PROJECT OBJECTIVES
• Reduce installation costs and startup risks during construction of new biotechnology facility
• Manage critical device configurations that have a direct impact on plant efficiency and product quality
• Reduce lifecycle device management costs
SOLUTION
• Integrate HART Communication with distributed control system (DCS)
• Install HART‐enabled instrumentation and products throughout facility
RESULTS
• Mitigated risks
• Eliminated addressing, network‐sizing, special communication requirements
• No learning curve
• Enhanced view of instruments
• Remote device setup and configuration
• Online configuration‐management database
• Regulatory compliance protection
Biotechnology manufacturer Genentech Inc. (San Francisco) is integrating HART Communication with the distributed control system (DCS) in its CCP2 facility in Vacaville, California, to manage critical device configurations that have a direct impact on plant efficiency and product quality. Genentech chose HART technology because of its cost‐effectiveness, availability, reliability, ease‐of‐use and flexibility.
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“You can use HART to implement all the high‐value functions of other bus technologies, but at a fraction of their cost, by using infrastructure that you probably already have in your plant today,” says Kevin Kerls, a senior automation engineer in Genentech’s automation group. Kerls is helping automate the Vacaville facility, which is currently under construction and is expected to produce 200,000 liters of oncology pharmaceuticals by 2009.
Biotech’s Digital‐Analog Future
Genentech is implementing HART technology with 15% of the I/O in the Vacaville facility. “There are a lot of instrumentation manufacturers that offer HART‐compatible products. That availability plus a huge installed base makes HART a proven technology,” says Kerls.
“This is technology that’s going to continue to be supported and developed. It uses the same 4‐20mA wiring you’d use in traditional I/O, so there’s no steep learning curve.” He emphasizes this means reduced installation costs and reduced risks during startup.
Kerls adds that the simultaneous analog and digital communication capability of the HART Protocol is a key attribute. “We’re able to implement HART over simple 4‐20mA twisted‐pair signal cable, a proven and simple installation method,” he says. “There are no addressing schemes, network‐sizing concerns, or special communication requirements to deal with.”
And because the protocol uses standard signal cabling methods, there’s no learning curve for installers either, he adds. “Since HART is so widely used already, there’s a very small learning curve for maintenance technicians.”
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Genentech reports it also chose HART Communication because its installed instruments are HART‐
enabled. “So, we need no new infrastructure other than a new database server. The information is seamlessly integrated throughout the I/O, the DCS controller, and the process data server,” Kerls says. In explains. Genentech chose HART Communication because other buses had design issues, which are different from HART and its 4‐20mA capability. “So it takes more time to get other buses operable. We really felt that we get the majority of the benefit via HART,” he adds.
Number one on Kerls’ list of HART benefits is an enhanced view of the instruments. “This includes status, alarming information, and remote configuration.”
Genentech also values the remote capabilities of HART technology. “The biggest bang for the buck is remote configuration and remote monitoring. HART won out over all the other buses,” Kerls asserts.
“Because HART provides remote capabilities, installation simplicity, and met our requirements, it easily beat the other buses.”
Remote device setup and configuration is essential because it allows Genentech to easily backup instrument configurations using a central database. The firm also can make changes to instrument configurations from a controlled database compliant with 21 CFR Part 11—Title 21 Code of U.S. Federal Regulations Part 11: Electronic Records; Electronic Signatures from the U.S. Food and Drug Administration. Kerls says this was possible without relying on handheld devices or a technician’s handwritten notes.
Overall Configuration Crucial
Central configuration management is another area where Genentech will use the HART protocol in their new facility. The company will use a database to capture, view, verify, test, and backup instrument configurations for more than 1,125 instruments during the startup of CCP2.
“The HART protocol with its online configuration‐management database eliminates the need for a time‐
consuming paper process,” says Kerls. “It probably saves an hour off each calibration which basically is a
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half a person‐year saved under normal operations. In initial documentation of parameters and startup, this may also save 3,000 hours. These are very conservative estimates.”
Compared to traditional I/O, Genentech can use HART Communication to diagnose an instrument just by opening a view, rather than sending someone out to the device’s location. “If anything goes wrong with that device, it’ll notify the operator though a DCS alarm,” he adds.
Genentech reports that HART‐associated work at CCP2 is enabling more efficient management of instrument configuration. “Once we get this up and running, part of corporate automation engineering’s role is to disseminate information about the project throughout the corporation,” says Kerls “This also means educating our maintenance group on our systems’ capabilities and developing efficient processes to leverage HART‐enabled technology.”
Another benefit provided by HART technology at this facility includes building the corporation’s instrument configuration‐and‐calibration Standard Operating Procedures (SOP) on how to use the protocol and Genentech’s configuration management database.
local automation engineering group—to use them, then the corporation never gets the full benefit.”
“We’ll continue to minimize the time required to perform configurations and calibrations,” Kerls emphasizes. “You can put these technologies in, but if you aren’t educating your lifecycle group—
maintenance and the
Benefits may be limited by not partnering with maintenance and local automation engineering on the front and back ends of a project. “You may provide a solution based on incorrect assumptions and it may not meet their business criteria,” says Kerls. “And, if you don’t partner with them on the back end of the project, the SOPs won’t be developed with HART technology in mind.”
Compliance Protects Doses
Diagnostics. Maintenance. Regulatory compliance. SOPs exist for them. All are taken seriously at CCP2, and HART technology plays a crucial role here, too.
“Our HART devices are installed as part of an 8,500‐I/O DCS. Any device errors or alarms will automatically be available to the operators/technicians,” explains Kerls. HART Communication allows Genentech’s staff to receive device‐specific alarm values, which reduces troubleshooting time, though they don’t know how much yet.
“On a new plant, we don’t really know what the issues will be,” Kerls says. “But we expect that we’ll find them quicker.” Faster problem identification goes directly to the bottom line.
In addition, the HART protocol helps CCP2’s service department minimize the time required for troubleshooting and calibrations. This is because all configuration parameters historically were noted by hand and often were misplaced, lost, or simply incorrect, Kerls adds. “Our HART implementation will ensure that the current configuration is always correctly backed up.”
And, if an instrument needs replacement, HART also simplifies this process. “We simply need to download the backed up configuration for the old instrument from our HART configuration management database. These configuration parameters then upload to the new device directly through the analog I/O card without special connections,” says Kerls. “Being able to effectively manage our instrument configurations reduces our regulatory risk and our risk to product.”
Risk to product involves reduced efficiency, which usually means producing less and producing poorer quality. “If a critical instrument is involved and you can’t prove you had adequate control over properly configured devices, it could lead to regulatory action and/or a recall of the entire batch,” says Kerls.
“More than likely, however, you’d have offline analytical measurements to monitor the batch so you might not lose the batch, but you might spend a lot of time defending it.”