8 Checkpoints Behind Every Chemical Risk Assessment

A medical device is never just the material it’s molded from — it’s also every chemical that material was ever in contact with along the way.

Chemical characterization is the analytical backbone of biocompatibility evaluation. Before any toxicologist can say a device is safe for its intended contact with the human body, they need a complete inventory of what chemicals could migrate out of it. That inventory is exactly what our testing produces at the Oragadam laboratory — a documented, defensible chemical profile that supports your biological evaluation, your regulatory submission, and your own internal risk file. This is material testing for medical devices at its most rigorous: not asking whether a material is mechanically sound, but asking what it releases, in what quantity, and under what conditions.

Our testing here is structured around two internationally recognized frameworks. ISO 10993-18 governs how materials themselves are analyzed — how a manufacturer identifies and quantifies the substances present in and extractable from a device material. ISO 10993-17 then governs how those identified substances are evaluated against toxicological thresholds, establishing allowable limits for leachable substances based on patient exposure. Used together, these two standards move a device from “here’s what we found” to “here’s why it’s acceptable” — the exact chain of evidence a regulatory reviewer expects to see.

Eight distinct analytical techniques sit under this umbrella at our lab. Extractables and leachables testing simulates worst-case and clinical-use exposure conditions to identify everything a device could shed into a patient. Residual solvent analysis quantifies processing solvents trapped in a material during manufacturing, referenced against Class 1, 2, and 3 solvent limits. VOC analysis and SVOC compounds extend that same logic to volatile and semi-volatile organic compounds that wouldn’t show up in a standard solvent panel, using headspace and thermal desorption techniques tuned to catch what other methods miss. Heavy metal analysis and elemental impurities analysis screen for metallic contamination — from processing catalyst residues to environmental contamination — using ICP-based instrumentation sensitive enough to detect trace-level presence. Chemical composition analysis confirms the base material matches its intended formulation, while degradation products analysis looks specifically for breakdown compounds that can form as a polymer ages, sterilizes, or degrades in vivo — substances that were never part of the original formulation but that a patient could still be exposed to.

What ties all eight together is toxicological data generation — the final step where every substance identified is checked against known toxicological thresholds, safety margins are calculated, and a documented safety rationale is built. A manufacturer doesn’t need to interpret raw chromatography data themselves; our report already frames each finding in terms a regulatory reviewer or your own toxicologist can act on directly. Whether you’re preparing a first-time submission or responding to a query on an existing one, this is the analytical foundation that makes the rest of your biological evaluation possible.

Kiyo R&D Lab – Oragadam

Our Oragadam lab is based at No.13, Srinivasa Perumal Street, Panapakkam, Serapanacheri, Greater Chennai, Tamil Nadu 601301.

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