Iso Class 8 Clean Room

A non hazardous sterile compounding cleanroom or a hazardous sterile compounding cleanroom in negative pressure are not the same price.

Iso class 8 clean room.

A cleanroom must have less than 35 200 000 particles 0 5 micron per cubic meter and 20 hepa filtered air changes per hour. Iso class 8 equals class 100 000 under fs209e. Iso clean room classifications are rated according to how much of a particulate of a specific size exists per cubic meter within a given enclosure see second chart. By comparison a typical office space would be 5 10 times more dirty.

Class 1 is the cleanest cleanroom in fs209e while class 9 is the dirtiest. Considerations for iso class 8 cleanrooms. Iso 14644 1 and older standard fs 209e determine class by the concentration levels of particles. Fs209e features six classes while the iso 14644 1 added two cleaner and one dirtier standard.

An iso 6 and an iso 8 cleanroom are not the same price per square foot. Classification is based on the amount of specific sized particulates per cubic metre. The class defines a minimum cleanliness level not a specific design. Iso 8 is the least clean cleanroom classification.

The cleanroom class is the level of cleanliness the room complies with according to the quantity and size of particles per volume of air. The lower the iso class the more stringent the requirements for keeping particles and contamination to the acceptable levels of the room class. First the amount of air is different in an iso 6 and in an iso 8. Iso 8 iso 7 iso 6 iso 5.

The particles range in size from 1 5 microns µm. Iso 7 class 10 000 0 051 0 076 10 15 60 90. Iso 6 cleanroom class 1 000 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. As an example iso 8 cleanrooms also known as class 100 000 cleanrooms can be modular or soft walled and have a maximum particle count of 100 000 particles 0 5 um per cubic foot of interior air.

Remember the air is 100 times cleaner in an iso 6 than in an iso8. The equivalent fed standard is class 100 000 or 100 000 particles per cubic foot. Iso 5 class. Class iso 146144 1 federal standard 209e average airflow velocity m s ft min air changes per hour ceiling coverage.

However class will greatly impact design considerations such as filtration hvac requirements and other design elements. Monobloc panel hardwall and softwall cleanroom envelopes are all effective at achieving the environment required for iso class 8. High efficiency particulate air hepa filtration is 99 99 efficient at 0 3 micron and should be considered when looking to achieve iso class 8. In reality however you can reach an iso 6 clean room with 1 recommendation is 2 airlock.