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Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
ICP-MS analysis for heavy metals suite
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
qPCR quantification with human-specific primers
Protein fingerprinting by mass spectrometry from colonies
ATR-FTIR spectrum comparison with reference
Recovery validation with BSA spike, 3 concentration levels
Crystal violet/iodine/safranin staining of colonies
Hexane extraction 72h at 37°C, GC-MS analysis
Growth promotion with 5 strains on TSA plates
UV spectrophotometry or ion chromatography
Direct LAL test on water sample
Membrane filtration, R2A agar incubation 7d at 20-25°C
Contact/settle plates, TSA incubation 3-5d at 30-35°C
Simulated use extraction, GC-FID headspace analysis
Luminescence detection after swab/rinse extraction
Selective enrichment and plating for target organisms
Water extraction 72h at 50°C, GC-MS screening
Bacteriostasis/fungistasis test with 6 challenge organisms
Recovery efficiency + method suitability + 2 ID of dominants
Membrane filtration, TSA plate count, 3d at 30-35°C
Direct measurement at 25°C with conductivity cell
Laser particle counter, 0.3 to 5.0 µm
Additional extraction cycle for EO/ECH
Fluorometric assay with RNA substrate degradation monitoring
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
Water extraction, LC-MS screening for non-volatiles
Method suitability study for product-specific sterility testing
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
Complexometric titration or colorimetric test
Direct pH measurement at 25°C with calibrated electrode
Interference test at 3 dilutions with spike recovery
GC-MS analysis for butanediol diglycidyl ether
Fluorescent DNA substrate degradation assay
DNA extraction, 16S/18S rRNA amplification and sequencing
IPA extraction, LC-MS non-volatile screening
Direct water analysis by combustion/oxidation method
Anaerobic incubation on TSA or FTM media, 5-7 days
Water extraction 72h at 37°C, HS-GC-MS analysis
Growth promotion test with C.albicans, A.brasiliensis on SDA
Decontamination, concentration, culture on Löwenstein-Jensen
Screening at multiple dilutions to find valid test range
qPCR amplification efficiency test with internal control
Biochemical profiling from pure colonies
Hexane extraction, LC-MS analysis
BCA assay after extraction in 1% Triton x100 solution
Recovery test with B.subtilis spike on products
IPA extraction 72h at 37°C, GC-MS screening