Manufacturing Facility Expansion

A pharmaceutical manufacturer expanded their Baltimore facility by constructing a new building to house a process suite for one of their new products. The installed process equipment consisted of nine solution preparation tanks, six coating pans, air handling system, and all associated mechanical, electrical, instrumentation and controls.  The processing area had a hazardous area classification of Class 1, Div 1 and was designed to comply with FDA GMP standards. The new control system consisted of an Allen Bradley PLC and associated I/O, eight PanelView Plus operator terminals and one master Operator Workstation running Wonderare Intouch. All devices communicated via Ethernet.

TAI provided the control system design, complete instrumentation specifications, control system installation drawings, all PLC and HMI programming, and control system commissioning and startup services. TAI also developed control system related validation documents and the training manual for the project.

• Developed the Control System panel design drawings, submitted them to a local panel shop and supervised the construction of the system.
• Developed the Instrument Data Sheets for all process instrumentation, solicited quotations from vendors and prepared all Instrumentation purchase orders.
• Developed the Instrumentation and Control system installation drawing package for the electrical contractor.
• Programmed the PLC and developed the HMI graphics for the eight PanelView plus terminals and the main Operator Workstation.
• Developed a PLC based recipe handling system and all Production Reports.
• Supervised the electrical installation and directed the control system commissioning and startup activities.
• Prepared the required validation documents including the Computer System Design Specification (CSDS), the Software Design Specification (SDS), the Factory Acceptance Test document (FAT), the Installation and Operation Qualification Document (IQ/OQ), and a System Training Manual.