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藥品陰涼庫建設要求管理
2015-09-22 09:31:23
陰涼庫要求管理
A cool library requirements management
1、藥品生產經營企業藥品陰涼倉庫溫度、濕度應嚴格按照藥品經營質量管理規范要求執行,陰涼庫溫度不高于20℃;各庫房相對濕度應保持在45%~75%之間;
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、帶記憶和打印的智能溫濕度記錄儀器配備數量應與企業倉庫面積相適應,除冷庫配備一臺外,藥品倉庫原則上每300平米配備一臺;并應固定安裝在倉庫墻壁上與門窗、溫控設備距離3米以上,并能于企業電腦連接,輸出歷史數據,實現企業溫度超標報警功能,溫濕度連續記錄至少2年以上,當冷庫或者陰涼庫發生異常時,能通過遠程呼叫系統通知工程維修部或者維保單位。
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、智能溫濕度記錄儀器必須能夠實現6秒鐘記錄一次,每三小時記錄一次大點,記錄存儲時間不少于兩年。
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、庫房的墻壁、天花、地板的要求
4, the wall of the warehouse, smallpox, the requirement of the floor
墻壁、天花要求使用輕鋼隔熱保溫板,并在接縫處使用圓弧處理,地板要求使用無毒的環氧自流平。
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、燈光要求使用防爆的日光燈或者等同的照明設施,照度為180-200LUX
5, light requires the use of lighting, explosion-proof fluorescent lamp or equivalent illuminance is 180-200 lux
6、空氣質量的要求,陰涼庫內部安裝紫外光管對空氣進行消毒,所有物料通道要求安裝防鼠板。
6, the requirement of air quality, a cool library internal installation ultraviolet tube for air disinfection, rat guard channel all materials required.
7、對冷凍機組的要求
7 and the demand of refrigerating units
冷凍機組分為室內冷風機和室外冷凝機組,冷凝機組有水冷和風冷的兩種,機組一定要選擇使用能達到國家制冷許可證企業的設備,能效比選擇2級以上節能產品。
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、在設備運行期間,冷庫工作人員每天上、下午對庫區進行兩次檢查,如發現溫濕度超標,應及時采取相應措施,并對相關措施及結果進行記錄。
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、工作人員進入冷庫時,應隨手關門并啟動風幕,不得將門大開,出庫時做到隨手關燈及風幕,非冷庫工作人員在非特殊情況下,不得擅自進入庫內。外來參觀人員須經領導同意后方可參觀,否則不與接待。
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、陰涼庫冷庫的設備應由專人建立設備養護檔案,由維修人員定期檢修。
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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