Preparation GMP plant composition planning

Preparation GMP plant composition planning

Preparation GMP workshop is generally composed of production part, auxiliary production part and administration-living part; production part includes general production area and clean area. The auxiliary production part includes material purification room, raw and auxiliary material outer packaging clean room, packaging material clean room, sterilization room, weighing room, distribution...

Text label: preparation GMP plant, GMP plant design planning, preparation GMP plant installation

Production GMP Plant Composition Planning

Preparation GMP pharmaceutical cleanroom is generally composed of production part, auxiliary production part and administration-living part; production part includes general production area and clean area. The auxiliary production part includes material purification room, raw and auxiliary material outer packaging cleaning room, packaging material cleaning room, sterilization room, weighing room, ingredient room, equipment container cleaning room, cleaning tool washing and storage room, cleaning work clothes washing and drying room, Power room, power distribution room, analytical pharma machinery, maintenance room, ventilation and air conditioning room, refrigerator room, raw material, auxiliary material and finished product warehouse, etc. The administrative-living part includes personnel purification room, rain gear storage room, management room, shoe changing room, coat storage room, toilet, clean work clothes room, air shower room, etc. The preparation workshop can be functionally controlled by storage area, weighing room, etc. It is composed of several parts such as pre-treatment area, intermediate storage area, auxiliary area, production area, quality inspection area, packaging area, public works and air-conditioning area, and human flow purification channel.

There are roughly two arrangements for the warehouse location of the preparation workshop. One is that the centralized raw materials, packaging materials and finished products are all in the same warehouse area. This form is relatively common, and it is convenient to collect and store goods in management, but requires clear separation. The other is that the raw and auxiliary materials and the finished product warehouse are set separately, and each is located on both sides of the pharmaceutical cleanroom. This form is smoother in the production process and reduces the round-trip route. Strict isolation measures should be adopted for the contents of the warehouse, which will not interfere with each other and facilitate access and storage. The warehouse can only have one management entrance and exit. If the incoming and outgoing goods are divided into two buffer rooms, it is allowed to be managed by one management room; The indoor environment is required to be clean, dry, and maintained within the approved temperature limits. The floor of the warehouse is required to be wear-resistant, free from ash, with high ground bearing capacity and moisture-proof. The setting of the weighing and pre-processing area is more flexible. This position can be located near the warehouse, or located in the warehouse or in the warehouse, so that the auxiliary materials used in the whole workshop can be processed and weighed in a centralized manner, and then stacked according to the batch number for collection. In this way, a large number of raw materials can be avoided, and it is also conducive to centralized cleaning and disinfection of containers; according to the production process requirements, there should be a storage room for raw and auxiliary materials, a weighing and batching room, a batch storage room for raw and auxiliary materials after weighing, and a production room. The storage room for the remaining materials in the process, when the raw and auxiliary materials need to be crushed before they can be used, it is also necessary to set up a crushing room, a sieving room, and a storage room for the raw and auxiliary materials after sieving; the processing and processing posts of raw and auxiliary materials, including the weighing post, are all dust In places with serious emission, effective dust collection and dust collection facilities should be set up in the layout, and posts should use as many independent small spaces as possible, which is conducive to the effect of exhaust and dust removal, and is also conducive to the processing and weighing of different varieties of raw materials. In these processing chambers, special attention should be paid to maintaining a negative pressure state in the air-conditioning design. Zhongjing Global Purification can provide consulting, planning, design, construction, installation, transformation and other supporting services for preparation GMP workshops and sterile workshops.

The middle storage area is extremely important and necessary for GMP management, whether it is a site or a room. It is one of the most reliable measures to reduce human error and ensure product quality when setting up the middle storage area. The requirements for sufficient space and site placement of materials, whether it is temporary storage between the upper and lower processes or the pending inspection of intermediates, need to be temporarily stored in an orderly place; the storage and inspection sites can be dispersed in the production process, or Set the central storage area relatively centrally. The disadvantage of the decentralized type is that it is inconvenient to manage, and many manufacturers or designers have set up a special material transfer door between the operating room and the intermediate storage area due to one-sided pursuit of the flow of people and the separation of materials, which is not conducive to ensuring the airtightness of the operating room and the intermediate station. sex and cleanliness; decentralized is commonly used in small and medium-sized enterprises. The advantage of centralized mode is that it is easy to manage and can effectively prevent confusion and cross-contamination. Which type of intermediate storage area to use in the process layout design should be determined according to the management level of the production enterprise. It is important that the designer should consider making the process process reasonable, and the route into and out of the intermediate storage area or between the intermediate storage areas should be compliant. The technological process, do not cross back and forth, and do not store in the operating room, and make the distance of material transmission the shortest.

The equipment and container cleaning room, cleaning tool cleaning room, clean work clothes cleaning room and their supporting storage rooms must be set up at appropriate positions in the GMP workshop; the equipment and containers in the Class A and Class B clean areas should be outside the area For cleaning, the cleanliness of the air in the cleaning room of tools and equipment should not be lower than Class D. In some cases, a laminar flow hood is set up in the cleaning room. The containers used in the high cleanliness area are cleaned, disinfected, and sealed under the laminar flow hood. , After cleaning, the tools can be sterilized by a disinfection cabinet for use. In conjunction with the container cleaning, a clean container storage room is set up, and the tools also need to be stored in a special storage cabinet.

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