Flexible IV bag systems have been in use for many decades. However, with recent regulatory expectations that require a more extensive approach to verifying container closure integrity, highlighted by USP 1207, the ability to effectively test these systems present many unique challenges. The size and fill volume, as well as the placement and quantity of ports, can drastically impact the overall integrity of the package system. While in some cases, technologies documented in USP 1207, such as vacuum decay may still be viable, in cases where these limiting factors play a critical role in method selection, the CS Analytical Team has developed methodologies that can be customized to your specific IV Bag configuration that still offer the ability to use positive controls and validate to specific micron level leak rates. Additionally, CS Analytical remains committed to exploring new technologies and applications in support of container closure integrity testing flexible IV bag systems.
About CS Analytical Laboratory
The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world’s leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP 1207 services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.
SOURCE CS Analytical