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Microbiological tests of sterile pharmaceutical products

Standard and international procedures

Our pharmaceutical experts conduct microbiological tests of sterile products according to international pharmacopoeias and to current DIN EN ISO procedures.

A gloved hand places a tray of small vials with blue caps into a laboratory instrument

Our services

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)

Endotoxin tests according to Ph. Eur. 2.6.32

  •  By rFC test (recombinant factor C test): preserves the natural occurrence of horseshoe crab, since no lysate is used
 
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