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Unilife Successfully Completes Industrialization of Unifill Syringe
Date:6/29/2011

itized prefilled syringes currently being marketed by incumbent device manufacturers. Our Unifill technology platform can deliver a unique competitive edge to pharmaceutical companies that are marketing their injectable drugs within increasingly crowded therapeutic markets."

Over the past eighteen months, Unilife has executed an extensive and rigorous verification and validation plan, a required step in the industrialization of medical devices, to ensure that the Unifill syringe is ready for commercialization. The verification and validation processes are designed to meet the requirements of Unilife's Quality Management System (QMS), which sets a high standard in the medical device industry.  The successful completion of these verification and validation steps by Unilife clears the path for the Unifill syringe to be shipped to pharmaceutical customers.  

Upon the receipt of the Unifill syringe, pharmaceutical companies will typically conduct drug compatibility and stability studies in which their injectable drugs or vaccines are tested in combination with the device. The resulting data is filed as the last step in completing the regulatory process for the drug-device combination product.  This step is typically followed by the pharmaceutical company building up inventory of the drug-device combination in anticipation of commercial launch.

One of the key components of Unilife's strategy is product quality.  Unilife has developed and implemented a best-practice QMS that adheres to the highest industry standards, including the FDA's Quality System Regulations and ISO 13485:2003. Unilife's QMS governs all product development and manufacturing activities to ensure the quality, reliability and functionality of its products.  The QMS is further enhanced by full integration with Unilife's SAP Enterprise Resource Planning [ERP] system, ensuring the highest level of quality and accuracy across its entire supply chain.

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SOURCE Unilife Corporation
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