The pharmaceutical industry is one of the largest industries in the world, and over 45 percent of the global market is held by the United States, according to Statista. Pharmaceutical companies play a huge role in the lives of individuals everywhere. Many people have a negative view of the pharmaceutical industry, but the fact is, pharmaceutical companies have worked diligently to develop life-saving drugs. They have made people live longer, more fulfilling lives. European citizens, for example, are now able to live 30 years longer than they did a hundred years ago.
Pharmaceutical plants are not without their challenges, however. There are regulations that must be followed, there are economic pressures, costs are accelerating, and technology is advancing rapidly, which means a pharmaceutical plant must always be adapting and evolving. Given all of these obstacles, it can be difficult for a pharmaceutical plant to stay competitive.
GOOD MANUFACTURING PRACTICES (GMP) MUST BE FOLLOWED AT ALL TIMES IN A PHARMACEUTICAL PLANT. IF THEY ARE NOT, IT CAN RESULT IN TRAGEDY.
There are many influences in the industry that demand higher quality, more efficient practices, greater industry collaboration, and superior manufacturing design. But as a pharmaceutical manufacturing facility advances, in order to stay competitive and cost efficient, attention must be paid to the maintenance performance.
While often overlooked, maintenance performance is crucial in many industries, but it is especially important for a pharmaceutical manufacturing plant. One of the most important things to avoid in a pharma plant is contamination, which can easily occur if old equipment isn’t maintained properly.
Good Manufacturing Practices (GMP) must be followed at all times in a pharmaceutical plant. If they are not, it can result in tragedy. An example of this would be the outbreak of fungal meningitis in the United States in 2012 when a compounding pharmacy distributed contaminated vials to medical facilities in 23 different states. This led to 48 deaths and 720 patients that required treatment for fungal infections.
To avoid such tragedies, effective cleaning and maintenance tasks must be performed. Whenever there is new equipment, maintenance procedures must be updated, and both cleaning and maintenance protocols must be followed strictly.
In addition to causing tragic contamination, improper maintenance can lead to unexpected downtime, which can cost a pharmaceutical plant quite a bit. Downtime is a problem that affects many different companies across a number of industries. The average manufacturer faces 800 hours of downtime annually. In the automotive industry, for example, this can cost (on average) $22,000 per minute of downtime. In the manufacturing field in general, IndustryWeek reports that unplanned downtime costs businesses $50 billion annually.
With unplanned downtime, there will of course be a loss of productivity, which can lead to a loss of customer trust. With pharmaceutical plants, downtime or maintenance performance issues can lead to drug shortages. It has been reported that 23% of drug shortages are caused by manufacturing issues.
One way to prevent downtime and maintenance performance issues is to spend more time on adequate training of maintenance staff. Of all the unscheduled equipment downtime, operator error causes 18% of it, according to Plant Engineering. When staff and contractors are trained properly, it is less likely that there will be detrimental errors and mistakes that can cost hundreds of thousands of dollars.
So what is the key to preventing costly downtime as well as tragic contaminations in pharmaceutical plants? Maintenance performance improvement. One of the most important things that all maintenance departments should implement is working on preventive maintenance. On average, businesses will spend 80% of their time responding to maintenance issues that come up as opposed to preventing them (eMaint). According to Mintek, if a company focuses on preventive maintenance as opposed to reactive maintenance, they can save 12-18%. In addition, preventive maintenance can also decrease machine downtime by 30-50% and increase the life of a machine by 20-40%, according to McKinsey.
Pharmaceutical plants can also improve their maintenance performance in a number of ways:
USING A RISK-BASED APPROACH TO MAINTENANCE
While many pharma plants treat all equipment equally, it’s more effective to classify each piece of equipment according to how much of an impact it has on product quality. It’s helpful to use four categories to assess each piece of equipment: direct impact (equipment that will affect product quality if it fails); indirect impact (equipment that will indirectly affect product quality if it fails); safety impact system (equipment that affects safety if it fails); and no impact (equipment that won’t affect product quality or safety if it fails).
USING COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEMS (CMMS)
A CMMS will typically perform GMP-critical tasks such as assigning Unique Identifying Numbers (UINs) to each piece of equipment, scheduling maintenance activities, and holding records of any maintenance activities. A Plant Maintenance Study from 2016 showed that 51% of manufacturing facilities were using a CMMS, and according to ReliabilityWeb, a CMMS can improve the reliability of your equipment by as much as 35-50%.
UPDATING MAINTENANCE PLANS AS A PART OF A NEW EQUIPMENT INTRODUCTION
While engineers can get excited about new equipment, the maintenance plans should not be overlooked in the excitement.
TRAINING MAINTENANCE STAFF PROPERLY
It’s important to ensure that all maintenance staff and contractors have the appropriate training before entering GMP areas. Documenting maintenance activities - Keep it simple, but document all maintenance activities. Describe the what, when, and how of the company’s maintenance.Considering maintenance when purchasing equipment - Maintenance is often the last thing that is considered when purchasing new equipment, but it should be given weight in these decisions.
The best way to increase maintenance performance is by having a maintenance performance assessment. Having an outside presence in your organization can be incredibly effective when it comes to improving your maintenance performance. With an objective analysis of your maintenance performance, you will get an unbiased view of your processes and systems so you will be able to see where you could improve.
At POWERS, we work with your organization to improve your maintenance performance based on our assessment and analysis of the following aspects of your maintenance operations:
- Organizational climate
- Equipment and tools
- Maintenance staffing
- Work cycle
- Quality control
- Training and growth
- Planning and scheduling
- Maintenance business impact
- Asset analysis
- Management structure
- Parts management
- Change management
- Predictive maintenance
- Preventive maintenance
To learn more about our services, have a look at our maintenance performance page.