USP <382>
Functional testing per USP <382> establishes the requirements for elastomeric components that are part of the final packaging system of drug products in parenteral packaging and delivery systems. This includes stoppers, plunger stoppers, tip caps, needle shields, and other rubber or elastomeric closures used in vials, prefilled syringes, cartridges, and similar primary containers. For manufacturers of injectable drug products, compliance with USP <382> is an expectation in regulatory submissions.
Injectable drug products have become more complex over time. In December of 2025, USP made the final version of USP <382> official. Functional testing per USP <382> was introduced so components could be evaluated to see how they perform in the finished container closure system.
USP <382> asks:
- Does the container closure maintain integrity?
- Does the container closure move with appropriate force?
- Can it seal properly?
Common tests performed under USP <382>
Test |
Purpose |
| Container Closure Integrity (CCI) | Demonstrates the package maintains sterility. |
| Fragmentation | Characterizes particles created during puncture. |
| Penetration Force | Measures the force required for a needle to pierce the stopper or septum. |
| Self-Sealing Capacity | Confirms the closure reseals after one or more punctures. |
| Spike Retention & Sealability | Evaluates IV bag and bottle closures after spike insertion. |
| Plunger Break Loose Force | Measures the force needed to initiate plunger movement. |
| Plunger Glide Force | Measures the force required to maintain plunger movement during injection. |
| Plunger Seal Integrity | Verifies the plunger continues to provide an effective seal. |
| Tip Cap & Needle Shield Functional Testing | Confirms proper removal and sealing performance. |
Frequently asked questions
Which elastomeric components does USP <382> apply to?
USP <382> applies to any elastomeric component that contacts the drug product in a parenteral packaging or delivery system. This includes vial stoppers, prefilled syringe plunger stoppers and tip caps, cartridge stoppers, and needle shields.
What is the difference between USP <381> and USP <382>?
USP <381> focuses on the elastomeric components of a packaging system. It includes requirements for biological reactivity, physicochemical testing, and functional performance. USP <382> updated the requirements for functional testing, while the biological reactivity and physicochemical testing requirements remain in USP <381>.
Are there specific CCI test methods that manufacturers must use to validate sterility?
USP <382> states "No specific container closure test method is applicable to all injectable product packaging systems. The leak test chosen are to be capable of verifying that the packages inherent integrity meets the maximum allowable leakage limit for the intended product package."