Facts About Cleanroom Certifications

are employed in pharmaceutical manufacturing, clean machining, and other industries to minimize airborne pollutants and other external factors. A cleanroom can regulate temperature, humidity, and cleanliness throughout the area.

Independent cleanroom certification companies inspect a cleanroom’s ability to satisfy ISO 14644-1 cleanliness standards. This testing ensures that cleanrooms are kept clean and sterile. The steps of the cleanroom certification process include a variety of tests determined by the industry and manufacturing process in question.

HEPA Filter Integrity Testing

This cleanroom certification test ensures that cleanrooms meet ISO 14644-1 cleanliness requirements. HEPA filter testing checks for leaks and particle counts/size distribution.

Room Pressurization Testing

Operating cleanrooms maintain positive room pressure (exceeding atmospheric pressure) to prevent air leakage. This cleanroom certification test ensures that cleanrooms maintain positive room pressure, an ISO 14644-1 cleanliness requirement.

Cleanroom Classification

The amount of dust per cubic meter that exceeds 0.5 micrometers determines a cleanroom’s categorization. One micrometer equals one-millionth of a meter. There are four distinct cleanroom categories:

Grade A

The zone for high-risk operations, filling zones and vials, provides a homogeneous airspeed. A Laminar Flow Workstation enables the user to work in a safe environment that is uncontaminated.

Grade B

Grade B is the zone in which Grade A zone goods undergo aseptic processing and filling.

Grade C and D

The C and D-graded areas provide space for less critical activities done throughout lesser portions of the manufacturing process. Cleanrooms are assigned the cleanliness class they have achieved, monitored with a cleanroom certification test. A cleanroom that has been classified as Class C and fails a cleanroom certification test is assigned the classification of Class D.

Cleanroom certification testing ensures cleanrooms meet industry cleanliness requirements, confirming that they maintain their class and cleanliness level. This certification proves that cleanroom cleanliness is above the standards required by ISO 14644-1.