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Alpha-Beta Technology, Inc. was established in 1988 to develop healthcare products based on complex sugars, called carbohydrate polymers. Realizing the need for large-scale production-level manufacturing capabilities, it planned the construction of its first commercial-scale manufacturing facility in Smithfield, RI.

The Alpha-Beta Technology project team faced the following challenges:

* Construct and operate a 50,000 square foot facility that would meet all the current good manufacturing processes (cGMP) and withstand the strict validation challenge of Federal Regulations concerning the production of drug products.

* Fully utilize available technology to connect all building and manufacturing facility environmental equipment on to one network in order to maintain operational efficiency and keep staff numbers to a minimum.

* Meet required parameters for control of pressure relationships, temperature, and humidity between clean rooms.

To meet these challenges, the team selected the following solutions:

* Install a Johnson Controls Metasys Facility Management System (FMS) that provides record-keeping capabilities to track all day-to-day activity, plus any occurrences out of the norm.

* Use the Metasys Integrator to connect together the Metasys temperature control system, York Rotary Screw CodePak chillers, IFC 2020 Fire Alarm System, IAC 600 Card Access System, and Phoenix fume hoods and room pressurization controls to ensure maximum operating efficiency.

* Negotiate a Planned Service Agreement with Johnson Controls to provide preventive maintenance of the HVAC controls, chiller, fire, and security systems.

Results were as follows:

* With the integrated facility management system, Alpha-Beta Technology is able to react to any variations from the norm and produce detailed reports to support validation requirements.

* Staff requirements and additional training are reduced by relying on the Planned Service Agreement for continual support from Johnson Controls.

"Because of the extremely good luck I had with Johnson Controls in the past, I had the faith to convince Alpha-Beta of what equipment we needed to install to make this environment run successfully," says Dick Auger, corporate facilities manager. "This included integrating the Metasys Facility Management System from Johnson Controls with Phoenix fume hoods and room pressurization controls, York chillers, and the security and fire alarm systems.

"We have relied heavily on the open architecture Metasys provides in order to successfully operate this uniquely demanding facility. For example, with Metasys we are able to program the fire alarm devices so the fans don't immediately shut off in the event of an alarm. Only if two devices are activated in the same area will the fans shut down," explains Auger. "This flexibility helps eliminate unnecessary disruptions to the production of our products."

According to Auger, the HVAC control system is the most critical part of the Metasys Network. "It must maintain temperatures, humidity, and pressure relationships between clean rooms to ensure an FDA validatable environment," he explains. "Should the controls system fail, there is a risk of contaminated air being infiltrated into classified areas which could lead to a serious loss of product."

The fire alarm system, like the access system, is fully integrated into the Metasys Network. This system was purchased for its unique ability to annunciate a specific device that has gone into alarm, as well as its ability to be integrated onto the Facility Management Network.

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