Microbiology Quality Control of Pharmaceuticals

Performance You Deserve, with the Compliance You Expect

As a quality control (QC) lab technician, you play a crucial role in the pharmaceutical manufacturing process. As QC in the pharmaceutical industry is highly regulated, you cannot afford to be less than 100% compliant. Our products and solutions for incoming ingredients, in-process bioburden and mycoplasma testing - as well as air monitoring and final release sterility testing - are aimed at providing full compliance and reliability. 

At Sartorius we offer smart solutions no one else can offer.

  • Full compliance
  • Robust performance
  • High-quality, reliable test results

Microbial Enumeration | Bioburden Testing

Forceps-free, effortless membrane transfer thanks to “magic lid”: with Microsart® @filter and Microsart® @media.

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Rapid Microbial Testing

Our validated mycoplasma, bacteria and fungi detection kits provide rapid sterile release of pharmaceuticals including ATMPs in only 3 hours...

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Sterility Testing

Aseptic sampling out of a closed, sterile system: due to Sterisart® Septum technology.

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Microbial Air Monitoring

Agar-free, continuous air monitoring: thanks to MD8 Airscan® with unique gelatin membrane filters.

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Addressing the Challenges of QC Labs in Vaccine Manufacturing

Take a look at a typical cell-based vaccine manufacturing process and see where our products and services can help you overcome your quality control challenges.

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Resources for Microbiological Quality Control

Featured Application Notes

The Sterisart® Septum Enables Reliable Sampling from a Closed System S...

The Sterisart® septum allows easy inoculation and sampling and enables the coupling of the conventional closed system sterility testing with rapid det...

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Equivalency of PCR-Based Rapid Sterility Testing and the Compendial Cu...

Sterility testing is a critical component of the release testing for any cell therapy product since microbial contamination of cell therapy products c...

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Continuous Microbial Air Monitoring in Clean Room Environments

Continuous Microbial Air Monitoring in Clean Room Environments Applica...

Environmental monitoring is an important part of quality assurance for the production environments of sterile pharmaceutical products.

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Resources

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