YORK, Pa., June 29, 2011 /PRNewswire/ -- 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 commod