Comprehensive Testing for Raw Materials & Medical Devices
- Chemical characterization studies (ISO 10993-18)
- Chemical testing of nylon resins (21 CFR 177.1500)
- Chemical testing of polymers (21 CFR 177)
- Cleaning validation – particulate matter (USP <788>)
- Cleaning validation – TOC, TPH, residual chemicals, inorganic matter (ISO 19227)
- Extractables, leachables, and biological risk assessment (ISO 10993 series)
- Breathing gas pathway testing (ISO 18562)
- Migration studies (EN 1186)
- Physico-chemical testing of intraocular lenses (ISO 11979-5)
- Physico-chemical testing of soft contact lenses (ISO 11981 & ISO 11986)
- Residual EO & ECH testing (ISO 10993-7)
- Residual phthalate testing (ASTM D7823)
- TSE/BSE testing for animal-origin raw materials (WHO guidelines)
What is physico-chemical testing for medical devices?
It evaluates chemical composition, material safety, and potential risks associated with raw materials and devices.
Do you perform extractables and leachables studies?
Yes, we conduct E&L studies along with biological risk assessment as per ISO 10993 guidelines.
Yes, we perform particulate and chemical residue testing including TOC, TPH, and residual analysis.
Yes, we provide IP valuation and management services to help maximize the value of intellectual assets.
Do you support polymer and packaging material testing?
Yes, we conduct chemical testing of polymers and packaging materials as per regulatory standards.
Are your tests compliant with global standards?
Our testing aligns with ISO, USP, ASTM, EN, and WHO guidelines to support regulatory approvals.
Material Safety. Confident Outcomes.
Physico-chemical testing is essential to evaluate the composition, safety, and performance of raw materials and medical devices. At Accuprec, we provide comprehensive testing services aligned with global standards to ensure product quality and regulatory compliance.
Our capabilities include chemical characterization, extractables and leachables studies, cleaning validation, and migration testing. We also support specialized evaluations such as breathing gas pathway testing, residual analysis, and device-specific testing for intraocular lenses and contact lenses.
With expertise in ISO, USP, ASTM, and regulatory guidelines, we deliver accurate, reliable, and audit-ready results to support product approval and safety assurance.
Our Approach to Accurate & Compliant Testing
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
