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Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
Interference test at 3 dilutions with spike recovery
Rabbit pyrogen test, saline extract, temperature monitoring
Recovery efficiency + method suitability + 2 ID of dominants
Agar overlay method with L929 cells, zone assessment
Recovery study with sucrose spike in extraction water
Water extraction 72h at 50°C, GC-MS screening
GC-MS analysis for butanediol diglycidyl ether
Bacterial reverse mutation assay with/without metabolic activation
Screening at multiple dilutions to find valid test range
GLP-compliant rabbit pyrogen test with saline extract
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
L929 cells exposed to extracts, XTT viability assay
Recovery validation with BSA spike, 3 concentration levels
Water extraction, semi-quantitative scan for 40 elements
Extraction then GC-MS with derivatization
Bacteriostasis/fungistasis test with 6 challenge organisms
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
Mouse systemic injection, polar/non-polar extracts
Anaerobic incubation on TSA or FTM media, 5-7 days
Guinea pig maximization test, polar/non-polar extracts
Spectrophotometric detection at 405nm after alkaline extraction
Quantitative analysis for single element after extraction
LC-MS/MS for PFAS compounds (EU list)
Method suitability study for product-specific sterility testing
Water extraction 72h at 37°C, HS-GC-MS analysis
Direct/extract contact with RBCs, hemoglobin release
Recovery test with B.subtilis spike on products
Rabbit intradermal injection of polar/non-polar extracts
Recovery study with hemoglobin spike at 3 levels
Additional element quantification by ICP-MS
Extraction in DMF, GC-FID quantification
72h extraction at 37°C or 50°C, TOC measurement of extract
IPA extraction 72h at 37°C, GC-MS screening
Simulated use extraction, GC-FID headspace analysis
Mammalian cell forward mutation assay with colony sizing
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
Rabbit skin application, 4h exposure, 72h observation
Surface elemental analysis at 3 locations, depth <10nm
L929 cells, 24h direct contact, morphology assessment
BCA assay after extraction in 1% Triton x100 solution
Hexane extraction 72h at 37°C, GC-MS analysis
Additional extraction cycle for EO/ECH