Utilize our comprehensive approach towards chemical characterization to identify extractables and leachables. Conducting this testing helps identify potential biological risks to the end user. Extractable and leachable testing is particularly relevant to medical device packaging, as leachables in devices may compromise patient safety.
Extractable and leachable compounds may be organic or inorganic in nature, typically from devices which contain additives. These additives include materials such as lubricants, accelerators, monomers, and high molecular weight oligomers from incomplete polymerization, and residual solvents. Extractables may also be formed due to temperature, absorption, hydrolysis, oxidation, corrosion, or dissolution events. Agents used the manufacturing process itself, such as mole release, anti-static, and anti-stick agents, may also contribute.
Chemical characterization studies for extractables subject your product to worse-case conditions and then characterizes the constituents extracted from the component under these exaggerated conditions. Extraction conditions, such as solvents, extraction time, and temperature, are chosen based on guidance, primarily ISO 10993-18. Our experienced team analyzes and semi-quantitates the extracts using the following techniques and instrumentation:
Ultra Performance Liquid Chromatography-Photo Diode Array-Time of Flight Mass Spectrometry (UPLC-PDA-QTOF-MS) to identify non-volatile organic compounds
Direct Injection Gas Chromatography-Mass Spectrometry (DI-GC-MS) to identify semi-volatile organic compounds
Static Headspace Gas Chromatography-Mass Spectrometry (HS-GC-MS) to identify volatile organic compounds
Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS) to identify elemental impurities
Non-Volatile Residue (NVR) analysis to establish exhaustive extraction conditions
Once extractables are evaluated, we often develop a targeted leachables study to specifically quantify compounds of concern that were identified in the extractables analysis. The methods we use to quantify leachables are validated and used in long term stability studies. Additionally, our team performs simulation studies to determine potential leachables under accelerated conditions.
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