The oven supplier’s role in validating and qualifying medical device thermal processing equipment

Before medical device manufacturers can begin production on a new product, they must validate their processes and qualify the equipment that will perform them.

Keeping up with the myriad regulatory mandates and organizing the required documentation is arduous to say the least.

But medical device manufacturing process validation and equipment qualification is smoother if the equipment provider knows what you’re responsible for and understands how they can play a supporting role.

Here’s what we’ve learned over the years as we’ve built custom medical and pharmaceutical ovens.

Side-by-side image of two medical device manufacturing ovens made by Davron.

Installation qualification (IQ)

In installation qualification, manufacturers must show that production equipment is installed properly. While the equipment provider is not “on the hook” during IQ, they can make IQ easier for their customers.

How?

It comes down to creating thorough engineering drawings and then following instructions closely.

Such drawings would exist as a matter of course whether a machine is subject to IQ protocols or not. But medical device manufacturers must often make those drawings available for FDA review, and the FDA is strict.

An attentive oven manufacturer should ask their customer:

  • What elements of drawings or diagrams matter to the FDA?
  • Do our drawings and diagrams adequately show what matters? If not, how can we improve them?
  • Do our drawings accurately reflect conditions in the customer facility that could impact installation?

From there, it’s a matter of following instructions. The machine as a whole (as well as its constituent components) must be installed exactly the way the drawings indicate.

It’s imperative that providers and customers examine any site characteristics or conditions that could cause even the slightest deviation in how equipment is installed, and make timely corrections to the documentation.

If anomalies are not detected, or if documentation is not updated quickly enough, manufacturers risk advancing too far along the qualification process only to be forced to start over with amended documentation. This delay is costly.

Operational qualification (OQ)

Thermal processing in medical device and pharmaceutical applications often requires extreme precision in temperature profiles and other parameters. Sometimes, oven providers are handed these parameters and tasked with building equipment that can achieve what is specified. Other times, only a product’s finished characteristics are given. Providers must work with customers to determine the parameters that will get them there.

Even though customers are responsible for demonstrating that their equipment operations within specified ranges, the right oven provider can pull some weight, ensuring success in this qualification stage with the work they do prior to installation.

One example of this work is ensuring that thermal processing equipment is specified with eventual OQ protocols in mind. This is important when you consider key accountabilities:

  • The customer must show that their new equipment meets FDA OQ requirements
  • The oven provider is responsible for meeting the customer’s specifications

Customers must be confident in advance that the machine specifications they pass to oven providers align with the OQ requirements customers must eventually meet. The oven providers must be sure that what they built matches the specification exactly.

The accountabilities do not overlap, but they must align. If they do not, and if operational qualification is not successful, oven providers may point to the customer specification and say that they built the oven they were told to build.

“We built what was specified. It’s not our fault that resulted in equipment that cannot be qualified,” they may say. They would be right.

Another example is conducting extensive testing prior to delivery and installation. Even though this testing doesn’t “count” for qualification and its results cannot be submitted for regulatory review, it helps medical device manufacturers predict in a lower-risk environment the success or failure of eventual operational qualification. There’s no substitute for sound engineering, but catching mistakes or identifying needed changes during factory acceptance testing (FAT) can save loads of time and money.

When you consider the cost and timeline consequences of failing OQ when you could have known you might fail in advance, pre-qualification testing is vital risk management.

Unfortunately, not every oven provider offers it. Of the few that do, it usually only occurs when machinery is installed in customers’ plants.

We insist on running these tests in our manufacturing facility prior to delivery unless the dimensions of the assembled system make that impossible. We believe our work isn’t done until we’ve proved our equipment does what we promised it would do.

Performance qualification (PQ)

PQ protocols prove that manufacturing processes result in finished products with characteristics in line with stated tolerances over time.

Here again, manufacturers are ultimately responsible at this stage.

But the same pre-qualification testing that can gauge OQ performance is also useful in predicting PQ performance.

During acceptance testing prior to delivery, oven providers should run practice batches of your product under conditions as close to real-world as possible. We want to use your exact raw materials and run the process at the same rate you will when you launch production.

A coil of purple-colored medical tubing against a white background.

You can even take this PQ dress rehearsal a step further and conduct quality tests on the products that are processed.

In one case a few years ago, we conducted some explorative pre-testing that led us to conclude that our customer could get a better product if they made a slight tweak to their initial process specification.

Changing specifications is risky depending on how far a project has progressed. Such a shift is comparatively minor if it occurs during engineering and decidedly more challenging if it comes during manufacturing.

That’s why it’s imperative that medical device manufacturers and their oven providers stay in close contact and share information openly so that any important adjustments to process or design can be as painless as possible.

A strong, collaborative partnership is priceless

The journey to qualifying medical device or pharmaceutical manufacturing equipment is long and challenging.

But a partnership with the right equipment provider can take some of the bumps out of the road. Davron’s custom equipment has proven to be instrumental to the production of devices, supplies and consumables found in hospitals and clinics worldwide.

We know ovens. We know the strict guidelines our customers must follow. And we know that we can help them do it. To learn more, contact us.