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    Sterility Testing of Products

    Pharmacopoeial requirements

    The pharmacopoeia sterility test continues to be an important requirement for many sterile products. The method and its use is widely discussed and criticised but it is simple in principle. Two nutrient broths, Tryptic Soy Broth for aerobic bacteria and fungi and Fluid Thioglycollate Medium for anaerobic bacteria, are incubated with a sample of the product for 14 days. If there is no growth in either broth, the test is passed.

    Sterility testing options

    There are many variations to the test because of the wide variety of products that must be tested. Some products contain preservatives or other antimicrobial ingredients that must be neutralised or diluted before the test. Some are large volume or dilute products that are passed through membrane filters to concentrate any potential microorganisms and to reduce any antimicrobial activity. Any and every variation of the test has to be validated for the suitability of the method to show that it is capable of detecting a range of microorganisms in the presence of the product being tested.

    Redipor® Prepared Media – flexible & validated

    Before you can begin this process it is essential that you have confidence in the media to be used. Redipor prepared media is supplied with a detailed certificate to show the results of the required pharmacopoeia tests as well as a batch record to enable full traceability of the raw materials and processing. Redipor broths are available in a wide range of containers and fill volumes and with appropriate neutralising agents where they are requested.

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