Laboratory Testing Services

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100108, 1001080, 100201, 100202, 100303, 100304, 100313, 100505, 100601, ISO 11737-2, Ph.Eur. 2.6.1, Ph.Eur. Mono. 0169, USP 71
Microbio - Product sterility - analysis

Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
USP 55, ISO 11138, ISO 11138-1, ISO 11138-2, 100103, 100108, 1001080, 100202
Microbio - Sterility of BIs (strips, threads, discs)

Direct incubation in growth media, 7d at optimal temperature
USP 55, ISO 11138, ISO 11138-1, ISO 11138-2, 100103, 100108, 1001080, 100201
Microbio - Sterility of BIs (spore suspension)

Spore suspension filtration and culture incubation 7d at optimal temperature
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 11737-2, 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

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