LEWISBERRY, PA--(Marketwire - November 19, 2009) - Unilife Medical Solutions Limited ("Unilife"
or "the Company") (ASX: UNI)(PINKSHEETS: UNIFF) today announced the
appointment of Mikron Group ("Mikron") as its contracted supply partner for
the development and supply of automated assembly systems to support the
commercial production of the Unifill™ ready-to-fill syringe (Unifill™
Mikron is a Swiss-based international leader for manufacturing technology
and assembly automation. They employ 1,000 staff worldwide, and specialise
in high-performance assembly and test solutions for the medical device,
pharmaceutical, automotive supply and electronics markets.
During the past 30 years, the Mikron Assembly Technology Division has
developed more than 2,000 assembly systems. Many of these were contracted
for supply by pharmaceutical and healthcare equipment companies to
manufacture medical devices that included inhalers, pen injectors, safety
syringes and insulin pens. They also have extensive experience in the
development of automated assembly systems for ready-to-fill glass barrels
used in the production of prefilled syringes.
After an extensive due diligence process, Unilife has engaged Mikron to
develop and supply the automated assembly lines that will be used in the
production of the Unifill™ syringe. The first Unifill™ commercial
line will have a target production capacity of approximately 60 million
units per year, which is 50% greater than originally anticipated when the
industrialisation program first commenced in July 2008.
The development of this commercial line is expected to commence next month,
with its scheduled installation into Unilife's new production facility in
Pennsylvania during the fourth quarter of 2010. This commercial line will
support the completion of the Unifill™ industrialisation program which
Unilife is currently undertaking in conjunction with its major
After the successful validation of the first commercial assembly line,
Unilife expects to work with Mikron on the development of a high-volume
line. This high-volume assembly line, which will have a target annual
production capacity of 150 million units per year, is scheduled for
installation at Unilife's new production facility towards the end of 2011.
Following the installation of both the commercial and high-volume assembly
lines, Unilife would have a total production capacity for the Unifill™
syringe of more than 200 million units per year. Subject to the successful
development and supply of these assembly lines to contract specifications
by Mikron, Unilife expects that it will order additional high-volume lines
to meet ongoing pharmaceutical demand for its ready-to-fill safety
To optimize production scalability and minimize operational risk, both
lines will utilize a modular assembly platform which has been successfully
applied by Mikron across several hundred previous projects. Prior to the
appointment of Mikron as the contracted supplier of automated assembly
systems for Unilife, they were required to undertake a number of
proof-of-principle activities to validate that their modular assembly
platform was capable of assembling the Unifill™ syringe at speeds
equivalent to those targeted for the high-volume line. As part of
proof-of-principle activities undertaken by Mikron, the Unifill syringe was
successfully produced at desired speeds using the same assembly system
station that will serve as the platform for the commercial and high-volume
assembly lines. Multiple versions of these scalable, industry-accepted and
highly flexible stations will be integrated into each commercial and
high-volume assembly line to be developed by Mikron to attain Unilife's
target production volumes. This process of replicating an already proven
assembly system has helped to significantly de-risk the path towards
high-volume commercial production of the Unifill Syringe.
Comments by CEO Alan Shortall
"It has been a key business priority for Unilife this year to select our
contract partner for the development of automated systems to assemble our
Unifill™ syringes at commercial levels. After carefully considering and
evaluating several high quality potential suppliers, Mikron was chosen
because it has a strong and proven background within the highly-specialized
pharmaceutical market for injectable drug delivery devices.
"Mikron has direct experience with developing assembly systems for
ready-to-fill syringes. As an established industry leader with strong
relationships with a number of pharmaceutical companies, they also have
sufficient resources to accommodate our aggressive production ramp plans.
Most importantly, we have validated that our Unifill™ syringes can be
assembled using their proven technology systems at commercially sustainable
levels. From here, the path to high-volume commercial production is a
scheduled process of replication rather than a complex technical challenge.
We believe the appointment of Mikron to be a safe choice that will
significantly de-risk the commercial feasibility and on-time delivery of
this key Unilife project."
Comments by SVP Operations Bernhard Opitz
"Unilife undertook a comprehensive and highly detailed selection process
spanning almost twelve months to identify the right partner to develop and
supply the automated assembly systems that will manufacture our Unifill
syringes. Following the successful completion of several critical
proof-of-principle activities by Mikron, we believe we have selected the
partner with the right level of industry experience and operational
capabilities to deliver this key project on-time and according to contract
specifications. We look forward to receiving Mikron's highly-efficient
automated assembly lines to help support the manufacturing of our
Unifill™ syringes for supply to international pharmaceutical customers."
Comments by President Mikron Corporation Denver, Paul Kuchay
"It is with great pleasure that Mikron Assembly Technology acknowledges the
responsibility to partner with Unilife on this ambitious program. For over
30 years we have delivered innovative, reliable, efficient assembly
solutions to the pharmaceutical and medical device industries. The robust
design of the Unifill™ product strongly complements our proven automated
assembly technology. Mikron Corporation Denver will be partnering with
Mikron Assembly Technology division's headquarters in Boudry, Switzerland
in order to deploy and fulfil our commitments to the customer's production
schedule. We look forward to building a strong relationship with a dynamic
company such as 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.