Following the Clients’ recovery methods on Microbiological purity and introducing proposals on testing procedure.
Comprehensive analysis of medicinal drugs, API and excipients for Microbiological purity.
Testing Dietary Supplements for the compliance to microbiological safety standards.
Testing of perfumery and cosmetic products for compliance to microbiological safety standards.
Participation in validation campaigns during the manufacture of medicinal products, as well as the qualification of the production environment.
Sampling to perform microbiological monitoring of the production environment.
Our Lab has an extensive range of accreditations:
Проведение испытаний на МБЧ ЛС, АФС и вспомогательных веществ
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.
Испытания на стерильность
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
Определение антимикробной активности антибиотиков методом диффузии в агар
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.
Проведение испытаний на МБЧ БАД-ов
Microbiological safety testing in Dietary supplements
Microbiological safety testing in Dietary supplements are carried out in compliance withRegulatory technical standard ТР ТС 021/2011.
Проведение испытаний на МБЧ парфюмерной-косметической продукции
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.
Проведение МБЧ воды для инъекций
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.
Определение бактериальных эндотоксинов (ЛАЛ-тест)
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.
Проведение МБЧ воды очищенной
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.
Мониторинг производственной среды – воздух (методы аспирации и седиментации)
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.
Мониторинг производственной среды – смывы с оборудования, поверхностей и персонала
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.