Hepa Filter Clean Booth Medical ISO 7 Modular Clean Room

ISO Class 8 cleanroom is one of the most popular cleanroom applications used in many industries, such as aerospace, automotive, pharmaceutical and research. Prior to the International Standards Organisation’s (ISO) adoption of global cleanroom standards and classification, the US FS209E was applicable worldwide.

• Product pass throughs
• HEPA fan filters
• Heat welded vinyl or epoxy floors
• Gowning atrium
• Air locks
• Air conditioners
• Entrance and exit sticky mats
• Sealed lighting
• Bunny suit, booties, and hood requirements
• Stainless steel bench and hands free sink

ISO Class 8 Cleanroom Industry Requirement Standards

Cleanroom performance requirements are delineated at three levels of condition for testing and characterisation of performance.

As built: This refers to an empty cleanroom with the filter system running. There is no equipment or workers present in the room. The cleanroom has never been used and is at its cleanest in this state.

At rest: Once equipment and products are added to the cleanroom, it is then referred to as ‘at rest’. Humans have entered the room, but it hasn’t been tested. The room is not as clean as ‘at built’ and may be rated ISO 6.

In operation: Once the cleanroom has been tested for performance requirement, benchmarked and documented, the cleanroom rises to ‘at operational’. Now, the cleanroom is used for the purpose it was created, with human traffic and equipment present within. Humans and processes contaminate the cleanroom environment, so this the dirtiest time for a cleanroom. Corrective steps will be taken if contamination in the operational state is not in compliance with ISO Class 8 requirements.