Preventive maintenance in pharmaceutical industry is a maintenance strategy that performs the maintenance according to a fixed schedule.
Maintenance in the pharmaceutical industry, such as preventive maintenance, is a critical area that affects the overall performance of equipment operation, output and product quality. Pharma manufacturers must invest in instruments, tools, and personnel expertise for an effective maintenance strategy.
Among all the maintenance strategies, preventive Maintenance is the most common maintenance strategy throughout the pharmaceutical industry worldwide.
What is Preventive Maintenance in the pharmaceutical industry?
Preventive Maintenance is a type of maintenance performed according to a fixed schedule. It aims to prevent a breakdown in equipment or any components, in the future, by inspecting and detecting any potential faulty part. It allows to remove or rectify the defective equipment component, such as electrical / electronics, mechanical, pneumatic and other related.
Preventive Maintenance is performed when the equipment is in working condition and satisfactorily produces a desired output within the capacity. Preventive Maintenance in the pharmaceutical industry helps to prevent unexpected problems, breakdowns and faults by detecting them in their early stage.
How is Preventive Maintenance in pharmaceutical industry executed?
Since preventive Maintenance is performed on running equipment and taking equipment for Maintenance can disturb the production plan, it is necessary to plan preventive Maintenance before executing it.
Planning for Preventive Maintenance involves some steps, which are listed below
- Preventive Maintenance scheduling
- Preventive maintenance checklist
- Distributing maintenance plan to production personnel and department
- Executing the Maintenance
- Filling out the checklist and signature
Let’s discuss each step briefly
Preventive Maintenance Scheduling
Scheduling for Preventive Maintenance is a critical process for timely executing preventive Maintenance in the pharmaceutical industry. It gives a centralized document for all the relevant departments and, most importantly, provides production personnel with the opportunity to plan their production activities keeping in view the Maintenance.
Preventive Maintenance scheduling is planning the Maintenance of individual equipment and deciding their frequency.
In other words, it is the process of noting down all equipment and then deciding whether the equipment requires preventive Maintenance according to the below-mentioned time
- Every month (Monthly)
- Every after two months ( Bi-monthly)
- Every after three months ( i.e. Quarterly)
- Every after six months (bi-yearly)
- Or once a year ( yearly)
A preventive maintenance schedule is commonly tabular, where all equipment is written in the first row. Each row is mentioned in the following rows to the left, with all the frequencies available at the top.
The schedule for preventive Maintenance also includes the time required for the Maintenance. It gives an idea to the production personnel about how much time the machine will be reserved for maintenance activities and will not be available for production.
For mentioning the frequency of a specific piece of equipment, a row indicating the desired frequency is marked with an appropriate sign. This procedure is continued for the rest of the equipment in the pharma facility.
Preventive Maintenance Checklist
The checklist for preventive maintenance in pharmaceutical industry is the list of tests/checks performed during preventive maintenance. It provides detailed guidelines to maintenance personnel, about how to perform maintenance, and what components/parts of equipment need to be inspected.
It becomes helpful in cases when a new member of the maintenance department is assigned the task of performing preventive maintenance.
A checklist should be prepared to keep the practical experiences in mind and include all the critical parts of equipment. Machine manufacturers also guide what to include in the checklist, which is often mentioned in the maintenance manual.
Format for checklist includes a tabular format, in which all the desired tests are mentioned. There is a checkbox included in front of each test. When a test has been successfully performed, checkbox is checked, indicating a successful completion. Otherwise, it is remain empty.
Distributing maintenance plan to production personnel and department
When the schedule for preventive maintenance is prepared and finalized, it is sent to the production personnel of the concerned department, typically at the start of the year. If the schedule is changed, for example, by adding a new machine or removing a previous one, the schedule is again distributed.
The main aim of schedule distribution is to ensure that.
- All production equipment has been included in the schedule.
- It helps the production department plan their production accordingly so that the machine is available during maintenance without any production loss. This is achieved by completing the production well in advance.
- Any valuable input from production personnel that would help in better execution of preventive maintenance
Executing the maintenance
When the time arrives for the maintenance of a particular piece of equipment, the maintenance department contacts the concerned production representative/supervisor / responsible for handing over the machine. The production personnel keeping in view the production activities, hand over the machine to maintenance personnel.
The maintenance department prepares the resources such as tools, spare parts and oil/grease for preventive maintenance. At the given time, maintenance personnel performs preventive maintenance.
If, during the maintenance, chances are that the preventive activity could take longer than the mentioned time, the maintenance department must inform the production department well in advance. If production approves, the maintenance personnel will take that long time. Otherwise, preventive maintenance for that machine is to be reserved for another time when there is no urgency of production activity.
Filling out the checklist and signature
After the completion of preventive maintenance activity, it is necessary to complete the checklist. The person who has performed the maintenance to complete the checklist is responsible. Documentation is necessary because regulatory and standardization bodies such as the United States FDA and the ISO review this documentation during their routine inspection. Preventive maintenance activity is inspected as a part of maintenance strategies for production equipment.
The maintenance supervisor is responsible for completing the entire documentation, in addition to maintenance activity.
After the checklist has been appropriately filled by maintenance personnel, it must be signed by production personnel and the maintenance supervisor to ensure the correct execution of the activity.