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Laboratory of Departmment of Sera and Vaccines Evaluation

Head of Laboratory

dr hab. Ewa Augustynowicz, prof. nadzw. NIZP-PZH

 

Scope of accreditation or attestation

  • The number of viable particles (BCG inoculation method on solid media);
  • The thermal stability of BCG vaccine and preparations Onco – BCG;
  • The identity of the BCG vaccine using multiplex PCR;
  • Activity tetanus intoxication using the mouse;
  • The activity of diphtheria intoxication by intradermal guinea pigs;
  •  The activity of pertussis vaccine (biological method -test Kendrick);
  • Toxicity specific component pertussis;
  • pathogenic mycobacteria;
  • Excessive toxicity;
  • The activity of the vaccine against hepatitis B (ELISA);
  • Identity in biological preparations (PCR);
  • The identity of the bacterial species non-specific vaccines (PCR);
  • The level of anti-HBs immunoglobulin preparations (ELISA);
  • The number of CFU lactobacilli in medicinal products / dietary supplements (plate method);
  • Identification of microorganisms which are active ingredients in the preparation of biological;
  • Antibiotic susceptibility of lactic acid bacteria in medicinal products (diffusion method Slitter);
  • Examination of microbiological purity of non-sterile products;
  • Streptokinase activity in pharmaceutical products (method fibrinolytic);
  • Streptodornase activity in pharmaceutical products (spectrophotometric method);
  • Determination of formaldehyde content in immunological medicinal products by colorimetric method;
  • Determination of bacterial endotoxins content in immunological or blood-derived medicinal products by chromogenic end-point method (LAL/BET test);
  • Determination of phenol content in immunological medicinal products by colorimetric method;
  • Potentiometric determination of pH in immunological or blood-derived medicinal products;
  • Test for extractable volume of parenteral preparations;
  • Visual inspection of liquid medicinal products in terms of presence of visible particles.