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FDA Laboratory

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Microbiological analysis department


 

MICROBIOLOGICAL ANALYSIS OF DRUGS

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)
  • Enterobacteriacea
  • 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
MICROBIOLOGICAL ANALYSIS OF FOOD AND WATER

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 22oC/37oC
  • Total coliforms
  • Thermotolerant coliforms
  • Escherichia coli
  • Enterobacteriaceaе
  • Enterobacter sakazakii
  • Salmonella spp.
  • Proteus spp.
  • Enterococcus (fecal streptococci)
  • Pseudomonas aeruginosa
  • Staphylococcus aureus
  • Listeria monocytogenes
  • Bacillus cereus
  • Yersinia
  • Vibrio parahaemolyticus
  • Sulfite-reducing clostridium (spores)
  • Clostridium perfringens
  • Yeasts/molds
  • Candida albicans
  • Psychotrophic bacteria
  • Lactic acid bacteria (lactobacteria)
  • Bifidobacteria
  • Probiotic microorganisms
  • Determination of antibiotics residues: group of tetracycline, penicillin, streptomycin
IMPORTANT

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

Laboratory
Complex 2012
"FDA Laboratory"LLC

International
Accreditation
2015 ANAB