How are cleanroom classifications classified?
The primary authority for cleanroom classifications is the International Standards Organizations (ISO), which ranks classifications from ISO 1-10 based on the number of particles within a specified area.
How should cleanrooms be classified following ISO 14644-1?
Cleanrooms and clean air devices should be classified following ISO 14644-1. Classification should be clearly differentiated from operational process environmental monitoring. Portable particle counters are used for cleanroom classification.
What are the FDA regulations for a clean room?
The FDA has regulations that regard compliance. Regulations specifically about drug products supersede more general CFR 210 and CFR 211 regulations. There are some strict environmental controls that start with the planning and construction of any clean room. It’s vital to have clean air standards in your clean room.
What is the equivalent fed standard for a clean cleanroom?
The equivalent FED standard is class 1000 or 1000 particles per cubic foot. ISO 7 is a common clean cleanroom classification. A cleanroom must have less than 352,000 particles >0.5 micron per cubic meter and 60HEPA filtered air changes per hour. The equivalent FED standard is class 10.000 or 10,000 particles per cubic foot.
