Commissioning & Validation
Founded in 2000, Insulet Corporation is an innovative medical device company dedicated to improving the lives of people with diabetes. Through its Omnipod Insulin Management System, the company seeks to expand the use of insulin pump therapy among people with insulin-dependent diabetes. The Omnipod is a revolutionary and easy-to-use tubeless insulin pump that provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet's Delivery Systems business also partners with global pharmaceutical and biotechnology companies to adapt the Omnipod technology platform for the delivery of subcutaneous drugs across multiple therapeutic areas.
ICO was selected to perform Commissioning for the build-out of Insulet’s new world headquarters in Acton, Massachusetts, featuring more than 300,000 square feet of office, conference, cleanroom, manufacturing, and warehouse space.
ICO was also retained to perform Validation Services for 40,000 square feet of ISO Class 8 cleanroom space to ensure the design of the facility fit its intended purpose. ICO ensured the facility, equipment, and environment met User Requirement Specifications as well as defined regulatory requirements, and functioned together as a system to meet defined standards. ICO’s services included oversight of third-party testing for HEPA Filter Certification and Particulate Air Sampling, along with the development of a Validation Master Plan and Impact/Risk Assessments.
Commissioning Services for new 300,000 square foot world headquarters
Validation Services for 40,000 square feet of ISO Class 8 cleanroom space