Mikrobiológiai vizsgálatok steril termékeknél

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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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