PerkinElmer Achieves 13485 Certification for the Manufacture of the JANUS Automated Workstation
2 Nov 2007Product news
PerkinElmer Life and Analytical Sciences, a global leader in life science research, drug discovery and cellular science, today announced at The Society of Neuroscience’s 37th annual meeting in San Diego that it has received ISO 13485 certification for the manufacture of its JANUS® Automated Workstation platform.
ISO 13485 is the international quality standard for medical device manufacturing. Recently certified by NSF International Strategic Registrations, the JANUS liquid handling workstation is manufactured in Downers Grove, IL. Compliance with the medical device manufacturing requirements set forth by the International Organization for Standardization will provide assurance of quality to current and future customers in global markets.
“The comprehensive, modular and scalable JANUS platform is vital for molecular diagnostic assay development, and is able to meet the growing demand from our customers for complete, precise, and accurate assay automation. This ISO 13485 certification demonstrates PerkinElmer’s ability to provide JANUS as a medical device that consistently meets customer and regulatory requirements for use in clinical applications,” said Robert F. Friel, President and Chief Operating Officer, PerkinElmer, Inc.
ISO 13485 supplements the ISO 9001 standard; additional requirements relate to design controls, risk management, environmental controls, special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry.
The JANUS Automated Workstation platform offers a wide selection of solutions:
- A 96- or 384 channel workstation offering Modular Dispense Technology® (MDT) with interchangeable dispense heads, including the proprietary NanoHead™ enabling assay miniaturization. MDT allows researchers to automatically program the selection of numerous dispense heads and formats to provide hands-off, “on-the-fly” adaptability in dynamic volume range and microplate densities up to 1,536 wells.
- A third arm labware movement option provides comprehensive movement within the JANUS deck and to external devices such as plate readers and shakers.
- A single arm workstation option with a smaller nine-position deck that includes an MDT interchangeable pipetting head system for 96-, 384, and 1536-well microplates.
For more information about PerkinElmer’s new product launch at Neuroscience 2007, visit the article webpage.