What Are the Different Classifications of Clean Rooms?

In certain industries, such as biotechnology and pharmaceutical, it is essential that your company has a clean room in order to conduct your business and remain in compliance. With a different classification of clean rooms based on several factors, such as the level of pollutants allowed in, it is important that you know at what level to build yours. You might find that you require different levels for different moments in your product's lifecycle.

How Is a Clean Room Classified?

Because the point of clean rooms is to remove all the particles from the air to reduce the chance of interference during research or production, the classification of clean rooms largely focuses on the measurement of molecules in one cubic foot or meter of air. The different levels denote how clean the room is, based on the number of particles allowed in. Generally, the smaller the number of class or ISO, the cleaner the air is.

Different Standards

There are a few different bodies that develop the classification of clean rooms. Federal Standard 209E is the domestic version that uses cubic feet. The International Standards Organization uses the metric system. There is also a version used in the UK, known as the British Standard 5295. All of them denotes a maximum number of particles allowed in either a cubic foot or cubic meter, depending on whether it uses the metric system or not.

The Defined Parameters of the Classes

All three systems use the term class to designate the different levels of clean in the room. There are also different numbers for the different size of particles, with the smallest class number having the cleanest air. In the ISO system, there are 9 classes, with ISO 1 allowing just 10 particles per cubic meter of the smallest particles, 0.1-micrometer, and just 2 of the next larger size, which is the 0.2-micrometers. Level two allows 100 and 24 respectively, as well as 10 and 4 of the 0.3-micrometer and 0.5-micrometer particles. It builds from there, with each class allowing 10 times the level of 0.1-micrometers particles than the previous. IOS 6 allows one million particles, and 1SO 9 is considered the general room air. The FED STD 209E has an equivalent building up by 10 times of the smallest level of particles. The British version only has four classes.

There are many considerations to make before deciding which of the classification of clean rooms you need for your business. A professional clean room management company will help you determine the level of clean you need and the best ways to control the environment, such as installing air purification and filters.