The testing strategy to be applied on a container closure system with the aim to demonstrate the proper Container Closure Integrity (CCI) depends on several aspects which need to be taken into consideration for the right analytical approach.
The importance of the ‘product-packaging’ coupling
The term product–packaging refers to the container–closure system plus the product contents while with “container–closure system” is usually intended as a primary and potentially a secondary packaging. In the choice of a leak test method the important aspects are: the chemical/physical composition of the product, which could be not compatible with some specific CCI analytical techniques and the nature/shape of the container closure system which, due to the presence of moving components or flexible parts, often requires specific attentions.
Product lifecycle phase
The product lifecycle phase can be divided in 4 phases:
- Packaging Development and process validation
- Batch release
- Commercial Product Stability
- Product transportation monitoring
It is important to address specific considerations about the leak testing basing on the phase of the process involved; this aspect has an strong impact on the choice of the CCI technique and on the analytical method development and validation. Our technical experts and consultants can provide to Customers a comprehensive analysis of the potential reguatory gaps which need be filled and the most suitable way to fullfill this goal from the technical point of view.
