In new and existing installations, case studies charting actual implementations show that savings from ISA-88 extend way beyond its original use for batch control systems. At a new Bristol-Myers Squibb Devens, MA, facility, which broke ground May 2, use of standards offers savings in manufacturing operations, makes training easier, and enhances regulatory compliance. The pharmaceutical company explained these anticipated benefits in a May 1 keynote presentation at the World Batch Forum (WBF) 2007 North American Conference, a manufacturing automation standards meeting, held April 30-May 3.

“Easier communication is among the key benefits of using standards,” says Dr. Paul McKenzie, vice president and general manager of LSCC, technical operations, worldwide medicines group, Bristol-Myers Squibb. At the new BMS large-scale multi-product bulk biologics manufacturing facility, still under construction, McKenzie is using ISA-88, ISA-95, and ASTM E55 standards to cut work out of processes, tying together manufacturing and laboratory operations and analysis. McKenzie says phase 1 at the Devens site includes 400 jobs, and a $750,000 investment for six 20,000 L bioreactors, with commercial operation expected by end of 2010.

For pharmaceutical and other manufacturers, use of automation standards provides a basis for change management, quality through consistent recipe management, and qualification management, with one version of the truth, more direct electronic batch records and electronic signatures, and better highlighting of process exceptions.

ISA-88 was originally designed for Batch Control Systems, but is being applied more broadly; ISA-95 is for Control-Enterprise Integration; and E55, from ASTM Committee E55 on Pharmaceutical Application of Process Analytical Technology (PAT), provides a “new thought path for validation,” according to McKenzie.

E55 separates validated patient-related processes and products from other requirements. “At end of day, we need to focus validation on patient related processes and do good engineering practices on the rest,” McKenzie says. Generally, he says, pharmaceutical firms have a paper-driven challenge. They need to move from:

• A documentation focus to a data focus;
• Having standard operating procedures (SOPs) to understanding critical process parameters; and,
• Following SOPs to measuring process capabilities.

Use of standards at BMS, especially with new automated laboratory and analytical services will help eliminate “sneaker net,” reduce phone calls, and ensure automated setup prior to sample arrival. While research people may see ISA-88 as limiting, its use means better data mining, analytics and modeling tools, and better management of parameters.

With use of lots of specialized equipment, drug development laboratories often appear as a separate organization from manufacturing operations, even within the same company. “The analytical space can have a lot of expensive equipment divorced from what’s going on in the rest of the facility, generally creating an IT nightmare,” McKenzie says.

In pharmaceutical facilities, McKenzie says, close to $1 billion have been spent on enterprise resource planning (ERP) and supply chain investments. In contrast investments in plant floor and laboratory automation, which could help ERP software work more effectively, have been under funded, in his view.

Plant floor has a lot to teach labs, he suggests; “Rather than go to the fifth decimal point on plant floor, I’d rather go to the first decimal point in the lab.” Shared software libraries and common interface expectations also would help a lot.

www.bms.com, www.wbf.org