In this section:

Clean Room Standards

Sensitive manufacturing processes require the use of an area where the environment is controlled to a certain degree to eliminate certain contamination levels. Such enclosures, known as clean rooms were then classified for a variety of applications.

The most common standards today are:

Standard: US FED STD 209E
Standard: ISO 14644-1
Standard: EU GMP

Despite the official revoke of FED STD 209E standard, it is still being used within the industry.

Download our Clean Room Standard Comparison Chart.

For further assistance, please contact one of our clean room certification specialists.

US FED STD 209E Standard

Cleanrooms are classified by the maximum allowable number of particles per volume unit of air. The standard classifies clean rooms based on the minimum sampling volume as well as the minimum number of points to sample.

EU GMP Standard

Good manufacturing practice (GMP) is “that part of quality assurance which ensures that products are consistently produced and controlled to the quality standards appropriate for their intended use”.