CLIFTON, N.J., Sept. 18, 2024 /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 pleased to announce that in partnership with Contract Laboratory they will host an educational webinar titled “Container Qualification: Assembling a Comprehensive Testing Strategy for Life Science Package Systems”. The webinar, to be hosted by CS Analytical Chief Scientific Officer Brandon Zurawlow, will take place on Tuesday October 15th at 1:00pm EST. The webinar is free of charge and attendees may register here: https://outsource.contractlaboratory.com/container-qualification-assembling-a-comprehensive-testing-strategy-for-life-science-package-systems/
“Over the past decade, the advances in the various types of medical and drug product package systems, coupled with numerous regulatory changes in qualification requirements has made the package system approval process much more complex,” noted Brian Mulhall, CEO of CS Analytical. “This webinar will provide an overview of current requirements and offer keen insights into how to ensure your container and package systems meet all regulatory guidelines.”
Testing of pharmaceutical packaging components and systems such as bottles and vials has been a regulatory expectation for decades. However, over recent years, there has been a proliferation in the types of materials used to create package components, novel package designs, and unique products they are intended to hold. Furthermore, drug-device combination products such as prefilled syringes and injection systems, now common formats, introduce unique considerations. As product-package systems, regulatory requirements, and best practices evolve, navigating appropriate test standards can be challenging.
Successful qualification requires reference to compendial standards, such as those found in the USP, non-compendial international standards, as well as custom studies and evaluations. The unique product-package system and lifecycle must be considered in assembling a suitable qualification strategy.
This webinar is intended to provide an overview of container and package qualification across the product lifecycle. Topics will include a review of relevant USP chapters as applicable to different packing materials and components such as glass, elastomers, plastic, and more, including a review of recently revised and pending chapters. Critical evaluations referenced in regulatory guidance and best practices, but not explicitly prescribed in compendial chapters, such as distribution simulation performed per ASTM / ISTA, will also be explored.
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.
About Contract Laboratory
Contract Laboratory is an interactive web-based platform for laboratory testing and outsourcing services. For the past 20 years, the platform has facilitated numerous contract laboratory testing, services, and business opportunities for government agencies, CROs, start-ups, and even large multinational corporations.
Contract Laboratory is now a division of LabX Media Group and will continue to expand services and offerings to meet the needs of the laboratory testing and outsourcing industry.