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Extraction then GC-MS with derivatization
Extraction in DMF, GC-FID quantification
Direct GC-MS with BSTFA derivatization
Direct measurement at 25°C with conductivity cell
Simulated use extraction, GC-FID headspace analysis
Additional extraction cycle for EO/ECH
Conditions per customer, Tenax extraction, GC/LC-MS
Volatile siloxane migration test on Tenax
Multiple cycles per customer, Tenax, GC/LC-MS
Multiple cycles per customer, gravimetry
Multiple cycles per customer in oil, gravimetric analysis
Conditions per customer in oil simulant, gravimetry
Conditions per customer in simulant, gravimetric analysis
Multiple cycles per customer, gravimetric measurement
Conditions per customer, gravimetric determination
Direct pH measurement at 25°C with calibrated electrode
Method validation with count standards at 10µm and 25µm
Direct water analysis by combustion/oxidation method
Extraction in particle-free water, light obscuration counting
Gravimetric analysis of residual water on devices
Membrane filtration, TSA plate count, 3d at 30-35°C
Challenge test with 5 organizms, log reduction monitoring
Direct LAL test on water sample
Recovery test with B.subtilis spike on products
Recovery efficiency + method suitability + 2 ID of dominants
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
Anaerobic incubation on TSA or FTM media, 5-7 days
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
Method suitability test with E.coli ATCC 8739
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
Screening at multiple dilutions to find valid test range
Interference test at 3 dilutions with spike recovery
Crystal violet/iodine/safranin staining of colonies
Growth promotion with 5 strains on TSA plates
Growth promotion test with C.albicans, A.brasiliensis on SDA
Membrane filtration, R2A agar incubation 7d at 20-25°C
Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
Method suitability study for product-specific sterility testing
Bacteriostasis/fungistasis test with 6 challenge organizms
Selective enrichment and plating for target organizms
Enrichment in LST broth, confirmation on EMB/MacConkey agar
Biochemical profiling from pure colonies
Underwater pressurization, leak detection by bubbles
Pressure validation for bubble emission test
Internal pressurization to seal failure point
Dye penetration test, passive diffusion method
Large format dye penetration, passive method
Cold water extraction, pH measurement
Additional sample pH test
Seal strength validation at multiple locations
Tensile test at 90° or 180°, strength measurement
Visual defects assessment per acceptance criteria
Laser particle counter, 0.3 to 5.0 µm
Contact/settle plates, TSA incubation 3-5d at 30-35°C
Rabbit pyrogen test, saline extract, temperature monitoring
GLP-compliant rabbit pyrogen test with saline extract
ATR-FTIR spectrum comparison with reference
Complexometric titration or colorimetric test
ICP-MS analysis for heavy metals suite
Particle extraction, SEM imaging + EDX elemental mapping
Additional SEM-EDX analysis on subsequent samples
UV spectrophotometry or ion chromatography
LC-MS/MS for PFAS compounds (EU list)
XRF analysis for Pb, Cd, As in food contact materials
XRF elemental screening for RoHS compliance
Fluorescent DNA substrate degradation assay
qPCR quantification with human-specific primers
qPCR amplification efficiency test with internal control
Fluorometric assay with RNA substrate degradation monitoring
DNA extraction, 16S/18S rRNA amplification and sequencing
Protein fingerprinting by mass spectrometry from colonies
Decontamination, concentration, culture on Löwenstein-Jensen
Sustained pressure test over extended time
Long-term seal integrity under constant pressure