Maintaining pharmaceutical manufacturing facilities (Part 1): Finding the sweet spot

September 18, 2019 Doyle Johnson

Over-maintaining a facility offers maximum reliability. Under-maintaining it yields long-term reliability issues. Can you meet halfway?

 

Owners and managers of pharmaceutical manufacturing properties have always faced challenges in keeping facilities current amidst evolving industry standards, manufacturing and product technologies, and regulations. But the pace of facility depreciation has heightened in recent years due to:

  • Products shifting away from small-molecule treatment toward biological products, those that treat rare diseases, or (even more recently) personalized immunotherapies.
  • Changes in manufacturing technologies away from large, permanent vessels toward plastic, single-use equipment.
  • Greater use of automation and electronic databases, with faster obsolescence than the simpler, more manual control and data systems they are replacing.
  • Increased emphasis on cost management, which encourages the continued use of and reduced investment in outdated facilities.

Proper maintenance is key to maximizing the value of these facilities. Over-maintaining a facility provides maximum reliability, but it comes with a cost. On the flip side, under-maintaining facilities yields cost savings but long-term reliability problems.

The key is to find that sweet spot where maintenance spending is just enough to prevent major failures but is not wasted on excessive effort. For a facility owner or manager, there are ways to get closer to that maintenance sweet spot.

 

 

The 6:1 ratio for maintenance

John Day, a plant manager at Alumax (later acquired by Alcoa), studied this dilemma in 1997 and found that the ideal ratio of preventive maintenance to corrective maintenance (PM:CM) is 6:1. If you have more PM work requests you are over-maintaining the facility, and if you have fewer PM work requests you are managing more reactive work requests.

CM work is always more expensive than PM work because it is unplanned and frequently takes away from production time, whereas PM work can be planned around the needs of the production plant. CM work also incurs investigation costs (e.g., Why did this failure occur? Was the product impacted? Which batches?) and must be carefully documented in the regulated pharmaceutical environment. The 6:1 ratio was as true at the Alumax plant in 1997 as it is in today’s pharmaceutical plants, if not more so.

It’s important to note, though, that lack of PM does not immediately result in more CM—it takes time for the results to show up as increasing equipment repair needs. This is one reason that we often see under-maintained facilities. The local management can take credit for cost savings in the short term and often move on to other plants before the equipment starts breaking down, leaving a ticking time bomb for the next management group to deal with. This is especially true with facilities that have outsourced their maintenance. Since the motivation for outsourcing maintenance is to reduce costs, the parties involved are driven to do exactly that.

 

 

Consider a typical outsourced maintenance contract. There may be three areas of priority defined in the contract:

  1. The good manufacturing practice (GMP) production and lab areas responsible for producing and testing the pharmaceutical product. The quality of the product is directly impacted by much of the equipment in these areas.
  2. The non-GMP support areas, which contain mostly utilities to support GMP areas. HVAC, electrical panels, and other indirect impact equipment are in these areas.
  3. Amenity areas that have no impact on product quality, such as office and cafeteria spaces.

_q_tweetable:The motivation for outsourcing maintenance is to reduce costs, so the parties involved become motivated to do exactly that._q_A contract is often set up for a three-year period, with a fixed fee, and some allowance for replacement of major equipment items that may fail during the contract period. It is not uncommon to set up the contract to reward performance in each of these three areas in different ways.

In Priority 1 areas, reliability metrics are the key. The supplier may get the maximum bonus if the equipment is available 100% of the time in a given period. Conversely, the supplier may receive the maximum bonus in Priority 3 areas by minimizing the cost of maintenance for those areas, since production is not affected. Priority 2 areas may have some metrics in between these extremes.

What happens in this contractual environment is pretty much what you might expect. With fixed-fee budgets, priority is given to GMP production and lab areas, and as little as possible is spent on amenity areas.

It is interesting to note that these strategies are not in the owner’s best interests and do not result in the optimum maintenance strategy. Having equipment available 100% of the time is sub-optimal because it is not actually needed 100% of the time, and you are likely to overspend on maintenance activities to achieve that goal. It is less expensive to apply just enough PM to avoid excessive CM.

 

 

Identifying the “right” amount of PM

A better approach is to apply the “right” amount of preventive maintenance so that the plant continues to perform at a high level for a longer period. With this in mind, there are three areas I recommend owners consider when shaping their facility management plans:

  • Employee morale: Often overlooked in maintenance plans, the condition of amenity areas can influence product quality by affecting the morale of those working at the plant. When they see dirty offices, unkempt lawns, and potholes in the parking lot, their attitude toward product defects becomes naturally more tolerant.

    Staff are less likely to make improvement suggestions if it appears to them that management does not care. Pride in your workplace is always reflected in lower operating costs and higher product quality.
  • Opportunities for failure: It is also important to identify those items that should not be maintained at all but rather should be run to failure. Few people replace light bulbs when they think they are near the end of their life.

    Light bulbs are replaced when they fail. In a similar vein, some items do not gain performance by being replaced before they fail, and their failure does not impact product quality.
  • Facility age: The age of the facility also presents special considerations. A new plant can “tolerate” less PM since all the equipment is new and requires years of under-maintenance before it will fail. Unfortunately, under-maintenance accelerates depreciation, so the owner is worse off but does not realize it until it is too late.

    An older facility presents more complex problems—it may have been over- or under- maintained, and some equipment may have been replaced when it failed or when new technology was required. For these facilities, it is helpful to have an independent assessment done by a third party (not the staff that works in the plant every day). By doing so, an optimum maintenance plan, combined with a capital plan to replace the most worn-out or outdated equipment, can be implemented.

Pharmaceutical manufacturing plants are expensive to build and expensive to maintain, but their costs pale in comparison to the value of the drug products they produce. Optimum maintenance practices can take full advantage of the value these plants can offer to the enterprise, while avoiding FDA enforcement actions that can add up to penalties and foregone profits that are much more significant than the cost of proper maintenance.

This is the first 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.

About the Author

Doyle Johnson

Doyle Johnson is a principal in our Science & Technology market, working from Boston, Massachusetts. Doyle's team and clients are collectively driven by a passion to care for the patients who are helped by the medicines produced in these advanced facilities.

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