What aspects should be paid attention to in the construction of a pharmaceutical factory?
Wall and ground
The exterior wall requires a clean and flat surface with thermal insulation layer. Typical building materials include brick concrete walls, shear walls, steel structures, etc., The interior wall surface should be solid, smooth, smooth, free of dust, static electricity, corrosion resistance, impact resistance, easy to clean, and free of pores, which are sealed without gaps. Typical internal wall uses clean room sandwich panel.
The ground should be smooth, flat, seamless, corrosion resistant, impact resistant, not accumulating electricity, easy to dust and clean, and resistant to moisture and water.
doors and windows
The surfaces of doors and windows in the clean room should be smooth and clean, without requiring surface polishing, but should be easy to clean and seal.
External wall windows are required to be sealed and cannot be opened to prevent air leakage and moisture condensation, and have thermal insulation performance. Windows and walls should be flat without leaving window sills. If there is a window sill, it should be angled to prevent dust accumulation and facilitate cleaning.
Ceiling and technical inter layer
The ceiling of the clean room should be sealed seamlessly, clean, and free of debris, and can withstand indoor pressure. According to the process and overall plant design requirements, a technical partition is provided above the ceiling of the clean room to lay water, gas, air conditioning, and power pipelines.
Electrical lighting facilities
In the clean area, lighting fixtures with simple external appearance, not easy to accumulate dust, easy to wipe, and easy to disinfect and sterilize should be selected. General lighting fixtures should be installed openly. When ceiling mounted, reliable sealing measures should be taken at the joints between the fixtures and the ceiling. The lamp structure must be easy to clean, replace the lamp tube under the ceiling, and maintain.
Plant layout requirements
1. Comply with production process flow;
(1) The layout of the production process should conform to the process flow, be compact and reasonable, reduce the roundabout and round-trip of the production process, facilitate the rapid transfer of materials, facilitate production operations, management, and minimize errors and cross contamination.
(2) There should be production and storage areas suitable for the production scale. Necessary process equipment shall be installed in the production area, and materials unrelated to operation are not allowed to be placed. The storage area shall not be used as a passageway for personnel not working in the area.
(3) Production operations within the same plant and between adjacent plants shall not interfere with each other.
(4) The preparation production workshop should not only have outdoor facilities for various production processes, but also be equipped with a sufficient area of production auxiliary rooms.
2. Reasonable trend of people flows and logistics;
Human flow refers to the movement of people into and out of a clean room and within it. Logistics refers to the flow of materials required for drug production and the resulting intermediates, semi-finished products, and other materials into and out of the clean room.
Shortcomings: The batching room should separate the flow of people from the logistics.
Second Change: Employees entering the clean area from the general area need to undergo a second change of clothing. The second changing room is usually divided into two areas, the non-clean changing area and the clean changing area.
Third shift: Employees who enter the sterile area from the clean area need to change their clothes for the third time.
Batching room
All auxiliary materials in the batching room must be placed as required, away from the ground and wall.
The accessories that are not used up every day must be resealed.
When abnormal auxiliary materials occur in the batching room, they must be reported in a timely manner.
disinfection room
The disinfection room must be designated by a dedicated person, and a dedicated room. The disinfection room must not be mixed or shared with other rooms.
The door of the disinfection room should be marked with the words "disinfection room", and the decontamination pool, disinfection pool, and cleaning pool cannot be mixed.
No items unrelated to disinfection shall be stored in the disinfection room.
Wet cleaning is adopted for the ground, and indoor mesas, cabinet tops, and walls shall be free of dust accumulation.
Incubator
Record the temperature, humidity, and light of the culture room regularly every day, and promptly adjust, replace, or report any abnormal reactions.
Keep the room clean and disinfect the culture room regularly. (spray or fumigate with bactericide)
Inoculation room
The inoculation room should be divided into two rooms, one inside and the other outside, with an area of 5-6 m2. The outer room is a buffer room, about 2-3 m2. The two doors should not be opened facing each other, and sliding doors are required for the entrance and exit. The height is 2~2.5 m. The inoculation room should not be too large, and it is not easy to maintain a sterile state.
Doors and windows should be tight and isolated from outside air after closing.
UV sterilization lamps and fluorescent lamps that can be lifted and lowered at will are installed above the workbench and on the ceiling of the buffer room.
Flow Planning - Air Shower Room
Air shower series products are a kind of local purification equipment with strong versatility, installed between clean rooms and non-clean rooms. When people and goods want to enter the clean area, they need to be blown through an air shower room. The clean air blown out can remove dust carried by people and goods, effectively blocking or reducing the entry of dust sources into the clean area. The front and rear doors of the air shower room/cargo shower room are electronically interlocked, which can also act as an air lock to prevent impure air from entering the clean area.
Logistics Planning – Pass Box
The pass box is mainly applicable to the transfer of small goods between clean areas and non -clean areas, or between clean rooms and clean rooms. It can effectively reduce the number of times the clean room door is opened and minimize the pollution in the clean area. According to the use requirements, the surface of the transfer window box can be sprayed with plastic, and the inner liner can be made of stainless steel, with a beautiful appearance. The two doors of the transfer window are equipped with electric or mechanical interlocking devices, which can effectively prevent dust from entering the low cleanliness level area into the high cleanliness area. It is a necessary and excellent product for clean room workshops.
Buffer chamber
It can be used to purify materials while maintaining the cleanliness and positive pressure of the equipment room.
The logistics purification system for drug production uses a buffer room or pass box with interlocking facilities, and cannot be used as a pedestrian passage.