Bioburden Testing ISO 11737

Why You Need Bioburden Testing

Do you work closely with the production of medical devices? Chances are, you have heard about bioburden testing. You need this test to stay compliant with the FDA’s regulations for medical device testing, which comes after completion of all steps prior to sterilization.

As a medical device manufacturer, ensuring the safety of end users is a major concern. Instances such as sterility failures, regulatory intervention (483s), and raw material contamination can threaten patient safety and your business. Utilizing a certified microbiological testing laboratory is a simple solution to prevent these circumstances.

If you want to relieve the pain of regulatory compliance with bioburden testing, Nova Biologicals can help. Don’t let your medical device performance suffer. Get the testing services you need from a professional and qualified team of microbiologists.

What is Bioburden Testing?

Bioburden Testing (ISO 11737-1:2018 / USP <61><62>) detects the total number of viable microorganisms – such as bacteria, yeasts, and molds – on a medical device before sterilization. It’s only one of the evaluations that are essential to determine the effectiveness of your component qualification, manufacturing and sterilization processes.

What Does it Detect?

  • Total aerobic microorganisms
  • Total number of yeasts and molds
  • A variety of specified microorganisms such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Salmonella species, Bacillus species and Bile Tolerant Gram Negative Bacilli

How is it Used?

  • 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

Want to Dive Deeper?

If you want to learn more about the bioburden testing process, we can help. Get additional information on how the test is conducted or quick tips for selecting product to submit for testing. Click the button below to get started.


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