Unilife commenced production of the Unitract 1mL Insulin Syringes at its Lewisberry facility in Pennsylvania in August 2008. This milestone marked the first time that U.S. production of the Unitract 1mL Syringes has occurred in clean room conditions.

Prior to transferring the automated assembly system into the clean room, it was required to pass a series of operational tests designed to validate its performance in areas such as run speed and product quality. These tests were successfully completed, with the automated assembly system reaching up to 90% productivity. Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of approximately 40 million units per annum.

In parallel to completing the transfer of the 1mL assembly system into the clean room, Unilife also installed and tested other related manufacturing systems, including an automated barrel printer and an automated packaging system.

The automated assembly line that is now manufacturing the Unitract 1mL Syringes was fully designed, developed, built and qualified by Unilife’s in-house team. There are few companies in the world, particularly of Unilife’s size, which have the core competency in-house to develop innovative medical devices and the automated assembly systems used to manufacture them. This core set of operational strengths is a testament to Unilife’s success in building a world-class business via the acquisition of Integrated BioSciences Inc (IBS) and the recruitment of global medical device industry leaders.

Initial production will be used to complete accelerated device ageing studies required to support regulatory submissions. Unilife will continue to manufacture the Unitract 1mL Syringes and hold them in quarantine until the completion of these ageing studies. Commercial release is expected to occur during the fourth quarter of 2009.

The start of U.S. production will enable Unilife to complete required product ageing studies and build inventory to fulfill current and anticipated orders for its Unitract 1mL Syringes. The Unitract 1mL Insulin Syringe has previously received key regulatory certifications for use within the U.S., Canada, Europe and Australia.

Unilife is currently in discussions with a number of interested pharmaceutical and healthcare companies located in the U.S., Europe and Asia regarding the Unitract 1mL Syringes. Unilife will also promote the products at key U.S. and European industry events.