Headspace Gas Chromatography–Mass Spectrometry (GC/MS) is a powerful technique for detecting and characterizing volatile organic compounds released from medical devices and packaging materials. By analyzing vapors above a sample, this method provides highly sensitive, non-destructive results that reveal potential contamination, residual solvents, and off-gassing. At Invision Biomedical, headspace GC/MS supports extractables and leachables testing, contamination studies, and regulatory submissions with precision and reliability.
Headspace GC/MS is uniquely suited for detecting volatile and semi-volatile compounds that may migrate from devices or packaging. By capturing these compounds before they reach patients, manufacturers can safeguard product safety and reduce regulatory risks.
Because the technique analyzes only the vapors above the sample, the material itself remains intact. This allows the same device to undergo additional testing, offering flexibility and efficiency in multi-step evaluations.
Our headspace GC/MS protocols are validated to meet ISO 10993-18 and FDA requirements. The results provide a recognized foundation for chemical characterization in regulatory submissions.
The method captures a wide spectrum of volatile organic compounds, ensuring no significant contaminants are overlooked. This comprehensive coverage supports both R&D investigations and compliance testing.
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Device or packaging materials are sealed in specialized vials that allow volatile compounds to migrate into the surrounding headspace. This controlled environment ensures consistency and reproducibility.
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The vaporized compounds in the headspace are sampled and introduced into the gas chromatograph. This isolates volatiles without disturbing the physical structure of the material.
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As vapors pass through the gas chromatograph, compounds are separated based on volatility and chemical properties. This separation provides distinct profiles for accurate analysis.
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Separated compounds are identified and quantified using mass spectrometry with high sensitivity. Results are interpreted and delivered as regulator-ready documentation.
Headspace GC/MS plays a vital role in detecting volatile chemicals that affect product performance and compliance. It is frequently applied to:
Headspace GC/MS is used to detect volatile organic compounds that migrate from device materials, coatings, or packaging. This ensures devices meet safety requirements and remain free of contaminants that could compromise biocompatibility.
Headspace focuses exclusively on the volatile fraction of compounds, which is critical for identifying potential leachables. It also leaves the original sample intact, making it ideal for multi-step or repeat testing.
The technique can detect compounds down to parts per billion, making it highly effective at identifying even trace-level volatiles. This level of sensitivity helps manufacturers address risks before they become regulatory issues.
Yes, regulators such as the FDA and ISO recognize headspace GC/MS as a standard method for characterizing volatile extractables and leachables. It is often an essential part of ISO 10993-18 compliance.
Invision Biomedical provides headspace GC/MS testing that delivers the clarity you need for regulatory compliance and patient safety.
