Taking these challenging package systems head on, the CS Analytical Team has spent almost two years developing alternative test strategies that meet the intent of USP 1207 and provide effective options for clients to consider when working with flexible bag systems.
CLIFTON, N.J., Sept. 19, 2023 /PRNewswire-PRWeb/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is excited to announce that it had expanded its capabilities to test the ever-challenging IV Bag Container System in accordance with the key concepts of USP 1207 Container Closure Integrity Testing (CCIT) requirements. The CS Analytical CCIT Team has developed new test approaches that enable a method to be effectively developed and validated to a defined micron leak level, while continuing to explore the application of novel technologies and instrumentation for these unique systems.
"The challenges that IV bags present specific to CCI Testing are well documented. The varying size of these systems, the multiple port configurations, the fill volume variability, and the polymeric materials of construction all play a role in limiting effectiveness of typical test methods" noted Brian Mulhall, CS Analytical CEO. "Taking these challenges head on, the CS Analytical Team spent almost two years developing alternative test methods that meet the intent of USP 1207 and provide effective options for clients to consider when working to qualify these unique systems, while continuing to explore new technologies and solutions with instrument manufacturers."
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.
Media Contact
Brian Mulhall, CS Analytical, +1-888-571-1207, [email protected], https://csanalytical.com/
SOURCE CS Analytical
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