Bioburden Testing

Products or components used in the pharmaceutical or medical field require control of microbial levels during processing and handling. Traditional bioburden or microbial limit testing in different industries is a key method to show that a process is fully under control and delivers a product within its specification. In recent years, many companies have implemented alternative methods with improved reliability and faster results.

Traditional membrane filtration method is still the reference compendial method, e.g., USP and EP. Since the decisions taken from the result of these tests have a big impact on the release or further processing of a product, it is absolutely necessary to avoid any possibility of secondary contamination. Millipore offers different safe and reliable membrane filtration devices for performing bioburden tests. One example is the Milliflex platform. This sterile, uniquely designed Milliflex device in combination with the easy to use Milliflex Plus pump offers the most reliable membrane filtration system.

In addition, a complete service package is available to help you develop methods and qualify and validate these systems and maintain it throughout its life-cycle.

In-process bioburden testing is a perfect method for establishing and evaluating many aspects of a manufacturing process. Tests can be made for general trending or tracking, for evaluating changes, for accepting incoming materials or for establishing sterilization processes.

Bioburden Testing

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