Laboratory Testing Services

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ISO 11737-1, Ph.Eur. 2.6.12, USP 61, 100108, 100301, 100303, 100304, 100313, 100333, 100501
Microbio - BBurden - method validation (inhibition/inoculation)

Recovery test with B.subtilis spike on products
Ph.Eur. 2.6.13, USP 62, 100108, 100301, 100305, 100310, 100326, 100327, 100332, 100501
Microbio - E. coli - Method validation (suitability)

Method suitability test with E.coli ATCC 8739
ISO 11737-3, Ph.Eur. 2.6.14, USP 85, USP 161, AAMI ST72, JP 4.01, 1001080, 100501, 100505, 100601
Microbio - Endotoxins - Feasability

Screening at multiple dilutions to find valid test range
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, 1001080, 100201, 100202, 100301, 100305, 100333, 100501
Microbio - Product sterility - method validation

Bacteriostasis/fungistasis test with 6 challenge organisms
ISO 11737-1, Ph.Eur. 2.6.12, USP 61, 100108, 100303, 100304, 100305, 100313, 100333, 100501
Microbio - Bioburden - Full method validation

Recovery efficiency + method suitability + 2 ID of dominants

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