Our microbiological portfolio includes a very broad spectrum of analyses to prove our clients’ product quality. Within our microbiological department – fully classified as genetic safety level 1 and partly as level 2 – we work with microorganisms of risk groups 1 and 2.

In addition to laboratory services, our clients appreciate our comprehensive and competent consulting services on all microbiologically relevant topics.

Our motivated team is pleased to support you and advise you on questions relating to your products or projects.

List of services: microbiological department

  • Microbiological examination of non-sterile products: total viable aerobic count (plate-count, TAMC/TYMC, bioburden, microbial enumeration test) acc. to Ph. Eur. 2.6.12 and USP <61>
  • Microbiological examination of non-sterile products: test for specified microorganisms acc. to Ph. Eur. 2.6.13 and USP <62>
  • Test acc. to acceptance criteria of Ph. Eur. 2.6.31 and 5.1.4
  • Test of herbal medicinal products for oral use acc. to acceptance criteria of Ph. Eur. 5.1.8
  • Microbiological water analysis following DIN ISO standards and the German drinking water regulation (Trinkwasserverordnung TrinkwV)
  • Identification of bacteria, yeasts and fungi
    • Morphological/microscopical identification
    • Mass spectrometric identification by means of MALDI TOF
    • Identification by sequencing (link to our molecular biological department)
  • Storage of vegetative microorganisms and spores
  • Preservation of pure cultures as master cultures
  • Test for sterility acc. to Ph. Eur. 2.6.1 and USP <71>, performed in an isolator
  • Microbiological assay of antibiotics acc. to Ph. Eur. 2.7.2
    (other designations: determination of potency, antimicrobial effectiveness test)
  • Efficacy of antimicrobial preservation acc. to Ph. Eur. 5.1.3 and USP <51>
  • Efficacy of antimicrobial preservation of cosmetics following DIN ISO 11930
  • Incoming goods inspection of biological indicators following and acc. to USP <55>:
    • Population determination
    • Purity testing
    • Identity check
  • Incubation and evaluation of biological indicators from sterilisation processes
  • Incubation and evaluation of samples from environmental monitoring
  • Sampling as part of environmental monitoring (hygiene examinations) by BioChem staff on site:
    • Active air sampling
    • Passive air sampling (sedimentation plates)
    • Surface monitoring and swab tests
  • Identification of found microorganisms (see above “Identification of microorganisms (bacteria, yeasts and fungi)”)
  • Training of staff in the laboratory and at customer’s site on a wide range of microbiological issues
  • Consulting services:
    • Advice on the preparation of a hygiene concept for pharmaceutical production areas, e.g. regarding clothing, cleaning, monitoring and personnel monitoring
    • Advice on cleanroom qualification
    • Support in the preparation of the qualification documents IQ | OQ | PQ as well as risk analyses for the determination of monitoring points
    • Advice on the conception of a microbiological hygiene monitoring as part of a Contamination Control Strategy (CCS) acc. to Annex 1
  • Non-routine tests and special tests for almost all microbiological issues e.g.:
    • Practical implementation of microbiological cleanroom qualification incl. incubation, evaluation and report
    • Efficacy testing of cleaning agents and disinfectants
    • Incubation and evaluation of media fills
    • Container Closure Integrity Test (CCIT)
  • Microbiological methods:
    • Method development, method transfer, method optimisation and method suitability testing
  • Analyses outside Ph. Eur./USP/JP on request, e.g. acc. to BP, CP or following DIN ISO
  • Microbiological tests for stability studies (microbiological examination of non-sterile products, test for sterility, test for bacterial endotoxins)

Contact the experts of our microbiological department


The experts in our microbiological department will be pleased to provide you with advice and support in planning and carrying out microbiological tests for your products or projects. We will be pleased to prepare an offer tailored to your current issues.

Please use our contact form for your enquiry.