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Cleanrooms and their Classifications

August 24, 2018


What is a cleanroom?

 

Cleanrooms are a controlled environment; they are used to keep the outside environment from getting in. They are typically used in any industry where small particles can negatively affect the manufacturing process or product.

According to an article in Clean Air Technology, Inc, “Typically used in manufacturing or scientific research, a cleanroom is a controlled environment that has a low level of pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors.”

Cleanrooms help reduce particulate contamination and control temperature, humidity, and pressure through special filters that work with the room’s HVAC system. High Efficiency Particulate Air (HEPA) filters can catch particles that are 0.3 µm, or micron and larger (one micron is equivalent to a millionth of a meter). In some cases, Ultra Low Particulate Air (ULPA) filters are used and can filter particles that are 0.12 µm and larger.

Personnel who work in cleanrooms are highly trained, wear clothing designed to trap contaminants, and go through showers and airlocks (a sterile transitional space) to maintain the integrity of the cleanroom.


 

Cleanroom Classifications:

 

Cleanrooms are classified by the number of contaminants that exist per cubic meter. Currently, the set of standards used to classify cleanrooms are by ISO (International Standards Organization) standards. ISO 14644-1 classifies a cleanroom based on the size and number of airborne particles per cubic meter. The ISO standard replaced the Federal Standard 209 classification (FED STD 209E), pictured below, but it is still used among many companies who prefer the traditional terminology. The following graphic, from Clean Air Technology, Inc, illustrates the different classes.

ISO 14644-1 Cleanroom Standards
Table - ISO 14644-1 Cleanroom Standards

An article from R&D Magazine explained that the lower the ISO class number, the more times air passes through the HEPA filter. This is called air changes per hour (ACH). For example, ISO 7 is required to have ACH of 30-50, whereas ISO 5 requires 150-250 ACH. Thus, the lower the ISO class number, the cleaner the room.

The requirement of a specific ISO class depends on the product or industry. For example, for manufacturing and assembly of medical devices requiring sterilization, cleanrooms are usually ISO 8 or ISO 7.

The following graphic, from R&D Magazine, illustrates that the recommended ACH is determined by the ISO class.

Table - approx air changes per hour needed

 

Comar IDworks®

 

Through our comprehensive IDworks® team, we service the medical device market with custom plastic solutions. In addition to manufacturing, we offer multi-component assembly, full-scale logistics, and distribution. We are known for our innovative design for manufacturing services, in-house mold making and prototyping, and diverse molding technologies.

Two of our facilities have ISO Class 8 Cleanrooms, we have five ISO 9001:2015 and two ISO 13485:2016 certified facilities, and we are FDA registered.

ISO 9001:2015 is the international standard that specifies requirements for a quality management system (QMS). We use this standard to demonstrate our ability to consistently provide quality customer service and meet regulatory requirements.

ISO 13485:2016 represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
Learn more about the custom capabilities of our IDworks® Team and how we can work with you. Your customer expects the best, trust us to deliver.


 

Check out these resources to learn more about Cleanrooms:

 

What is a Cleanroom?

How Classification Impacts the Design of a Cleanroom



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