What is a cleanroom classification?
Clean room classification – ISO Class. This refers to the level of cleanroom particulate cleanliness based on a number of airborne particles of a certain size per cubic metre. ISO 8 is the starting cleanroom level. A sterile cleanroom for the pharmaceutical industry will need to achieve ISO 5.
What are the cleanroom classes in semiconductor manufacturing?
Table 1. Cleanroom Classes In semiconductor manufacturing, wafer fab processes usually require a sub-Class 1 to Class 10 cleanroom, while assembly processes prior to encapsulation of the die require a Class 10K cleanroom. A class 100K cleanroom is all that post-encapsulation assembly and test processes typically require.
What are the cleanroom requirements for medical device manufacturing?
Broadly, medical device manufacturing is conducted in an ISO 5 – 8 cleanroom (Class 100 – 100,000). Medical device packaging is conducted in an ISO Class 7- 8 cleanroom. An ISO 8 environment may include a dedicated gowning room and sometimes softwall environments in packaging or preparation areas.
What is the Fed level of a cleanroom?
The equivalent FED standard is class 10.000 or 10,000 particles per cubic foot. Common applications are pharmacy USP800 compounding rooms, electronics manufacturing and medical device manufacturing. ISO 8 is the least clean cleanroom classification.
