Our Lab has an extensive range of accreditations:
Microbiological purity testing
Microbiological purity testing includes the quantitative determination of aerobic microorganisms, yeast and mould fungi, as well as the identification of certain types of microorganisms, the presence of which is unacceptable in non-sterile drugs, APIs and excipients intended for the production of pharmaceutical drugs. The tests are carried out under aseptic conditions.
Sterility testing is very important for a variety of pharmaceutical products and dosage forms. These include preparations for injections, infusions, eye drops, APIs and excipients, tissue materials, biologics and solvents that claim to be sterile as prescribed in pharmacopoeial monographs or regulatory documentation. The tests are carried out under aseptic conditions
The antimicrobial activity of antibiotics
The antimicrobial activity of antibiotics is assessed based on their ability to inhibit microbial growth. The assessment is carried out by agar diffusion method using a dense nutrient medium. The diameters of the inhibited growth zones of microbial test stains are compared in size. Such stains result from the testing of the reference standard and test substance of specific concentration.
Microbiological safety testing in Dietary supplements
Microbiological safety testing in Dietary supplements are carried out in compliance withRegulatory technical standard ТР ТС 021/2011.
Analysis to determine the Microbiological safety of beauty, personal care and cosmetic products
Analysis to determine the Microbiological safety of beauty, personal care and cosmetic products are performed in compliance withRegulatory technical standard ТР ТС 009/2011.
Microbial analysis of WFI
Microbial analysis of both Purified Water (PW) and Water for Injections (WFI) is carried out as prescribed in Pharmacopoeia Monograph. Membrane Filter technique is an effective, accepted method for testing water samples in aseptic environment.
Bacterial Endotoxin (BET)/LAL
This method is used to detect the presence of Bacterial endotoxins in medicinal drugs for parenteral administration and in pharmaceutical substances used for their formulations.
Microbial analysis of Purified Water
Microbial analysis of Purified Water is carried out as prescribed in Pharmacopoeia Monograph. Membrane Filter technique is an effective, accepted method for testing PW samples in aseptic environment.
Monitoring of production environment – Air quality
Air quality. Monitoring of microbial air contamination is performed through the scheduled observations or by measuring parameters at critical control points, thus detecting the exceedance of limits and getting access to the required information for developing preventive actions. Aspirational and Sedimentation methods of testing are applied.
Microbiological Swabbing method to monitor contamination on the equipment surface, PPE and hands
Such monitoring is carried out in compliance with the Guidelines on Microbial Control of manufacturing facilities.