Efficient, Reliable, User-Friendly Microbiological Testing Solutions for Medical Devices
Product Safety Means Patient Safety - Confidence in Medical Device QC Testing
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.
Find out how we can help you meet regulatory requirements in your microbiological testing.
NEW APPLICATION NOTE
Be prepared for Annex 1 regulations and download our application note. Learn how to benefit from implementing continuous microbial air monitoring to entire...
Continuous Active Air Monitoring solutions for Clean Room environments - Be prepared for Annex 1 regulations
Monitor Air Contamination in Your Clean Rooms every 8 Hours or 8 Hours Non-Stop and Ensure Safe Medical Device Manufacturing and Quality Control
You have to continuously monitor airborne microbes in your Medical Device manufacturing Clean Room environment facilities, yet every time you change your agar plates you face the risk of cross contamination. Using active Sartorius MD8 Airscan® technology you’ll benefit from the security and flexibility of continuous sample collection using just one single gelatine membrane filter. The MD8 Airscan® air sampler eliminates the need to change agar plates and allows your facility to focus on other important manufacturing or quality control process tasks. Our proprietary, USP-approved filter retains even the smallest airborne micro-organisms at the most accurate level possible – practically ruling out false negative results, to provide unrivalled convenient, continuous air monitoring and control.
Opt for total safety and convenience. Future-proof active air monitoring and sampling by Sartorius, allows your lab to be fully prepared for Annex 1 regulations.
Learn how NASA utilizes Sartorius MD8 Airscan®️ technology for cataloging and characterizing potential disease-causing microorganisms aboard the International Space Station (ISS).
Sartorius products for continuous air monitoring
Water Testing Solutions
Water - do you have it under control?
Streamline your workflows and simplify your microbiological testing
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.
To help you streamline your workflows and simplify your microbiological testing, take a look at Sartorius’ range of user-friendly consumables and equipment.
Bioburden Testing Solutions
Control your Manufacturing Processes
Simplify your bioburden testing while complying with regulations
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. Thus, using the right products and procedures to determine bioburden is essential and helps you reduce any risks which could impact patient safety.
Take a look at Sartorius’ range of user-friendly consumables and equipment to help you simplify your bioburden testing and comply with regulations.
Sartorius products for water and bioburden testing
- Save time and minimize the risk of secondary contamination
- Reliable results as no liquid remains after filtration
- Ready-to-use, sterile Microsart® @filter units combine a funnel, a filter base and a gridded membrane filter in one unit
- Membrane filters for colony counting, particle testing and microscopy
- Outstanding recovery rates for microorganisms
- Individually sterile-sealed filters are packed on a special pleated band
- Convenient dispenser enables automatic, touch-free membrane filter dispensing
- Single and multi-branch manifolds for microbiological analysis of liquid samples in quality assurance
- Fully autoclavable stainless steel manifolds are easy to clean and rinse
- High flexibility thanks to quick connections for adapting filter base and tubing
- Ergonomic and intuitive handling of the valves