If increase rh in clean area above 60%

GOOD MANUFACTURING PRACTICE (cGMP)
1

GOOD EVENING to all

plz suggest me

if we increase RH of clean area above 60%, than what effect on clean room condition.(like micro. growth etc…)

Regards
Ajit

2

First of all the relative humidity should be within prescribed limits of GMP that is the stability of product under manufacture, comfort to work in clean room area by personnel with perspiration and prevention of Fungal as well as bacterial growth.

Any deviation from these principles will effect the quality of product and performance of staff should be immediately rectified by adjusting the relative humidity of a clean room.

Why and when you need to increase RH of a clean room must be discussed by your engineering, quality and production groups. Then make an assessment of possible risk it poses to Materials in operations, Equipment, Processes, Men and Environment in a clean room.

It cannot be changed often as you have a button to push and a pen to write on a paper.