Understanding Cleanroom ISO Classes

Understanding Cleanroom ISO Classes

Cleanroom classification can be confusing, especially when there are multiple standards used in multiple industries and there is overlap in those standards. Here we’ll focus specifically on ISO classes: what they are and why they matter.

What are the ISO classes?

The ISO classification system has eight classes, ISO Class 8 being the least controlled and ISO Class 1 being the most controlled.

Maximum Number of Particles in Air by Particle Size

ISO Class ≥ 0.1μm ≥ 0.2μm ≥ 0.3μm ≥ 0.5μm ≥ 1μm ≥ 5μm
ISO 1 10 2 0 0 0 0
ISO 2 100 24 10 4 0 0
ISO 3 1000 237 102 35 8 0
ISO 4 10000 2370 1020 352 83 0
ISO 5 100000 23700 10200 3520 832 29
ISO 6 1000000 237000 102000 35200 8320 293
ISO 7 352000 83200 2930
ISO 8 3520000 832000 29300

 

Why does ISO classification matter?

Most laboratory and cleanroom applications require a controlled environment. The level of control depends on both the industry and the specific application. Cleanroom classes serve as a standard that can be easily referenced for the required level of environmental control. Additionally, they serve as a standard for certification to ensure that a cleanroom meets the proper level of control for the industry and the specific tasks performed in that cleanroom.

To create a cleanroom that meets your required ISO standard, contact Angstrom Technology. For more on cleanroom classifications and standards, including Federal Standard 209E, check out our guide.

Designing Your Food Microbiology Cleanroom

Designing Your Food Microbiology Cleanroom

Food microbiology labs have a variety of special considerations due to the sensitive nature of the work and its importance. Not only do they need dedicated laboratory space for testing, but the controlled environment of a cleanroom is also critical. Here are some things to consider when designing a cleanroom for food microbiology applications.

Location

Food microbiology cleanrooms should be located conveniently to the production area from which samples are being tested; however, it should be away from main transportation arteries, noisy areas, boilers, and other heavy equipment.

Setup

Depending on your company’s production needs or your specific lab’s application, your food microbiology cleanroom will likely include a chemical laboratory, bacteria laboratory, and office spaces. These areas will likely require multiple rooms. The bacteria lab will probably require a sterile room, examination and operation rooms, and media production studios. Biological testing should always and necessarily be separated from other cleanroom operations. The chemical lab may require a chemical analysis room as well as an instrument room. The offices will need to be accessible to lab personnel as well as other employees, and will likely require a different level of access and control than the rest of the cleanroom space, meaning separation from other cleanroom areas.

ISO Classification

Generally speaking, food manufacturing and food microbiology cleanrooms must meet ISO Class 5 or 6 (Fed-Std 209E Class 100 or 1,000). This means that recommended air changes per hour are between 150 and 600, with 25 to 70 percent ceiling coverage. (For more information on the maximum number of particles in air allowed per cubic meter of each particle size, check out our guide to cleanroom classifications & standards.)

Maintaining a controlled environment is critical for a food microbiology cleanroom. If you want a cleanroom that’s designed and built right, call Angstrom TechnologY.