Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?

Did you miss MD&M Texas? Check out the Tech Theater presentation given by Nelson Laboratories scientist Martell Winters. As biological and tissue products and combination products become more prevalent, new questions are often asked related to microbiology that are different from those asked for traditional medical devices.  As these questions become more common, additional guidance is necessary for the industry.  Much of this additional guidance will be added to the new version of the ISO bioburden standard, 11737-1.  Some of this information must be added due to the lack of microbiological expertise in the industry.  However, when the information is added it will not be easily understood by non-microbiologists, meaning that some understanding must be present to fully appreciate it. Following are some main points to be added to the standard which will be discussed in the Tech Theater presentation.  Also some discussion will be provided regarding the microbiological expertise in the medical device industry.

  • Low bioburden products
    • How low is low?
    • Why are they different?
  • How should the bioburden test be performed?
    • Review of raw materials/manufacturing process
  • Optimization of bioburden testing
    • Increasing sensitivity (e.g. volume factors)
    • Pooling of bioburden samples
  • Reviewing bioburden data
    • Addressing TNTC values
    • Addressing spreaders/lawns

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