Test on the Microbiological Purity
25 April 2019
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 measuring devices, scanners, quality control