A Joint Webinar with LIGHTHOUSE and CS Analytical
Since December 1, 2025, USP <382> has required a “systems approach” to elastomeric component testing — your entire packaging/delivery system, not just the stopper material, must prove fitness-for-intended-use. For multi-dose vials, that includes demonstrating that the elastomeric closure reliably reseals after repeated needle punctures, per USP <382> section 5.2’s reference to deterministic methods in USP <1207>. Meeting the full scope of USP <382>, however, often means combining more than one testing approach.
In this joint webinar, LIGHTHOUSE Instruments and CS Analytical bring together their complementary capabilities to show how a combined testing strategy can address USP <382> in full — from needle self-sealing capacity to the broader functional and physicochemical requirements of the chapter.
What we’ll cover:
- Why USP <382> replaced the blue dye immersion test with a requirement for deterministic methods, and what that means for your CCIT strategy
- How laser-based headspace gas analysis detects loss of container closure integrity by measuring changes in headspace pressure or gas concentration
- Real-time monitoring of stopper resealing dynamics during repeated needle punctures, using both nitrogen and vacuum headspace conditions
- How a carbon dioxide tracer gas ingress method was validated to detect defects with a flow-effective size as small as 5 μm
- Our approach to inherent integrity testing, and how it fits alongside needle self-sealing evaluation across the product lifecycle
- CS Analytical: The additional functional and physicochemical testing requirements under USP <382> that fall outside headspace analysis, and how these are evaluated
- Combined case studies showing how headspace analysis and CS Analytical’s complementary testing methods work together to build a complete USP <382> compliance package
Who should attend: Pharmaceutical scientists, quality managers, regulatory affairs professionals, and manufacturing engineers responsible for container closure integrity testing and USP <382> compliance.
Webinar Series - 1
Are You Ready for USP <382>? A Complete Approach to Elastomer Resealing Capacity and Container Closure Integrity
Wednesday, October 14, 2026
- Amsterdam: 4:00 PM CEST
- New York: 10:00 AM EDT
This webinar is the first in a series of four on Container Closure Integrity (CCI). We begin with the first stage of the product lifecycle, focusing on primary packaging and elastomer selection, USP <382> requirements, and the early CCI testing strategy needed to establish a robust container closure system. In the next webinars we will cover method development and validation and go further in the product life cycle through regulatory compliance in commercial manufacturing and quality control.
SPEAKER
Dr. Francesca Caprioli, Laboratory Director, Lighthouse Instruments
Leads the Analytical Service Laboratory in Amsterdam, overseeing study managers and analysts, and manages customer projects across Europe for pharmaceutical companies and primary packaging suppliers. She also supports the design of application studies, including container closure integrity testing.
SPEAKER
Brandon Zurawlow, Chief Scientific Officer, CS Analytical
As Chief Scientific Officer at CS Analytical, Brandon leverages over 10 years of cGMP experience applying compendial chapters such as USP <382>, <660>, <661> and their EP counterparts; as well as the choice, development, and validation of CCI methods now found in USP <1207>. Brandon is a contributor to industry documents and textbook chapters, and a speaker on the topic of compendial container testing and CCI at client sites, training seminars, and conferences in the US, Europe, and Asia.