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GC-MS extraction method
Method validation with count standards at 10µm and 25µm
Evaporation of extract, gravimetric determination
GC-MS analysis for butanediol diglycidyl ether
Pressure validation for bubble emission test
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
Rabbit muscle implantation, histopathology evaluation
Volatile siloxane migration test on Tenax
Long-term seal integrity under constant pressure
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
L929 cells exposed to extracts, XTT viability assay
Conditions per customer, gravimetric determination
Additional sample pH test
Bacteriostasis/fungistasis test with 6 challenge organisms
Interference test at 3 dilutions with spike recovery
ATR-FTIR spectrum comparison with reference
Titration of aqueous extract
Extraction in DMF, GC-FID quantification
Challenge test with 5 organisms, log reduction monitoring
Rabbit intracutaneous reactivity test with extracts
Direct GC-MS analysis for 13 phthalates
Seal strength validation at multiple locations
Anaerobic incubation on TSA or FTM media, 5-7 days
Rabbit intradermal injection of polar/non-polar extracts
Multiple cycles per customer, gravimetric measurement
Visual defects assessment per acceptance criteria
Method suitability study for product-specific sterility testing
Screening at multiple dilutions to find valid test range
Simulated use extraction, GC-FID headspace analysis
Direct GC-MS with BSTFA derivatization
Contact/settle plates, TSA incubation 3-5d at 30-35°C
Water extraction, LC-MS screening for non-volatiles
Multiple cycles per customer, gravimetry
Dye penetration test, passive diffusion method
Recovery test with B.subtilis spike on products
Rabbit pyrogen test, saline extract, temperature monitoring
Solvent extraction, GC-MS for 13 phthalate esters
Tensile test at 90° or 180°, strength measurement
Particle extraction, SEM imaging + EDX elemental mapping
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
DCM extraction, FTIR quantification at 1260 cm-1
Extraction then GC-MS with derivatization
Laser particle counter, 0.3 to 5.0 µm
IPA extraction, LC-MS non-volatile screening
Conditions per customer in oil simulant, gravimetry
Large format dye penetration, passive method
Crystal violet/iodine/safranin staining of colonies
GLP-compliant rabbit pyrogen test with saline extract
Conditions per customer in simulant, gravimetric analysis
Internal pressurization to seal failure point
Additional SEM-EDX analysis on subsequent samples
L929 cells, 24h direct contact, morphology assessment
Conditions per customer, Tenax extraction, GC/LC-MS
LC-MS/MS for PFAS compounds (EU list)
Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
Extraction in particle-free water, light obscuration counting
Hexane extraction, LC-MS analysis
Multiple cycles per customer in oil, gravimetric analysis
Underwater pressurization, leak detection by bubbles
Selective enrichment and plating for target organisms
Mouse systemic toxicity per USP Class VI requirements
Additional extraction cycle for EO/ECH
Sustained pressure test over extended time
Recovery efficiency + method suitability + 2 ID of dominants
Agar overlay method with L929 cells, zone assessment
Multiple cycles per customer, Tenax, GC/LC-MS
Cold water extraction, pH measurement