What should be frequency for temperature and RH monitoring in filling room and packing room of parenteral preparation.
as per ISO 14644 frequency for monitoring of temp. and RH for ISO grade clean room mentioned as daily. but this should be considered as temp and RH should be within limit during critical operation. for this purpose many company s installed the BMS (building management system) software based operation, monitoring, data storing, alarm trading system (21 CFR compliance software). In that system run and monitor temp. and RH and Differential pressure for 24 X 7. if this facility not available then per shift we have to monitor and additionally start, approx. middle and end of filling activity.
and for packing area daily once or per shift monitoring is accepted with additional monitoring of temp and RH min and max for last 24 HRS in case of daily monitoring.
reply given based on my information and knowledge. before taking consideration take expert opinion.
thanks