Reason for 0,5 and 5,0 quantification for HVAC validation?

GOOD VALIDATION PRACTICE (cGVP) HVAC VALIDATION
1

Hi

I would like to know what is the reason to quantify 0,5 and 5,0 particle sizes for HVAC Validation in the pharmaceutical industry, especifically in a ISO 5 area.

Also, is there a criteria for 0,5 and 5,0 particles in injectable solutions?

Thanks!!

2

Hi, in the pharmaceutical industry you have to have as a reference GMP regulation, in which clean room conditions divide into 4 types, A,B,C,D.