10 Jun Class 10000 Cleanrooms: Definition, Requirements, and More

Before creating any cleanroom, whether for manufacturing or research, you’ll need to know how clean the space ought to be, or at least which particles (and what sizes) may cause issues. For better or for worse, many industries and their related standards still require so-called “class 10000 cleanrooms,” even though the classification system it was originally part of is now defunct. In this guide, we’ll walk you through what a class 10000 cleanroom is, some of their requirements and design features, applications, and more.

What Is a Class 10000 Cleanroom?

A class 10000 cleanroom is a controlled environment in which airborne particle levels are controlled to a maximum of 10,000 particles (0.5 micrometers or larger) per cubic foot of air. This classification comes from the Federal Standard 209E, which has now been retired.

Furthermore, as we mentioned already, the term “class 10000” is still widely used, even though Federal Standard 209E is no longer in use. The new international standard is ISO 14644-1, which uses particles per cubic meter rather than cubic foot. So, under ISO standards, a class 10000 cleanroom is equivalent to an ISO 7 cleanroom. The two are the same.

The term class 10000 is well-known and familiar across industries, which is why its use persists to this day.

Class 10000 Cleanroom Requirements and Design

The design of a class 10000 cleanroom, like the other cleanroom classes, focuses on controlling suspended particles. While each project is liable to be different, and therefore require different features, here are some common considerations.

Airflow and Air Changes Per Hour

Airflow is one of the most important elements in a class 10000 cleanroom. A typical cleanroom of this classification will replace its air around 60 times per hour. In the industry, this is called air changes per hour, which is a measurement of how many times in one hour the air is fully replaced. (But given the mixing of air, it’s by no means exact.)

In other words, in a class 10000 cleanroom, the air is replaced roughly every minute, which is much more than a standard room or office. This cycling helps keep particles from staying in the air.

Furthermore, cleanroom builders must also consider the way the airflow moves. In class 10000 cleanrooms, turbulent airflow (where clean air mixes with the room air) is generally sufficient to meet the standard. However, in vulnerable areas, you may sometimes need to use laminar (or unidirectional) flow, where air moves in a straight or parallel path.

Filtration

Filtration is another important factor. It does most of the heavy lifting as far as particle removal is concerned. Class 10000 cleanrooms mostly rely on HEPA filters, which trap 99.97% of particles at 0.3 micrometers (actually, they can trap even smaller particles than this, but 0.3 micrometers is the most difficult size to capture). These filters are typically built into the ceiling as part of a fan filter unit (FFU) system, which pushes clean air down into the space from a plenum.

Some cleanrooms use ULPA filters as well, but for class 10000 they are usually not necessary.

Where Are Class 10000 Cleanrooms Used?

Class 10000 cleanrooms, also known as ISO 7 cleanrooms, are used in many industries. Some common applications include:

• Pharmaceutical production
• Biotechnology
• Medical device manufacturing
• Electronics and semiconductors
• Aerospace and defense
• Food and beverage processing
• Automotive industry

The Bottom Line

A class 10000 cleanroom is a controlled environment that limits airborne particles to no more than 10,000 particles (0.5 micrometers or larger) per cubic foot of air. Though the Federal Standard 209E is no longer active, the term is still used within many industries. If your project requires a “class 10000 cleanroom,” it’s important to understand that its airflow, filtration, and room design all support that required level of cleanliness, and that it is the same as ISO 7-classified spaces.

Interested in setting up class 10000 cleanrooms at your location? Reach out to the experts at Allied Cleanrooms today to get a quote on new controlled environments:

FAQs About Class 10000 Cleanrooms

1. How much does a class 10000 cleanroom cost?

It’s difficult to predict the exact costs of cleanrooms. It is often said that cleanrooms can cost anywhere from $100 to $1,000 per square foot. However, this will depend on the features you choose from your space, your specific requirements, materials you need, and more.

2. How long does it take to install a class 10000 cleanroom?

Installation time will almost always depend on the size and complexity of the cleanroom. Modular cleanrooms can sometimes be installed in as little as a few weeks after fabrication, whereas traditional stick-built rooms may take months/years.

3. Can a class 10000 cleanroom be expanded later?

If your cleanroom is modular, then absolutely. One of the biggest advantages of modular class 10000 cleanrooms is that they can be expanded or adjusted as your needs inevitably change.