Laboratory Testing Services

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ISO 11737-3, Ph.Eur. 2.6.14, Ph.Eur. Mono. 0008, Ph.Eur. Mono. 0169, USP 85, USP 161, AAMI ST72, JP 4.01, 100103, 100303, 100304, 100313, 100501, 100502, 100601
Microbio - Endotoxins - analysis

Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
ISO 11737-3, Ph.Eur. 2.6.14, USP 85, USP 161, AAMI ST72, JP 4.01, 100103, 100303, 100304, 100313, 100501, 100502, 100505
Microbio - Bacterial endotoxins (liquid) - analysis

Direct LAL test on water sample
ISO 11737-2, Ph.Eur. 2.6.1, USP 71, 100103, 100108, 100201, 100202, 100502
Microbio - Product sterility - feasibility

Method suitability study for product-specific sterility testing
ISO 11737-3, Ph.Eur. 2.6.14, USP 85, USP 161, AAMI ST72, JP 4.01, 100108, 100301, 100305, 100333, 100502, 100505, 100601
Microbio - Endotoxins - method validation

Interference test at 3 dilutions with spike recovery

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