition, it minimizes contamination of the work environment. All Merck culture media are quality controlled according to the highest standards. This guarantees the consistency and high quality of our products.