The situation of Continuous Particle count monitoring in Grade A area in case of aseptically filling a powdery product

Continuing the discussion from Particle count inside the Powder filling room and LAF:

This paragraph mentioned by Dr. Andmentor Andres is very important paragraph to be seriously considered by manufacturers of sterile powder products in the filling area , and the auditors strictly demand complying with this paragraph where it is applicable

This paragraph is from the new EU Annex 1 which is similar to new PIC/S Annex 1 & new WHO Annex 2 (TRS 1044) , the new globally harmonized GMP Guideline for sterile products manufacturing

1 Like