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药品阴凉库建设要求管理
2015-9-22 9:31:23
阴凉库要求管理
A cool library requirements management
1、药品生产经营企业药品阴凉仓库温度、湿度应严格按照药品经营质量管理规范要求执行,阴凉库温度不高于20℃;各库房相对湿度应保持在45%~75%之间;
1, the pharmaceutical production enterprise drug cool warehouse temperature and humidity should be in strict accordance with the drug management quality management regulations, a cool library temperature is not higher than 20 ℃; Relative humidity of the warehouse should be kept between 45% ~ 75%;
2、带记忆和打印的智能温湿度记录仪器配备数量应与企业仓库面积相适应,除冷库配备一台外,药品仓库原则上每300平米配备一台;并应固定安装在仓库墙壁上与门窗、温控设备距离3米以上,并能于企业电脑连接,输出历史数据,实现企业温度超标报警功能,温湿度连续记录至少2年以上,当冷库或者阴凉库发生异常时,能通过远程呼叫系统通知工程维修部或者维保单位。
2, with memory and print number of recording instrument equipped with intelligent temperature and humidity should be adapted to enterprise warehouse, in addition to the refrigerator with a, drug warehouse, in principle, each equipped with a 300 square meters; And should be installed in the warehouse walls and doors and Windows, distance of 3 meters above the temperature control equipment, and can in enterprise computer connection, output history data, realize the excess temperature alarm function, temperature and humidity record at least 2 years in a row, when the cold storage or a cool library when an exception occurs, can through the remote calling system notify the engineering maintenance department or maintenance unit.
3、智能温湿度记录仪器必须能够实现6秒钟记录一次,每三小时记录一次大点,记录存储时间不少于两年。
3, intelligent temperature and humidity record instrument must be able to achieve 6 seconds once every three hours recorded a big point, records storage time not less than two years.
4、库房的墙壁、天花、地板的要求
4, the wall of the warehouse, smallpox, the requirement of the floor
墙壁、天花要求使用轻钢隔热保温板,并在接缝处使用圆弧处理,地板要求使用无毒的环氧自流平。
Walls, smallpox, requires the use of light steel heat insulation board, and using the circular arc in the joint processing, epoxy self-leveling floor requires the use of non-toxic.
5、灯光要求使用防爆的日光灯或者等同的照明设施,照度为180-200LUX
5, light requires the use of lighting, explosion-proof fluorescent lamp or equivalent illuminance is 180-200 lux
6、空气质量的要求,阴凉库内部安装紫外光管对空气进行消毒,所有物料通道要求安装防鼠板。
6, the requirement of air quality, a cool library internal installation ultraviolet tube for air disinfection, rat guard channel all materials required.
7、对冷冻机组的要求
7 and the demand of refrigerating units
冷冻机组分为室内冷风机和室外冷凝机组,冷凝机组有水冷和风冷的两种,机组一定要选择使用能达到国家制冷许可证企业的设备,能效比选择2级以上节能产品。
Refrigerating units are divided into indoor air cooler and outdoor condensing units, condensing units with water cooling and air cooling two kinds, units must choose to use can meet the national license the equipment of the enterprise, can effect comparing to choose more than 2 levels of energy-saving products.
8、在设备运行期间,冷库工作人员每天上、下午对库区进行两次检查,如发现温湿度超标,应及时采取相应措施,并对相关措施及结果进行记录。
8, during the period of equipment operation, refrigerator staff every day, in the afternoon on the examination of the two, such as found that temperature and humidity levels, should take corresponding measures in time, and the related measures and results are recorded.
9、工作人员进入冷库时,应随手关门并启动风幕,不得将门大开,出库时做到随手关灯及风幕,非冷库工作人员在非特殊情况下,不得擅自进入库内。外来参观人员须经领导同意后方可参观,否则不与接待。
9, staff into the refrigerator, and start the air curtain, close the door after door can not open, outbound do with hand to turn off the lights and air curtain, when the cold storage staff in the special circumstances, shall not enter the house of the rolls. Foreign visitors can be visited only subject to the consent of the leadership, and not with the reception.
10、阴凉库冷库的设备应由专人建立设备养护档案,由维修人员定期检修。
10, a cool library cold storage equipment should be established by a specialist equipment maintenance records, maintenance regularly by the maintenance personnel.
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