During the 12 years since it was released, the ISA88 standard has helped countless batch manufacturers make their plants more efficient and productive.

Biotechnology company Genentech Inc., of South San Francisco, Calif., for example, saved $4 million by re-using previously developed batch modules. While the implementation of ISA88 required a significant amount of planning, Genentech expects to gain further savings thanks to the ease of making changes and reduced downtime that come with using the standard.

Likewise, Indianapolis-based pharmaceutical maker Eli Lilly & Co. used ISA88 to decrease standard deviations for cycle time and yield by 50 percent. Yields increased by 1 percent to 10 percent, and the company’s plants experienced improved operator efficiency with a more flexible system.

Eastman Chemical Co. provides yet another example. The Kingsport, Tenn.-based firm used ISA88 to take its conformance-to-specification from 96 percent up to 100 percent. Batch cycle times were reduced by 20 percent and production yields rose by 5 percent. Eastman also reduced process development and change time.

ISA88 heritage

  The ISA88 batch control standard was developed by the Instrumentation, Systems and Automation Society. ISA released it in 1995, and the standard was widely adopted in batch manufacturing. Adoption began in the chemical industry and quickly spread to consumer packaged goods (CPG) and pharmaceuticals. In recent years, the principles embodied in ISA88 have been applied to other forms of manufacturing. The semiconductor industry and other discrete manufacturers have used it, and a new version—ISA88.5—is being developed for packaging and other discrete manufacturing.

ISA88 was initially developed specifically for batch processing. “ISA88 has become the de facto standard for any batch process in the last 10 years,” says Bruce Kane, consultant for the Center of Excellence for Batch and Life Sciences, at vendor Honeywell Process Solutions, in Phoenix. “Prior to ISA88, plants used monolithic code. ISA88 allows you to create a structure and framework to build modular systems that offer greater flexibility.”

Using a standard brings coherence to automation. Each time a new recipe is introduced, it comes in the same format that can be re-used. Once validated, the particulars of a recipe may change, but the overall logic of the data is the same. “It helps people organize their thoughts, their code and their configuration, which helps them be more organized overall,” says Ken Keiser, senior product specialist at Siemens Energy and Automation Inc., the Alpharetta, Ga.-based automation supplier. “ISA88 helps manufacturers write object-oriented code with sequences and makes it more flexible. It also helps with validation, so you don’t have to change the whole recipe.”

Benefits abound

 There are a number of benefits in using ISA88, including reduced engineering time, greater flexibility and quicker changeovers. “The modularization creates many benefits—reduced costs of engineering through re-use, easier trouble shooting and easier methods for changing something,” says John Blanchard, principal analyst at ARC Advisory Group Inc., in Dedham, Mass. “You also get easier validation in the life sciences, and that means lower costs.”

Because ISA88 provides a predictable way to manage data, communication with manufacturing and business systems becomes much easier. “Having a set structure on the plant-level automation system will help make integration less messy when you connect to the high-level business systems,” says Steve Murray, principal engineer at controls vendor Emerson Process Management, in Austin, Texas. “Because of its modular structure, ISA88 is coming into play with MES (manufacturing execution systems) and other business systems.”

The ability to re-use data structures also simplifies validation for those industries that need to report to regulatory agencies. “As far as the regulated industries, the modular approach is a benefit for validation of operations and procedures for the FDA (Food and Drug Administration),” says Honeywell’s Kane. “Since you re-use the module, you don’t have to validate all over again.”

While the chemical industry was the first to adopt ISA88 widely, other industries quickly followed. “There was a lot of adoption in the chemical industry, and then it moved into CPG, where we’re seen 70 percent to 80 percent adoption,” says Dennis Brandl, head of BR&L Consulting Inc., of Cary N.C. and chair of the ISA88 committee. “The pharmaceutical and life sciences industries followed quickly.” He notes that some manufacturers gain the benefit of ISA88 because their controls vendors have adopted the standard. “Sometimes they don’t know the control system is based on the ISA88 standard,” says Brandl.

Pharmaceutical and biotech companies turned to ISA88 for help with product development as well as manufacturing. “We’re seeing it in biotech in particular, where they provide ...