Pharma expo puts stress on performance, security, and compliance
by Staff -- Manufacturing Business Technology, 7/1/2005 12:00:00 AM
Interphex 2005, a pharmaceutical conference and exposition held in New York in late April, showcased solutions and strategies for three top-of-mind issues that resonate across this and other sectors of the manufacturing industry.
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Improve production performance to reduce costs;
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Achieve security efficiencies; and
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Enact regulatory compliance processes.
Production strategies
While the manufacturing industry in general attempts to embrace lean to improve production processes, the pharma industry itself finally appears poised to embrace demand-flow technology, or DFT, an offshoot of lean.
According to JCIT International—a DFT consultancy previously acquired by PeopleSoft and now part of Oracle— DFT uses math-based tools to realize production processes that are balanced and flexible. Material replenishment systems are designed for flexibility, and seek to reduce overhead and enable early visibility to shortages.
JCIT is launching DFT seminars for pharmaceutical makers following the consultant's work with one Fortune 500 company that reportedly freed $600 million in working capital over four years, and reduced cycle time from 53 to 18 days.
"There are unique challenges to demand flow in pharmaceuticals," says Bill Swisher, a JCIT VP, citing lengthy batch runs that can extend lead times to weeks or even months, thereby inhibiting responsiveness in demand-driven production. Companies must still build to forecast, "but demand-flow technology reduces the horizon of the forecast," Swisher adds.
Boosting IT cost-efficiency performance is the focus of server consolidation services provider Court Square. Because of strict regulatory requirements for system validation, pharmaceutical companies often take the approach of "once it's validated, don't touch it," says Keith Parent, CEO. "This has resulted in huge server farms, where individual servers are running at only 20-percent efficiency. If you had a manufacturing line at that rate, you'd close it down."
Court Square has developed a disciplined methodology it calls GSP—for good system practice—that can achieve server consolidation rates as high as 15 to 1, boosting efficiency and dramatically reducing data-center floor space that can cost as much as $1,000 per square foot.
To streamline plant reporting, industrial automation vendor ICONICS, which offers Web-enabled visualization software for manufacturing, says its BizViz data visualization tool for the pharmaceutical industry now enables integration, consolidation, dashboard display and reporting from disparate systems based on Microsoft's SharePoint Portal and .NET technology.
Compliance begets security
Rockwell Automation says its RSBizWare Batch software now supports electronic signature processes with enhanced functionality. To streamline setup and maintenance of such signatures, RSBizWare Batch offers signature templates for predefining the number and purpose of sign-offs, and the required authority. RSBizWare Batch also supports configurable signatures for both automatic and manual operations, which is key for regulatory compliance and data security.
Claiming an industry first in virus protection for the production environment, Foxboro Automation, a business unit of Invensys, is shipping all new I/A Series Workstations for Windows with pre-installed McAfee VirusScan Enterprise software. "Factory installation is critical, because potential vulnerability to computer viruses begins the minute the system is started and connected to a network," says Ernie Rakaczky, director of process control system security, Invensys Process Systems.
Issues related to product labeling in the pharmaceutical process make it a critical step calling for close consideration of any unforeseen circumstances. Now, Innovatum says it has what it calls the first "enterprise-class labeling system," in that it employs a template-based system integrated directly with the production process.
"If you have a manual labeling process, errors are going to happen," says Ardi Batmanghelidj, president. "Labeling problems are the single-largest cause of returns."
Innovatum's ROBAR Enterprise Label Management System can be integrated with ERP to print labels that are applied directly in the manufacturing process. Bar code- and RFID/EPC-enabled, the vendor says for one user, the template format reduced the number of labels it maintains from 4,000 templates down to 100.
