GMP Class 7 Hardwall Type Clean Room for Cosmetics

A Hardwall cleanroom is an enclosed zone where airborne particulates and pollutants are maintained at specific levels. The cleanroom is used to filter polluted air as per the requirements of certain industries such as pharmaceuticals, E-liquids, healthcare facilities, as well as science and technology.

There are many types of contaminants that can harm the processes of research and production. Some of these include fibrous materials, aerosol particles, microorganisms, and chemical vapours among many others. We build Hardwall Modular Cleanrooms that are compliant to the international organisation for standardisation (ISO) 14644-1: 2015.

The ISO 14644-1:2015 standard of Hardwall Modular Cleanrooms are classified into different categories, from class 1 to 9. The classification of each Cleanroom changes dependent on size and prevalence of the air particulates in the cleanroom. Cleanrooms that fall in Class 1 (which is the greatest in the classification) are tested for the smallest air pollutant size and lowest frequency while Class 9 cleanrooms are tested for a larger air particulate size range and higher frequency.

ISO Class 5, (Class 100, FED STD 209E)

Despite the fact that it’s ISO class 5, many people in the industry call this level Class 100. This is due to the FED STD 209 cleanroom classification of measurement, commonly known throughout cleanroom circles. With these particular clean rooms, particles that are smaller than 0.1 µm start at 100,000, and for less than 0.2 µm, measure at 23,700. These cleanrooms also allow for bigger particles than the previous two classes, allowing 832 particles that are less that 1 µm in size.

SO Class 6, (Class 1,000 FED STD 209E)

Commonly referred to as Class 1000 by the FED STD 209 standards, this class allows up to 1,000,000 particles that are smaller than 0.1 µm. It’s also similar to class 5., in that it allows for larger particles. In fact, up to 8,320 particles per cubic meter are allowed, as long as they are smaller than 1 µm.

SO Class 6, (Class 1,000 FED STD 209E)

Commonly referred to as Class 1000 by the FED STD 209 standards, this class allows up to 1,000,000 particles that are smaller than 0.1 µm. It’s also similar to class 5., in that it allows for larger particles. In fact, up to 8,320 particles per cubic meter are allowed, as long as they are smaller than 1 µm.

ISO Class 7, (Class 10,000 FED STD 209E)

This particular class is often called class 10,000, and for particles smaller than 0.5 µm, there can be up to 352,000 cubic meters. For larger particles that still fall under 1.0 µm, there can be up to 8,320 particles. In addition, particles in this class can be up to 5 µm but are limited to 2,930 particles per square cubic meter.

In addition, ISO Class 7 is typically classified as Grade C. This means that at rest, 352,000 particles smaller than 0.5 µm can be present at any given time. During operation, this number multiplies to 3,500,000 particles. Most of these are generated due to the use of equipment and movement that occur.

ISO Class 8, (Class 100,000 FED STD 209E)

Also known as Class 100,000, ISO class 8 provides an environment that is slightly different than room air, allowing 3,520,000 particles that are smaller than 0.5 µm. For particles that are less than 5 µm, the room can have upwards of 29,300.

ISO Class 8 is also commonly associated with clean rooms that are Grade D. At rest, they are limited to less than 3,500,000 particles that are smaller than 0.5. During operation, this number isn’t specified, but allows for the largest grade differential.