There Must Be A Better Weigh

Most pharmaceutical companies have made major inroads in applying advanced control technology to improve their manufacturing processes. However, these efforts often stop abruptly at weigh-and-dispense operations.

The weighing and dispensing of pharmaceutical ingredients may seem mundane, but it's crucial. If a mistake is made at this traditionally manual point in the manufacturing process, no matter what happens later on, the entire batch may need to be thrown out or remade.

Unfortunately, errors can occur when operators write information down or when other employees enter process data into a computer-based system, says Glenn Restivo, life sciences solution marketing manager at Rockwell Automation in Philadelphia. In most cases, a weigh-and-dispense error isn't picked up until after the fact. "By then," he says, "you have a wasted batch."

In modernizing weigh-and-dispense operations, one goal is to drive errors out of the operation, and record data properly and accurately, Restivo says. Another goal is to use data more effectively. "Weigh-and-dispense has become an integral part of a plant's electronic batch record," observes Thomas Farenholtz, director of professional services at Honeywell Life Sciences in Herndon, Va., which offers the popular POMS manufacturing execution system (MES). "Many manufacturers today are seeking to use the data from the weigh-and-dispense operation and extend this automation toward the rest of the plant," he adds.

Although new pharmaceutical plants are typically built with extensive automation and electronic controls, older plants that make established products or commodities still depend largely on manual or semi-manual data collection and record-keeping. "Most companies [use] off-line scales to prepare materials for a batch," says Janice Abel, director of pharmaceutical marketing at Invensys Production Solutions, Foxboro, Mass. "Electronic record-keeping tends to be [seen] as a want, and not a need," adds Robin Laub, account manager at Schneider Electric (Palatine, Ill.), "and record-keeping activity gets put off."

Perceived cost savings often play a key part in this technological lethargy. As profit margins continue to be pressured, managers at leading drug firms are scrutinizing manufacturing costs as they never have before. A recent GlaxoSmithKline survey, for example, found that the 16 largest drug firms spent more than twice as much on manufacturing as they did on R&D.

Some firms resist upgrading because such changes would necessitate a fresh review and approval from regulators. "When you want to make some changes to automate certain functions, you have to revalidate the entire control system," says Mark Liston, pharmaceutical business director at Scneider.

Even the validation of the scales used for weighing materials can be problematic, says Steve Smith, applications support manager at Kistler Morse Co., a Bothell, Wash., manufacturer of weighing systems. "The cost to bring everything up to date may not be worth it to them, because they would have to revalidate the whole process."

However, manual checking, testing, weighing and recordkeeping may end up costing far more than they save, opening the door for monumentally expensive, often preventable human errors. Consider the fact that 354 prescription drugs were recalled last year, a 50% increase from the previous year and more than double 1997's figure, according to the U.S. Food and Drug Administration (FDA). Recalls can cost manufacturers several millions of dollars. In addition, observers say, five to 10 percent of the medicine currently produced in the U.S. falls short of quality or other specifications and has to be thrown out or reprocessed.

Even if companies aren't making weighing or dispensing errors, outmoded equipment can prevent them from utilizing data, or streamlining or automating processes. "Data collection goes hand in hand with analysis---the idea is to turn the data into knowledge to improve your process," says Steve Pulsifer, marketing development manager in the life sciences group at control systems manufacturer GE Fanuc in Northamptom, Mass.

Caught between a Scylla of regulation and a Charybdis of rising manufacturing costs, more drug makers are starting to modernize their weighing and dispensing functions to reduce expenses and ensure better quality control. Instead of developing software in-house, many are evaluating control vendor platforms to improve the speed and accuracy of their weighing and dispensing functions. And many are implementing this automation in phases, says John Blanchard, director of research and principal analyst for the food, beverage, and life sciences industries with the ARC Advisory Group, a manufacturing technology research firm in Dedham, Mass.

"These improvements make good business sense," says Jim Marshall, engineering team leader with Eli Lilly (Indianapolis). "Better data integrity helps the plant with uptime and to run better."

FDA is providing added incentive for modernization as it revamps its manufacturing guidelines. "FDA is putting incentives in place so that pharmaceutical companies can improve the efficiency of their manufacturing operations," says Bob Lenich, business development director at Emerson Life Sciences in Austin, Texas.

Weigh and dispense begins with an operator getting a bill of materials for ingredients that make up a recipe for a batch to be manufactured. Each material must be gathered from a warehouse or other storage area. Then it must be verified as the proper material, carefully weighed, checked again, and finally readied for mixing in the recipe. Sometimes the mixing occurs immediately upon assembly of the various ingredients, and sometimes it occurs later on, with the materials being chosen, weighed, and removed to a staging area in advance.