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GMP/GSP Cool Room Temperature And Humidity Regulation
Dec 18, 2017

     GMP cool room has no set requirements for temperature and humidity. Different item has different requirements, usually around 0-30℃, relative humidity is 45-75%, it will set as per specific requirements.

    阴凉库

    HaoCool refrigeration is the professional GSP/GMP standard cool room solution provider and builder, it served customers include hospitals, disease control center, pharmaceutical companies, medical goods logistics companies etc..

    New edition GSP requirement on temperature and humidity monitoring

    1、automatic monitoring and recording of temperature and humidity.

    (a)The customer shall install the automatic monitoring system, to get 24-hours continous and automatic monitoring and ontime recording.

    (b)System is composed of management main machine, monitoring end module, softwares etc.. every 5 seconds the monitoring data will be updated and at least 30 minutes automaticlly record the actual values of temperature and humidity.

    (c)The accuracy of temperature and humidity data shoul be : temp.±0.5℃, RH±3%.

    (d)The monitoring data of system should be real, complete, accurate, effective. All monitoring locations tranfer to managment main machine through internet, and will be kept in good means, preventing tamper of users.

    2、 configuration of temperature and humidity monitoring equipment

    (a)Each separate medical warehouse room shall install temperature and humidity monitoring equipment, used to monitor and collect data of temperature and humidity.

    (b)Normally every 300 square meters floor space need at least 1 monitoring equipment, for automatic cubic warehouse , it shall have at least 9 for upper, middle, lower positions evenly.

    (c)The setting of monitoring equipment shall consider the warehouse structure, wind outopening, locations of doors and windows and specifical medical storage needs etc.. to ensure well suited to monitoring data.

医药冷库

    3、 regulation and recording of temperature and humidity

    (a)The warehouse shall install effective monitoring and controlling equipment for temperature and humidity. It shall has control points signal output function. When out of limits the system shall realize audible and visual alarm onsite or in specified place.

    (b)The housekeeper of cool storage shall respond accordingly as per the system signal to regulate effectively till the conditones get back to normal. And the regualtion process shall keep record.

    4、The system shall keep working even in power down condition. And alarm once power down to notifty personnel in time.

    5、 there shall be at least 2 monitoring equipment, when out of limits it can realize ontime temperature regulation and alarm and text message responsible person.

    6、 For chain network pharmaceutical companies, it shall have a comprehensive integrated automatic monitoring platform for temperature and RH, and realize remote monitoring and data collection, recording, equipment control and emergency alarm functions.

    7、Every year calibration of equipments and record kept for at least 3 years.

    8、The sytstem can receive medical supervision maganement units` random check.



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