Batch Release Testing

The data obtained from the testing of the stress-tested product(s) for leachables is used by M‑Scan, in conjunction with the Study Sponsor’s toxicologist to determine which leachables should be analysed in of each new batch of packaged product.

Methods developed for the analysis of the leachables of interest are validated under GMP with the full involvement of SGS M-Scan’s QA Department.

These validated methods are subsequently used to assess the levels of leachables in each new batch of packaged product.