The Department of Microbiological Control (MBC) due to highly qualified personnel and appropriate equipment has the opportunity to test medicines, medical devices, dietary supplements according to the following parameters:
- Bacterial endotoxins (gel-clot method).
- Microbiological examination of non-sterile products: microbial enumeration tests (TAMC, TYMC, MAFAnM, bioburden)
- Microbiological examination of non-sterile products: test for specified micro-organisms (bile-tolerant gram-negative bacteria, Escherichia coli, Salmonella, Staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans).
- Efficacy of antimicrobial preservatives
- Quantitative determination of antibiotics (or vitamins) according to the requirements of the European Pharmacopoeia, using parallel line models, and according to the requirements of the United State Pharmacopoeia, using a calibration curve, turbidimetric method and agar diffusion method.
- Quantitative determination and identification of microorganisms in probiotics – live biotherapeutic medicinal products (LBMPs).
- Determination of microbiological purity (TAMC, TYMC and individual species of microorganisms) for LBMPs.
- Determination of a population of microorganisms (Bioburden) on products with preliminary validation of the determination method.
In addition, we offer our services for conducting microbiological monitoring tests, namely: seeding, incubation and interpretation of results taken during production of environmental samples and other production process factors that affect microbiological indicators of product quality (purified water, packaging materials, etc.). The manufacturer collects and delivers samples of the surrounding production environment to the laboratory.
We also test the growth, inhibitory, and identification properties of ready-made nutrient media used during monitoring of the surrounding production environment and product quality control according to the “Microbiological Purity” indicator.
We are ready to provide the possibility of conducting other tests according to your tasks.