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    3. 實驗室裝修
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      GMP車間規劃

      2020-01-01 09:05:18
      GMP車間規劃
      詳細介紹:

      實驗室裝修設計哪家好

      Planning  designing_GMP workshop planning

      規劃設計_GMP車間規劃

      GMP-(Good Manutacturing Practice tor Drug)refers 1o the responsible tor thoe quality control odl pharmaceutcal production personnel  production operator's quality lo the production workshop, faclitios, bulldings. equipment. storage. production process, quality management, tochnology  health, packing materials  labels, unitl the isthed product storage  sale of a complete set of management system which is to ensure the qulty of medicines.

      GMP--(Good Manufacturing Practices tar Drug)指 從負責指導藥品生產質量控制的人員和生產操作者的素質到生產廠房。設施,建筑,設備。倉儲,生產過程,質量管理,工藝衛生。包裝材料與標簽,直至成品的貯存與銷售的一整套保證藥品質量的管理體系。

      The base of GMP is to ensure drug quality, must be to prevent the production of medicines mixed batch, mixed contamination  cross-contamination, in order to

      ensure the quality of the drug.

      GMP的基點是為了要保證藥品質量,必須做到防止生產中藥品的混批,混雜污染和交叉污染,以確保藥品的質量。

      Basic content of GMP involves the personnel, plant, equipment, sanitary conditions, the starting materials, the production operation, the packing  label, quality

      control system, self- examination, sales records, user opinions  adverse reactions report, etc.To be met in terms of hardware environment. it needs to have plant

      equipment; On software. it need to have reliable production technology, strict management system  perlecting validation system.

      GMP基本內容涉及到人員,廠房, 設備,衛生條件,起始原料,生產操作,包裝和貼簽,質量控制系統,自我檢查,銷售記表,用戶意見和不良

      反應報告等方面。在硬件方面要有符合的環境,廠房。設備:在軟件方面要有可靠的生產工藝。嚴格的管理制度。完善的驗證系統。

      The GMP workshop requires to regard the technology as the leading tactor,  completed the prolecet with the help ot other professlons such as general layou, chvll

      engineering, islation., electrical, hvac, close coordination with the outer tube  so on.

      GMP車間要求以工藝為主導,并在其它專業如總圖,土建。設備,安裝,電力,腰通,外管等密切配合下完成工藝布置; 

      實驗室裝修設計

      1.Production area should have enough plane  space,  need to have enough space put equipment  materials reasonablely, to prevent mixing among iferent

      drugs  cross contamination  other drugs  other substances.

      生產區應有足夠的平面和空間,要有足夠的地方合理安放設備和材料。防止不同藥品的中間體之間發生混雜,防止由其它藥品或其它物質帶來的交叉污染;

      ①Storage of raw materials to be detected, Semi finished products area.①存放待檢原料,半成品面積。

      2Intermediate laboratory area 2 中間體化驗室面積

      ③Equipment cleaning area③設備清洗面積

      ④Cleaning tool room area④清潔工具間面積5⑤ The processing of raw materials, processing area.⑤原輔料的加工,處理面積。

      ⑥Stored pending unqualified raw materials, semi-tinished products of the area, in order to avoid error operation.

      ⑥存故待處理的不合格的原材料。半成品的面積,以免錯誤投產。

      2.Appropriate measures to ensure that there are dfftrent operating  in the same area at the same time

      有相應精施來保證不同操作不在同一區域同時進行:

      3.Cleanlness level of interconnectedness between ditferent rooms have antifouling measures

      相互聯系的潔凈級別不同的房間之間要有防污措施:

      4.In the layout should be compatible with the cleanliness level of purification facilities  rooms;

      在布置上要有潔凈級別相適應的凈化設施與房間; 

      5. Raw materials, semi-finished  finished products  packaging materials storage area should be clear. to be seized products, qulified  unqulified products

      should have sufficient storage area  strictly separated, storage areas  production areas to try to shorten the distance;

      原輔料,半成品和成品以及包裝材料的存貯區域應明顯。待檢品,臺格品和不合格品應有足夠區域存放并嚴格分開。存放區與生產區的距離要盡量編短:

      6.Full workshop flow. logistis should be simple, reasonable, to avoid flow. logistics conlounding;

      全車間的人流,物流應簡單,合理,避免人流,物流混雜;

      7. Different processes of production area best links at reasonable order process;

      不同生產工序的生產區需要按工序先后次序合理連接;

      8. Should be wide enough alisle, to mark the junction to prevent mixing drug injection;

      應有足夠寬的過道,結合處注以標志以防混藥: .

      9.Should be sterile clothes washing(Especially in the production  packing peniclins), drying room,  meet the requirements ol the appropriate air cleaner;

      應有無菌服裝(特別是生產或分裝青霉素類藥物)的洗滌,干燥室,并符合相應的空氣潔凈要求;

      10.Should have equipment  containers with washing area.

      應有設備及容器具洗滌區。

      實驗室裝修設計

      Process conditions aremet, there is room cleanliness level requirements are arranged according to the fllowing requirements.

      在滿足工藝條件的前提下,有潔凈級別要求的房間按下列要求布置:

      1.High level of cleanliness of the clean room(area)should be arranged in person at least reach the place,  should be close to the air conditioning room;

      潔凈級別高的潔凈室(區)宜布置在人員最少到達的地方,并宜靠近空調機房:

      2.Diterent levels of clean room(area)cleanliness cleanliness lovel should be at the lovel  the inside  the outside layout;

      不同潔凈度等級的潔凈室(區)宜按潔凈度等級的高低由里及外布置:

      3.The same level of air cleanliness should be relatively concentrated cleanroom;

      空氣潔凈度等級相同的潔凈室(區)宜相對集中; :

      4.Personnel  materials between dtferent clanliness class room discrepancy should provent the pollution measures, such as setting the locker room, butter,

      transfer window;

      不同空氣潔凈度等級房間之間人員及物料的出入應有防止污染措施,如設置更衣間,緩沖間,傳遞窗等;

      5.Cleanroom air punification how recycling, should take effective measures to avoid contamination  Cross-contamination;

      潔凈室(區)的凈化空氣如何循環使用。應采取有效措施避免污染和交叉污染:

      6.Tank installation of clean room(area), The floor drain to be on the drugs produce pollution;100 clean room must  be set t0o drain, Operation should

      bare-handed operation, unavoidable, hands should be disinfected. 10000 clean room used transmission equipment shall  pass through lower-level zones;100,000

      more reglons in the clean room clean clothes should be washed, drled, organize, when necessary, should be required to disintection.

      潔凈室(區1內安裝的水池,地漏不得對藥品產生污染: 100級潔凈南(區)內不得設置地漏,操作人員不應裸手操作,妥不可避免時。手部應及時消毒: 10000級潔凈室1區)使用的傳輸設備不得穿越較低級別區域: 100000級以 上區域的清凈工作服應在清凈室(區)內洗滌,干燥,整理,必要時應按要求滅菌。

      實驗室裝修設計


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