Unilife Medical Solutions Limited (Unilife) 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 syringe).
Mikron is a Swiss-based companyfor manufacturing technology and assembly automation.
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 pharmaceutical partner.
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 syringes.
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.