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Solvent extraction, GC-MS for 13 phthalate esters
Water extraction 72h at 37°C, HS-GC-MS analysis
IPA extraction 72h at 37°C, GC-MS screening
Hexane extraction 72h at 37°C, GC-MS analysis
Water extraction 72h at 50°C, GC-MS screening
L929 cells exposed to extracts, XTT viability assay
MatTek EpiDerm™ reconstructed human epidermis model
L929 cells, 24h direct contact, morphology assessment
Agar overlay method with L929 cells, zone assessment
Extraction in DMF, GC-FID quantification
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
Recovery validation with hydrocarbon standard, GC-MS method
Gravimetric analysis of residual water on devices
Recovery study with hemoglobin spike at 3 levels
Recovery validation with BSA spike, 3 concentration levels
Recovery study with sucrose spike in extraction water
Challenge test with 5 organizms, log reduction monitoring
Recovery test with B.subtilis spike on products
Recovery efficiency + method suitability + 2 ID of dominants
Spore enumeration by heat shock and plate count
Method suitability test with E.coli ATCC 8739
Screening at multiple dilutions to find valid test range
Interference test at 3 dilutions with spike recovery
Membrane filtration, R2A agar incubation 7d at 20-25°C
Method suitability study for product-specific sterility testing
Bacteriostasis/fungistasis test with 6 challenge organizms
Spore suspension filtration and culture incubation 7d at optimal temperature
Direct incubation in growth media, 7d at optimal temperature
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
Bacterial reverse mutation assay with/without metabolic activation
Mammalian cell forward mutation assay with colony sizing
Direct/extract contact with RBCs, hemoglobin release
Mouse systemic injection, polar/non-polar extracts
Rabbit intradermal injection of polar/non-polar extracts
Rabbit eye irritation test (Draize method)
Guinea pig maximization test, polar/non-polar extracts
Rabbit skin application, 4h exposure, 72h observation
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
Hamster cheek pouch or oral mucosa irritation test
GLP-compliant rabbit pyrogen test with saline extract
ATR-FTIR spectrum comparison with reference
Additional element quantification by ICP-MS
Quantitative analysis for single element after extraction
Water extraction, semi-quantitative scan for 40 elements
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
Surface elemental analysis at 3 locations, depth <10nm
XRF analysis for Pb, Cd, As in food contact materials
XRF elemental screening for RoHS compliance
Sustained pressure test over extended time
Long-term seal integrity under constant pressure