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
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