Cambridge Polymer Group routinely performs tests according to ASTM, USP, ISO, and other standards. Some projects require testing assays that are not described in published standards, such as novel materials, unusual product designs, new manufacturing procedures, or new regulatory requirements.
Clients often request custom test development to address:
- Product Design: verification tests to ensure a process or component is meeting its input requirements.
- Regulatory Submission: Tests to establish safety and efficacy that fall outside of published standards or require interpretation of the standard so that it reflects the function of the client’s product. These tests often require suitability and verification activities.
- Quality Release: Test methods that target product features identified as critical points for release criteria. Cambridge Polymer Group with either perform the quality release testing, or will develop and validate the method, and then assist in the method transfer to the client.
Custom test design usually requires validating the procedure, particularly if it is to be used for quality purposes. Cambridge Polymer Group is experienced in setting up and executing validation studies of test methods so that they are compliant with ISO standards (for example ISO 9001, ISO 17025).