27 Apr Sterile Rooms vs Cleanrooms: What’s the Difference?

If you walked first into a sterile room, and then into a cleanroom, you might not be able to tell the difference. From a quick look around, they’ll seem identical, with white walls, white gowns, and the sound of air filters buzzing. But in truth, these spaces are not at all the same. In this article, we’ll explain everything you need to know about sterile rooms vs cleanrooms.

What is a Cleanroom?

A cleanroom is a controlled environment that limits both the size and number of particles, which could be anything from dust and microbes to vapors. The purpose of a cleanroom is, fundamentally, to protect products (like electronics, aerospace parts, or pharmaceuticals) and outcomes during manufacturing or research.

Each cleanroom is classified based on how clean the air is (how few particles linger within them), and these standards usually come from the ISO classification system.

Classes range from ISO 1, the cleanest, to ISO 9, the least clean. ISO 5 cleanrooms, for instance, are extremely clean and used for things like pharmaceutical manufacturing. ISO 7 cleanrooms are often used for packaging and assembly, while ISO 8 cleanrooms are intended for less important work, but which still needs some layer of protection.

In a cleanroom, the goal is to control particles, period. Whether viable or non-viable.

What is a Sterile Room?

A sterile room, on the other hand, focuses more on eliminating microorganisms like bacteria, viruses, fungi, and spores. In short, their purpose is to keep the space free from germs.

In pharmaceutical compounding, biotechnology labs, hospitals, and vaccine production, sterile rooms are an absolute necessity. In addition, they often have to meet stricter standards than “regular” cleanrooms (some common regulations are USP 797 and cGMP).

But unlike many cleanrooms, sterile rooms involve much more than filtering the air. They often need the right architectural finishes (the antimicrobial kind), special cleaning protocols, staff must wear special gowning, and more. The space will also likely need microbial testing, using methods like air sampling or surface swabbing.

What Are the Main Differences Between Sterile Rooms and Cleanrooms?

While cleanrooms and sterile rooms are both designed to control contamination, they have different focuses. A cleanroom is supposed to reduce the size and number of airborne particles. A sterile room, on the other hand, focuses on reducing microorganisms and other viable particles. The word “sterile,” of course, means there is an absence of living materials.

In cleanrooms, operators might mostly measure particle counts using air sampling equipment. However, in rooms that also need to be sterile (sterile rooms), additional testing will be required.

Materials used in each type of room may differ slightly as well. Cleanrooms often use smooth, non-shedding materials to reduce particle generation (from the walls themselves). Sterile rooms can sometimes use similar materials, but they often add antimicrobial surfaces or use seamless construction techniques to remove any possibility of hiding spots where microorganisms may grow.

Finally, staff protocol and dress requirements will be very different. In cleanrooms, workers typically wear gowns, gloves, and masks. In sterile rooms, staff often dress in full sterile garb and need to follow strict aseptic protocols.

The Bottom Line

While they may look similar, cleanrooms and sterile rooms are used for different purposes. Cleanrooms control particles, plain and simple; sterile rooms are meant to be as absent of microorganisms as possible.

Whether you need a cleanroom or a sterile room will come down to what you need to protect, as well as the specific risks involved in your project. If microbial contamination could harm your product, patients, or research, then you certainly need a sterile room. If you’re focused mainly on dust and particles, a cleanroom may be sufficient.

Interested in setting up controlled environments in your space? Reach out to the experts at Allied Cleanroom to get a quote on clean spaces today:

Sterile Rooms vs Cleanrooms FAQs

1. Do all cleanrooms have to be sterile?

No, not all cleanrooms have to be strictly sterile. A cleanroom controls the number of particles in the air, but it may still have microorganisms present unless it is specifically designed to be sterile.

2. Can I upgrade a cleanroom to a sterile room later?

Yes, you certainly can, and especially with modular. However, it can get complicated. Upgrading your cleanroom to a sterile room may involve changing cleaning protocols, gowning procedures, architectural finishes, testing requirements, and more.

3. What makes a sterile room harder to maintain than a cleanroom?

The exact difficulty of maintaining a cleanroom will depend on its ISO class and industry requirements. However, all else being equal, sterile rooms may have to have more frequent cleaning (with special disinfectants), regular microbial testing, stricter gowning procedures, and tighter control over staff. Even small mistakes can introduce contamination, so sterile rooms will most likely need extra attention to details.