Outsourcing control system integration makes sense
Data tracking mandatory for medical manufacturer
There is also a continuing and still-accelerating trend in manufacturing to implement data tracking software like Historian or MES software to track productivity, materials, waste and machine downtime. Incremental process improvements are tied to the quality of the data that can be obtained from elements within the manufacturing process. In an industry that is carefully tracking capital expenditures and measuring return on investments, this type of software improves predictability, efficiency and control over a production line.
A Fortune 100 medical manufacturer contracted ASG to do just that. Their production process includes applying a special coating to a substrate. Processes at the facility include formulation (batch processing), coating (continuous web processing), slitting and chopping (packaging). According to the scope of work, the entire process had to comply with FDA 21CFR Part 11 regulations so that any and all records could be stored electronically regardless of which product was being produced at the facility. This type of paperless traceability is highly regulated. Previous records had been stored electronically on disparate systems provided by the various equipment OEMs; however this facility upgrade was needed to comply with revised FDA regulations and current good manufacturing practices (cGMP).
The decision was made to outsource. The existing engineering and operations staff simply didn’t have the bandwidth or the expertise to do their own work and take on this year long project simultaneously, and since it was likely that limited process improvements would be made once production was restarted, hiring additional staff was not a desirable solution.
System integrator ASG was able to leverage a combination of off-the-shelf GE Intelligent Platforms software along with custom software development to meet the project’s challenges and requirements. The ultimate goal was to integrate a server-based system to support the needs of production, quality systems and engineering personnel.
The system comprised a high-availability computing environment with three servers. One is dedicated to a 3,500 tag GE Proficy Historian, the second is an unlimited tag GE Proficy iFIX SCADA, and the third a Proficy Real-Time Information Portal Server.
Working as a coordinated project team, the system integrator and the manufacturer implemented a progressive action plan to replace the disparate data collection systems (that were the result of several different OEM installations over time) by translating all old historical files to an updated usable format.
Specifically in the coating area there was an outdated Westinghouse distributed control system (DCS) that had been in place since the late 1970’s. The DCS’s data historian used a format that was not compliant with contemporary data collection historians (such as the OPC-compliant GE Proficy Historian.) To add to that, the old historian could not be modified to meet the regulatory requirements of 21 CFR Part 11. ASG reverse engineered the WDPF historian file formats, migrated the historical data and provided a connection to the Proficy Historian server. It was imperative that seven years of contiguous historical data be available to comply with 21 CFR Part 11.
Additional actions that were implemented over the year by the joint project team included:
- Providing modifications to an existing SCADA, connection to the Proficy Historian, and a new National Instruments LabVIEW front end for high-speed data acquisition requirements on a slitter.
- Upgrading a winder system to provide connection to the Proficy Historian.
- A coating area machine that utilized a VAX VMS based recipe management system was upgraded to include a solution built around Microsoft SQL Server and a Visual C# GUI interface. Of particular importance was the manufacturer’s desire to have the recipe management system look as similar to the older VAX system as possible to make the re-education of the floor personnel as seamless as possible.
- An Invensys Wonderware node with its own internal proprietary historical format was converted to the GE Proficy Historian. The system in the formulation area communicates with 10 Allen-Bradley PLCs.
- Lastly, ASG upgraded the GE Proficy iFIX and Real-Time Information Portal Servers to take advantage of advanced new redundancy features of the latest versions of the software. The iFIX SCADA server now consists of redundant primary and secondary servers. The data were tightly synchronized between the two servers such that if the primary server had a failure, the secondary server would continue to run with no interruptions to the control or data collection process. This provided a high degree of fault tolerance and was designed to allow critical systems to continue running without loss of data. Additionally, this system now communicates to an off-the-shelf hardware/software solution from Emerson Process Management (Ovation Distributed Control System) to replace the obsolescent Westinghouse-distributed control hardware and software.
Kim Grant is business development manager at Applied Sciences Group. ASG is a member of the Control System Integrators Association. For more information about ASG, visit www.asgrp.com. To learn about the Control System Integrators Association, visit www.controlsys.org.
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