Learn All About Cleanrooms | Classification & ISO Standards

A cleanroom is a room in which viable & non viable particle count, temperature, humidity & differential pressure is maintained within standard and defined ranges.In this article you will learn all about the cleanroom classification in pharma.

Cleaning is a strict requirement for cleanrooms and it is necessary to maintain their defined cleaning level all the time.Cleanrooms play a critical role in the manufacturing of pharmaceutical products.

• Cleanroom classification in pharma is based on the size of particles and the number of particles per cubic meter of air.
• There are specified limits of particle count,microbial counts and air changes for the cleanrooms.

Cleanroom Classification In Pharma

Cleanroom classification in pharma is per following standards,

• ISO 14644-1
• Federal Standards (FS 209)
• European Standards

According to ISO 14644-1

Classification of cleanrooms ap per ISO 14644-1 is as follows

1. ISO 1
2. ISO 2
3. ISO 3
4. ISO 4
5. ISO 5
6. ISO 6
7. ISO 7
8. ISO 8
9. ISO 9

In ISO there are 9 cleanroom classes, ISO 1 to IOS 9.ISO 1 is the cleanest from all classes of ISO and ISO 9 is least clean or dirtiest in all ISO classes but cleaning level of ISO 9 is superior than a regular room. In pharmaceutical Industries following ISO, classes are generally required

• ISO 5
• ISO 6
• ISO 7
• ISO 8

According to FS 209

According to the federal standard, FS 209 Cleanrooms are classified as,

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