Microbiological tests of sterile pharmaceutical products

Our pharmaceutical services

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