Technical requirements for the layout of GMP workshops

Technical requirements for plant layout of GMP workshop

The GMP workshop supporting personnel purification room includes rain gear storage room, shoe changing room, coat storage room, toilet, buffer room and air lock room or air shower room. The requirements for personnel purification room should be gradually increased from the outside to the inside. The degree level can be lower than the production area; the entry of the personnel purification room...

Text label: GMP workshop design and installation, GMP workshop layout, GMP workshop technical requirements

Technical requirements for GMP workshop layout

The GMP workshop supporting personnel purification room includes rain gear storage room, shoe changing room, coat storage room, toilet, buffer room and air lock room or air shower room. The requirements for personnel purification room should be gradually increased from the outside to the inside. The degree level can be lower than the production area; the entrance of the personnel purification room should be equipped with clean shoes. In the personnel purification room in the A, B, and C clean areas, the coat storage room and the clean work clothes room should be set up separately, according to the maximum shift. Each person is provided with a coat storage wardrobe and clean work clothes; the bathroom should be equipped with hand washing and disinfection facilities, and a dryer should be installed. To maintain the cleanliness and positive pressure of the clean area, an air lock room or air shower room should be installed at the entrance of the clean area, and the access door of the air lock room should be interlocked, and should not be opened at the same time during use; set up a single-person air shower room When there are more than 5 workers in the clean area, a bypass door should be installed on one side of the air shower room.

The clean room for the outer packaging of raw and auxiliary materials is located outside the clean area. After processing, it is sent to the storage room and weighing room from the air lock room or transfer window. In addition to the clean room, the sterilization room should be set up for the materials and inner packaging materials entering the sterile area. The clean room and sterilization room should be set in the D-level area and sent to the C-level through the air lock room or transfer window. Area; the waste outlet generated in the production process should be set up with a dedicated transfer facility, and should not share an airlock or transfer window with the material inlet; the GMP workshop should reduce the net height of the clean room as far as possible under the process conditions. The height can be controlled below 2.6m, so as to reduce the air volume of air-conditioning purification treatment, reduce the air-conditioning cost, reduce the cost, and also help to improve the dust-proof effect; but the refining and dispensing equipment is equipped with a stirrer, and the height of the room should be considered. Maintenance height, when the magnetic stirring batching tank is selected, the stirrer is located at the bottom, so there is no need to increase the height of the room. For rooms with high requirements on cleanliness, less anchor bolts should be used, and they should be placed on the ground as flat as possible to reduce the dust on the ground. . Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for GMP workshops and GMP workshops.

The layout of the GMP pharmaceutical cleanroom should take into account the conveying channel and the stock of the intermediate product class. During tablet production, the processes of crushing, primary screening, fine screening, granulation, granulation, total mixing, and tablet pressing have large dust and noise. , should be separated from other processes, separated into independent chambers, and use noise reduction and sound insulation devices to improve the operating environment; drying and sterilization ovens, sterilization tunnel ovens, material ovens, etc. should be arranged across walls, and the main equipment should be arranged in the low-clean area. , send the bottles or materials to be dried, take the wall as the dividing line, the other side of the wall is the high-clean area, and the dried bottles or materials are taken out from the high-clean area; the selected equipment should be double-sided opening, not allowed to simultaneously When turned on, the equipment not only plays the role of disinfection and drying, but also plays the role of a transfer window. The routes for material cleaning and human cleaning should be set up independently. The material transfer route should be short and quick, and try to avoid crossing the personnel route. Raw materials and containers and packaging should be cleaned according to GMP requirements. Therefore, a cleaning outside should be arranged at the material entrance into the workshop. The purpose of the packaging site is the same as that of personnel cleaning and changing shoes; all material containers and tools entering the Class D clean area must be treated in the buffer room on the outer surface or stripped of the contaminated outer skin, and replaced with the ones used in the production area. Turnover containers and pallets; all material containers and tools entering the A, B, and C clean areas must be scrubbed with disinfectant water in the buffer room, and then sterilized by ultraviolet light through the transfer window or airlock room.

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