Over recent years, the pharma industry has witnessed increased demand for pharma products, especially biologics and vaccines. The main reason for this surge is the heavy investment in the field of pharma R&D, which is increasing the efficiency and efficacy of existing drugs. It facilitates the discovery of new medicines that can solve modern-day health issues.
The increased demand for pharm drugs calls for extensive arrangements that allow the pharma manufacturer's continuous supply of Pharma products to its user. It can include a number of steps, such as efficient sourcing, an increase in quality testing facilities, and, most importantly, maintenance.
What is equipment maintenance?
Equipment maintenance is a process or activity that keeps equipment in running condition with all of its quality attributes and requirements. The main aim of maintenance is to prevent a breakdown in the equipment and continuously produce the required product, whatever the circumstances.
The equipment maintenance can be done on demand, i.e., when there is a fault or breakdown, or it can be planned for later maintenance. Whatever the form, maybe its main purpose is to keep running the equipment.
Like other industries, maintenance in the pharmaceutical industry is an integral part of business and requires dedicated resources, expertise, and skills.
In addition to the benefits mentioned above, maintenance is also a requirement by regulatory and standardization bodies that must be properly performed and documented and appropriate records be prepared and kept. Because these bodies review these activities during their routine inspection and inspect documentation and records as proof
What are the personal requirements for conducting maintenance?
Maintenance is generally carried out by skilled personnel responsible for dealing with all equipment-related problems. For this purpose, the maintenance personnel must contain qualities that can include but are not limited to the following.
Degree or a diploma
Maintenance personnel must have a college degree or a diploma in their relevant field, such as mechanical, electrical electronics, or refrigeration, from an approved or accredited college and university. They must possess basic theoretical knowledge in understanding equipment systems, working, and applying different troubleshooting techniques.
The experience of maintenance personnel in its field is essential for a successful maintenance activity, and they must be equipped with the necessary technical knowledge to understand machinery repair procedures. Additionally, maintenance personnel must be proficient in understanding and reading various documents, such as diagrams, maintenance procedures, and alarm codes.
Problem-solving is the ability to solve different complex situations and react efficiently. Because during maintenance, a critical problem can occur that requires a high degree of problem-solving techniques. This is in addition to technical expertise, which is developed over a period of time.
Problem-solving skills enables personnel to handle situation beyond their control and concludes a wise decision.
Documentation and record-keeping
Documentation and record keeping are necessary and critical in Pharma equipment maintenance. Because regulatory bodies inspect these records as a part of their regulatory requirement. Additionally, record-keeping helps improve equipment performance by providing historical faults, machine behavior, and working trends.
The maintenance personnel must be able to handle all the documentation and understand how to complete the records. The maintenance department must arrange dedicated resources for documentation, such as storage, personal expertise, and tools.
Types of equipment maintenance
The list discusses some standard maintenance in the pharmaceutical industry.
Corrective maintenance is performed to rectify problems that occur in equipment. In other words, it is performed on demand and when required. The need for corrective maintenance can rise at any time.
Personnel, tools, and other necessary items remain on standby for corrective maintenance.
In the event of a problem or breakdown, the production department requests the maintenance department about the issue, such as the machine, nature of the fault, and time of occurrence, through various means, such as over the telephone, email, or CMMS. The maintenance staff is then deployed to solve the issue.
Depending on the nature of the problem, the maintenance personnel can immediately perform the work. It can also be scheduled for later, for reasons such as the availability of spare parts or the urgency of production.
After completing corrective maintenance, the equipment is handed over to the production department. Production personnel must acknowledge the maintenance and verify satisfactory machine performance. Maintenance personnel records the nature of the problem, work performed, production comments, and acknowledgment.
Preventive maintenance is performed to prevent a breakdown in the machine by checking in advance for any faults, erratic parts, or components. It is performed regularly at a fixed frequency by planning, usually at the start of the calendar year.
Some integral elements of preventive maintenance are described below.
Schedule: it is a preventive maintenance schedule for every piece of equipment in a pharma facility. It determines when a specific piece of equipment will be maintained. Generally, it is a tabular format in which frequency is mentioned for every piece of equipment. Commonly, there are three frequencies for preventive maintenance.
Monthly: if the maintenance of equipment is performed every month
Quarterly: if the maintenance of equipment is performed after every three months
Yearly: if the maintenance of equipment is performed once a year.
The checklist lists checks or tests performed during preventive maintenance on a machine. These are specific guidelines related to the maintenance of a particular equipment by the maintenance personnel. The maintenance department prepares these checklists in response to machine faults, production complaints, and manufacturer recommendations.
How is preventive maintenance executed in a pharma facility?
For typical equipment, preventive maintenance is executed in the following manner.
· The maintenance department prepares or updates the checklist for given equipment.
· The schedule is prepared by the maintenance department and is distributed to the production department at the start of the year to production department for their feedback. Upon receiving feedback and reviewing, the schedule is approved.
· The approved schedule is distributed to all concerned departments so that they can plan their production activities accordingly.
· When a maintenance schedule for a specific equipment arrives, the maintenance personnel performs the activity according to the checklist.
· The checklist is signed by an authorized signatory and is made part of the record.
Predictive maintenance is performed by predicting faults or errors in advance and performing maintenance before the specific component or part becomes faulty. The heart of predictive maintenance is a condition-monitoring sensor that continuously monitors the machine's performance. The sensor indicates performance degradation, which is then used by the software system to observe if the output of the sensor drops below a specific limit or a threshold value.
Some common condition monitoring sensor includes the following.
Thermal imager: an instrument that can detect and measure the heat emitted by an object. For predictive maintenance, it detects overheating in a machine, part, or component, indicating a potential error.
A vibration sensor is used to measure vibration in rotating or moving parts. The standard machine has a specific vibration pattern with changes if there is any problem with the machine. The change in vibration pattern can be detected, which is subsequently related to an occurring fault in the machine.
Oil sensor analyzes oil used in various components, such as the gearbox. It measures and indicates the amount of contamination in oil, which, under abnormal conditions, increases and can be attributed to a potential fault in an attached part or component.
In predictive maintenance, the software system monitors the machine's performance. It consists of various algorithms that continuously monitor the output of condition-monitoring sensors. It can automatically initiate maintenance if the output of condition sensors falls below the threshold value.
The software also contains:
· Additional functions such as historical trends.
· Error details.
· Maintenance history of a particular equipment.
Some tips for effective maintenance in the pharmaceutical industry
Let's discuss some tips for effective maintenance in the pharmaceutical industry.
Use CMMS for your daily maintenance activities.
CMMS is a software system that automates your maintenance activities. It provides an easy interface for the production personnel to lodge complaints for benefits such as preventing difficulties associated with manual paper-based systems and keeping and prioritizing complaints. Its most significant advantage is that it can also generate notifications for a particular maintenance activity and lets maintenance personnel know about the problem related to a specific equipment.
CMMS also provides documentation for maintenance activities, such as complaints and historical records, which can be presented to the regulatory bodies during their routine inspection.
Always train your maintenance staff.
Always train your maintenance staff so that they can perform maintenance in an optimum way. Training can include
· Importance of maintenance in the success of an organization
· Impact of breakdown on production and organization
· Latest maintenance strategies
· latest machine, tools, and accessories
· How to safely perform maintenance
Another major source of training and gaining technical knowledge is by attending seminars conducted by vendors, equipment manufacturers, regulatory bodies and government officials. It is great source of obtaining latest market trends, innovation and research & development going in a particular area.
Use the latest tools and accessories.
Tools and accessories are essential for maintenance personnel, and it is impossible to perform maintenance without them effectively. Using the latest tools and accessories enables maintenance personnel to complete their job efficiently and on time.
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