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

[Awad (Dr. Ahmed Mohamed Awad)]

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

@Andmentor

Taken from PIC/S Annex 1 (GUIDE TO GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS ANNEXES ):

9.20 In the case where contaminants are present due to the processes involved and would potentially damage the particle counter or present a hazard (e.g. live organisms, powdery products and radiation hazards), the frequency and strategy employed should be such as to assure the environmental classification both prior to and post exposure to the risk. An increase in viable particle monitoring should be considered to ensure comprehensive monitoring of the process. Additionally, monitoring should be performed during simulated operations. Such operations should be performed at appropriate intervals. The approach should be defined in the CCS

I hope this helps

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