Microbiological Testing

Either you produce a sterile substance, an aseptic manufactured material or a product to be delivered unsterile, BSL BIOSERVICE supports you with the necessary microbiological tests.

Microbial count (TAMC, TYMC)

  • Total aerobic microbial count Clean room
  • Total yeasts and moulds count
  • Suitability of the counting method in the presence of product

Test for specific microorganisms

  • Bile-tolerant gram-negative bacteria (qualitative / quantitative)
  • Escherichia coli (qualitative / quantitative)
  • Staphylococcus aureus
  • Pseudomonas aeruginosa
  • Salmonella
  • Candida albicans
  • Suitability of the test method

Sterility tests

  • Under cleanroom conditions acc. to EU-GMP guidelines
  • Membrane filtration
  • Direct inoculation Quality Control
  • Method suitability test

Pyrogens / Bacterial endotoxins

  • LAL test (gel clot, turbidimetric technique)
  • Validation/test for interfering factors
  • Pyrogen test
  • Monocyte activation assay
  • Validation of depyrogenation with dry heat

Environmental monitoring

  • Establishment of a hygienic program incl. sampling plan
  • Sampling
  • Particle count
  • Microbial count of air
  • Microbial count of surfaces, personal
  • Identification of microorganisms
    • Agar plate_

Examination of water samples

  • Total viable aerobic count
  • Identification of isolates
  • Bacterial endotoxins

Identification of microorganisms

  • Bacteria and yeasts / moulds
  • Macroscopical and microscopical examination
  • Biochemical identification (API)
  • Molecular-biological identification (partnered service)

Test for Mycoplasma

  • Detection of mycoplasma with PCR

Efficacy of antimicrobial preservation / Challenge test

  • All variations of tests acc. to EP and USP for parenteral, ophtalmic, topical and oral, preparations

Test for the efficacy of antimicrobial products

  • Microbial assay of antibiotics (diffusion and turbidimetric method)
  • Test for growth inhibition on agar plate or in media (determination of MIC)
  • Standardized or tailor-made studies

Evaluation of bioindicators / Sterilization processes

  • Evaluation of quality, quantitative, qualitative evaluation after application of the sterilization process of bioindicators
  • Microbiological tests necessary for performance qualification of sterilization processes