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Bioburden Testing is the Key for Method Development

Bioburden testing determines the number of microorganisms living on a surface that has not been sterilized. 21 C.F.R. 211.110 (a)(6) states that bioburden testing must be conducted pursuant to written procedures during the manufacturing process of drug products.

The AAMI/ANSI/ISO 11737-1 outlines several bioburden testing methodologies that are used to quantitatively recover the bioburden of non-sterile medical devices. It is important when conducting these tests to ensure that the testing method does neither introduce microorganisms into the test sample nor kill microorganisms in the test sample.

Knowledge from bioburden testing can be used in a number of situations as part of:

  • Validation and revalidation of sterilization processes;

  • Routine monitoring for control of manufacturing processes;

  • Monitoring of raw materials, components or packaging;

  • Assessment of the efficiency of cleaning processes;

  • An overall environmental monitoring program.

How is Bioburden Testing Regulated?

  • All Bioburden testing must conform to the procedures outlined in AAMI/ANSI/ISO (International Organization for Standardization) 11737-1

Choose Gibraltar Labs for Bioburden Testing

  • Gibraltar Laboratories’ eminent scientific staff and stellar track record make it the gold standard of contract labs. It was one of first and is still one of only a few contract labs in the country currently ISO 17025 Biological certified.

  • Gibraltar Laboratories follows the bioburden testing procedure described in ISO 11737-1.

  • Bioburden and microbial detection are also required for process validation, cleaning validation, aseptic operation, qualification of water systems, and personnel monitoring.

Classical and Rapid Bioburden Testing

  • In accordance with ISO regulations, classical bioburden testing takes 7 days for yeast and molds results.

  • By using Gibraltar’s Rapid Bioburden Testing system liquid filterable products can be completed in only 2 to 4 days.

Contact us today!

To learn more about Bioburden Testing from Gibraltar Labs, please call us at (973) 227-6882 or submit a contact form by clicking here.