Equipment Qualification, Process Validation, and Test Method Validation

Employee Spotlight - Clayton Cole

Nathan White, Co-Founder and VP of Product Design and Development

Nate has over 20 years of medical device product development experience, with diverse roles in technology innovation, R&D engineering, manufacturing engineering, program management, technical leadership, and organizational leadership. He has an extensive background in complex technologies, including minimally invasive laparoscopy, endoscopy, interventional cardiology and radiology, surgical stapling, vessel sealing, and ablation therapies. He is a named inventor on more than 30 U.S. patents. He holds a B.A. in Engineering Sciences from Dartmouth College and an M.S. in Mechanical Engineering from Stanford University, Design Division, and Biomechanics Division. Throughout his career, Nate has helped dozens of companies conceptualize, develop, and commercialize novel medical products and technologies for improved patient outcomes.

 

Introduction

Following Design Verification and Validation, the remaining activities are focused on readiness for human-use manufacturing. The extent of the effort will vary depending on the commercial launch strategy and annual volumes, but it broadly includes equipment qualification, assembly processes validation, test method validation, component qualification, and qualification of the overall manufacturing process in preparation for design transfer to manufacturing. Typically, these activities start in an earlier phase – in design and development or verification and validation – but are completed prior to production manufacturing. These topics will be covered in the following two articles.

Equipment Qualification

Equipment used in the manufacturing process undergoes Installation Qualification (IQ) and Operational Qualification (OQ) to ensure that meets its specified requirements, is properly installed, and operates as intended.

Installation Qualification (IQ)

During the Installation Qualification (IQ), we verify that the equipment is installed as per the manufacturer’s specifications. During this phase, we check that the equipment is correctly installed, meets safety requirements, and is ready for operation in its intended location.

Operational Qualification (OQ)

Following IQ, Operational Qualification (OQ) tests the equipment across its intended operating range to ensure it functions correctly under various conditions. We put the equipment through its paces, testing it at different settings and operating conditions to verify that it performs as expected. For example, if the equipment is a thermal sealer, we would test it at different temperatures, pressures, and sealing times to confirm that it can operate at the limits of each parameter.

Process Validation

Assembly processes that are used to perform a critical-to-function assembly step are considered for process validation. Some assembly processes can be verified – for example, an arbor press that inserts a pin into a hole to a specified depth can be measured to confirm acceptability. However, other processes cannot be verified without destructive testing. The quality of an ultrasonic weld joint cannot be evaluated without pulling apart the welded parts, for example. Process validation is performed on processes that cannot be verified through monitoring or measurement.

Process Characterization (PC)

A range-finding study known as Process Characterization is often conducted first to identify critical process inputs and outputs. A Design of Experiment (DOE) may be required to fully understand how the process inputs affect different outputs of interest.

Operational Qualification (OQ)

Process-specific Operational Qualification is considered for critical processes that have a process window. This window is typically driven by the operational range of the equipment and the operator’s discretion to run the process within the established process window. The OQ demonstrates that the process can achieve an output that meets specifications at the limits of the process window.

Performance Qualification (PQ)

Process-specific Performance Qualification is used to demonstrate that the process can achieve an output that meets specifications at the nominal process settings under planned manufacturing conditions. It typically involves multiple operators performing the process in different setup batches. It can be used for processes that have an operational process window as well as those without defined operational limits.

Test Method Validation

Test Method Validation is performed to demonstrate that a custom test method or inspection method is suitable for its intended purpose and can produce valid results. A classic example of a test method that should be considered for validation is a manufacturing End-of-Line (EOL) test that is used to check each assembled unit for proper function. A properly executed TMV will demonstrate that the test method can capably identify good units as good and bad units as bad – regardless of operator or inspector.  

Conclusion

During the New Product Introduction (NPI) phase, the manufacturing process is scaled appropriately and validated for production capability. At Meddux, we develop customized plans based on the product risk level, the launch strategy, and target product volumes. We excel at navigating the challenges that are common to new product launches, and our processes can scale to accommodate the starts and stops that typify early manufacturing while ensuring that each device is manufactured consistently and to the exact quality standards.

Key Takeaways:

  • Equipment Qualification: Ensures a seamless transition from design to production, meeting all regulatory requirements.
  • Process Validation: Verification and validation of design outputs guarantee accuracy and completeness.
  • Test Method Validation: Testing manufacturing processes under real-world conditions ensures robustness and scalability.

Contact Meddux to see how we can help you bring your product to market. 

Let us be your strategic partner in navigating the complexities of medical device innovation, from concept to commercialization.

Let’s Team up and Bring your
innovation to Life!