Non-sterile products

Total microbial count determination

For the microbiological quality and safety of a product, the number of viable microorganisms such as bacteria and fungi that a product contains is decisive. The total germ count is determined and this test is an important part of ensuring product quality. Testing is performed in accordance with pharmacopoeia regulations, standardised procedures, customer-specific test procedures or DIN EN ISO standards.

The suitability test of the method and method transfers are performed in coordination with our customers within the framework of accreditation according to DIN EN ISO 17025 or under GMP. Labor LS offers the following services in the field of total microbial count testing:

  • Quantitative testing: determining the total microbial count in the product (number of viable microorganisms such as bacteria and fungi)
  • Qualitative testing: detection of specified microorganisms in the product (e.g. salmonella, Pseudomonas aeruginosa and Staphylococcus aureus)
  • Testing in accordance with the requirements of the valid pharmacopoeias (Ph. Eur., USP, JP) and other international pharmacopoeias (e.g. CP, Ph. Rus.),
  • Testing within the framework of standardised procedures such as DIN EN ISO 11737-1 for medical devices and packaging materials
  • Testing within the framework of DIN standards for cosmetic products
  • Preparation of risk assessments by Labor LS
  • Total microbial count of high-purity water, pure steam and process water (AP water and WFI) and raw materials
  • Total microbial count within the context of in-process controls

Your contacts on this topic

We would be pleased to advise you and prepare an individual quotation for you! For more information and enquiries, please contact our team of experts:

 

Routine testing

Dr. Christian Krug
Microb. testing of non-sterile products
+49 9708 9100-873
christian.krug@labor-ls.de

Dr. Ina Buchholz
Microb. testing of non-sterile products
+49 9708 9100-709
ina.buchholz@labor-ls.de

Suitability test

Christine Weiß
Microb. testing of non-sterile products
+49 9708 9100-716
christine.weiss@labor-ls.de

Christian Lomb
Preservative Efficacy
Testing
+49 9708 9100-319
christian.lomb@labor-ls.de