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
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
ISO 11737-1, Ph.Eur. 2.6.12, USP 61, 100103, 100301, 100303, 100305, 100313, 100505, 100601
Microbio - Bioburden: anaerobic germs - analysis -complement art. 100303

Anaerobic incubation on TSA or FTM media, 5-7 days

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