Common challenges to consider when purchasing a new pharma equipment

Purchasing new equipment in the pharmaceutical industry is an essential process that impacts the entire line of products. It affects a product's quality and defines the manufacturing process's success rate.

For the pharma industry, purchasing new equipment requires the input of all relevant departments, such as engineering, quality, and production. These departments must be actively involved in purchasing equipment until the equipment is installed correctly and is ready for production. 

Let's discuss some common challenges in purchasing new equipment, but first, discuss what role different departments play when purchasing new equipment.

Role of various department in during purchasing process of a new equipment

Purchasing an equipment in pharma industry is not the responsibility of a single department, but it is a coordinated activity involving all the relevant stakeholders. These stakeholders main aim is to procure an efficient equipment that best suits the organization’s requirement.

The most critical departments in a pharma organization are Production, Engineering, and Quality, which are responsible for executing the production process with the highest quality.

Similarly, when purchasing new equipment, these departments work collaboratively, each having its distinct role and responsibility. Let’s see what the roles of this department are. 

Production Department 

The production department is the primary user of every pharma equipment. It devises and executes the production plan, commonly given by the supply chain department. This department also maintains and manages the production planning for specific equipment. 

The production department commonly decides to purchase new equipment when it feels that the existing equipment cannot meet the market demand for a specific product. 

When this happens, it can be implied that.

• The equipment’s output capacity cannot meet the market growing demand, as it has reached its maximum available capacity.

• The equipment is unable to process and produce a specific product. For example, equipment is unable to process biological effects.

• The equipment cannot operate normally due to any defect, as declared by the engineering department.

When the production department decides to purchase new equipment, it informs the higher management, which starts the purchasing process in consultation with other departments. After approval from the higher management, the production department prepares its requirement for new equipment in a document called User Requirement Specification – URS.

Engineering Department 

The engineering department is responsible for overseeing the technical aspects of the equipment being purchased. It helps the production department prepare URS for equipment aligned with the available resources and services. 

Some areas that an engineering department helps include the following

• Selection of equipment in accordance with the available utility services, such as power supply and steam 

• Prepares the area for the installation of the machine. For example, constructing areas in accordance with the dimensions of the equipment, providing the required space on the technical floor, and routing duct.

• Ensures adequate safety systems are available and provided on the machine or equipment, such as machine guards and over-temperature alarms.

• It ensures that the manufacturer provides adequate electrical, electronic, and mechanical components with the equipment.

• The equipment manufacturer provides all the necessary engineering-related documentation, such as the operating manual and calibration procedure.

• Preventive Maintenance schedule and procedure

Quality Department

The quality department ensures that the equipment being purchased includes all the relevant quality processes in accordance with the guidelines of major regulatory authorities such as the Chinese National Medical Products Administration or the United States FDA. 

The quality department also ensures that the proposed installation follows the regulatory guidelines and will not affect the quality principles of the installed area. Additionally, it also provides that all the quality-related documentation is also included with the equipment purchase, such as 

• Validation documents

• Material and Calibration Certificates

• Other relevant document necessary by the regulatory bodies

After the equipment is installed and ready for production, the quality department must perform validation activities, i.e., Installation Qualification, Operational Qualification, and Performance Qualification, before actual production.

Some challenges when purchasing a new pharma equipment

Let’s discuss some challenges when purchasing a new pharma equipment.

Maintenance costs

Every piece of equipment, whether new or old, undergoes and requires maintenance. New equipment can require less maintenance, and it can be cost-effective. However, these studies must be carried out before purchasing and finalizing the supplier.

Always perform a detailed study to evaluate the effectiveness of new equipment for maintenance in terms of time and associated costs. Some factors to consider regarding maintenance include but are not limited to 

• What is the estimated cost of maintenance for new equipment? Either new equipment costs more than the old one or is less expensive. 

• Spare parts are an essential requirement during maintenance. Always confirm the availability of spare parts in the local market because it is possible that spare parts are not available in the equipment buyer’s market and must be imported or purchased from the equipment supplier at the time of need. This situation often creates a supplier’s monopoly, making the equipment buyer dependent on the supplier whenever needed.

• Are maintenance personnel capable of handling maintenance activities? This is critical because new equipment often includes parts, technology, and operational technique different from previously installed equipment.

• Similarly, production personnel such as operators must be able to operate new equipment with minimum downtime. They must understand the working and functionality of different sections and parts. 

Training

Personnel training is a critical requirement during the purchase of new equipment. The equipment manufacturer or supplier must design a training plan that educates the buyer personnel regarding operation, maintenance, and risk aversion. This must be provided without any additional costs, and the buyer must ensure it during the acceptance testing of new equipment.

Some aspects of training necessary for new equipment include the following.

• Equipment operation should include all the phases of operation and effectively operate the equipment. Some common examples include change part training, control panel, and software systems.

• Maintenance – it includes common maintenance practices for the equipment, such as changing a mechanical or electrical part, wiring, safety system, and troubleshooting software part

• Machine safety includes training on how to safely operate equipment without damage to man, machine, and material. 

Operational costs

Operational costs are the expenses incurred while operating equipment, including various sub-expenses. It must be calculated for new equipment because it is not always the case that the operational cost of new equipment is less than the old one. It can be more than the old equipment.

Operational costs includes various sub-areas, and can include the following.

• Maintenance costs – as described above, it is the cost associated with maintaining equipment which in turn depends on various factors ( discussed above)

• Regulatory Inspections – pharma sector worldwide experiences various regulatory and standardization inspections such as the United States FDA and the ISO. If regulatory bodies do not approve, producing and marketing the products is impossible. These inspections require extensive preparation, including documentation, area requirements, and product characteristics. Preparation of such inspections also requires investment and significantly contributes to operational costs.

• Spare parts 

• Changeovers – it is common for pharma equipment to produce different dose strengths for a single product, and it requires other changeover parts for every strength. The cost associated with manufacturing these change parts contributes to operational costs. The time the machine remains idle during a changeover is also an operational cost.

After-sales support

After-sales support means providing support to equipment buyer if it faces problems running the machine or any quality-related issue. The nature of support required varies and varies from buyer to buyer. 

The equipment supplier must provide after-sales support to the equipment buyer. It will increase trust and confidence in the equipment supplier and will again consider the buyer if there is a requirement for new equipment. Additionally, the equipment buyer must also include the support required in the URS when the equipment is finalized.

Some after-sales support in the pharma industry include

• Resolving operational problems such as electrical/electronic / software hindering regular operation.

• Providing help in product or process scale-up if the equipment buyer faces a problem. For example, if a machine buyer faces issues in developing and implementing change parts for a new product

• Providing spare parts if these are not available in the local market of the machine buyer. 

• Providing guidelines if a part has become absolute. 

Equipment software

There is increased usage of software systems in the pharmaceutical industry in various processes such as machine operation, testing, warehousing, supply chain, and documentation. Software is also becoming an integral part of equipment operation. Regulatory bodies also guide software systems that the equipment buyer must fulfill.

Always shortlist equipment that uses software for machine operation and other necessary processes. The software system must possess essential features such as an audit trail and data security. 

Actual output

Actual output is the practical yield from the equipment. It differs from the design output because, during functional equipment operation, various parameters affect and reduce the design output, such as the size of the product container and the mechanical effect of multiple parts.

When considering purchasing new equipment, always consider the actual or practical output. It will help to design the installation area better, make arrangements for utility services, provide construction service, and helps in accurately forecasting the organization’s progression.

About the Author

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.