Unitary withdrawal spike unit suitable for factory fitting

摘要

A withdrawal spike unit (200) comprises a withdrawal spike component (30′) and an integrally formed adapter component (60′) that is adapted to couple with a vial (10) in a safe and secure manner. The integral formation of the component parts (30′, 60′) makes fully automated manufacture and assembly of assemblies comprising such a withdrawal spike unit (200) coupled to a vial (10) possible. As such, human errors associated with the assembly at the point of use are mitigated.

主权项

1. A withdrawal spike unit including a withdrawal spike and an integral adapter configured to couple with a multidose vial, wherein the configuration of the withdrawal spike and the integral adaptor irreversibly engaged with the multidose vial will maintain sterility therein during and after withdrawal of a first sterile dose therefrom into a first device and will maintain sterility of a second dose withdrawn therefrom into a second device, the adapter comprising:
a hollow body defined by an outer wall having a first end and a second end formed integrally with the withdrawal spike; and a retaining member at the first end adapted to irreversibly engage at least a portion of the multidose vial such that the withdrawal spike is locatable in a predetermined position with respect to the multidose vial.