Medical Device Lab Expert Explains What Makes a Testing Facility Reliable | Pressure Tested

What does a facilities coordinator do?

I look after the equipment and the facilities here at the lab to make sure that all of our testing meets high standards.

That means looking after every little bit of equipment, whether it’s a £100 pipette or a £30,000 autoclave.

What is equipment calibration?

Equipment calibration is a broad term, but you’re essentially verifying the accuracy of your equipment.

The way you do that changes depending on what the equipment is. For example, at home, you might put a one-kilo weight on your scale to see how accurate it is. That’s essentially a simplified version of calibration in a lab as well.

We use all sorts of equipment, so the methods of calibration vary greatly depending on what we are calibrating.

What facility audits need to happen to maintain compliance?

We carry out a lot of internal audits to keep the lab running effectively, including weekly audits supported by the operations team.

We also conduct quarterly inspections and more thorough annual inspections through the quality and compliance team.

These audits cover everything from health and safety to environmental standards, and we are always reviewing our quality management systems as well.

What test chambers do you have in your facility?

We have three chambers in the facility: two smaller 11m³ chambers and one larger 67m³ chamber.

All three have internal sensors that can be monitored externally, and we’ve set them up so data can be downloaded for client reports.

They’re one of the biggest points of pride in the facility for me.

How do you install new equipment in your facility?

This depends on the equipment.

If it requires installation and commissioning, we’ll work with the operations team to minimise disruption to client work.

Anything that comes into the lab, regardless of size or cost, is logged into our asset management system with all relevant information as soon as it arrives.

What type of bespoke test rigs can you develop?

As long as it’s safe and legal to build, we can develop it.

We’ve built pressure chambers, touchscreen stress testers, and even a portable autoclave.

We’ve also developed a series of test rigs to test 60 different types of pumps continuously for 3,000 hours.

So, almost anything and everything.

What is your favourite test rig that you developed?

My favourite was for a manufacturer of sensors used to monitor industrial pipework in agricultural, pharmaceutical, and other settings.

We built a replica pipework system complete with steam sterilisation and temperature monitoring functions. It was a fantastic project to work on.

What standards do you follow for custom rig development?

There isn’t a one-size-fits-all standard because every test rig serves a different purpose.

The standards we follow depend entirely on the application, alongside basic health and safety requirements.

We’re experienced in developing new testing solutions, so if an existing standard doesn’t fit your needs, we can create a bespoke solution.

Do you use an asset management system?

Yes. We use one that I developed in-house.

After evaluating available options, we found it would be just as efficient to build our own system. It allows us to continually improve it as our requirements evolve.

We’ve used it successfully for the last four years.

What type of equipment do you have in the lab?

We have a wide range of equipment across microbiology, reprocessing, and cell culture disciplines.

This includes autoclaves, washer disinfectors, pipettes, balances, and many other specialist and shared pieces of equipment.

We have equipment to support a broad range of testing activities.

What do auditors look for in facilities?

Test Labs is accredited to several standards, including GLP, ISO 17025, ISO 9001, ISO 14001, and ISO 27001.

As a result, auditors assess everything from health and safety systems to quality management and information security.

The facility plays a key role in maintaining compliance with all of these standards.

What makes a lab audit-ready?

A robust quality management system.

You also need a strong quality and compliance team that works closely with operations and test facility management.

When those teams work together effectively, audits become much easier to manage.

How do facilities impact turnaround times?

Facilities directly affect the lab’s capacity to take on work.

If equipment or test chambers are unavailable due to maintenance, servicing, or calibration, capacity is reduced and fewer projects can run simultaneously.

Efficient sample handling is also critical. A strong goods-in process prevents delays and misplaced samples.

Keeping equipment maintained and calibrated maximises capacity and supports faster turnaround times.

What’s the biggest misconception about testing labs?

Many laboratories operate like black boxes—you send in a device and receive results without seeing what happens in between.

At Test Labs, we take a different approach. We aim to be open and consultative, encouraging clients to visit the lab and see how their devices are tested.

Testing doesn’t have to be a black box.

How do you manage contamination control?

Training is one of the most important methods.

All staff working with organisms are thoroughly trained and signed off before carrying out relevant work.

For visitors, we provide clear signage throughout the facility so it’s obvious where lab coats are required and where access is restricted.

How do facilities reduce risk for clients?

One of the biggest risks is receiving results that later fail to withstand scrutiny from notified bodies or regulators.

A strong quality management system, up-to-date certifications, and maintained accreditations significantly reduce this risk.

They provide confidence that testing results are reliable, credible, and trustworthy.

What defines a world-class lab?

A strong quality management system.

Without one, a lab cannot achieve important accreditations such as GLP or ISO 17025.

Those accreditations provide assurance that testing is carried out to recognised standards and that results can be trusted.

For me, that’s the defining characteristic of a world-class laboratory.

What happens to my samples when they arrive at the lab?

Samples first go to our goods-in area, where they’re registered in our sample management system.

All relevant details are recorded, including batch numbers and product descriptions.

The samples are then moved to a controlled storage environment until they’re needed for testing.

Why should manufacturers visit the testing labs?

It’s important to understand what your product will actually experience during testing.

Reading a study protocol doesn’t always provide the context needed to fully understand the process.

Visiting the facility allows you to see testing first-hand, ask questions, and better understand the results you’ll receive and how they relate to real-world performance.

Final Thoughts

The most important takeaway is the importance of a strong quality management system.

Beyond that, bespoke test rigs are one of our strengths. If you have a unique testing challenge, we can design and build a solution tailored to your needs.