Sterility Assurance - Concept and fundamentals

[@manikumar-kw7kc]

Neat n simple explanation... Thank you

[@TheMaheshLawate]

Can you clarify this from EU Volume 4 annex 1 as I am confused how to include load dryness by visual inspection in SOP or part of line clearance? 8.56 The items to be sterilised, other than products in sealed containers, should be dry, packaged in a protective barrier system which allows removal of air and penetration of steam and prevents recontamination after sterilisation. All loaded items should be dry upon removal from the steriliser. Load dryness should be confirmed by visual inspection as a part of the sterilisation process acceptance.

[@ravinderreddy2676]

sir please explain about Risk assessment on new facility creation