GMP #13: Preventive Maintenance in GMP
Authored By: Michael Sassano & Antonio Guedelha
Consistent and reliable pharmaceutical manufacturing depends on many factors, but a critical one is the process equipment. If the process equipment is faulty, the product quality may be at risk, and downtime may be inevitable. This can lead to product contamination and safety risk. Additionally, faulty equipment will impact the production costs, so you must ensure the process equipment is well maintained. Well-run equipment will reduce the time to produce a batch, reduce stops during manufacturing and even eliminate long stops for extreme repairs. The target of maintenance is to run the process equipment at maximum use, avoid unpredictable stops and/or decrease maintenance costs.
Maintenance Strategies (Predictive, Preventive, Corrective)
There are several maintenance strategies. For low-priced equipment like typical pumps, the basic industry standard for average good manufacturing practices (GMP) is sometimes to let the equipment work until it fails and then simply replace it. However, in the pharmaceutical industry and GMP cannabis, maintenance strategies are the preferred method to minimize equipment costs and are divided into three categories:
Under predictive maintenance programs, the operators use advanced techniques with various tools — artificial intelligence (AI), Internet of Things (IoT), Industry 4.0, etc. — to predict equipment faults. This will lead to intervention before a problem occurs or even before a preventive maintenance plan set date may find a problem.
Preventive maintenance programs use the process equipment manufacturer’s recommended intervals and parameters to check the equipment depending on the time of use and historical data that may define different intervention plan timings. Planning will prevent severe faults that can stop the manufacturing equipment for long periods to repair. Faults and equipment errors will always happen, but an excellent preventive maintenance plan will significantly reduce the probability of future occurrences. This is the pharmaceutical industry’s most-used strategy, and the most prominent players invest heavily in predictive systems to supplement preventative roadmaps.
As problems inevitably arise, you must prepare a plan to correct potential issues. All equipment needs a corrective maintenance plan for any occurrence. Sometimes the equipment intervention is done much before required; other times, only after a problem. This leads to several unpredictable stops of your equipment and processes. You must be prepared to work with various elements, from experienced maintenance technicians, web support, virtual reality and equipment supplier maintenance, spare parts and maintenance KPIs.
Experienced Maintenance Technicians are critical for process equipment performance in any manufacturing facility. Their intervention, if well done, leads to higher performance and maximum run times. Less experienced technicians can cause decreased performance by needing many stops and interventions. Sometimes, errors in the equipment intervention are damaged, and malfunctions originate from this cause. And if the technicians’ experience is low, the repairs may take too long and create unnecessary downtimes. Hiring and building a team under the technician requires balancing salary costs with your desired results.
Maintenance with Web Support for your process equipment is becoming a standard in the industry. The more complex equipment uses a Programmable Logic Controller (PLC) and industrial computer to control equipment operation. All new equipment comes with a web connection socket and is ready to connect to a remote computer at the equipment manufacturer. Suppose you have a problem at your facility and the supplier is in another country. In that case, the manufacturer can quickly identify your equipment issues through the established internet connection, and the manufacturer’s technician can access your equipment to understand the problem. They will locate the issue remotely and walk you through the repairs no matter what country you are in.
Virtual Reality (VR) for equipment was developed in the last few years to decrease maintenance technician errors. The technician uses special VR glasses that provide directions and actions to perform while they are looking at the equipment. In some systems, the glasses have a video camera that will identify the screws and parts you need to adjust in real-time and even tell you if you are making a mistake. As an example of such VR, please see this link: https://www.youtube.com/watch?v=E9Ln7Iq1FDc.
Equipment Supplier Maintenance is always preferred during the first year until your staff has gained more knowledge. Like buying a new car, it’s always advisable to have the dealer do repairs in the early years. Generally, one year is included, or you have the option to have the equipment manufacturer work on the equipment for a low cost. For complex equipment, their regular service is needed and highly recommended.
Spare Parts must always be on site when costs permit. It’s important not to forget to stock spare parts of equipment that need consistent replacing. This is usually a list the equipment manufacturer will provide to you based on experience with their equipment.
Maintenance KPIs are indicators that define targets in a new plant. KPIs are based on historical data and must be updated yearly as more data becomes available. Maintenance KPI can be broken down into a few categories that will help improve your maintenance performance: total maintenance cost; maintenance cost versus total equipment value; maintenance cost versus manufacturing cost; maintenance cost versus unit output; maintenance cost versus total sales; mean time between failure; failure frequency; and unscheduled maintenance-related downtime.
Scale According to Plan to Maximize Output
A well-designed and followed maintenance program is critical to your manufacturing facility’s performance and GMP compliance, so control it well. Make sure your technicians are capable and develop solid plans for predictive, preventative, and corrective measures. It is critical to your profitability and maximum outputs to make cost-effective strategies suitable to your size and scale to keep pace with your growth.