Test on the Microbiological Purity

Determination of the total viable aerobic count and detection of specified microorganisms Testing the microbiological purity of non-sterile dosage forms is an essential part to guarantee the product quality.

In order to ensure that a product meets the minimum requirements regarding the microbiological purity, we offer the following services:

  • Quantitative analyses: Determination of the total viable aerobic count (quantity of viable microorganisms such as bacteria, yeasts and moulds)
  • Qualitative analyses: Detection of specified microorganisms (e.g. Salmonella, Pseudomonas aeruginosa and Staphylococcus aureus)
  • Analysing in accordance with the requirements of the current pharmacopoeias (Ph. Eur., USP, JP) and other international pharmacopoeias (e.g. CP, Ph. Rus.), standardised procedures such as DIN EN ISO 11737-1 for medical devices and packaging materials or DIN standards for cosmetic products
  • Method development (separate department for methodological suitability tests and years of experience based on multi-thousands of samples)
  • Preparation of risk assessments by a medical director coordinated by Labor LS
  • Testing of the bioburden and in-process controls (separate laboratory with enhanced security standard)
  • Test reliability and short processing times guaranteed by large lab capacities
  • The test on the microbiological purity is transferable on various areas of application. These include, in addition to non-sterile dosage forms, medical devices and cosmetics, but also commodities, water for pharmaceutical manufacturing and testing purposes, raw materials and other non-sterile products of diverse branches of industry.
Further info
Product groups:
Measuring devices, scanners, quality control
    Further measuring devices, scanners, quality control

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Dr. Christian Krug

Labor LS SE & Co. KG

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