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FDA Laboratory

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Microbiological analysis department


 

Microbiological testing of drugs

The department carries out microbiological testing of various pharmaceutical dosage forms and raw materials for pharmaceutical use. Testing 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
  • fungi: yeasts and molds
  • enterobacteriacea
  • pseudomonas aeruginosa
  • staphylococcus aureus
  • escherichia coli
  • salmonella

 

Sterility testing:

 

  • aerobic bacteria
  • anaerobic bacteria
  • fungi

 

Bacterial endotoxin detection.

 

Determination of the effectiveness of antimicrobial preservatives.

 

Determination of antibacterial activity of antibiotics.

 

Probiotic medicines are tested for the following parameters:

 

  • microbiological purity
  • detection of lactic acid bacteria
  • detection of bifidobacteria
  • detection of probiotic titer
Microbiological testing of food

Bacteriological department carries out microbiological testing of water, raw food materials and food products, feed, additives, perfumery and cosmetics, as well as toys. Testing is performed in accordance with:

 

  • technical regulation of the Eurasian Customs Union
  • sanitary and epidemiological rules and norms
  • technical regulation of the Republic of Armenia
  • international standards
  • technical standards
  • client's requirements

 

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

 

  • total bacterial count Listeria monocytogenes V. parahaemolyticus Campylobacter Bacillus cereus
  • coliforms
  • escherichia coli (including pathogenic strains)
  • enterobacteriaceae family
  • enterobacter sakazakii
  • salmonella sp.
  • yersinia genus
  • pseudomonas aeruginosa
  • staphylococcus aureus
  • pseudomonas aeruginosa
  • staphylococcus aureus
  • listeria monocytogenes
  • V. parahaemolyticus
  • campylobacter
  • bacillus cereus
  • sulfite-reducing clostridia
  • yeasts/molds
  • psychrotrophic bacteria
  • lactobacteria
  • bifidobacteria
  • probiotic bacteria
Testing

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

 

  • selective, elective, diagnostic, chromogenic media
  • microscopy, different ways of staining of bacteria
  • biochemical tests
  • serologic tests

 

Bacteriological department equipment and facilities:

 

  • sertified, quality control passed growth media and agents of such reputed manufacturers, as Liofilchem, SigmaAldrich, Panreac, etc. are used. Ancillary equipment used is sterile, single use
  • test strains from American Type Culture Collection (ATCC)
  • II class A2 type biosafety cabinet, which is located in the zone В (according to the International Classification).

 

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

 

  • growth media quality control
  • use of disposable, sterile auxiliary equipment (Pipettes, Petrii dishes, etc.)
  • control of air purity and cleanness of premises
  • calibration of measuring equipment with the help of certified standards
  • regular qualification trainings

Laboratory
Complex 2012
"FDA Laboratory"LLC

International
Accreditation
2015 ANAB