Taming the Cleanroom: Challenges in Medical Device Manufacturing

Taming the Cleanroom: Challenges in Medical Device Manufacturing

Cleanrooms might sound sterile and simple - but managing one for medical device production is anything but. It's a world of airflow, microbes, and meticulous standards. And while it may look spotless, keeping it that way takes serious effort.

Here’s why running a cleanroom is like hosting a dinner party for invisible guests - with a whole lot of rules.

Why Cleanrooms Matter

Medical devices come into direct contact with the body. That means there’s zero tolerance for contamination.

Cleanrooms control:

• Airborne particles
• Microbial load
• Humidity and temperature
• Electrostatic discharge

A single lapse can compromise product safety and lead to costly recalls.

The ISO 14644 Playbook

Cleanroom design and operation rely on the ISO 14644 series. Think of it as the cleanroom bible.

Key parts of the standard include:

• ISO 14644-1 – Sets particle concentration limits by class (from ISO 1 to ISO 9)
• ISO 14644-2 – Outlines monitoring to ensure ongoing compliance
• ISO 14644-3 – Covers test methods (like airflow and recovery tests)
• ISO 14644-5 – Looks at operational protocols, gowning, and behaviour

It’s not just about building a cleanroom - it’s about maintaining its integrity every day.

Enter EN 17141: The Microbial Watchdog

Particles aren’t the only culprits. Microbes love cleanrooms - especially in warm, humid spots like seals and filters.

EN 17141 fills the microbiological gap. It replaced the older ISO 14698 and brings:

• Defined limits for microbial contamination
• Validation methods for microbiological monitoring
• Guidance on sampling locations and frequencies

If ISO 14644 is about dust, EN 17141 is about the bugs.

Daily Challenges in Cleanroom Management

Let’s break down the real-world hurdles.

1. People: The Biggest Contaminant

No matter how advanced your HEPA filters, human beings are walking particle factories.

• Skin flakes and hair are constant threats
• Poor gowning technique can undo everything
• Training must be ongoing and engaging

2. Environmental Monitoring

Consistent testing is a must. But it's easy to:

• Miss trends in particle or microbial spikes
• Neglect under-sampled areas
• Delay responses to out-of-spec results

Monitoring isn't just about collecting data. It's about interpreting it fast.

3. Cleaning Regimes

Cleaning a cleanroom isn't like wiping down your kitchen.

• Chemicals must be residue-free
• Rotation is key to avoid resistance
• Every step must be validated

And remember - too much cleaning can be just as risky as too little.

4. Maintenance Mayhem

HEPA filters don’t last forever. Neither do pressure gauges or air handling units.

• Planned preventative maintenance (PPM) is vital
• Repairs need to be fast and controlled
• Downtime equals lost production and ££

Top Tips for Success

Want to keep your cleanroom (and sanity) intact? Start here:

• Set clear SOPs and keep them updated
• Train your team like they're astronauts - every detail matters
• Make monitoring visual with dashboards and alerts
• Audit regularly, not just when it’s required
• Celebrate good behaviours, don't just spot the mistakes

Final Thought

Managing a cleanroom is like running a high-stakes game of "don’t let it touch the floor." Between ISO 14644, EN 17141, and the reality of human error, success demands vigilance, teamwork, and a sense of humour. Because if you’re not sweating the small stuff in a cleanroom… you might be doing it wrong.

Join our new training course, Cleanroom Requirements for Medical Device Manufacturers to learn more about common pitfalls and their solutions in successfully designing and maintaining a cleanroom. Gain detailed knowledge, understanding and expertise in the physical, microbiological and human (!) challenges of managing this essential part of your business.

Published on Jul 31, 2025 by Annette Callaghan