Microbiological tests of sterile pharmaceutical products

The pharmaceutical experts at WESSLING conduct microbiological tests of sterile products according to international pharmacopoeias.

Pharmceutical analysis of sterile products

Our range of 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 development

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)

Recombinant endotoxin determination (quantitative determination): preserves the natural occurrence of horseshoe crab, since no lysate is used