Analytical leachable methods are developed and validated by our CRO partners, to ensure leachables are detectable at levels equivalent to relevant safety thresholds. These analytical methods can be either ‘specific’ and/or ‘screening’ in nature. For example, screening methods will be appropriately developed and validated for the determination of:

• Volatile Leachables
• Semi Volatile Leachables
• Non-Volatile Leachables
• Other Elemental Leachables

If in addition, the client requires support with determining what levels of the 38 named PMTA constituents are in their product, or with determining what levels of these constituents are delivered by their product, ExtLe Solutions can manage the development and validation of specific analytical methods to establish these levels.

Where any leachable is observed above a pre-agreed action threshold, which will have been defined from the Analytical Evaluation Threshold, which in turn will have been defined from a relevant daily exposure threshold (e.g. PQRI SCT), a full safety assessment will be performed by a qualified toxicologist.

An interim leachables report is produced at each time point, including trending of any observed leachable levels, with a final version generated at the end of the study.