Product quality risks mitigated by package integrity expertise
West has an extensive portfolio of Container Closure Integrity (CCI) techniques and analysis for various packaging and delivery systems to meet the needs of pharmaceutical, biotech and medical device manufacturers. The road from concept to patient can sometimes be a "tortuous path," but the CCI analytical group has the resources, expertise and insight to provide a thorough understanding of container systems from package development to market launch and lifecycle management.
West has a complete and comprehensive grasp on packaging components, delivery systems and functionality. As consultative problem solvers, customers can work with West through each and every phase of the product lifecycle, because we have the understanding and capabilities our customers need to ensure efficiency, reliability, and safety, from concept to patient.
West's analytical services offers the full battery of techniques and capabilities as described in USP chapter <1207>, including:
Tracer Gas Detection, vacuum mode (helium mass spectrometry)
High Voltage Leak Detection
Frequency Modulation Spectroscopy (oxygen headspace)
Tracer Liquid (dye ingress)
In addition to the technology above, West offers a wide variety of storage capabilities to fit a variety of needs for products and packages. We are able to perform CCI analysis at the below temperature conditions in real time, providing an accurate CCI assessment:
As packaging systems become more complex and research continues to develop new biologics, the ability to store container systems in a comparable way to their lifecycle storage is of the utmost importance.