Alkermes' New Facility: A Process Automation Success

July, 2003

Superior Controls engineers recently completed the design and installation of a major process automation system for Alkermes' new $40 million pharmaceutical manufacturing facility (90,000 sq. ft.) located in Chelsea, MA. One of the first products to be produced at the new facility is an inhaled formulation of insulin for the treatment of diabetes.

Alkermes, a Cambridge-based pharmaceutical company, is a world leader in the development of products based on sophisticated drug delivery technologies. One of these proprietary technologies involves the delivery of drugs to the lungs using pharmaceutical products based on Alkermes' inhaled Advanced Inhalation Research (AIR) pulmonary delivery system. This technology produces particles with a low density, porous structure for efficient delivery to the lungs using a simple, convenient, breath-actuated inhaler.

In collaboration with Eli Lilly, Alkermes is using the AIR system to develop an inhaled formulation of insulin for the treatment of diabetes and is also developing other partnered and proprietary products. This effort required the renovation of a 100-year-old building in Chelsea, MA and the creation of a 90,000 square foot, fully validated production facility.

The manufacturing process involves a sophisticated spray drying operation along with specialized formulation, handling, and filling processes for the low density and easily aerosolizable inhalation product. Capsule filling operations are also performed at the Chelsea facility.

Superior Controls designed and implemented the entire GMP, validated automation system to control and monitor more than 2500 production process values with Alkermes and PFI personnel. The networked system is based on Allen Bradley PLCs and RSView SE software technology and includes six Superior Controls-designed control enclosures and four industrial operator interfaces. Redundant servers collect and store GMP data in compliance with 21CFR Part 11 (FDA Electronic Record Requirements) from 12 separate skids and support systems.

The system is Web enabled allowing real-time graphics, reports, and alarms to be monitored from Alkermes' Cambridge, Chelsea, and Ohio sites through their wide area network. The entire project was implemented by Superior Controls, Alkermes, and PFI personnel in less than ten months. Superior Controls engineers also assisted with the IQ and OQ validation tasks.