Laboratory Testing Services

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ISO 10993-1, ISO 10993-3, OECD TG471
Biocomp - Genotox - AMES test

Bacterial reverse mutation assay with/without metabolic activation
ISO 10993-1, ISO 10993-23
Biocomp- Acute oral irritation

Hamster cheek pouch or oral mucosa irritation test
EPA 8270, EPA 525
Chemistry - Phthalates - Liquid

Direct GC-MS analysis for 13 phthalates
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - direct contact

L929 cells, 24h direct contact, morphology assessment
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Overall Migration - Tenax - reusable

Multiple cycles per customer, gravimetric measurement
Ph.Eur. 5.1.3, USP 51
Microbio - Antimicrobial effectiveness testing

Challenge test with 5 organisms, log reduction monitoring
ISO 10993-18
Chemistry - FTIR analysis for material identification

ATR-FTIR spectrum comparison with reference
ISO 10993-18, EU 10/2011
Chemistry - Bisphenol (without extraction)

Direct GC-MS with BSTFA derivatization
ISO 10993-1, ISO 10993-18
Chemistry - XPS analysis (X-ray) - 3 measures

Surface elemental analysis at 3 locations, depth <10nm
ISO 10993-1, ISO 10993-23
Biocomp - in vivo Ocular Irritation

Rabbit eye irritation test (Draize method)
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Overall Migration - 1 simulant (A, B, C or D1) - multiple use

Multiple cycles per customer, gravimetry
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - indirect contact

Agar overlay method with L929 cells, zone assessment
EPA 8270, EPA 525
Chemistry - Phthalates - Solid

Solvent extraction, GC-MS for 13 phthalate esters
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8260
Chemistry - GC screening - VOC

Water extraction 72h at 37°C, HS-GC-MS analysis
ISO 10993-18, USP 231, EU 10/2011
Chemistry - XRF (Food contact)

XRF analysis for Pb, Cd, As in food contact materials
ISO 10993-18, EU 10/2011
Chemistry - Bisphenol (extraction included)

Extraction then GC-MS with derivatization
ISO 11737-1, Ph.Eur. 2.6.12, USP 61
Microbio - Bioburden: bacteria, yeasts and molds - analysis

Extraction/rinse, filtration, TSA 3-5d & SDA 5-7d incubation
ISO 10993-1, ISO 10993-23
Biocomp - In Vitro Irritation Test (Medical device 10993-23)

MatTek EpiDerm™ reconstructed human epidermis model
ISO 10993-18, USP 231
Chemistry - Tenax Specific migration - Full package testing

Acid digestion, ICP-MS for heavy metals
ISO 10993-1, ISO 10993-5, ISO 10993-12
Biocomp - Cytotoxicity - extract (XTT)

L929 cells exposed to extracts, XTT viability assay
EN 1186-13
Chemistry - XRF (Screening)

XRF elemental screening for RoHS compliance
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry - GC screening - semi-polar SVOC

IPA extraction 72h at 37°C, GC-MS screening
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Migration & Caracterisation - Food contact - single use

Conditions per customer, Tenax extraction, GC/LC-MS
ISO 10993-18, EPA 8260, EPA 8270
Chemistry - PFAS analysis

LC-MS/MS for PFAS compounds (EU list)
ISO 11737-1, Ph.Eur. 2.6.12, USP 61
Microbio - Bioburden: anaerobic germs - analysis -complement art. 100303

Anaerobic incubation on TSA or FTM media, 5-7 days
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chemistry - LC screening - polar NVOC

Water extraction, LC-MS screening for non-volatiles
EU 10/2011, EN 1186-1, EN 1186-13, SR 817.023.21
Chemistry - Overall Migration - 1 simulant (D2) - single use

Conditions per customer in oil simulant, gravimetry
ISO 10993-1, ISO 10993-10, ISO 10993-12
Biocomp - in vivo sensitization - GPMT

Guinea pig maximization test, polar/non-polar extracts
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Overall Migration - 1 simulant - single use

Conditions per customer in simulant, gravimetric analysis
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry- GC screening - non-polar SVOC

Hexane extraction 72h at 37°C, GC-MS analysis
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Migration/ Characterisation Food contact Repeated use

Multiple cycles per customer, Tenax, GC/LC-MS
ISO 10993-12, ISO 10993-18, USP 467
IPA residual solvant testing

Extraction in DMF, GC-FID quantification
Ph.Eur. 2.6.13, USP 62
Microbio - Research of specified germ, individual

Selective enrichment and plating for target organisms
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chimie - LC screening - semi-polar NVOC

IPA extraction, LC-MS non-volatile screening
EU 10/2011, EN 1186-1, EN 1186-13, SR 817.023.21
Chemistry - Overall Migration - 1 simulant (D2) - multiple use

Multiple cycles per customer in oil, gravimetric analysis
ISO 10993-1, ISO 10993-3, OECD TG471
Biocomp - Genotox - Mouse Lymphoma Assay (MLA, Limit test)

Mammalian cell forward mutation assay with colony sizing
ISO 10993-1, ISO 10993-12, ISO 10993-23
Biocomp - in vivo skin Irritation

Rabbit skin application, 4h exposure, 72h observation
ISO 10993-18, EU 10/2011
Chemistry - Migration (Volatile compounds Silicone) - complement Tenax

Volatile siloxane migration test on Tenax
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664, EPA 8270, EPA 525
Chemistry - GC screening - polar SVOC

Water extraction 72h at 50°C, GC-MS screening
EU 10/2011, EN 1186-1, EN 1186-11, SR 817.023.21
Chemistry - Overall Migration - Tenax - single use

Conditions per customer, gravimetric determination
ISO 11737-1, Ph.Eur. 2.6.12, USP 61
Microbio - Bioburden: aerobic germs only - analysis

Extraction, filtration, TSA incubation 3-5d at 30-35°C, aerobic conditions
ISO 10993-12, ISO 10993-18, USP 1663, USP 1664
Chemistry - LC Screening - non-polar NVOC

Hexane extraction, LC-MS analysis
ISO 10993-18
THC/CBD complete analysis

GC-MS for cannabinoid profile

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