Microbiology

Our Analytical Services

BioChem´s microbiological laboratory offers:

  • quality control release testing
  • EU reanalysis
  • microbiological methods
    • development
    • optimization
    • validation / verification
  • sterility testing
  • bacterial endotoxin testing
  • microbiological contamination testing
  • identification of microorganisms
  • efficacy of antimicrobial preservation
  • microbial assays of antibiotics
  • environmental monitoring
  • in use stability test
  • detergent and disinfectant efficacy
  • testing of biological indicators
  • microbial container closure integrity
  • registration support / expert opinion

for all pharmaceutical

  • finished dosage forms
  • intermediates
  • excipients
  • raw materials

as well as

  • chemical
  • medical
  • cosmetic products

including

  • cytostatics
  • narcotics

Microbiological Equipment and Technologies

Within our Microbiological Department – entirely classified as safety class 1 – we are able to handle microorganisms of risk-groups 1 and 2. All activities are supported by a broad range of high-tech equipment and technologies including:

  • sterility testing with isolator technology
    • membrane filtration method
    • direct inoculation method
  • bacterial endotoxin testing (LAL) applying
    • gelclot method
    • kinetic-turbidimetric method
    • kinetic chromogenic method
  • microbial examination of non-sterile products
    • total viable aerobic count (TAMC/TYMC)
    • test for specified microorganisms
  • identification of microorganism based on
    • colony morphology and growth
    • biochemical characteristics(e.g. API system
    • molecular biological parameters(e.g. 16S-rDNA
  • microbial assays of antibiotics by
    • agar-diffusion method
    • turbidimetric method
  • comparative release studies of antibiotics
  • efficacy of antimicrobial preservation
  • in use stability
    • by repetitive challenge test
    • by application-oriented simulation
  • model experiments and assessments for a multitude of microbiological questions

With more than 40 years of experience in applying different kinds of pharmacopoeial and customer-specific methods we have gained an extensive knowledge in development, optimization, verification and validation of microbiological methods.

State -of-the-art Laboratory

Fully air-conditioned separate lab units, each dedicated to specific analytical procedures, are available in the Microbiological Department which was modernized in 2005.

The best product safety environment is at your disposal.

Equipment and Production Line Qualification

We offer the incubation and evaluation of media-fills and biological indicators as well as a specifically designed microbiological container closure integrity test (CCIT) applying e.g. Brevundimonas diminuta as well-proven test species.

Additionally, our qualified staff performs on-site environmental monitoring at client facilities using air sampling techniques, sedimentation or surface contact plates as well as swab tests.

Evaluation, biochemical or molecular biological typing up to species level and classification of potential isolates complete our services.

Detergent and Disinfection

To verify the efficacy of cleaning and disinfectants on specific manufacturing surfaces used in the GMP environment we established a solid scientifically approved microbiological approach.

We support you in optimizing and validating your cleaning and disinfectant procedures by microbial challenge tests.