SGS M-Scan has developed methods for the analysis of extractables and leachables from food packaging and pharmaceutical container and closure systems.
Following the identification of extractables, SGS M-Scan can assist with the organisation of appropriate stress testing studies as the precursor to leachables testing. The compounds leaching into the product during its lifetime are likely to be related to the product’s storage conditions (e.g. temperature, humidity and life time), its contact area with its packaging or container/closure system and the properties of both the product and the container/closure system (eg pH, adsorbance). These parameters are all considered in the design of the stress testing regime.
Stress tested samples of finished product are analysed for leachables.
Using SGS M-Scan’s breadth of experience in method development, the design of our leachables studies are typically based on:
- An evaluation of extractables data by the Study Sponsor’s toxicologist.
- Particular compounds of interest due either to their abundance in the extractables study or their toxicity.
- SGS M-Scan’s knowledge of the best analytical techniques for these compounds which is usually based on their anticipated concentration, interferences from other compounds present (e.g. excipients) and robustness of the analytical method.