[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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