Unilife moves into new manufacturing facility

Installs retractable syringe assembly line at York, PA

US-based medical device company Unilife is to move its operations into a new, 165,000ft2 manufacturing facility and global headquarters in York, PA.

All essential production equipment, including the automated assembly and packaging systems used to manufacture the Unitract range of 1mL retractable syringes, has now been transferred from Unilife's original Lewisberry site into designated cleanrooms at the US$31m York plant.

The company says all 170 employees will be working out of the new facility by 20 December.

Alan Shortall, chief executive of Unilife, said the combination of the new facility with advanced production systems is helping the company to set a new industry benchmark for safety syringes.

The new facility will produce up to 400 million syringes a year. A second stage is already approved, which would add another 100,000ft2 of production space, and take the total production capacity of the site to around one billion units a year, subject to commercial demand.

Unilife will restart production of the Unitract 1mL syringes in February 2011 following the recertification of the automated assembly line, as required by regulatory agencies.

The automated assembly system for the Unifill ready-to-fill syringe will be transferred into the York facility during the first quarter of 2011 when Factory Acceptance Tests at the Denver, Colorado facilities of the Mikron Group are completed.

Commercial supply of the Unifill syringe to pharmaceutical customers is expected to begin during the second quarter of 2011.

The amenities at the new factory include:

  • Eight Class 8 (100,000) and three Class 7 (10,000) cleanrooms where temperature, humidity, microbial and particulate matter are tightly controlled;
  • An advanced Water-for-Injection (WFI) system that will meet established pharmaceutical standards of water purity required for the production of the Unifill ready-to-fill syringe;
  • A microbiology lab, product development centre and quality physical and analytical inspection labs;
  • A 20,000ft2 temperature-controlled warehouse and 54,000ft2 office space to serve the company's global headquarters and provide support management functions.