The Long Arm of S88

PharmaManufacturing.com

Batch automation standards are having an impact far from the control room, changing approaches to plant design, specification, and validation

By Nick Basta, Contributing Editor

Economic pressures and regulatory uncertainties are forcing many drug manufacturers today to operate in “hurry up and wait” mode. “Capital expenditures have to be made as late as possible in the drug-manufacturing process, yet companies must be ready to implement them once drugs meet regulatory approval,” says Lou Pillai, IT team leader at Pfizer, Inc. (New York, N.Y.).

“Process design and specification used to be a somewhat unstructured process; now there’s a language and a methodology that allows everyone involved in design and process control to communicate with each other.”

Modular construction (see Pharmaceutical Manufacturing, September 2004, p. 36) is helping drug makers manage these pressures in new plant construction. But for plant design, specification and validation, standards developed in the process control field are having a far-reaching impact on drug manufacturing. S88 (see sidebar, below), which originated as a way to write control logic for batch processes, has become a preferred route for designing and specifying all the production equipment in a pharmaceutical plant.

The standard, first established in the 1990s by the World Batch Forum under the imprimatur of ISA International (Raleigh, N.C.), began as an approach to process control for batch manufacturing. It has also influenced a broader, parallel program, S95, “Enterprise Control System Integration,” designed to rationalize how information leaves the plant floor and is transferred to enterprise IT systems.

Simple structure, significant benefits

S88 is grounded on three principles:

• Batch functions should be modular sequences of such actions as filling, heating or drying;
  
• The “recipe,” or procedural steps, should be written independently of the equipment in which the actions are performed;
  
• The “logic,” or capabilities, of the equipment should be captured in a data file.

As the requirements of a recipe are matched up with the equipment logic, an overall production process can be specified, and from this, the actual control logic can be coded. Multipurpose plants, with an array of recipes, can be run on differing sets of equipment, and the overall automation system can keep track of it all.

S88’s success in codifying how processes are analyzed has made a big difference in process design and construction. The standard is providing some companies with a foundation for Six Sigma programs, connecting manufacturing execution systems (MES) to ERP and other platforms, and linking batch control with other efforts such as packaging automation. It also promises to help manufacturers deal more effectively with FDA’s electronic recordkeeping requirements under 21 CFR Part 11, and in handling data from process analytical technologies (PAT) programs.

“S88 is playing a key role in how the pharmaceutical industry specifies, designs and builds its facilities,” says Pfizer’s Pillai, head of the education committee of World Batch Forum. “It helps us speed up the process of validating systems; it is key to designing multipurpose plants; it provides ways to approach re-validating or re-purposing process lines.”

“A lot of smart, far-sighted people got this effort going years ago, and we’re enjoying the benefits of it now,” says Dennis Brandl, president of BR&L Consulting (Cary, N.C.), and editor of the S95 standard committee. “Process design and specification used to be a somewhat unstructured process; now there’s a language and a methodology that allows everyone involved in design and process control to communicate with each other.”

Older facilities still tradition-bound

Most current or new capital projects and control system installations use S88 methodology, according to Brandl, and other industry sources agree. However, the industry is tradition-bound when it comes to industrial automation; currently, only 30% of existing pharmaceutical facilities use S88, Brandl notes.

As time goes on, Brandl feels, the standard’s impact will only broaden. S95 is expected to have a similar impact; at this fall’s annual ISA meeting (Houston, Oct. 5-7), Part 3 of the standard was ratified and will now go out to ISA membership for approval.

Because S88 does not specify control methods or communication protocols, the standard was easy for automation vendors to embrace, and several of them have actively participated in its development. And the same principles of modeling processes and procedures of S88 have been carried into S95. Today, most of the leading automation vendors serving the pharmaceutical industry have control-design software or related IT tools to help clients specify and code their control systems by S88/S95 standards:

• Rockwell Software (Milwaukee, Wis.) employs S88 methods in RSBatch, for developing control programs, and RSView, its human-machine interface (HMI) software for displaying production activities. Without S88, the company says, writing batch code for its programmable-logic controllers can consume 50-60% of an automation project’s time; S88-based software allows this time to be cut to 15%.
  
• Honeywell (Phoenix, Ariz.) offers its POMS manufacturing execution software with S95 compliant features.
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