Implementation of an FDA-Compliant Process Control System
E Tech Group’s process control solutions included a manufacturing execution system for FDA-compliant data collection and reporting, as well as a building management system and other vendor-supplied control systems.
E Tech Group implemented a $1.8M process control system (PCS) for the Massachusetts Biologic Laboratories (MBL) state-of-the-art facility in Mattapan, MA. The MBL facility performs cell culture and purification of monoclonal antibodies (MAb) and filling of licensed and R&D stage liquid parenteral (injectable) products that cannot be terminally sterilized. The monoclonal antibody production centers around cell culture and purification.
E Tech Group installed a PLC- and SCADA-based PCS system utilizing redundant Allen-Bradley ControlLogix 5550 processors with 1756 series I/O, 1794 Flex Series I/O, Festo solenoid blocks, and Mettler Toledo scale indicators. The I/O is distributed between 13 control panels which are interconnected with DeviceNet and ControlNet I/O networks. The PCS communicates approximately 400 data points over Ethernet to the various equipment vendor-supplied systems.
The PCS consists of a SCADA/Historian fault-tolerant server, manufacturing execution system (MES) fault tolerant server, web reporting server, 11 portable client workstations, 7 fixed client workstations, and 2 engineering workstations. The 11 portable workstations contain wireless Ethernet capability and are mounted on a portable cart with an onboard battery and barcode scanner.
The following software packages were used as part of the PCS system:
- SCADA – GE/Proficy iFix
- Historian – GE/Proficy Historian
- Data Analysis – GE/Proficy Real Time Information Portal
- Reporting – Crystal Reports
- Manufacturing Execution System – Elan XFP, Oracle database
- Alarm/Event Storage – SQL Server
The following equipment is located in the MAb production area:
- Buffer preparation tank
- Portable pH adjustment tank
- 55L, 500L, and 2500L bioreactors
- Portable Q-eluate tank
- Harvest tank
- Portable nanofiltration tank
- Chromatography skid
- Final bulk tank
- Ultrafiltration / diafiltration skid
- Fill / finish production
- Vial washer, parts washer, and autoclave
- Depyrogenation tunnel and filling line
- Labeling and packaging equipment
The following utility systems are located in the MPL Mattapan Facility:
- Water for injection (WFI) pre-treatment / soft water generation
- Acid day tank
- WFI still, and hot WFI storage tank
- Caustic day tank
- Compressed air generation
- Clean in place (CIP) skid
- Chilled process glycol generation
- Clean steam generation
- Hot process glycol generation and distribution
Our engineers implemented a PCS to control process and cleaning steps for the buffer preparation tank, harvest tank, pH adjustment tank, Q-eluate tank, and nanofiltration tank through hardwired I/O. The PCS coordinates CIP operations with the CIP skid, controls CIP and WFI distribution, and interfaces with the various equipment vendor-supplied systems over Ethernet. The PCS stores alarms and process data from the skids and hardwired I/O.
The PCS provides a MES that includes material tracking, equipment management, barcode recognition and creation, and electronic work instructions (EWI) for execution of process steps in the MBL facility. Operators use barcode scanners to verify and record raw materials, semi-finished goods, finished goods, and equipment that is created and/or used in the MBL facility.
The system also consists of a number of equipment vendor-supplied control systems and a building management system (BMS). The PCS provides supervisory control and data acquisition (SCADA), batch execution, electronic work instructions, material tracking, equipment management, barcode recognition and creation, historical data collection, and reporting. All data collection is in accordance with 21 CFR Part 11.