Keeping an older pharmaceutical plant from obsolescence is challenging, but a predictive approach to maintenance and the right modernization can help
In part 1 of this blog series, I touched on the trials and tribulations of reaching that sweet spot for maintenance of pharmaceutical manufacturing facilities. With the pace of facility depreciation increasing in recent years due to factors like greater use of automation and increased emphasis on cost management, proper maintenance has become even more critical in maximizing the value of these facilities. The key is to find that spot where maintenance spending is just enough to prevent major failures but is not wasted on excessive maintenance.
Now, in part 2, I’d like to focus more on older pharmaceutical plants. They are not necessarily bad plants, but with a heightened pace of change in pharmaceutical manufacturing, keeping an old plant from obsolescence is more challenging than ever.
The most important step to slowing the aging process is to recognize that you have an aging facility. There are ways to determine that the facility is aging. For example, trends in quality measures may show increases in deviations, corrective and preventive actions (CAPAs), or audit/inspection observation, either by other firms or by regulatory authorities such as the Food and Drug Administration. Your quality system should already be set up to give you these trends on a regular (usually quarterly) basis. You may also find that your maintenance practices are difficult to fulfill due to lack of available spare parts or increasing repair rates resulting in more downtime and lost production.
However, recognition is often difficult for those who work in the facility. Aging is a very gradual process, and there is no one point where you realize that the facility used to be modern—but is no longer. Therefore, the best way to assess the physical condition of the facility is to bring in a third party. This may be a group from another manufacturing plant within the same company umbrella, or a professional architecture/engineering services firm.
A predictive approach to maintenance
The good news is that once you have realized that your plant is aging, you can slow it down by implementing predictive maintenance practices in place of some preventive maintenance you may already be doing. Predictive maintenance uses physical measurements like noise or vibration to predict when a piece of equipment will break—and enable you to fix it before it breaks.
_q_tweetable:The most important step to slowing the aging process is to recognize that you have an aging facility._q_This approach is far more efficient than using calendar-based predictive maintenance and light years ahead of the old “run it until it breaks” approach to corrective maintenance. It can also extend the life of old equipment by avoiding the need to disassemble and replace certain parts.
Real-time process monitoring can also slow down the aging process as minute changes in process measurements can be corrected before they become major—and require major repair. Such changes can also improve quality and increase the knowledge of the manufacturing process.
It’s also important to stay aware of trends in the industry. As automation evolves, for example, the availability of spare parts can become more of a problem, and software needs to be kept up to date. When software and hardware are not maintained, the plant can age more rapidly and become suddenly obsolete. The good news here is that software updates have become more streamlined in recent years, making this less of a task.
Other methods for slowing the aging process include the use of proper cleaning procedures and materials to avoid damage to plant surfaces and equipment. When these surfaces do become damaged, proper repair can prevent further damage and enable the plant to be maintained in operating condition. But when cheaper or inappropriate parts are used, damage often results. For example, using caulk to make up for replacement parts that do not fit properly is very common in older plants where the owner does not want to spend money for the proper repair. This can result in mold or other types of microbiological contamination down the road—an even costlier problem to fix.
The push for further modernization
Since clean-in-place and water systems are subject to some of the fastest rates of aging, changing the plant to single-use systems can reduce the aging rate. But the difficulty is that single-use systems often require a different layout to accommodate moving equipment around the facility and dealing with disposal of used equipment.
Instead, isolators can be more effective over clean rooms. They can be placed in rooms of lower classification, reducing the need for HVAC of high specification to produce clean room air. Isolators can be replaced as a unit and can also be fitted with robots to further modernize the manufacturing facility.
In short, a program of regular investment that focuses on systems that become obsolescent more quickly, combined with advanced predictive maintenance practices, can actually slow the rate of aging of pharmaceutical production plants and increase the rate of return on capital compared to plants that are allowed to slowly fade into obsolescence.
This is the second in a four-part blog series that will explore best practices for maintaining pharmaceutical manufacturing facilities in light of changing regulations and shifts in product development. For more on this topic, don’t miss Doyle’s presentation on October 30 at the 2019 ISPE Annual Meeting & Expo in Las Vegas.
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