Expert Characterization Testing Services
Protect patient safety with our characterization techniques. Characterization testing supports patient safety by evaluating medical devices or packaging for any materials in potentially hazardous quantities for the intended exposure. Chemical characterization provides the data necessary to identify extractable and/or leachable compounds present in a medical device or, in the case of drug products, the container closure systems used for storage. These products must be evaluated for their intended use from an extractable and leachable perspective and compatibility of those materials to preserve the integrity of drug products.
Analytical characterization is required from a regulatory perspective and provides a foundation for toxicological risk assessments using the test article in its intended application. Our expert team adapts and applies regulatory guidelines to your device or container closure to ensure the study design and execution suit your product(s) and requirements. Partner with us for a broad spectrum of methods designed to provide a representative chemical profile of your products, including:
- UPLC Time Of Flight Mass Spectrometry (Non-Volatile Compounds)
- GC Mass Spectrometry (Semi-Volatile and Volatile Compounds) ICPMS For Elemental Impurities
- Quantitation / Semi-Quantitation
- Elucidation Of Unknowns
- In Matrix Method Development and Validation for Leachable Compounds
- Comparison Studies to Support Change Control
- Stability Studies
- Simulated Use Studies
- Accelerated Aging Studies
Secure Data Accessibility
Analytical methods, including both the Client Laboratory Methods (CLM) and Laboratory Methods (LM), are available for your access and review in PacePort®. PacePort® is our secure client data access portal and web-based data delivery system where you have access to methods, specifications, stability protocols, pull schedules, stability reports, final reports, sample receipt data, instrument raw data, and additional information at any time, from any location.
The copies are offered in high-resolution and in color, giving your team easy and clear viewing for review. Scanned images are of sufficient quality that they are often used during quality and regulatory (US FDA) audits. The information available via PacePort® is thorough and complete, such that most, if not all, aspects of a data audit are available so your audit could be conducted remotely, guided by our Quality Assurance personnel.
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.