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Microbiological tests of sterile pharmaceutical products
The pharmaceutical experts at WESSLING conduct microbiological tests of sterile products according to international pharmacopoeias.
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
Pharmaceutical Testing Laboratory in WESSLING Hungary Ltd. performs quality control testing of pharmaceutical raw materials (APIs) and finished products.