미국약전 382

Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

시험 자료

USP 382 applies to elastomeric closures used in pharmaceutical packaging, such as vial stoppers, syringe plungers, and infusion set seals. Test specimens must represent production batches, be free from defects, and be stored under controlled conditions. Proper material selection ensures accurate, reproducible results and compliance with regulatory requirements.

테스트 프로세스

USP 382 specifies functional tests to verify closure performance. Key evaluations include fragmentation (checking for particles after needle penetration), self-sealing (ability to reseal after puncture), and penetrability (force required to pierce the closure). Tests are conducted under controlled temperature and humidity with calibrated instruments, using sample sizes that ensure statistical validity.

테스트 결과 해석

Results are assessed against USP 382 acceptance limits. Fragmentation must remain below the specified maximum, self-sealing must prevent leakage, and penetrability must meet ergonomic and sealing integrity standards. Data trends help verify batch consistency, guide process improvements, and demonstrate compliance with FDA and international regulations.