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
ISO 11737-1, Ph.Eur. 2.6.12, USP 61, 100103, 100301, 100304, 100305, 100313, 100505, 100601
Microbio - Bioburden: bacteria, yeasts and molds - analysis

Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
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
ISO 11737-1, Ph.Eur. 2.6.12, USP 61, 100103, 100107, 1002104, 100301, 100303, 100304, 100305, 100505, 100601, 100602
Microbio - Bioburden: aerobic germs only - analysis

Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
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 11737-1, 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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