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.

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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...

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Discover Sartorius Microbiological Testing Solutions

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.

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Learn how NASA utilizes Sartorius MD8 Airscan®️ technology for cataloging and characterizing potential disease-causing microorganisms aboard the International Space Station (ISS).

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Sartorius products for continuous air monitoring

MD8 Airscan® - active air monitoring solution for Clean Room facilities. 

  • Reduce risks with convenient 8 hours non-stop active air monitoring
  • Be prepared for Annex 1 regulations

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Safe and flexible air sampling with gelatine membrane filters and MD8.

  • Agar-free filters - no need to change agar plates, no risk of cross contamination.
  • USP-approved filter retains even smallest viable airborne microorganisms at the most accurate of levels.

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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.

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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.

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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

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  • The innovative active lid enables touch-free membrane transfer 
  • Eliminate False-Positive results 
  • Pre-filled with agar, Microsart® @media dishes are sterile-packed and ready to use

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  • 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

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  • 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

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  • Maintenance-friendly and efficient pump
  • Vacuum flask free, smooth and reliable filtration
  • Space-saving footprint for benchtop use

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Resources

Product Datasheet: Gelatin Membrane Filters in Biosafe® Bags

PDF | 151.4 KB

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Product Datasheet: MD8 Airscan

PDF | 698.8 KB

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Product Datasheet: Microsart® @filter 100 | 250

PDF | 109.9 KB

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Product Datasheet: Microsart® e.jet — Laboratory Transfer Pump with Quick Connection for Microbiological Analysis

PDF | 137.5 KB

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Product Datasheet: Microsart ® @media — Advanced System for Touch-free Membrane Transfer

PDF | 213.4 KB

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Product Datasheet: Microsart® e.motion Dispensers — Make Membranes Move

PDF | 158.1 KB

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Product Datasheet: Microsart® e.motion Membrane Filters

PDF | 127.5 KB

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Product Datasheet: Microsart® Manifolds

PDF | 823.0 KB

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