Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor

The Chemfort® 28-day 20 mm Vial Adaptor is a single-use, sterile closed system transfer device (CSTD) that prevents the release of hazardous and antineoplastic drugs in vapor, aerosol, or liquid form during drug preparation, reconstitution, and administration. It also prevents microbial and airborne contaminants from entering the drug pathway for up to 28 days or 10 activations.

The device is physically and materially identical to the predicate 20 mm Vial Adaptor, featuring a 0.2-micron microbial membrane barrier, elastomeric seals, charcoal cloth, mechanical snap connections, and ethylene oxide sterilization at SAL 10⁻⁶. The primary difference is the extended usage time limit from 7 to 28 days, while maintaining the same 10-activation limit and 3-year shelf life.

ISO 10993 series for biocompatibility and FDA guidance; bench testing protocols covered microbial ingress, bidirectional flow, vapor containment, disconnection force, air tightness, fluid tightness, and particulate matter.