The workshop will provide an overview on the assessment and tests needed to be in compliance with the up-to-date regulations and guidances. Starting with the testing on the materials of constructions (plastic pellets, foils, films) and components (stoppers,glass,) we will see the rational behind the choice of the testing, following specific chapters of the US and EP Pharmacopoeias.
We will move then to the required testing when these materials and semi-finished product became a Primary Packaging, a Medical Device or a Single/Multiple Use System used in the product manufacturing. This testing embraces the Extractables & Leachables assessment, which evaluates the safety of the materials in terms of potential toxic compounds releasing, and the Container Closure Intergrity Testing (CCIT) which has the aim to evaluate the capability of the chosen closure system to preserve the product chemical properties and to avoid contaminations.
In the last years the requests by regulatory authorities and notified bodies become more and more demanding about this testing.
In the workshop it will be explained how to manage the risk assessment for these two complex field of the analytical chemistry, and the related Design of the Experiments based
on the items’ shape, use and, in case of the closure systems, on the chemical/physical properties of the product contained. Several case studies and hands on will help to fix the
key concepts of the decisional workflows.