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Growth promotion test with C.albicans, A.brasiliensis on SDA
Particle extraction, SEM imaging + EDX elemental mapping
Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
IPA extraction 72h at 37°C, GC-MS screening
Mouse systemic toxicity per USP Class VI requirements
Additional extraction cycle for EO/ECH
Large format dye penetration, passive method
Spectrophotometric detection at 405nm after alkaline extraction
Anaerobic incubation on TSA or FTM media, 5-7 days
Interference test at 3 dilutions with spike recovery
Rabbit intradermal injection of polar/non-polar extracts
ATR-FTIR spectrum comparison with reference
Internal pressurization to seal failure point
Method suitability study for product-specific sterility testing
Direct pH measurement at 25°C with calibrated electrode
Method suitability test with E.coli ATCC 8739
Gravimetric analysis of residual water on devices
MatTek EpiDerm™ reconstructed human epidermis model
Extraction then GC-MS with derivatization
Direct inoculation or membrane filtration, 14d at 20-25°C & 30-35°C
Additional SEM-EDX analysis on subsequent samples
DNA extraction, 16S/18S rRNA amplification and sequencing
Hexane extraction 72h at 37°C, GC-MS analysis
Rabbit muscle implantation, histopathology evaluation
Direct GC-MS analysis for 13 phthalates
Underwater pressurization, leak detection by bubbles
Hexane extraction 24h, GC-MS quantification
Recovery test with B.subtilis spike on products
Screening at multiple dilutions to find valid test range
Rabbit skin application, 4h exposure, 72h observation
Simulated use extraction, GC-FID headspace analysis
Sustained pressure test over extended time
72h extraction at 37°C or 50°C, TOC measurement of extract
ICP-MS analysis for heavy metals suite
Contact/settle plates, TSA incubation 3-5d at 30-35°C
L929 cells, 24h direct contact, morphology assessment
Water extraction, LC-MS screening for non-volatiles
Cold water extraction, pH measurement
Bacterial reverse mutation assay with/without metabolic activation
Direct incubation in growth media, 7d at optimal temperature
Biochemical profiling from pure colonies
Water extraction 72h at 50°C, GC-MS screening
Rabbit intracutaneous reactivity test with extracts
Acid digestion, ICP-MS for heavy metals
Pressure validation for bubble emission test
Recovery validation with hydrocarbon standard, GC-MS method
Crystal violet/iodine/safranin staining of colonies
Kinetic chromogenic LAL assay, 0.005-5.0 EU/ml range
Rabbit pyrogen test, saline extract, temperature monitoring
XRF analysis for Pb, Cd, As in food contact materials
Long-term seal integrity under constant pressure
BCA assay after extraction in 1% Triton x100 solution
UV spectrophotometry or ion chromatography
Laser particle counter, 0.3 to 5.0 µm
Agar overlay method with L929 cells, zone assessment
IPA extraction, LC-MS non-volatile screening
Additional sample pH test
GC-MS extraction method
Spore suspension filtration and culture incubation 7d at optimal temperature
Protein fingerprinting by mass spectrometry from colonies
Water extraction, semi-quantitative scan for 40 elements
Direct/extract contact with RBCs, hemoglobin release
GC-MS analysis for butanediol diglycidyl ether
Spore enumeration by heat shock and plate count
Recovery study with hemoglobin spike at 3 levels
Selective enrichment and plating for target organisms
Direct LAL test on water sample
GLP-compliant rabbit pyrogen test with saline extract
DCM extraction, FTIR quantification at 1260 cm-1
Seal strength validation at multiple locations
Recovery study with sucrose spike in extraction water
Recovery efficiency + method suitability + 2 ID of dominants
Extraction in particle-free water, light obscuration counting
L929 cells exposed to extracts, XTT viability assay
Hexane extraction, LC-MS analysis
Visual defects assessment per acceptance criteria
Growth promotion with 5 strains on TSA plates
Membrane filtration, R2A agar incubation 7d at 20-25°C
Challenge test with 5 organisms, log reduction monitoring
Quantitative analysis for single element after extraction
Hamster cheek pouch or oral mucosa irritation test
Ethylene glycol by GC-FID after extraction
Extraction in DMF, GC-FID quantification
Mammalian cell forward mutation assay with colony sizing
Surface elemental analysis at 3 locations, depth <10nm
Heat shock, serial dilution, TSA plate count
Water extraction 72h at 37°C, HS-GC-MS analysis
Mouse systemic injection, polar/non-polar extracts
Solvent extraction, GC-MS for 13 phthalate esters
Dye penetration test, passive diffusion method
Recovery validation with BSA spike, 3 concentration levels
Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
Method validation with count standards at 10µm and 25µm
Guinea pig maximization test, polar/non-polar extracts
Evaporation of extract, gravimetric determination
Tensile test at 90° or 180°, strength measurement
Bacteriostasis/fungistasis test with 6 challenge organisms
Direct measurement at 25°C with conductivity cell
Enrichment in LST broth, confirmation on EMB/MacConkey agar
Additional element quantification by ICP-MS
Rabbit eye irritation test (Draize method)
Titration of aqueous extract