Microbiology

We provide microbiological testing for sterile and non-sterile APIs and drug products. A fully-equiped laboratory is available including a cleanroom with airlock tecnology and HEPA filters for the most sensitive operations. A 4 gloves isolator ISOFLEX-S is equiped with a Steritest pump and a H2O2 generator. The main advantage of using isolation technology for sterility testing is to assure that non-false positive results are obtained.

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List of services:

  • Non-sterile microbiological testing:
    • TAMC (total aerobic microbial count)
    • TYMC (total yeasts and moulds count)
    • Determination of pathogens (Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa and Burkholderia cepacia, Candida albicans, Enterobacteriae and other gram-negative)
    • Identification of microorganisms
    • Total viable spore count 
  • Sterility testing
  • Particulate matter: visible and subvisible particles
  • Microbiological assay of antibiotics
  • Suitability and validation of microbiological tests
  • Development and validation of microbiological assay methods (antibiotics)
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  • Minimum Inhibitory Concentration (MIC test)
  • Statistical analysis of results of biological assays and tests according to European
    Pharmaco poeia
  • Growth promotion test
  • Run media fill
  • Water for Pharmaceutical Use (including TOC and conductivity analysis)
  • Bacterial endotoxins
  • Biocides effectiveness
  • Environmental microbiological control:
    • Air contamination and air classification
    • Surfaces contamination

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