AHU Validation Guideline

Which guideline to be use for AHU validation in Pharma industry?

Iso 140644, PDA , Schedule M and many more

Hi Kiran,
Which country your organisation is working for? The specific answer depends on this information.

ISO 14644-1,2,3,

ISO14644 and WHO TRS

Hello sir,
When carry out clean room validation test like Air velocity measurement for grade A area ,HEPA filter size 2’X2’ feet then 5number of location taken then as per acceptanace criteria 0.36 to 0.56M/S ok.
Should be either every velocity reading meet with criteria or avrage velocity?

https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS1010annex8.pdf?ua=1

WHO TRS 1019 Annex 2

https://ec.europa.eu/health/sites/health/files/files/gmp/2020_annex1ps_sterile_medicinal_products_en.pdf

ISPE Draft HVAC Guide