The process layout of the clean room (area) shall be in accordance with the air cleanliness level required by the production process and each process, so that the layout is reasonable and compact, which is not only conducive to production operation and management, but also conducive to the control of air cleanliness. At the same time, we should not only consider the production process, but also prevent the mixing and cross pollution between people flow and logistics. It shall mainly meet the following requirements:
(1) the entrances and exits of personnel and materials in and out of clean workshops (areas) of different cleanliness levels shall be set respectively. Special entrances and exits shall be set for materials that are easy to cause pollution (such as toxic and harmful materials, wastes in production, etc.). The entrance of personnel and materials into the clean room (area) shall be equipped with their own purification room and facilities.
(2) only necessary process equipment and facilities shall be set in the clean room (area). The area used for production and storage shall not be used as a passageway for personnel or materials not in the area.
(3) the elevator for inputting personnel and materials should be set separately. Elevators should not be located in clean rooms (areas). When it is necessary to set up due to the process requirements, a buffer room or other measures shall be set up in front of the elevator entrance to ensure that the air cleanliness level of the clean area is not affected.
(4) each clean area of each production floor of the clean workshop for veterinary medicine production shall be provided with a safety exit, generally one in the opposite direction. If the area is small or the number of personnel is small, one can be set according to the code for fire protection design of buildings.
(5) the opening direction of the door in the clean area shall be the same as that of the outdoor door and the safety door. The other doors shall be opened in the direction of high pressure.
(6) clean rooms with explosion-proof requirements shall be set according to relevant regulations.
(7) measures and flow of people. The layout of personal purification (referred to as personal purification) in the plane of production area includes several parts, such as changing clothes (including shoes), washing and buffering.
First, change clothes.
A. the GMP requirements for changing clothes are as follows:
The material, style and wearing mode of work clothes shall be suitable for the requirements of production operation and air cleanliness level. The work clothes of different levels of clean rooms (areas) shall be clearly marked and shall not be mixed
The texture of clean work clothes shall be smooth, free from static electricity, shedding fibers and particles. The sterile work clothes must cover all hair, beard and feet, and can prevent human body falling off to the maximum extent
The work clothes used in different air cleanliness levels shall be cleaned and arranged separately, and disinfected or sterilized if necessary. No additional particulate matter shall be brought into the washing and sterilization of work clothes. Cleaning system shall be established for work clothes, and cleaning cycle shall be determined. The work clothes used in the pathogenic microorganism culture or operation area shall be cleaned after disinfection
Clean work clothes of 100000 level and above shall be washed, dried and sorted in clean room (area), and sterilized as required if necessary
B. the dressing stage should be divided into ordinary work clothes, clean work clothes and sterile work clothes.
C. The first time is to change shoes for the first time, take off the coat and change the ordinary work clothes, and it is not allowed to enter the clean area; the second time is to change shoes and change the clean work clothes, and the second time is to design according to 300000 level or 100000 level, so that the clean air flow is forced out by the positive pressure. One does not need to send clean air, of course, less can also be sent. After changing the clean work clothes, you can enter any level area except the level 100 or level 10000 clean room under level 10000 of aseptic operation. It can be clearly marked in different clean rooms (areas) or different levels of work clothes colors, etc., and it is not allowed for people wearing different clean rooms (areas) or different levels of clothing to run around.
When the clean area (room) is large or there are many clean rooms, dressing rooms can be set up in different level areas
D. three changes are required to enter the sterile operation area (local level 100 or level 10000 under level 10000) and change the sterile work clothes. According to the calculation, even if the environment for dressing and dressing is 300000, when all the particles falling on the body are shaken off in a clean room of 25m3 (25 times of air change) in 3min, the dust concentration of each liter of air in the room only increases by 2.02 particles in 1min, which is really a little insufficient.
E. at the door or in the door of the class 100 clean room for aseptic operation, set up the third change aseptic clothing cover, and the staff can cover another aseptic clothing. Of course, you can directly change into sterile clothes after shower and enter the sterile operation room nearby.

F. take off clothes and put on work clothes when entering must be carried out in different rooms. It is a very important principle to adopt the pass type in the design of shoe changing, undressing and changing (second change).

G. as the laundry is a place with water and steam, it is required to exhaust air and keep negative pressure. If the cleanliness of finishing environment is higher than that of adjacent environment (such as corridor), the environment (part of laundry or another room) also requires relative positive pressure, which can be achieved by setting buffer room.
Wash. Lavatory includes the following contents: A. one or two toilets B. wash hands before and after the first or second shift C. hand disinfection before and after the second or third shift D. shower before changing sterile underwear.
It is better to set the toilet in front of the first change, but it is inconvenient to use, so it can also be set in the non clean area in front of the second change
Shower facilities shall be considered in combination with local environment, personnel health and process requirements.
In order to reduce the impact of water, as pointed out by EU GMP, "the general hand washing equipment is only set in the first level dressing room", and only the equipment for disinfection and hand soaking is set before and after the second and third shift Enter non sterile clean room (area) personal purification procedure enter sterile clean room (area) personal purification procedure
③ buffer facilities. Buffer facilities include airlock room, air shower room and buffer room. Normal differential pressure control is also one of the buffer facilities A. airlock is a small room where two doors cannot be opened at the same time, which has little effect on preventing pollution invasion.
B. the air shower is a high-speed (over 20 m / s) clean air blowing equipment to remove dust particles from clothes, with only a certain effect. Generally speaking: there is no need to set 300000 and 100000 clean rooms;
Generally, it is not necessary to set up a class 10000 clean room. It can also be set up for the purpose of warning
When a single person shower room is set up, one should be set up for no more than 30 people. When there are more than 5 people in the clean area, a bypass door should be set up on one side of the shower room C. buffer room: the buffer room must be provided with clean air, and its cleanliness level is the same as that of entering the room, but it can not be higher than 10000. When one side door is open, the other side door shall not be open at the same time
The area of buffer chamber shall not be less than 3m 2.
There is no need to set up buffer room between the clean rooms with one grade difference
The buffer room shall be set between the clean rooms with difference of two levels according to their specific conditions. When the self-cleaning time cannot exceed 3-5min, the buffer room shall be set
If the adjacent rooms are equipped with different pollution sources, buffer rooms shall be set up in the rooms even at the same level. In the process, such situations shall be avoided to be arranged in a plane or an area as far as possible (8) material purification measures and material circulation
① material purification on the plane of production area (referred to as material purification) can be divided into outsourcing purification (primary purification) and underwear purification (secondary purification). The primary purification does not need the purification of indoor environment, but can be set in the non clean area, and only exhaust is set in the room. Or supply clean air at the same time, but keep negative pressure or zero pressure for the clean area; the secondary purification requires a certain degree of cleanliness in the room at the same time, so it should be set in the clean area or adjacent to the clean area, and keep negative pressure for the clean area, and sometimes ultraviolet lamp can be set for disinfection.
② transfer window can be used for short-term discontinuous transfer of objects between clean rooms.
Transfer window is divided into general type, chain type and purification type.
General inter room transmission (including different levels) can be of general type, and warning signs can be used to indicate whether the door is open or not when necessary; sterile and non sterile or strong pollution source and non pollution source inter room transmission can be of interlocking type
Very worried about cross contamination between important occasions of transmission, available purification type. UV light can be set inside the transfer window
③ long time continuous transmission of crop parts between clean rooms can be realized by conveyor belt and material elevator.
A. the transmission equipment shall not cross between the strong toxic and living toxic biological clean rooms (areas) of 10000 level, the strong sensitization clean rooms (areas) and the low-level clean rooms (areas). The opening of the transmission equipment shall ensure that the air flow from the relative positive pressure side to the relative negative pressure side. If necessary, the hole shall be covered or air curtain shall be set.
B. material elevator. All elevators should not be set in the clean area. If it is necessary to set them, a buffer room should be set in front of the elevator entrance and exit.
The professional technicians of EDE purification engineering design the scheme that is suitable for the production process and reasonable project cost. The design technical indicators meet the national standard of clean room. The experienced purification engineering construction team is fast and efficient, and the after-sales service is perfect. For more knowledge of medical purification industry, please pay attention to WeChat public address: Aide-188 (Ed purify oxygen supply).