Unilife, a US based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes, has commenced initial production of the Unifill ready-to-fill (prefilled) syringe at its FDA-registered manufacturing facility in York, Pennsylvania.
The Unifill syringe is designed for integration into fill-finish systems used by pharma manufacturers to load a measure dose of an injectable drug or vaccine into equivalent standard prefilled syringes, and features USP compliant materials inside the fluid path.
An automatic (passive) needle retraction mechanism is activated in the Unifill syringe upon full dose delivery, allowing operators to control the speed of needle retraction directly from the body into the barrel to virtually eliminate the risk of infection from potential transmission modes such as needlestick injuries or splatter.
Once Unilife completes final product validation activities for the Unifill syringe during the second quarter of 2011, it can begin to fulfill initial sales orders to its existing pharmaceutical partner.
Initial production batches are expected to be for a number of activities including the initiation of drug stability studies, market evaluations, and validating the integration of the product into fill-finish systems currently used to load a measured dose of an injectable drug or vaccine into equivalent standard prefilled syringes.