Microbiological Testing Solutions

Medical devices can improve the quality and even extend a patient’s life. In an increasingly complex regulatory landscape, continuous microbiological testing during manufacturing is crucial to ensure consistent, reliable product quality and more importantly, patient safety. With our established expertise in microbiological quality control, Sartorius enables you to achieve accurate, reproducible results for in-process and final release microbiological testing. We provide medical device manufacturers with fully compliant membrane filtration solutions, ideal for use in water, bioburden and sterility testing, as well as active air monitoring for clean room and production environments.

Continuous Active Air Monitoring solutions for Clean Room environments - Be prepared for Annex 1 regulations

Be prepared for Annex 1 regulations and download our application note. Find out how you can implement continuous microbial air monitoring throughout your entire medical device manufacturing and quality control systems.

Water Testing Solutions

When manufacturing medical devices, water is often in direct contact with your product. Therefore, microbiological control of water is essential to ensure that your quality processes comply with regulations. Additionally, the procedures you use to monitor, and control potential contaminants are also crucial for reducing any risks which could impact patient safety.

Bioburden Testing Solutions

Prior to sterilization, bioburden testing to determine the total number of viable microorganisms, or total microbial count on all or part of your medical device’s surface, is one of the most commonly used microbiological tests in the Medical Device industry. As required by industrial standards such as ISO 11737-1, you need to suspend microorganisms in the right liquid, capture them using membrane filtration and then grow them on a culture medium.