Services Quality Control

  • Bioassays in vitro and in vivo Quality Control

  • Microbial count (TAMC, TYMC)

    • Total aerobic microbial count
    • 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 (accepted by bavarian government)
    • Membrane filtration
    • Direct inoculation
    • 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

  • 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

  • Infection studies

    • Broad variety of test strains
    • Cultivation of the pathogenic strain
    • Evaluation of organic material with microbiological and molecularbiological (real time PCR) methods

  • 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