The pharmaceutical industry's equipment is a critical asset in an organization, which takes time, money, personnel expertise, and the organization's various resources, such as building, utility, and quality. Additionally, the final product depends on the satisfactory equipment performance and can make or break the entire batch.

Whenever a pharma organization plans to add new equipment, a series of tests is performed to select an ideal equipment and to ensure its performance meets product, quality, and regulatory requirements. If these checks are not performed or are performed poorly, the procured equipment will lack the required attributes, and all investments made will be wasted.

Importance of selecting an accurate equipment

Let’s discuss importance of selecting an accurate equipment, and how its impacts the production process in a pharmaceutical industry

Helps to achieve product requirements

Accurate equipment will help a pharma organization produce a product that meets all the product requirements, in accordance with the regulatory guidelines. There are various requirements in the pharmaceutical industry, and equipment is 0ne of them.

Some advantages of appropriately selected equipment in pharma product manufacturing includes.

·        It prevents any change in acceptable physical characteristics such as shape, size, and color, which are the basics of success of a product and approval from quality department

·        Prevents contamination during the production process due to area, personnel, and environment

·        Ensures the required therapeutic effects by maintaining accurate chemical composition

·        Helps to deliver production timely by having fewer breakdowns, and maintaining equipment in working condition

Helps to achieve regulatory requirements

Most competitive and lucrative pharma markets, such as the United States, China, and Europe, have strict regulatory requirement and does not allow any manufacturer to market its product if it fails to fulfill the requirements.

Appropriate equipment plays its part in achieving regulatory requirements such as safety, equipment qualification, and validation.

Helps in safe production operation

Safety is an essential factor in the success of pharmaceutical operations, and appropriately selected equipment helps in safe production operations for man, machine, and material. Safe machine operation is a critical requirement for all pharma manufacturers. Additionally, it hampers the reputation of a pharma manufacturer, if safety is not implemented or an accident occurs, during production processes.

It prevents damage to products due to reasons such as product mix-up contamination from the area or environment. It also ensures personnel safety by preventing accidents due to moving parts, heating mechanisms, or product exposure.

Helps to achieve market demands

Fulfilling market demands is critical for any pharmaceutical manufacturer because it helps retain business and provides confidence to its customers.  

An appropriately selected equipment can play its parts in achieving market demands as follows

·        Running and operating according to its rated capacity and output

·        Less breakdown during production

·        Safe operations also result in less breakdown due to machine damage, investigations, and corrective actions

·        Fulfilling all quality attributes enables the quality department to pass the batch quickly.

Steps in finalizing a pharma equipment

As discussed above, various sensitivities related to pharmaceutical equipment need to be addressed. For this reason, equipment selection for the pharmaceutical industry goes through a rigorous process that results in efficient equipment.

Let’s discuss some steps involved in finalizing a pharmaceutical equipment

Requirement by the department

At the initial stage, the relevant department (production or laboratory) raises requirements for new equipment to concerned authorities such as higher management, engineering department, or supply chain. It depends on an organization’s structure or policies.

A department may raise requirement for a new equipment due to following reasons

·        The engineering department has declared the equipment faulty and irreparable.

·        Present capacity or output does not meet the market demands due to reasons such as increased demand in the market

·        The quality department has suggested change due to a breach in quality characteristics

Planning and Finalizing requirements

In the planning stage, all critical departments, such as production, engineering, quality, and other related, plan and finalize new equipment requirements.

In it, representatives of all departments assess the requirements of the production department and see whether it is necessary to purchase new equipment. The process proceeds further if necessary, and conditions are finalized in a document called User Requirement Specifications - URS.

URS is an official document containing all equipment requirements and structure.

Reaching out to OEM

After all requirements are finalized and laid down in URS, it is sent to all equipment manufacturers. The data of OEM is accessed through multiple sources, such as exhibitions, promotions, and personal visits to OEM factories.

Studying different OEM’s proposal and shortlisting

After different OEMs express interest in manufacturing equipment and have their proposal, the team that finalized the requirements again sits down and studies it. There are two aspects of studying the proposal – technical and commercial.

The proposal is assessed based on technical requirements, i.e., whether the equipment manufacturer provides all the features or not.

In commercial assessment, the proposal is analyzed based on financial feasibility, I.e., whether the price of the equipment is justified or not.

Based on the above points, typically, three proposals are shortlisted and qualified for the next stage.

Final meeting

After shortlisting three proposals, the representatives of the equipment buyer again contact the equipment manufacturer for final discussion.

In this stage, some points discussed include but not limited to

·        Further financial discussion

·        OEM’s dedication and assurances in manufacturing equipment and meeting all the requirements.

·        Timeline of completing equipment manufacturing and when the equipment will be ready for shipment

·        When and How will FAT and SAT will be performed

Intimating OEM to start manufacturing

After all necessary decisions have been made and the final OEM is shortlisted, the OEM is intimated to start manufacturing the equipment.

Things to consider when selecting a new equipment

Let’s discuss some features or requirements that must be considered during equipment buying process. Please note that acceptance criteria depends on an organization’s policies and future road-map.

Capacity

Capacity is the ability to produce a product in one hour and mainly depends on the speed of the machine. Factors such as driver (motor), mechanical assembly, and product characteristics affect the actual rate.

Capacity is considered because, in most cases, new equipment is being procured due to the inability of older equipment to meet the required production volume. Pharma manufacturer faces difficulty in achieving demands and can lose their market.

To save its market and fulfill demands, new equipment is being procured. It must produce the product at the required capacities or at least more significant than the older equipment.

Operation

Operation of pharma equipment reflects the capabilities of personnel to operate equipment without any difficulty and causing damage to it. Today’s equipment manufacturers use the latest technology to enhance machine’s capacity, efficiency, and output. Additionally, today, regulatory bodies are also required to use the latest techniques, such as electronic signatures, for secure operation.

 The pharma equipment must be easy to operate by personnel having basic machine knowledge and technical skills. Some regions lack highly specialized labor, and some pharma manufacturers see it as a financial burden when hiring highly technical laborers.

Aftersales support

Aftersales support is the ability of equipment manufacturers to provide support and help when the buyer runs into problems, which is common during production operations. Additionally, a pharma manufacturer also can deliver require spare parts when required.

 There are various forms of aftersales support, such as

·        Software-related support, if it is installed on the machine

·        Providing spare parts in cases when parts become obsolete and are not available in the buyer’s market

·        Helps in machine operation if error occurs during production

Spare parts availability

Spare parts availability is the probability of availability of spare parts when required by the pharma manufacturer. Because it is common during machine operation to replace some parts due to machine fault or capacity upgradation. Additionally, equipment manufacturer often relies on 3rd party components and use them in their machine, and often, these parts become obsolete and difficult to find in the local market.

When selecting equipment, always consider whether spare parts are available or not. If these are not available, the equipment manufacturer must provide them promptly.

Lab Scale VS Commercial Scale

The pharma industry has two major categories of equipment – lab scale and commercial scale.

Lab-scale equipment has limited capabilities and is provided with minimum features. They are mainly designed and built for small batches during product and formulation development. Lab-scale equipment is often cheaper than commercial scale.

Commercial scale equipment operates at full capacities and is provided with complete features and accessories. They are used for routine production operations, which have already been marketed. Commercial scale equipment is often more expensive than lab scale.

Know your requirements, whether the procured machine will be used for routine operations or formulation development. It helps to set clear goals during the design and procurement stage.

Manufacturer’s reputation

The manufacturer’s reputation is previous buyers' acknowledgment of the equipment quality and facilitation provided during installation and machine operation. It also increases the customer’s trust in using its equipment.

Give weight to equipment manufacturer that has a good reputation in providing support during machine installation and routine operations. It will help pharma product manufacturers fulfill customer demands, retain market share, and overcome all challenges of manufacturing equipment.

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.