Adapt to the industry:Raw materials Suggested level for fine chemical industry: 10000 to 300000

Layout of the production area for precision drying and packaging of active pharmaceutical ingredients

Placed on the upwind side of the dominant wind direction, the raw material production area should be located on the downwind side, with a clean surrounding environment and areas where flow and logistics do not or rarely pass through. If limited by conditions, sufficient distance should also be maintained from areas with severe dust, smoke, and corrosive gas pollution. The cleanliness level of the crystallization, drying, packaging and other processes of finished oral active pharmaceutical ingredients is between 30000 and 10000 levels. Clean air is filtered at the initial and intermediate stages, while clean air at level 1000 is used for the crystallization, drying, screening, packaging and other processes of sterile active pharmaceutical ingredients.

technological process:

The large precision drying and packaging process should be separated according to the needs of the process flow. Generally, it should be divided into recrystallization, separation room, drying room, inspection room, qualified product storage room, packaging room, personnel and logistics purification room, and channel. These rooms have different functions and roles, but they should complement each other to form a whole; Rooms with the same cleanliness level should be combined together as much as possible for ventilation and reasonable air conditioning layout. Rooms with different cleanliness levels should be interconnected with anti pollution measures, such as air shower rooms, buffer rooms, transfer windows, and airlock rooms; The number of people and logistics personnel in the fine drying and packaging process should be minimized as much as possible, which makes it easier to control the cleanliness of the entire workshop;

Air conditioning room layout:

The air-conditioned room should be located close to the clean area, with the shortest ventilation ducts and a reasonable arrangement of return air ducts to achieve the effect of clean air conditioning; In windowed factories, rooms with high cleanliness requirements should generally be arranged on the inside or center, and sterile GMP workshops can also be arranged on the outside, but with a closed external corridor buffer.

Personnel entry and exit regulations:

All personnel entering the 10000 or 30000 level clean area, including operators, mechanics, and logistics personnel, must change shoes, wear clean clothes, and wear clean hats; All personnel entering the 1000 level clean area must change shoes, store clothes, take a shower, change clothes, wear sterile clean clothes, disinfect and wash hands, and be exposed to air shower before entering the clean area.

Ground engineering specifications:

The ground of the GMP workshop's raw material fine drying package should be smooth, flat, and easy to clean. The commonly used ground is terrazzo, plastic, and acid resistant magnetic board, which are not prone to dust; The surfaces of walls and ceilings should be smooth, dust-free, flat, and easy to clean. Common interior wall materials include stone magnetic walls, special coatings, terrazzo, or color steel plates.

Partition doors and windows:

The selection of doors and windows should be simple, not prone to dust accumulation, and easy to clean. Doors and windows should be sealed and connected to the wall smoothly to prevent the infiltration of pollutants;

The door should be opened from the direction of high to low cleanliness level, and the windows in the clean area should be sealed. Double layered windows should be installed on the partition wall between the air-conditioned area and the non air conditioned area, at least one of which should be a fixed window.