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Release Testing >> Quality Control Testing >> Microbiological Testing

Microbiological Testing

Routine Microbiological Testing 

The following tests are only a small part of our microbiological testing service portfolio and are performed routinely on a large scale basis. Contact us to receive information about our microbiological testing capabilities.

 

GMP compliant Microbiological Testing available

  • Biological assays of antibiotics
  • Efficacy of antimicrobial preservatives (challenge testing)
  • Microbial identification
  • Mycoplasma testing
  • Mycobacterium testing
  • Sterility testing, membrane filtration
  • Sterility testing, direct inoculation
  • Total Aerobic Microbial Count (TAMC)
  • Total Yeasts and Molds Count (TYMC)
  • Test for specified micro-organisms
  • Endotoxin testing, Bacterial Endotoxins (LAL), kinetic turbidimetric
  • Endotoxin testing, Bacterial Endotoxins (LAL), kinetic chromogenic
  • Endotoxin testing, Bacterial Endotoxins (LAL), gel-clot

 

Validation of analytical methods

Not only can we assist you with routine QC microbiological testing, we also offer method development and validation services. A validation project comprises a study plan, study design, performance of analytical work and subsequent data handling. All data is presented in a detailed study report.

 

Environmental Monitoring Program

Except for product testing we can also help you monitor your clean / aseptic areas to ensure that daily operations are not negatively influencing the required cleanliness level. Environmental Monitoring testing is a critical assessment of the performance of your employees, machines, process etc. Eurofins can help you setting up a customized Environmental Monitoring Program and perform the required monitoring and testing:

 

Viable monitoring:

  • active air sampling
  • passive air sampling
  • surfaces
  • operators

Except for the determination of the bioburden level in your clean areas, it is also important to know what your house flora is. This should be continuously under review (annually) and be monitored on a regular basis as house flora may change during the different seasons.

House flora is also used to validate disinfectants, and during simulations of your products processes (media fill).  

 

Why choose Eurofins BioPharma Product Testing  

  • Single-point-of-contact. Eurofins BioPharma Product Testing Netherlands has all expertise within the same organization, allowing clear and reliable communication.
  • All services available internally. As Eurofins BioPharma Product Testing Netherlands has several complementary companies, all this expertise is brought together in one multi-disciplinal organization.
  • Standard and custom solutions. If our standard solutions do not fulfill your requirements, our skilled technicians are able to develop specialized solutions. Please contact us if you want to discuss your needs.