Equipment upgradation is a process of adding new features, removing current constraints & hazards, and improving equipment productivity through structured planning and dedicated tools. Its main aim is to help the owner in achieving quality products and market requirements more than as compared to the existing. It also focuses on increased regulatory regulations compliance.

An organization's maintenance department is typically responsible for upgrading existing equipment through internal or external resources. If a minor upgrade is required, it is normally carried out in-house with internal resources.

On the other hand, if upgradation is significant and requires considerable alteration, the equipment is sent to an external contractor. The maintenance department is responsible for executing the upgrade including the follow-up upgrade activities and final assessment before shifting equipment back to the pharma manufacturer's premises.

After upgradation, equipment is installed in the desired production area under the supervision of the maintenance department. After a trial run, the quality department performs its validation and allows the production department to start production if it passes the validation.

Why equipment upgradation

Given the heavy production load and strict marketing schedules, upgrading equipment in a competitive industry like Pharmaceutical is difficult. However, to compete with market challenges, the decision-makers have to do this. 

Some reasons that compel pharma manufacturers to upgrade their equipment include the following:

Incorporating new technology

Like every industry, pharma equipment manufacturers invest in upgrading their equipment and systems to compete with other equipment manufacturers, improve their equipment's efficiency, and increase productivity. 

Pharma manufacturers can't frequently purchase new machines to incorporate new technology. Instead, they go for upgrading their existing machine with external contractors.

An example is replacing manual inspection with a machine vision system on blister machines or adding a stepper motor to filling machines to increase filling accuracy.

Incorporating new technology could be a result of many feedback, consistent problem in a process or increased sales requirements.

The existing system is continuously malfunctioning.

In some instances, the system deployed by the machine manufacturer continuously malfunctions and does not produce the desired results. It can be due to many reasons, such as incompatibility with the product. For example, if a manufacturer-made vision system faces problems while detecting tablets in blister packing. 

In this scenario, upgrading an entire problematic machine or a portion of the system is beneficial. It will help mitigate the problem and provide the optimum performance for the machine purchased.

Increased Productivity

Increasing productivity is one of many reasons for upgrading pharma equipment. When a pharma manufacturer opts to expand its product portfolio, arranging process equipment is necessary. The same applies when the pharma manufacturer increases its product batch size in response to increased market demands. 

Upgrading equipment automates the existing process that previously involved humans, thereby increasing the processing speed. Upgrading also replaces the slow and legacy system that takes less time to perform a task. Technological upgrades also enhance the impact of existing automation, making the process error-free and reliable. 

The factors mentioned above, and much more alike, increase total productivity, enabling pharma manufacturers to produce less in more time.

Unavailability of Spare Parts

Spare parts play a vital role in recovering equipment during breakdown and provide machine users with a way to enhance their life and performance. 

In some cases, spare parts can only be supplied by the machine's manufacturer, especially proprietary parts that require high precision. The machine user is bound to purchase spare parts from the machine manufacturers. However, it can become complicated when the machine manufacturer discontinues these spare parts.

When spare parts are unavailable, upgrading the existing machine is the only option to keep running the machine. Replacing old (spare) parts with new ones also guarantees the increased time period during which spare parts can be made available, with continual support from the machine manufacturer.

How to follow a structured approach towards the machine upgradation process

Upgrading equipment in the pharmaceutical industry should be followed by a structured procedure to cater to the requirements for quality, production, and product. 

Let's discuss a possible design for this approach.

Planning 

Planning is the first stage in equipment upgrading process. It requires detailed work on the machine upgrading and answers questions such as why, what, when, and how.

The main objective behind machine upgradation is determined in this stage, which involves many dimensions. 

Reason - In this stage, the reason for equipment upgrade is defined, because since uprdatio2n activity is time- and money-consuming, proper reasoning helps to get approval from higher management. The reason can be defined w.r.to different sources, such as 

• Production department: feedback about the machine's difficulties and breakdown in completing the production plans

• Quality department: feedback about the machine's ability to produce quality products and the level of rejection in an entire batch

• Maintenance department: the ability of equipment to operate with minimal breakdowns and the spare parts availability of existing machine

Best Time - During planning, it is also decided what the best time to perform the upgrades is. Because, the machine will have no productivity, and the organization has to rely on the stored product to fulfil market demands. 

The best time would be when the production department produces enough batches of the product not to disturb the existing product supply line. Another time can be in days of minimum requirements due to off-season

What to Upgrade - It includes the scope of work during the upgrade process, i.e., whether the entire machine will be updated or a part of it. 

Risk assessment can also identify, document, and quantify the upgradation level activity.

External Contractor vs Internal Resources

An internal or external team can perform the upgrade process, depending on the scope of work, capabilities, and the available time.

Internal Team

In most cases, the internal team has fewer capabilities regarding tools, personnel expertise, and spare parts availability. Since internal team is also responsible for the ongoing maintenance of other equipment, it becomes difficult for it to perform upgradation , if it is a major one 

The internal team comes into action if the scale of upgradation is relatively low, includes low machining & modification, and can be completed in less time

External Team

The external team is the outside contractor specializing in this field and contains all the required necessities. The upgrade work is assigned to an external team in cases where significant work is needed due to time constraints. Additionally, if the internal team is busy with maintenance work and cannot spare time for upgrade work, the external team can also be engaged.

External teams offer advantages over internal teams, such as 

• It takes less time compared to the internal team

• Less production disruption

• More excellent knowledge and experience in equipment upgradation 

• Can give valuable advice during the upgradation process

• Vast pool of hardware and software solutions to assist in the activity

In contrast to the advantages mentioned above, the cost of upgradation from an external team is relatively higher, which can increase depending on the scope of work.

Start of Work

After deciding whether to work internally or assign it to an external contractor, the upgrade is officially started by transferring the machine to the work location.

Machine installation

After transferring, the machine is installed with all its accessories and utilities at its designated location. Depending upon the agreement, the machine can be installed by an external contractor or an internal team. 

Trial Run and Validation

After satisfactory machine installation, a trial run of the machine is performed to verify its upgradation status. Initially, a dummy product is used to run the machine, and after the original product is used to trial-run

After maintenance and production departments are confident in their performance, the quality department performs validation, which consists of Installation Qualification ( IQ), Operational Qualification (OQ), and Performance Qualification (PQ)

After completion of valuation activities, production can take the machine on regular production.

Work Execution – Internal vs External

Internal Team

The maintenance department manages the entire work, from procuring parts to performing all the engineering tasks. From the beginning, a dedicated team is assigned to accomplish the task overseen by the maintenance head. A periodic report is sent to higher management and the production department to inform them about progress. 

After completion of upgradation work, production, and quality, inspect the machine and run a trial run to assess the production process and quality. If they suggest improvement, it should be implemented on the machine. Equipment is transferred to the production department if the upgradation is satisfactory and approved by production and quality.

External Team

If the maintenance department decides to upgrade from an external contractor, they are selected based on technical expertise and cost. After selection and finalizing the agreement, the machine is transferred to the contractor's location.

The maintenance department is responsible for following up and ensuring work is completed on time. Upon intimation from the contractor, maintenance, quality, and production visit the contractor's location to inspect the machine and ensure satisfactory machine performance.

After the equipment team approves, the machine is transferred to the production department for installation and trial runs.

About the Author:

Muhammad Asim Niazi

Muhammad Asim Niazi has a vast experience of about 11 years in a Pharmaceutical company. During his tenure he worked in their different departments and had been part of many initiatives within the company. He now uses his experience and skill to write interested content for audiences at PharmaSources.com.