Chemical Characterization to Ensure Product Safety
Utilize our comprehensive approach towards chemical characterization to identify extractables and leachables. These 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, also may contribute.
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.
Analyze Extractable & Leachable Compounds
When we conduct chemical characterization studies for extractables, our approach is to subject your device to worse-case conditions. We then characterize the constituents extracted from the component under these exaggerated conditions. Extraction conditions, such as solvents, extraction time, and temperature, are chosen based on guidance, such as ISO 10993-18. Our experienced team then analyzes and semi-quantitates these 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 quantitate 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.
Integrated Laboratory Services
When your team needs additional support, our scientists & professional services are ready. Our state-of-the-art facilities and highly trained experts add power to your project.
Additional Resources
Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.
Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.
Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.
Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.