Microbial culture media preparation is a routine task in the regular detection, count and monitoring of microbial flora in microbiological testing. Microbial culture media preparation is the process of mixing nutrients, agents for buffering and maintaining the osmotic balance, as well as selective inhibitors or indicators to create an agar or broth that supports the growth and the differentiation of microorganisms. MicroLIMS provides recording of all pertaining information for culture media, subculture of Certified Reference Microorganisms (CRMs) and other preparations that support integration of laboratory preparations.

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The growth promotion test (GPT) is a quality control requirement that confirms the ability of a new batch of media to support growth of a predetermined selection of representative microorganisms. All media used in a cGMP facility should be tested, including media for microbial limits, environmental monitoring and sterility testing. Therefore, Leeuwenbook provides the interaction between pertaining informations of media preparation and associated GPTs to support metrological traceability.

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The goal of a microbiological method suitability test is to demonstrate that any residual antimicrobial properties of the product or the recovery method have been neutralized using the challenge microorganisms as a kind of biological indicator of neutralization. The method of assessing if neutralization has been successful varies depending on the method employed. The ability of the test to detect microorganisms in the presence of product to be tested must be established (USP 41). Therefore, Whatever a quantitative procedures or qualitative detection methods, MicroLIMS provides integration of pertaining informations of varies suitability protocols. Pertiaining informations like culture media, test organisms and growth conditions should be conducted. MicroLIMS supports direct exporting data and generation of printed document.

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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. USP tests allow quantitative enumeration of mesophilic bacteria and fungi that may grow under aerobic conditions. MicroLIMS designed primarily to determine whether a substance or preparation complies with an established specification for microbiological quality. MicroLIMS provides integration of pertaining information of total aerobic microbial count (TAMC), Total yeast and mold count, count of bile tolerant gram negative bacteria and tests for pathogenic microorganisms.

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Sterility testing is a GMP microbiology testing requirement used to confirm sterile products do not contain viable microorganisms before release and patient administration. Sterility testing methods must be as accurate as possible, due to their importance for medical devices, pharmaceutical products, and formulations, tissue materials, and other products that claim to be sterile or free from viable microorganisms. Otherwise any recommended methods of sterility testing membrane filtration or direct inoculation.

Demonstration of equivalent amounts of the same active pharmaceutical ingredient (API) between generic and innovator products (pharmaceutical equivalence) is a basic requirement of regulatory agencies for intravenous generic drugs prior to clinical use, and constitutes the pivotal point to assume therapeutic equivalence. Microbiological assay helps in estimating active constituents, biological activity and in monitoring the stability of antibiotics. Any small change in the antibiotic molecule, which may not be detected by chemical methods, will be revealed by a change in antimicrobial activity. Microbiological assay is very useful for resolving doubts regarding possible change in potency of antibiotics and their preparations.

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