Bioburden Testing

All manufactured products, even those created in sterile environments, may have some sort of harmful organism on them. This organism could have been in the raw materials, on the containers the item was stored in, or on the machines used to create the item. Bioburden testing is one way to check products to make certain they are safe for use. Medical device testing, in particular, is very essential. Because patients in hospitals are typically already dealing with a weaker immune system or a shock to their system, it's of paramount importance that the device used on and around them contains no harmful bacteria, viruses, or other agents. This means every aspect of the product, including the materials it's made from, and the environment in which it's created, must be sterile.

Medical Device Testing and Sterilization

While the FDA and other boards regulate bioburden testing and have very strict requirements for all aspects of manufacturing, they are particularly strict about medical device testing and the amount of CFUs, or colony forming units per gram, that each device has. If a product is over this limit by even just a small amount, it is rejected. Dynatec Labs holds companies to the highest standards not because we desire to cause problems but because we know the medical realm is one that literally can mean life or death. Manufacturers are already committed to creating the best, safest items they can--our goal is to serve as a second set of eyes, guaranteeing that medical professionals will only have the best tools to use.

More information:

• Clean Room Certification Testing
• Product Sterility Tests
• Spore Forming Bioburden