We provide microbiological testing for sterile and non-sterile APIs and drug products. Our fully-equipped laboratory includes a cleanroom with airlock technology and HEPA filters for the most sensitive operations. Our 4-glove isolator ISOFLEX-S is equipped with a Steritest pump and an H2O2 generator. The main advantage of using isolation technology for sterility testing is to ensure that no fals- positive results are obtained.
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)
- 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)
- Challenge test
- 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
