FAQ - Pharmaceutical/Life Sciences Particle Counting

Question
Is there a standard or specification for monitoring particules from an oil free air compressor which is used in contact with pharmaceutical products?

Answer

Yes. The expectation is that the process air used in pharmaceutical manufacturing meets (or exceeds) the room quality it will be used in. Therefore, if it is a compression gas used for transporting product it should meet ISO Class 5 (i.e. <3500 particles per cubic meter at 0.5 microns). There are also other ISO standards used that identify the limits for moisture (dew point), and temperature.