Cleanrooms are built to control contamination. Whether it’s pharmaceuticals, electronics, or medical device manufacturing, the tiniest particles can ruin entire batches or compromise product safety.
That’s where Environmental Monitoring (EM) steps in. It’s not just some formal process; it’s the backbone of contamination control. In this article, we will discuss what EM is and what areas and practices should never be overlooked.
What is Environmental Monitoring?
Environmental monitoring is a process of collecting and analyzing data to control potential contamination. This includes monitoring airborne particles, surface gunk, and even microorganisms hanging around on people’s gloves or gowns. The reliable environmental monitoring solutions help companies catch problems early before they snowball into costly recalls and regulatory headaches.
Areas That Require Frequent EM
Some spots in a cleanroom need more attention than others. High-risk zones like Grade A areas with open product containers need constant checking. These are the heart of the cleanroom, and even the tiniest slip-up can ruin everything. Then there are Grade B, C, and D zones, which still matter but are less intense.
Things you monitor might include:
- Air near product contact zones
- Floors, walls, and ceilings
- Equipment surfaces
- Air supply vents
Personnel Monitoring and Gowning Effectiveness
Humans are probably the biggest contamination threat in any cleanroom. Even fully gowned, we’re still shedding skin, hair, and bacteria. This makes the gowning protocols so strict. But how do you know if they’re working? That’s where personnel monitoring comes in.
Operators are often tested after critical operations to track how much microbial burden they’re bringing into the space. If contamination spikes, it could mean improper gowning, poor technique, or insufficient training. By linking data from personnel monitoring with EM trends, you can spot weak links in the gowning process before they become major issues.
Air Sampling Techniques
Air is a major route of contamination, especially in sterile or aseptic processing areas. There are two main ways to check it:
Active air sampling: where a device pulls in a measured amount of air and impacts it onto a culture medium. After incubation, you count how many colony-forming units (CFUs) show up.
Passive air sampling: These are simply exposed petri dishes that catch falling microorganisms over a fixed time.
Active is more precise. Passive gives you a general feel for what’s in the airspace over time. This shows how clean the air is, whether airflow systems are functioning, and how movement in the room affects air quality.
Non-viable particle counters are used for real-time data collection. They help indicate whether something unusual is going on that needs further investigation.
Staying Compliant with ISO
If you’re working in a regulated environment, compliance isn’t optional. ISO 14698-1 and 14698-2 are like the rulebook for microbiological control in a cleanroom. It tells you what you should monitor, how to evaluate risks, where to set your limits, and what to do when something goes sideways.
This includes:
- Set alert and action limits
- Choose sample locations based on actual process risks
- Trending data over time
- Investigate and document any out-of-limit results
Following ISO 14698 helps you comply and ensure the safety, quality, and integrity of your products.
