We are pleased to share our most recent Testing Services TechTip, focusing on bioburden testing and considerations. This new TechTip joins our existing comprehensive library of technical resources for sterilization and laboratory testing.
What is Bioburden?
Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical.
The Importance of Bioburden Control:
Bioburden control is key to a successful sterilization validation and ongoing routine operations. Bioburden testing is important not only in determining the microbiological quality or cleanliness of a finished product, but can also be critical to the dose used for some methods of sterilization.
A higher bioburden count can lead to:
- Greater sterilization process challenges
- The more resistant the bioburden is, the increased probability of longer sterilization times or higher dose, and more difficult comparative resistance becomes in sterilization validation
- The greater the probability of significant levels of toxins or deleterious effects to the product
At STERIS, our bioburden testing is developed and validated for each individual product or device type and testing is performed in accordance with ISO 11737-1 for terminally sterilized medical devices. Our bioburden testing ensures the best accuracy and repeatability, and each method is designed to best suit our Customers’ specific needs. Controlled testing documentation is issued to Customers for every bioburden method developed, ensuring consistency in testing throughout product/device life span and product warnings and/or alert limits are included in individual bioburden methods.
Contact us today to discuss your individual project requirements.