Process validation - IQ, OQ, PQ

Ensuring Safe Medical Devices for Patients with Effective Process Validation

Medical device manufacturing process validation is crucial for ensuring reliable product quality. Our comprehensive IQ, OQ, and PQ approach guarantees that your product is safe and effective. We have decades of experience in medical device contract manufacturing and guarantee you will love our work!


The Importance of Process Validation

Process validation is important to ensure that the manufacturing process produces consistent, high-quality devices. It’s an essential aspect to meet your regulatory and compliance requirements and to meet customer’s needs.

Medical device contract manufacturing process validation


Manufacturing processes validated in the IQ, OQ, and PQ phases are repeatable, ensuring every device is manufactured the same way, every time.

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Validating the manufacturing process reduces the risk of product defects, making it easier to meet compliance standards.

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Customer satisfaction

High-quality medical devices improve patient outcomes, reduce complaints, and enhance brand reputation.



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Installation Qualification (IQ)

IQ confirms that the manufacturing equipment, environment, and utilities are installed, validated and documented correctly.

Equipment IQ:

Ensures that all the equipment used during the manufacturing process has been installed and calibrated correctly and that it works as intended.

Environment IQ

Confirms that the manufacturing environment has been set up appropriately to ensure the health and safety of the team working on the manufacturing floor.

Utility IQ

Verifies that the systems and equipment used to create the product, cameras, printers, computer and networking hardware, and their supporting infrastructure are working as intended.


Operational Qualification (OQ)

OQ ensures that specific operating ranges are validated and equipment performs consistently within those ranges.

Equipment Functionality OQ

Show that the equipment operates with the established parameters and that it will maintain these conditions during normal use.

User Training OQ

Ensure that the team is properly trained to use the equipment and can produce consistent, quality devices.

Monitoring and Control OQ

Demonstrate that the conditions needed during the manufacturing process for optimal performance are maintained consistently with the equipment.

Software OQ

Validate software’s capability to effectively perform scheduled tasks and comply with the technical requirements.

PolarSeal Operational Qualification

Performance Qualification (PQ)

PQ evaluates the equipment’s performance in a real-world scenario, indicating if it’s the correct choice for your medical device manufacturing process.

Performance OQ

Verifies that the equipment performs consistently according to its intended use.

Scale-Up OQ

Ensure that the manufacturing equipment can accommodate an increase in production to avoid operational issues and process alterations in the unit.

Product OQ

Assess product quality by performing in-depth tests on specific devices. This testing ensures that the device conforms to strict quality requirements and regulations.


IQ, OQ, and PQ in medical device manufacturing

  • In IQ, it may be necessary to demonstrate whether the supply of power to an autoclave is stable.
  • An example of OQ might be to test that an ultrasound machine performs consistently, regardless of the operator.
  • Most commonly, PQ tests equipment to ensure that it’s consistently capable of delivering the intended levels of product quality and regulatory compliance without deviation.

Medical device manufacturing process validation through IQ, OQ, and PQ testing can deliver substantial benefits, such as confidence in the equipment’s performance and regulatory compliance, minimizing inconsistencies, and efficient use of resources. For more information about our validation services, please contact us.

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