Medical Device Testing
Our facilities maintain quality systems compliant with cGMP, GLP and ISO 17025, and conduct testing in accordance with ISO, ASTM, ANSI, ISTA, AAMI, AAALAC standards, as well as custom test methodologies to meet our customers’ unique challenges.
Scope of Services
• Extractables & Leachables
• Material & Product Stability
• Dissolution
• Raw Materials Purity
• Particle Characterization
• Residual Ethylene Oxide
• Mechanical Testing
• Method Development/Validation
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• Sterilization Validations
• Sterility
• Bioburden
• Endotoxins
• Antimicrobials / Infection Control
• Cleaning & Reprocessing Validations
• Microbial Identification
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• Chemical Characterization
• Toxicological Risk Assessment
• Cytotoxicity
• Sensitization
• Irritation
• Acute Systemic Toxicity
• Pyrogenicity
• Subacute / Subchronic / Chronic Toxicity
• Genotoxicity
• Implantation
• Hemocompatibility
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• Sterile Barrier / Seal Integrity Testing
• Package & Transit Testing
• Shelf Life: Real Time & Accelerated Aging
• Label Durability
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• Drug Release and Dissolution
• Chemical Compatibility
• Container & Closure Integrity
• Syringe Testing
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