Unilife Commences US Production of Unitract 1mL Syringes
August 12 2009 - 1:17PM
Marketwired
Unilife Medical Solutions Limited ("Unilife" or "the Company")
(ASX: UNI) (PINKSHEETS: UNIFF) today announced that it has
commenced US production of the Unitractâ„¢ 1mL Insulin Syringe
("Unitract 1mL Syringes") at its FDA-registered manufacturing
facility in Pennsylvania.
This significant milestone follows the successful transfer of
the automated assembly system for the Unitract 1mL Syringes into
its designated clean room in accordance with previously announced
schedules.
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 running
speeds and product quality. These tests were successfully
completed, with the automated assembly system now rated at up to
90% of efficiency. 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 start of US production will enable Unilife to complete
required product ageing studies and build inventory to fulfil
current and anticipated orders for its Unitract 1mL Syringes. The
Unitract 1mL Insulin Syringe has received key regulatory
certifications for use within the US, Canada, Europe and
Australia.
Commercial release of the Unitract 1mL Syringes is expected to
occur during the fourth quarter of 2009 once product ageing studies
have been completed. Unilife is currently in discussions with a
number of interested pharmaceutical and healthcare companies
located in the US, Europe and Asia regarding the Unitract 1mL
Syringes. Unilife will also promote the products at key US and
European industry events.
Unilife's CEO Alan Shortall said, "I encourage shareholders to
visit Unilife's website to view a video of the production of the
Unitract 1mL Syringes inside its designated clean room. This
automated assembly system has been fully designed, developed, built
and qualified by Unilife using our own internal resources and
world-class operational team. The technical challenges Unilife has
overcome to commence high-volume production of the Unitract 1mL
Syringes has turned our in-house operational capabilities into a
key commercial strength.
"The lessons we have learned during the successful completion of
fully automated production for the Unitract 1mL Syringes are now
serving as a gateway to the creation of additional substantial
opportunities such as the Unilife Ready-to-Fill Syringe."
Unilife's Senior Vice President of Operations, Bernhard Opitz
said, "Unilife has taken several significant steps this year to
reach this moment where US production of our Unitract 1mL Syringes
has commenced. The continued strengthening of our world-class
operational team and its technical expertise in the development of
innovative safety medical devices has contributed to us reaching
this milestone. We look forward to further increasing the
efficiency of the automated assembly system in anticipation of the
scheduled commercial release of the product later this year."
A production video of the Unitract 1mL Syringes is available for
viewing at: www.unilife.com
About Unilife
Unilife Medical Solutions Ltd is an ISO 13485 certified company
that designs, develops and supplies innovative safety medical
devices. Listed on the Australian Securities Exchange (ASX: UNI)
since 2002, Unilife has FDA-registered manufacturing facilities in
the US State of Pennsylvania and a proprietary portfolio of
clinical and prefilled safety syringes designed for use within
healthcare and pharmaceutical markets.
Unitract 1mL Syringes
The Unitract 1mL Syringes are a patent-protected range of safety
syringes designed to protect those at risk of needlestick injury
and other unsafe injection practices. A proprietary passive
(automatic) needle retraction mechanism allows operators to control
the speed of needle withdrawal into the barrel, where it is locked
in place to prevent re-use or product tampering. Product variants
include the Unitract 1mL Insulin and Tuberculin (TB) Syringes
suitable for use within healthcare and pharmaceutical markets, and
a Safe Syringe designed for use within harm reduction markets.
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61 2 8346 6500 United States Stuart Fine Phone: + 1 908 469 1788
Media Enquiries: Australia Michael Mullane Phone: +61 2 8284 9990
United States Sharon O'Shea Phone: + 1 610 659 9091
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