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Hamster cheek pouch or oral mucosa irritation test
L929 cells, 24h direct contact, morphology assessment
L929 cells exposed to extracts, XTT viability assay
Agar overlay method with L929 cells, zone assessment
Bacterial reverse mutation assay with/without metabolic activation
Mammalian cell forward mutation assay with colony sizing
Direct/extract contact with RBCs, hemoglobin release
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
MatTek EpiDerm™ reconstructed human epidermis model
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
GLP-compliant rabbit pyrogen test with saline extract
Fluorescent DNA substrate degradation assay
Luminescence detection after swab/rinse extraction
qPCR quantification with human-specific primers
qPCR amplification efficiency test with internal control
Fluorometric assay with RNA substrate degradation monitoring
Direct pH measurement at 25°C with calibrated electrode
Titration of aqueous extract
GC-MS analysis for butanediol diglycidyl ether
Extraction then GC-MS with derivatization
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
ATR-FTIR spectrum comparison with reference
Complexometric titration or colorimetric test
ICP-MS analysis for heavy metals suite
Quantitative analysis for single element after extraction
Additional element quantification by ICP-MS
Water extraction, semi-quantitative scan for 40 elements
Volatile siloxane migration test on Tenax
Conditions per customer, Tenax extraction, GC/LC-MS
Multiple cycles per customer, Tenax, GC/LC-MS
Additional SEM-EDX analysis on subsequent samples
Particle extraction, SEM imaging + EDX elemental mapping
GC-MS quantification in CBD products
UV spectrophotometry or ion chromatography
Evaporation of extract, gravimetric determination
Multiple cycles per customer in oil, gravimetric analysis
Conditions per customer in oil simulant, gravimetry
Multiple cycles per customer, gravimetry
Conditions per customer in simulant, gravimetric analysis
Multiple cycles per customer, gravimetric measurement
Conditions per customer, gravimetric determination
LC-MS/MS for PFAS compounds (EU list)
Direct GC-MS analysis for 13 phthalates
Solvent extraction, GC-MS for 13 phthalate esters
Recovery study with hemoglobin spike at 3 levels
Spectrophotometric detection at 405nm after alkaline extraction
BCA assay after extraction in 1% Triton x100 solution
Recovery validation with BSA spike, 3 concentration levels
Ethylene glycol by GC-FID after extraction
Hexane extraction, LC-MS analysis
Hexane extraction 72h at 37°C, GC-MS analysis
Water extraction, LC-MS screening for non-volatiles
Water extraction 72h at 50°C, GC-MS screening
IPA extraction 72h at 37°C, GC-MS screening
Water extraction 72h at 37°C, HS-GC-MS analysis
DCM extraction, FTIR quantification at 1260 cm-1
Method validation with count standards at 10µm and 25µm
Acid digestion, ICP-MS for heavy metals
Recovery study with sucrose spike in extraction water
72h extraction at 37°C or 50°C, TOC measurement of extract
Direct water analysis by combustion/oxidation method
Recovery validation with hydrocarbon standard, GC-MS method
Hexane extraction 24h, GC-MS quantification
Surface elemental analysis at 3 locations, depth <10nm
XRF analysis for Pb, Cd, As in food contact materials
XRF elemental screening for RoHS compliance
IPA extraction, LC-MS non-volatile screening
Extraction in particle-free water, light obscuration counting
GC-MS extraction method
Extraction in DMF, GC-FID quantification
Membrane filtration, TSA plate count, 3d at 30-35°C
Challenge test with 5 organisms, 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
Spore enumeration by heat shock and plate count
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
Heat shock, serial dilution, TSA plate count
Laser particle counter, 0.3 to 5.0 µm
Contact/settle plates, TSA incubation 3-5d at 30-35°C
DNA extraction, 16S/18S rRNA amplification and sequencing
Crystal violet/iodine/safranin staining of colonies
Growth promotion test with C.albicans, A.brasiliensis on SDA
Growth promotion with 5 strains on TSA plates
Protein fingerprinting by mass spectrometry from colonies
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 organisms
Selective enrichment at 42°C, microaerophilic conditions
Acid/heat treatment, BCYE agar culture, 10d at 35°C
Selective enrichment and plating for target organisms
Enrichment in LST broth, confirmation on EMB/MacConkey agar
Spore suspension filtration and culture incubation 7d at optimal temperature
Direct incubation in growth media, 7d at optimal temperature
Biochemical profiling from pure colonies
Underwater pressurization, leak detection by bubbles
Pressure validation for bubble emission test
Internal pressurization to seal failure point
Sustained pressure test over extended time
Long-term seal integrity under constant pressure
Large format dye penetration, passive method
Dye penetration test, passive diffusion method
Seal strength validation at multiple locations
Tensile test at 90° or 180°, strength measurement
Cold water extraction, pH measurement
Additional sample pH test
Visual defects assessment per acceptance criteria
Gravimetric analysis of residual water on devices
GC-MS for cannabinoid profile
Decontamination, concentration, culture on Löwenstein-Jensen