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Identification of Microorganisms

Qualitative and quantitative microbiological analysis according to the common rules (European Pharmacopoe; DAB; CTFA; § 64 LFGB; et. al.) from every matrix you are interested in.

Expert: Andreas Dreusch (http://www.micromol.com)

Phage-detection

One of our specialities is the detection of phages in prokaryotic cell banks. We can provide this test for samples directly or with enrichment on many typical expression strains. Furthermore we test expression hosts for the presence of unknown lysogenic phages. We also can detect phages from production environments, as we do identification of phages by PCR, strain preferences and other methods.

Expert: Andreas Dreusch (http://www.micromol.com)

Proof of production strains

Contamination detection, phenotypical identity, genetical identity, determination of plasmid-counts, absence of lytical phages, absence of lysogen phages

Expert: Andreas Dreusch (http://www.micromol.com)

Efficacy of antimicrobial preservation

We test your products for the efficacy of antimicrobial preservation according to Ph. Eur, USP, CTFA or your own protocol. Adjustment of the formulation or the total re-formulation of your products for a sufficient performance is done by us, too. We perform these tests on aqueous, lipid or dry formulations as well.
For good preservation the use of strains isolated from the production environment is recommended. Here we can help you with the identification of your microbial fauna to select the most recalcitrant organisms for testing.

Expert: Andreas Dreusch (http://www.micromol.com)

Bactericidal and fungizidal testing

This area includes tests according to the methods for disinfectants of the DGHM, DVG, and the relevant ISO and DIN standards. We also develop means for testing with uncommon disinfectants. And if your disinfectant is missing the standard, we can do more for you. We developed several innovative formulations for our customers according to their aims. Sterilization validation is a further topic we are familiar with. We plan and carry out validations with intentionally contaminated materials according to ISO 11737 in our validated steam autoclaves. Furthermore we provide consultancy and research capacities for other sterilization methods. We also provide you with spores of typical validation strains for your in-house investigation. We can provide e.g. A. niger with defined UV-resistance or B. licheniformis isolates with increased heat tolerant spores.

Expert: Andreas Dreusch (http://www.micromol.com)

Qualifications (DQ / OQ / PQ)

We have experts for design qualification, operational qualification and process validation. We are familiar with FMEA and HACCP just to mention some of the topics one has to deal with when it comes to pharmaceutical production processes. Here these methods for failure prediction and evaluation are standard. But they help to prevent fatal errors in other industries, too.
The fact that we have the in-house capabilities for microbiological validations and inspections makes our services outstanding. We are not only an engineering bureau that coordinates investigations, but that has the intimate knowledge of the meanings of single results. Let us help you to plan your production environment and processes. We have specialists for nearly all sectors from cell culture to packaging machines and we can be a valuable source for your team.

Expert: Andreas Dreusch (http://www.micromol.com)