Aptar Pharma Announces Expert Webinar on USP <382>, Guiding Industry Through New Extractables Regulations

Aptar Pharma is preparing to host an in-depth technical webinar to support pharmaceutical manufacturers, packaging engineers, and regulatory teams as they navigate the new requirements established under USP <382>, a critical chapter focused on extractables assessments for elastomeric packaging components.

The regulatory landscape for pharmaceutical packaging has shifted significantly with the introduction of USP <382>, which replaces the long-standing USP <381> and establishes new expectations for characterizing elastomeric components used in drug product packaging and delivery systems. These components include vial stoppers, syringe plungers, and a wide range of elastomer-based closures essential to maintaining container closure integrity and product sterility.

Aptar Pharma’s webinar aims to clarify the scientific, technical, and compliance obligations arising from the chapter, helping companies prepare for audits and ensure packaging systems meet the latest safety and quality benchmarks. With many organizations still adapting their testing strategies and documentation frameworks, the need for authoritative guidance has become increasingly urgent.

What USP <382> Means for the Pharma Supply Chain

USP <382> marks a major evolution in how extractables are assessed. It requires robust chemical characterization, standardized testing conditions, and improved risk assessments for potential leachables during the product lifecycle. The shift impacts pharmaceutical manufacturers, packaging suppliers, contract organizations, and analytical laboratories, all of which must align procedures with the new chapter by upcoming enforcement dates.

The Aptar Pharma webinar will unpack the scientific rationale behind the regulation, explaining how extractables profiles differ based on material composition and how to interpret test results within a compliance-driven framework. Attendees can expect guidance on selecting appropriate test methods, validating data, and collaborating effectively with packaging suppliers to ensure full regulatory readiness.

Expert-Led Guidance From Industry Specialists

As a global leader in drug delivery and elastomeric component technologies, Aptar Pharma brings deep expertise to the topic. The webinar will be led by senior technical and regulatory specialists who have been closely involved in interpreting the chapter and aligning product portfolios with its requirements. Their insights will provide clarity on how the regulation affects both legacy products and new developments.

The session will also explore typical extractables challenges encountered in real-world packaging systems—including chemical variability, testing uncertainties, and data comparability—and present best practices for building a compliant, science-based extractables program.

Supporting the Industry Through Regulatory Change

With the pharmaceutical sector placing increased emphasis on patient safety, supply chain transparency, and regulatory harmonization, Aptar Pharma’s initiative to host this webinar reflects its ongoing commitment to industry education and compliance support. By creating a platform for dialogue and knowledge-sharing, the company aims to equip partners and customers with the tools needed to adapt confidently to USP <382> and to implement stronger packaging controls across global operations.

The webinar is open to professionals across regulatory affairs, quality control, R&D, packaging development, and analytical testing. Interested participants can register through Aptar Pharma’s official events page.

As regulatory expectations continue to evolve, Aptar Pharma’s webinar offers timely, expert-led guidance to help the industry ensure safe, compliant, and high-performing elastomeric packaging systems.