Bioburden and Sterility Test for Live Biotherapeutic Products

Producing safe products is a core goal of all manufacturers and sterility assurance is a key component in achieving this goal. The FDA and other regulatory organizations require that the sterilization process typically possesses a bioburden and sterility testing. With expertise in live biotherapeutic products (LBPs) discovery and regulations, Creative Biolabs is the expert you can rely on when you are navigating the LBP development industry. Our sterility testing and bioburden testing are also performed on devices as part of our routine quality control.

What Is Bioburden Testing?

Bioburden testing, or total viable count testing, is the measure of microbial contamination levels on or in a product. Bioburden can be introduced from the raw materials used in the manufacturing process or be introduced via the workforce or manufacturing environment. Bioburden testing helps provide an accurate basis for calculating effective sterilization. Bioburden is an important part of quality control and in determining the bioburden of a given device.

The Way of Bioburden Testing

Workflow of bioburden testing at Creative Biolabs. Fig.1 Workflow of bioburden testing at Creative Biolabs.

What Is “Sterility”?

  • Within the strictest definition of sterility, a specimen would be deemed sterile only when there is a complete absence of viable microorganisms from it.
  • Absolute sterility can’t be demonstrated without the destruction of every article from a lot of compounded sterile preparations (CSPs).

The Way of Sterility Test

Workflow of sterility testing at Creative Biolabs. Fig.2 Workflow of sterility testing at Creative Biolabs.

What Is the Difference Between Bioburden and Sterility?

Bioburden testing may be done using several different techniques, but minimally a typical assessment of anaerobic bacterial assay as well as a fungal assay. Sterility testing determines whether the articles tested to comply with the requirements outlined in the individual monograph concerning sterility.

Why Do Bioburden and Sterility Tests?

Probiotics can be delivered in the form of conventional foods, infant formula, pet foods, dietary supplements, drugs, cosmetics, and even medical devices. The regulatory requirements and types of allowable claims for each of these products differ. Most probiotics today are components of either food or dietary supplements.

Biologic Evaluation and Research (CBER) requires a very detailed characterization of any microorganisms in this category. So, LBPs would have to be produced to comply with Good Manufacturing Practice (GMP) standards. Amongst, bioburden and sterility tests are very important. Besides, CBER allows for the development of recombinant LBPs, composed of microorganisms that have been genetically modified through the purposeful addition, deletion, or modification of genetic material. These new recombinant LBPs must be tested about bioburden and sterility to ensure their safety.

We are firmly committed to the research and development of LBPs to offer a unique service that can accelerate your success. Creative Biolabs ensures the best accuracy and repeatability in bioburden and sterility testing by method development and validation to address each product/device type. If you have any scientific research requirements or questions, please feel free to contact us .

For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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For Research Use Only. Not intended for use in food manufacturing or medical procedures (diagnostics or therapeutics). Do Not Use in Humans.

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