The USP <382> General Chapter is an excellent example of how container and package systems and their regulations have evolved over the past decade. The “old days” of solid tablets packaged in plastic containers frequently hitting the market seem like a distant memory. With the advent of unique product formulations including proteins, monoclonal antibodies, cell and gene therapies including mRNA, and more, package and delivery systems have, understandably, become more advanced. While not scheduled to become official until December 1, 2025, the USP <382> on functional suitability of elastomeric materials used in container and package delivery systems outlines the advanced functional qualification test requirements that will apply to systems containing these materials.
The CS Analytical team has been at the forefront of changes and developments to all USP packaging chapters and is well positioned to provide training, guidance and implementation of testing programs for specific applications of elastomeric materials as part of a package or delivery system. Similar to our advisory guidance on USP <661.1> and USP <661.2> revisions scheduled to be effective December 1, 2025 we encourage early adoption of these techniques, limiting risks, and conserving time and money that requalification would require.
The USP <382> chapter provides a more extensive approach to the functional testing that is part of the current USP <381> chapter and addresses various package configurations. Key points of the USP <382> chapter include:
- Testing is required for all elastomer materials that will be used for packaging of parenteral dosage forms.
- Test are designed to meet specific use situations for the elastomer. If the elastomer will serve as a plunger, required tests are different from the elastomer that will serve as a multi-dose stopper used as the closure for a vial.
- Functional test requirements are to be applied to the elastomer component in the same manner and format as it is intended to be used. If the elastomer is to be sterilized, the elastomer should be sterilized prior to the performance of functional suitability testing.
- The chapter includes a direct reference to USP <1207> that addresses the concepts of “maximum allowable leakage limit” and “inherent integrity”, which are critical elements of any comprehensive container qualification program for high-risk products.
While any elastomer component used in a container or package delivery system is subject to USP <382> test procedures, the USP outlines some of the more common uses:
- Vial and Bottles Systems that use elastomer in some form of fitted or compressed manner.
- BFS (Blow Fill) Systems that typically have a plastic closure fitted with an elastomeric liner.
- Plastic Systems that usually have multiple chambers that use elastomer as a port access point or as a chamber separator.
- Cartridge Systems that use elastomer components at critical seal points.
- Prefilled Syringes using elastomer material for the plunger, or as a luer-lock or needle shield seal
- Single Use Syringes that are fitted with an elastomeric plunger and may be used for vials that have multiple injection elastomeric stoppers sealing them.
Testing requirements are dependent on the intended use of the elastomeric material. Common tests referenced as part of the USP <382> General Chapter include:
- Fragmentation
- Penetration Force
- Needle Self Seal Capacity
- Spike Retention and Sealability Capacity
- Plunger Break Loose and Extrusion Force
- Plunger Seal Integrity
- Tip Cap and Needle Shield Functional Suitability
Due to the uniqueness of testing requirements, specialized instruments including universal testing machines (Instrons), various force gage systems, and other instruments uncommon in chemistry laboratories may be required. In addition, an in-depth understanding of the chapter, its requirements, and its intent relative to other USP tests and in the context of a broader qualification strategy is paramount to successful implementation. The CS Analytical Team, leveraging state-of-the-art laboratories explicitly designed and created for these types of analyses in a cGMP environment, has the experience to ensure the test program outlined for a particular elastomeric component adequately evaluates its suitability for intended use.