Performance & Quality Testing

At Cambridge Polymer Group (CPG), we offer comprehensive performance and quality testing services tailored to meet the complex needs of materials science and product development. Our expertise spans method development, regulatory compliance, and advanced analytical techniques. 

Method Development and Validation 

We excel in developing and validating custom test methods for your specific requirements. Our services include: 

  • Testing to ASTM, ISO, and USP standards
  • Custom protocol development for unique products and materials
  • Validation studies demonstrating accuracy, repeatability, range, detection limits, and linearity
  • Support for regulatory submissions and design history files

GLP Testing 

For projects requiring regulatory submission, we offer Good Laboratory Practice (GLP)-compliant testing. Our GLP services ensure: 

  • Control: FDA-compliant sample handling and tracking
  • Security: Offsite data backup and secure archiving
  • Accuracy: Comprehensive SOPs and equipment maintenance
  • Comprehensive Reporting: Detailed documentation meeting FDA guidelines

Contact our scientists to learn more about how GLP can benefit your project. 

Custom Test Design 

As materials become more complex, so do the tests required to evaluate them. We specialize in: 

  • Developing non-standardized test methods
  • Modifying existing protocols for unique applications
  • Validating custom methods for specific client needs

Quality Hold Investigation

When faced with potential out-of-specification (OOS) results, our rapid response team can: 

  • Determine reasons for OOS or manufacturing deviations
  • Assess risk levels associated with results
  • Quickly resolve issues to minimize costly delays

Unknown Material Analysis 

Our advanced analytical capabilities allow us to: 

  • Identify unknown residues on parts
  • Isolate and characterize individual particles or fibers
  • Support risk assessments and process improvement

Why Choose CPG for Your Testing Needs? 

  • ISO 9001 certified quality management system
  • Extensive experience with FDA guidelines and regulatory submissions
  • Rapid turnaround times for time-sensitive investigations
  • Customized solutions for unique material challenges
  • State-of-the-art analytical equipment and techniques

Don’t let material testing challenges slow down your product development or compromise quality. Contact CPG today to discuss your performance and quality testing needs.