Legislation in the United States requires healthcare employers to select safer needle devices and to involve staff in identifying those devices that meet the safety requirements.
Integrated BioSciences Inc. (IBS), based in Lewisberry, PA, has signed two memorandums of understanding (MOUs) with syringe engineering company Unilife Medical Solutions (Sydney, Australia). The MOUs enable IBS to manufacture syringes that are in compliance with this legislation.
Unilife has created a platform technology for syringes called Unitract, which is designed to reduce the risk of needlestick injury and to prevent reuse. Ed Paukovits, president of IBS, said in a release, “I am confident that the Unitract technology has significant potential to help revolutionize the global syringe market.”
One MOU states that IBS will establish the first automated assembly line for the Unitract Clinical line of safety syringes. The Unitract Clinical syringes feature an automatic retraction mechanism that controls retraction speed of the needle. An interchangeable needlemount allows for the use of common luer-slip and luer-lock needle products.
IBS will be the exclusive manufacturer of the clinical syringes in the United States. West Pharmaceuticals has agreed to provide assistance with design and development. Alan Shortall, chief executive officer of Unilife, said, “Unilife recognizes that the preexisting relationship between IBS and West Pharmaceutical Services adds great value to our capacity to rapidly commercialize the Unitract portfolio of safety syringes.” Production is scheduled to begin in late 2006, once IBS has completed and validated several Class 8 cleanrooms.
The second MOU establishes that IBS will create a production center for the Unitract Safe Syringe at its headquarters in North America. In exchange, IBS will contribute 50% of all capital expenditure associated with the development of the assembly line. The outsourcing company will be the sole manufacturer to North American markets, as well as to China, the UK, and other markets as they emerge. Unilife has already received orders for 30 million units in China and the UK. As with the clinical syringes, production of the Safe Syringe will begin in late 2006.
IBS is a full-service contract manufacturer with ISO 9001:2000 certification. The company is CGMP compliant and FDA registered for Class I and Class II devices.