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Extraction then GC-MS with derivatization
Solvent extraction, GC-MS for 13 phthalate esters
L929 cells exposed to extracts, XTT viability assay
L929 cells, 24h direct contact, morphology assessment
Agar overlay method with L929 cells, zone assessment
Extraction in DMF, GC-FID quantification
Titration of aqueous extract
GC-MS analysis for butanediol diglycidyl ether
Direct GC-MS with BSTFA derivatization
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 GC-MS analysis for 13 phthalates
DCM extraction, FTIR quantification at 1260 cm-1
Method validation with count standards at 10µm and 25µm
Extraction in particle-free water, light obscuration counting
Challenge test with 5 organizms, log reduction monitoring
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
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
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
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 intradermal injection of polar/non-polar extracts
Rabbit pyrogen test, saline extract, temperature monitoring
Mouse systemic toxicity per USP Class VI requirements
Rabbit intracutaneous reactivity test with extracts
Rabbit muscle implantation, histopathology evaluation
GLP-compliant rabbit pyrogen test with saline extract
ATR-FTIR spectrum comparison with reference
Hexane extraction, LC-MS analysis
Water extraction, LC-MS screening for non-volatiles
IPA extraction, LC-MS non-volatile screening
Particle extraction, SEM imaging + EDX elemental mapping
Additional SEM-EDX analysis on subsequent samples
Evaporation of extract, gravimetric determination
LC-MS/MS for PFAS compounds (EU list)
Sustained pressure test over extended time
Long-term seal integrity under constant pressure