Clean Room Certification Levels

Cleanrooms are used for manufacturing where high levels of cleanliness and sterility are required.

Clean room certification levels.

In the uk british standard 5295 is used to classify cleanrooms. In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock. Room pressurization measurement purpose to check the specified room pressurisation to avoid cross. Maintaining clean air with low levels of particulates in your cleanroom is critical to meeting performance requirements and staying in compliance.

A properly designed clean room must have a high rate of air changes to scrub the room of particulates. Common applications are medical devices pharmaceutical and semiconductor manufacturing. Iso 14644 1 cleanroom standard eu guidelines to good manufacturing practice. Pace holds a cleanroom performance testing certification from the national environmental balancing bureau nebb.

Contact us for more information regarding clean room classifications requirements and iso 14644 1 cleanroom standards or call us at 888 984 8801 with any questions that you may have. A cleanroom or clean room is a room that has hepa filtration to remove particles from the air. Broadly medical device manufacturing is conducted in an iso 5 8 cleanroom class 100 100 000. In theory for an entire room to reach iso 6 air cleanliness you need to enter the cleanroom via an iso 8 ante room then go through an iso 7 to finally get into the iso 6 as shown in the image.

The cleanroom classification standards fs 209e and iso 14644 1 require specific particle count measurements and calculations to classify the cleanliness level of a cleanroom or clean area. A class 5 room can have an air change rate of 400 to 600 times per hour while a class 7 room can change at 50 to 60 changes per hour. A clean room gmp cleanroom in my mind are a combination of engineering design fabrication finish and operational controls control strategy that are required to convert a normal room to a clean room. Once the room is completed most specifications call for testing and certification.

Medical device packaging is conducted in an iso class 7 8 cleanroom. Details of the used measuring method reference standard and deviations. Acceptance criteria for the cleanroom or clean zone including the iso classification the occupancy state and the considered design criteria 5. Authoritative documents such as iso 14644 and fs 209e provide no specific instructions regarding activities carried out in medical device environments.