Physical, Functional and Packaging

Extractables & Leachables Organic & elemental impurities Leachables in condensate Particulate Emission Volatile Organic Substances (VOC & Carbonyls) Cytotoxicity Irritation Sensitisation Material mediated pyrogenicity Acute Systemic Toxicity Subacute, Subchronic & Chronic toxicity Genotoxicity Carcinogenicity Hemocompatibility Implantation Reproductive / developmental toxicity Degradation studies | Combination Device Testing Needle-based Injection System Device Verification & Validation Bespoke & Custom Testing Particulate Matter Contamination Packaging Validation & Testing ASTM D4169 Transit Testing ASTM F1980 Accelerated Ageing ISO 11607 Sterile Barrier Validation