Summary of the Bioburden Testing
Bioburden refers to the population of microorganisms on raw materials, product components or finished medical devices before sterilization. These microorganisms can be introduced from the raw materials used in the manufacturing process, or via the workforce or manufacturing environment. Bioburden control emphasizes two aspects: maintaining consistency from lot to lot and avoiding spikes within a single lot. Due to the numerous sources of contamination, the bioburden of the product may fluctuate from batch to batch. Therefore, it is recommended to conduct routine tests regularly. For medical devices, bioburden test data helps establish the parameters for an effective sterilization process. In order to ensure the ongoing safety of the sterilization process, it is necessary to verify that the bioburden level remains consistent over time. When the bioburden of a product is two or more times than the group average, a bioburden spoke will occur. A significant increase in the device bioburden will reduce the sterility assurance level of the sterilization process.
Before performing the test, a suitability test must first be performed. The purpose of bioburden suitability testing (or method validation) is to ensure that the bioburden test method is effective and to show that the test method will allow the growth of the device microorganisms.
The Bioburden Testing Provided by Creative BioMart Microbe
Creative BioMart Microbe has powerful technology platforms and strict control systems. Our experienced researchers can provide customers with:
- Bioburden testing methods developed and verified for different types of products/devices to ensure the best accuracy and repeatability of bioburden testing.
- Controlled testing documents issued to customers for each bioburden method developed, ensuring test consistency throughout the product/device life span.
- Customize the bioburden testing program according to the different needs of each customer.
- Product warnings and alert limits included in individual bioburden methods.
What can be detected?
- Total aerobic microorganisms
- Total number of yeasts and molds
- A variety of specified microorganisms such as Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Bacillus species, Salmonella species, and Bile Tolerant Gram-Negative Bacteria.
Creative BioMart Microbe has nearly 20 years of successful experience and has introduced numerous technical personnel and advanced technology platforms to ensure that it can provide customers with high-quality and high-accuracy bioburden testing. Our excellent service has won us a lot of praise all over the world.
If you want to know more about this service, please feel free to contact us by phone or email, or you can consult through our inquiry form. We will ensure to provide you with efficient and high-quality experimental outsourcing services.
