Good Manufacturing Practice you can rely on
The Unitract® range of safety syringes is backed by a strong patent position, an experienced device design team and proven production processes.
Unilife is an ISO 13485 (2003) certified U.S based manufacturer of Class II medical devices with U.S. Food and Drug Administration (FDA) registered production facilities in Pennsylvania.
The automated assembly system used to manufacture the Unitract® range of 1mL safety syringe was fully designed, developed and qualified by Unilife using its own in-house operational expertise. Twenty-two fully networked high speed machine vision inspection cameras examine every component during the assembly process, and report correct placement and positioning within the syringe assembly. Inspection and assembly verification occur throughout all stages of the production sequence.