The department implements microbiological analysis of various pharmaceutical dosage forms and raw materials for pharmaceutical use (purity, sterility). Analysis is performed in accordance with:

 

• The State Pharmacopoeia of the Russian Federation
• United States Pharmacopeia
• European Pharmacopoeia
• Individual monograph specially written for drug development

 

The following tests are carried out assessing microbiological purity:

 

• Aerobic bacteria (TAMC)
• Fungi: yeasts and molds (TYMC)
• Enterobacteriaceae
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Escherichia coli
• Salmonella spp.

 

Sterility testing:

 

• Aerobic bacteria
• Anaerobic bacteria
• Fungi

 

Determination of endotoxins (LAL test).

 

Determination of the effectiveness of antimicrobial preservatives.

 

Determination of antibacterial activity of antibiotics.

 

Probiotic medicines are tested for the following parameters:

 

• Microbiological purity
• Determination of lactic acid bacteria
• Determination of bifidobacteria
• Quantification of probiotics

Analysis is performed in accordance with:

 

• Technical Regulation of the Eurasian Customs Union
• Technical Regulation of the Republic of Armenia and EU
• Sanitary Rules and Norms
• International standards (ISO, ISO/TS, DIN, EN)
• National standards (GOST, GOST R, MUK, MU, STB ISO, STK)
• Technical standard of product

 

Qualitative and quantitative testing of the following parameters is carried out:

 

• MAFAM (TAMC)
• Colony count 22^oC/37^oC
• Total coliforms
• Thermotolerant coliforms
• Escherichia coli
• Enterobacteriaceaе
• Enterobacter sakazakii
• Salmonella spp.
• Enterococcus (fecal streptococci)
• Pseudomonas aeruginosa
• Staphylococcus aureus
• Listeria monocytogenes
• Bacillus cereus
• Sulfite-reducing clostridium (spores)
• Clostridium perfringens
• Yeasts/molds
• Candida albicans
• Psychotrophic bacteria
• Lactic acid bacteria (lactobacteria)
• Bifidobacteria
• Probiotic microorganisms

Laboratory analayses implements as classic, as well as express methods: RT PCR.

 

For analysis, identification of detected microbes the following methods are used:

 

• Selective, elective, diagnostic, chromogenic media
• Microscopy, different ways of staining of bacteria
• Biochemical tests
• Serological tests

 

Microbiological department equipment and facilities:

 

• Sertified quality control passed growth media and agents of such reputed manufacturers, as Carl Roth, Biomerieux, Genekam, Eppendorf, Sartorious, Liofilchem, SigmaAldrich are used
• Test strains from American Type Culture Collection (ATCC)
• 3 clean zones of class B with laminar boxes of class II type A2, according to the international classification
• Real Time PCR system «Quant Studio 5» (Thermo Fisher Scientific)

 

Testing Quality control is carried out with the help of the following parameters:

 

• Quality control of nutrient media and all auxiliary equipment and devices, as well as the environment and air, which directly or indirectly can affect the validity of the results
• Documentation of analysis
• Regular qualification trainings