FDA Laboratory

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Microbiological analyses department



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:


  • Colony count 22oC/37oC
  • 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

Complex 2012
"FDA Laboratory"LLC

2015 ANAB