[b][COLOR="#0000FF"]What are the Points to be covered during Area Qualification
How Can measure the LUX level? What is Acceptance criteria for Manufacturing, Inspection, coating, primary packing & secondary packing Quality control and Quarantine.
If any guidelines is there? regarding this Please post it[/color][/b]
Regards
Siva
09894114092
Dear Siva
during area quaification you have to perform the flowing test . 1) Air velocity test for AHU. 2) HEPA filter integrity test 3) Particle count test 4) Temperature Humidity and differential Pressure test 6) Air flow visulization 7) Recovery study.
Additionally you hav to perpared room data sheet for each room which include all the information of room.
Lux level for manufacturing should not less than 350 lux. for inspection the lux level very high about 3000 lux. for more infomation you have to refer ISO 14644 guide line