Strategies for Improving Maintenance in Pharmaceutical Manufacturing Examined

April 27, 2007
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

Interphex2007, New York, NY (Apr. 26)-Maintaining reliable equipment in pharmaceutical manufacturing operations is critical not only for achieving productivity goals and safety, it also is a prerequiste for moving operations to a lean-manufacturing environment.

Interphex2007, New York, NY (Apr. 26) -Maintaining reliable equipment in pharmaceutical manufacturing operations is critical not only for achieving productivity goals and safety, it also is a prerequiste for moving operations to a lean-manufacturing environment. Methods to assess the maintenance programs of pharmaceutical manufacturing operations and strategies for improving was examined by Terry Keown, managing principal, Life Cycle Engineering (Charleston, SC,, in his presentation, “Reliability Excellence: Reducing Redundancy and Mitigating Vulnerability,” at a conference session at Interphex on Thursday.

Keown shared preliminary finding from a study on pharmaceutical manufacturing operations, which revealed certain problematic areas in the maintenance programs of pharmaceutical manufacturers. Some key findings included:

  • 86% did not have accurate asset detail within their computerized maintenance management systems (CMMS).

  • 81% have not reviewed or optimized their preventive maintenance (PM) information within the last five years.

  • 91% relied on their original equipment manufacturers to provide and/or perform PM on their assets.

  • 54% stated they practiced some sort of predictive maintenance (PdM) activity, but 86% stated they did not have sufficient staff or knowledge to conduct PdM activity.

  • 84% reported that it was virtually impossible to get manufacturing equipment routinely scheduled for PM, yet reported that 75% of all PMs were performed on time.

  • 78% reported that they had redundant equipment in place to support operations.

  • 58% reported they did not have a routine system to engage the redundant equipment or to PM the redundant equipment.

The study also revealed problems in inventory management of spare parts, particularly in maintaining the correct inventory. Although 90% of the survey participants reported they had the right level of spare parts on hand, 66% of participants reported that they had an emergency outage in the last 30 days where the appropriate part to repair the issue was not on hand. And 13% reported that they had a maintenance-related outage in the last 90 days.

To address these problems, Keown shared a methodology that his firm uses to assess the reliability of manufacturing operations. The “reliability principles” measure 29 components in five areas: sustainability, optimization, process, culture, and principles. Sustainability components include such elements as PdM, equipment history, and budget and cost control. Optimization components include CMMS, training, work planning and measurement, facilities, and equipment. Examples of process components are work control, scheduling, operator care, procurement, and materials management. Cultural components include such factors as organizational behavior and performance management, and principles evaluate such issues as management commitment.

The utility of applying this diagnostic tool, explained Keown, is to access how a company may improve its maintenance operations as well as provide the needed foundation to implement lean-manufacturing tools. He offered a case study of a pharmaceutical manufacturer that developed a master plan around four distinct work streams: reliability engineering, work control, planning/scheduling, and materials management. The company created focus teams to design and implement the changes in the four work streams across the site.

Some key results were a reduction in work backlogs, external contractor work, maintenance, repair, and operating inventories as well as improvements in completion times for PM. The operational efficiency gained by improving maintenance increased capacity of the plant by 14%, thereby offsetting present year capital requirements by $96 million.

“Reliability can drive you to a reduction in redundancy and mitigate vulnerability,” said Keown. “And once stability is achieved, significant gains can be made in installing Lean tools.”

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