USP <382>: A Shift in Injectable Packaging Requirements

In this interview, Laure-Hélène Guillemot, Technical Product Manager at Aptar Pharma, shares insights on the upcoming USP <382> regulation and its impact on injectable drug delivery. Replacing parts of USP <381>, this new standard introduces a system-based approach to evaluating elastomeric components used in parenteral packaging systems such as vials, prefilled syringes (PFS), and cartridges.

Unlike its predecessor, USP <382> focuses on the elastomeric components’ functional suitability when placed in the complete system—stopper, plunger, needle shield, and container—under real-use conditions. This shift ensures improved container closure integrity, needle and spike access functionality, and overall system performance. As Laure-Hélène explains, pharmaceutical companies will now be responsible for validating the full system, not just individual components.

The regulation introduces new and revised tests, including spike retention, sealability, and plunger seal integrity. It also recommends deterministic testing methods over probabilistic approaches, reinforcing the need for precise and consistent packaging validation.

To support this transition, Aptar Pharma has already conducted USP <382> testing on its vial stopper standards. The company provides tailored support through its R&D specialists, helping customers adapt their testing protocols and regulatory documentation. Additionally, Gateway Analytical, an Aptar Pharma company, provides GMP-compliant analytical testing to assist with regulatory submissions.

As the December 2025 deadline approaches, USP <382> sets a new benchmark for injectable drug delivery systems, reinforcing the importance of safety, reliability, and performance. With its proactive approach and technical expertise, Aptar Pharma is well-positioned to guide pharmaceutical partners through this evolving regulatory landscape.