Mikrobiológiai vizsgálatok steril termékeknél

Intro

Pharmceutical analysis of sterile products

Abstract

Mikrobiológiai vizsgálatok steril termékeknél

[Translate to Magyar:]

Test for sterility using two insulators according to Ph. Eur. 2.6.1

  • Membrane filtration method
  • Direct feeding method
  • Testing with special test systems
  • Testing of large-volume samples
  • Media additives
  • Subsequent growth control, per germ
  • Identification of germs with positive results
  • Testing of cytostatic agents
  • Transmission of intermediate results

Validation of sterility testing

  • Preparation of a validation plan/report
  • Validation according to Ph. Eur. with 6 test germs
  • Method devlopment

Endotoxin tests according to Ph. Eur. 2.6.14

  • By Limulus amoebocyte test (LAL test)
  • Gel formation limit value method / gel clot (method A, limit test)
  • Kinetic turbidimetric method (Method C, quantitative determination)
  • Recombinate endotoxin determination (quantitative determination): preserves the natural occurrence of horseshoe crab, since no lysate is used

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