HOW TO SELECT MANUFACTURING EQUIPMENT FOR A NEW PHARMA FACILITY

Selecting manufacturing equipment is one of the most important decisions in developing a pharmaceutical facility. The equipment you choose will influence production capacity, GMP compliance, operating costs, validation, maintenance and future expansion for years.

The selection process should therefore begin with the process — not the supplier.

Before evaluating equipment, clearly define what the facility needs to manufacture.

Dosage form, batch size, throughput, process parameters, operating range, future products and expected production growth should all be considered. Equipment selected only for today's requirement can quickly become a limitation when production expands.

BUILD THE URS BEFORE COMPARING SUPPLIERS

START WITH THE PRODUCT AND PROCESS

A well-defined User Requirement Specification (URS) provides the technical foundation for equipment selection.

It establishes what the equipment must achieve and gives the project team an objective basis for comparing different suppliers, technologies and commercial proposals.

EVALUATE GMP DESIGN

Equipment should be assessed beyond its basic function.

Materials of construction, product-contact surfaces, surface finish, cleanability, dead-leg elimination, containment requirements, accessibility and ease of maintenance are important considerations for GMP-compliant pharmaceutical manufacturing.

The equipment must also fit appropriately within the proposed room classification and process flow.

CHECK UTILITIES, SPACE AND INSTALLATION REQUIREMENTS

Equipment selection must be coordinated with facility engineering.

Power, compressed air, water, steam, HVAC requirements, exhaust, heat load and other utilities should be established early. Physical requirements such as equipment height, access routes, door dimensions, maintenance clearance and installation space should also be confirmed before finalizing the equipment.

PLAN VALIDATION FROM THE BEGINNING

Validation should not be considered only after installation.

Supplier documentation, technical drawings, manuals, material certificates, calibration certificates, FAT support and IQ/OQ documentation should form part of the selection and procurement evaluation.

The better the documentation available from the supplier, the smoother the qualification and validation process can become.

LOOK BEYOND THE PURCHASE PRICE

The lowest initial quotation does not necessarily represent the lowest project cost.

Spare-parts availability, maintenance requirements, service response, operator training, energy consumption, reliability and expected equipment life can significantly affect the total cost of ownership.

A technically suitable machine that is difficult to maintain or support can become expensive over its lifecycle.

SELECT WITH THE FUTURE IN MIND

Good equipment selection connects the product, process, facility, utilities, GMP requirements and future capacity.

SELECT FROM THE PROCESS.
COMPARE AGAINST THE URS.
EVALUATE THE COMPLETE LIFECYCLE.

The right equipment is not simply what fits the budget.

It is what fits the process, the facility, the compliance strategy and the future.

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