Putting it to the Test (Method Validation)

Failure to maintain consistent and traceable test processes at all stages of the product lifecycle is a recipe for disaster, according to the test engineers at STERIS.

As a test laboratory itself, Galway-based STERIS knows only too well how important it is that all test processes utilized by a company deliver consistent, accurate and traceable test results.

STERIS’s services include Test Method Validation (TMV) and verification along with equipment qualification.

What is Test Method Validation?

TMV is a risk-based arm of quality control designed to demonstrate the validity of a test or inspection method. Using TMV, the process under examination must show at various stages that it meets intended requirements and produces usable results.

According to STERIS’s lead engineer Philip Roxby, there are a number of occasions when Test Method Validation is required.

These are:

• Developing a new test method
• Revising an existing test method
• Establishing an existing test method in a new facility
• Comparing the effectiveness of two methods

“Under any of these circumstances, employing Test Method Validation would be an advisable course of action. Test Method Validation confirms that a test method can consistently provide valid and compliant results,” explained Philip.

“It also introduces testing at various stages of the Product Lifecycle and ensures their accuracy while creating a solid foundation for traceable evidence practices throughout the lifecycle.”

When it comes to Equipment Qualification, Philip says STERIS is “in a unique position” due to its “multi-discipline engineering team” which makes up mechanical, biomedical, electronic and quality engineers.

He says this means they have valuable experience in many relevant disciplines including:

• Developing test equipment
• Calibration & maintenance
• Designing tests
• Medical device development
• Manufacturing

“TMV and equipment qualification go hand-in-hand. We can support equipment selection and user requirement specification (URS) development, equipment installation and operational qualification (IQ/OQ). These studies ensure equipment capability with the delivery of reproducible test results, which provides a concrete base for subsequent TMV”, explained Philip.

Among the key challenges facing successful implementation of a test method is the inconsistency of much record keeping. To tackle this, Test Method Validation introduces templates for each test that can be followed to ensure ongoing consistency and compliance.

“STERIS will send representatives to work with you and carry out Test Method Validation on-site. Using TMV they can go with you through every part of your test process and verify that it is fit for purpose and capable of producing valid results,” said Philip.

STERIS is an independent ISO 17025 accredited test laboratory offering both standardized product and packaging testing for a variety of sectors along with customized tests and procedures to meet specific Customer needs and test requirements.

A version of this article is featured in Med-Tech Innovation Magazine and is also available on their website.