USP 381

USP 381 Vial Stopper Functionality Test Penetrability, Fragmentation, and Self Sealing

Understanding USP 381 and Its Role in Pharmaceutical Packaging USP 381 defines the performance requirements for elastomeric closures used in injectable drug packaging. These closures must maintain container integrity while allowing repeated needle access without compromising sterility. The standard focuses on three critical functionality evaluations: penetrability, fragmentation, and self-sealing capacity. Pharmaceutical manufacturers and quality control […]