Laboratory Testing Services

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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
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
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, 100108, 100301, 100305, 100333, 100502, 100505, 100601
Microbio - Endotoxins - method validation

Interference test at 3 dilutions with spike recovery
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, 100103, 100301, 100304, 100305, 100313, 100505, 100601
Microbio - Bioburden: bacteria, yeasts and molds - analysis

Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation

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