Welcome to Compliance Advice and Services in Microbiologys website

 

Our microbiology laboratory has been founded in 1999. We have specialized in consulting- and laboratory-services in the microbiological area. Besides microbiological consultancy services, our laboratory offers analytical laboratory research as well as support in the field of microbiological quality control for aseptic processes and sterilization processes.

Our main field of work lies within the pharmaceutical microbiology. Therein, we provide our customers a wide range of services to effectively support their internal quality control. Due to our GMP-certified quality management and documentation our customers can always be certain to receive trustworthy results. Our pharmaceutical laboratory services include:

 

 

Our area of expertise: Examination of biological indicators

Within Europe, there are few independent laboratories with comparable experience with biological indicators. Within this field, we offer:

 

  • D-Value determination (decimal reduction)
  • z-Value determination
  • Confirmation of the survival-kill-time in our BIER-Vessel (Steam)

 

The microbiological D-Value stands for decimal reduction, which refers tot he time necessary to reduce the initial amount of spores to one tenth. The z-Value however describes the necessary increase of temperature to reduce the d-value to one tenth, or, in other words, to increase the kill-rate by ten.

Our Biological Indicator Evaluation Resistometer (BIER-Vessel) recertifies biological indicators according to the requirements of United States Pharmacopoeial Convention, the European Pharmacopoeia (Ph. Eur.) and the Association of Medical Instrumentation (AAMI). D-Value determinations in dry heat will be performed in our dry-heat sterilizer.

 

Microbiological Analysis according to the European Pharmacopoeia (Ph. Eur.)

  • Determination oft he total viable count (bacteria), and the amount of yeast or mold (TVC / TAMC / TYMC)
  • Examination of water for pharmaceutical purposes
  • Testing for specified microorganisms according to Ph. Eur. 2.6.13 and combined examination of microbial contamination
  • product or water examination on bacterial endotoxins through LAL-test according to Ph. Eur. 2.6.14
  • Efficacy of antimicrobial preservation according to Ph. Eur. 5.1.3.
  • Validation of test methods in the presence of the product (according Ph. Eur. or USP respectively)

 

Our pharma- laboratory also offers you services outside the pharmaocopoeia:

 

Analysis of hygienic monitoring-samples:

  • Contact plates
  • Sedimentation plates
  • Active air samples
  • Qualification of culture media

 

Individual studies and development of sterilization methods

 

In recent years, we could accomplish several individual projects and studies in close collaboration with our customers. We supported them by solving highly complex microbiological problems and questions, and could also steadily improve and advance our knowledge on microbiological issues.

 

Due to our expertise in D-value and z-Value determinations of biological indicators, particularly contained in your product, we are also able to support you with the development of sterilization methods and project plans to your individual microbiological problem.

 

We would be pleased to inform you individually in detail about all services that we can offer for you.