Unilife Successfully Completes Industrialization of Unifill Syringe
York, PA (July 29, 2011) - Unilife Corporation (“Unilife” or the “Company”) (NASDAQ: UNIS; ASX: UNS) today announced that it has successfully completed the validation phase of the Unifill® ready-to-fill (prefilled) syringe. This key industrial milestone represents the final step in the industrialization process for the Unifill syringe.
Mr. Alan Shortall, CEO of Unilife said “The completion of all validation tests associated with the Unifill syringe signals that the device is fully compliant with all key regulatory requirements and conforms to our own stringent specifications for device reliability and quality assurance. This is a testament to our unparalleled capacity for device innovation, the robustness of our Quality Management System and the commitment of our team to achieve what others within the industry had considered impossible.
“We are extremely pleased with how the Unifill syringe has performed across an extensive array of stringent validation tests. Production of the Unifill syringe is continuing at our FDA-registered facility in York, Pennsylvania to support expected initial sales to many of the 20 pharmaceutical companies we are currently in discussions with. Having already had our Quality Management System successfully audited by customers and certified to ISO 13485 by two notified regulatory bodies, we look forward to commencing initial sales of the Unifill syringe in the near future.”
Dr. Ramin Mojdeh, COO of Unilife said: “The Unifill syringe is the world’s first and only prefilled syringe with safety features fully integrated within the primary drug container. It is a primary drug container, a safety device and a sharps container all rolled into one. I believe this game-changing technology is poised to revolutionize the fast-growing $2.7 billion device market for prefilled syringes, as it is light years ahead of the commoditized 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.