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GMP车间规划

2020-01-01 09:05:18
GMP车间规划
详细介绍:

实验室装修设计哪家好

Planning  designing_GMP workshop planning

规划设计_GMP车间规划

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 从负责指导药品生产质量控制的人员和生产操作者的素质到生产厂房。设施,建筑,设备。仓储,生产过程,质量管理,工艺卫生。包装材料与标签,直至成品的贮存与销售的一整套保证药品质量的管理体系。

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的基点是为了要保证药品质量,必须做到防止生产中药品的混批,混杂污染和交叉污染,以确保药品的质量。

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基本内容涉及到人员,厂房, 设备,卫生条件,起始原料,生产操作,包装和贴签,质量控制系统,自我检查,销售记表,用户意见和不良

反应报告等方面。在硬件方面要有符合的环境,厂房。设备:在软件方面要有可靠的生产工艺。严格的管理制度。完善的验证系统。

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车间要求以工艺为主导,并在其它专业如总图,土建。设备,安装,电力,腰通,外管等密切配合下完成工艺布置; 

实验室装修设计

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.

生产区应有足够的平面和空间,要有足够的地方合理安放设备和材料。防止不同药品的中间体之间发生混杂,防止由其它药品或其它物质带来的交叉污染;

①Storage of raw materials to be detected, Semi finished products area.①存放待检原料,半成品面积。

2Intermediate laboratory area 2 中间体化验室面积

③Equipment cleaning area③设备清洗面积

④Cleaning tool room area④清洁工具间面积5⑤ The processing of raw materials, processing area.⑤原辅料的加工,处理面积。

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

⑥存故待处理的不合格的原材料。半成品的面积,以免错误投产。

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

有相应精施来保证不同操作不在同一区域同时进行:

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

相互联系的洁净级别不同的房间之间要有防污措施:

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

在布置上要有洁净级别相适应的净化设施与房间; 

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;

原辅料,半成品和成品以及包装材料的存贮区域应明显。待检品,台格品和不合格品应有足够区域存放并严格分开。存放区与生产区的距离要尽量编短:

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

全车间的人流,物流应简单,合理,避免人流,物流混杂;

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

不同生产工序的生产区需要按工序先后次序合理连接;

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

应有足够宽的过道,结合处注以标志以防混药: .

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

应有无菌服装(特别是生产或分装青霉素类药物)的洗涤,干燥室,并符合相应的空气洁净要求;

10.Should have equipment  containers with washing area.

应有设备及容器具洗涤区。

实验室装修设计

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

在满足工艺条件的前提下,有洁净级别要求的房间按下列要求布置:

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;

洁净级别高的洁净室(区)宜布置在人员最少到达的地方,并宜靠近空调机房:

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

不同洁净度等级的洁净室(区)宜按洁净度等级的高低由里及外布置:

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

空气洁净度等级相同的洁净室(区)宜相对集中; :

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

transfer window;

不同空气洁净度等级房间之间人员及物料的出入应有防止污染措施,如设置更衣间,缓冲间,传递窗等;

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

洁净室(区)的净化空气如何循环使用。应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.

洁净室(区1内安装的水池,地漏不得对药品产生污染: 100级洁净南(区)内不得设置地漏,操作人员不应裸手操作,妥不可避免时。手部应及时消毒: 10000级洁净室1区)使用的传输设备不得穿越较低级别区域: 100000级以 上区域的清净工作服应在清净室(区)内洗涤,干燥,整理,必要时应按要求灭菌。

实验室装修设计


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