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Precautions for the layout of the 100,000-level clean workshop - frequently asked questions

Precautions for the layout of the 100,000-level

According to relevant requirements, the layout of the should comply with the principles of reasonable layout, strict division of areas, prevention of pollution and convenient production and operation. The following are the precautions for the layout of the .

One, pay attention to prevent...

Text label: Class 100,000 , Class 100,000 workshop layout

Precautions for the layout of the 100,000-class

According to relevant requirements, the layout of the should comply with the principles of reasonable layout, strict division of areas, prevention of pollution and convenient production and operation. The following are the precautions for the layout of the .

1. Pay attention to prevent insects from entering

Insects are an important factor causing pollution. In addition to setting up insecticide lights at the door, the following two measures can be taken:

①On the plane, the isolation belt can be prohibited from planting grass and flowers within a width of about 3m outside the outer wall of the , and paving the cement floor, or 'digging the ground three feet' to make it dozens of centimeters deep and wide The ditch, plastered with cement, filled with pebbles, can also have drainage. Because there is no water in it, chemical liquids can even be sprayed frequently. In the south where there is a lot of rain, the lower part of the ditch can be filled with a sand layer, which can also be used for drainage, and then paved with pebbles, so that insects can neither survive in it, nor can it be difficult to cross such a long-distance isolation zone to prevent them from climbing into the pharmaceutical cleanroom.

2 After the air curtain is installed on the outside doors and windows of the , that is, install the air curtain on the outside of the entrance and put it into operation. It is also necessary to open the air curtain first and then open the door and close the door first and then close the air curtain, which will be more effective than pest control. The lights are even better at preventing insects from flying into the workshop. If a soft strip diaphragm is installed under the curtain and flutters with the wind, the effect is better.

③Anti-flying insect blowing shower device.

Second, safe evacuation

There is another important issue in the layout. Although it is not specifically pointed out in the GMP, as a with a complex plane, it should be paid attention to, which is safe evacuation.

1. Features of

(1) The space is closed, which is not good for evacuation and rescue.

(2) The tortuous plane layout increases the obstacles on the evacuation route and prolongs the distance and time for safe evacuation.

(3) Several clean rooms communicate with each other through air ducts.

(4) Some polymer synthetic materials are used for decoration, which will produce special smoke when burning.

2. Fire partition

According to 'Code for Fire Protection of Architectural Design' and 'Code for Design of Clean

3. Evacuation distance

Consider the crowd walking speed is about 16 on flat ground

m/min, 10m/min on the stairs, additional obstacles on the way, if the evacuation distance is controlled to 50m, the evacuation can be completed in about 4 minutes. Of course, this also requires clear guidance signs and emergency lighting. The evacuation distance is the basis for determining the location of the safe exit.

4. Safe Exit

When the building area exceeds 50m2 and the number of people exceeds 5, there should be no less than two safety exits for each production floor, each partition or each clean area of u200bu200bthe .

Safety exits should be scattered and arranged in different directions, as far as possible in opposite directions. From the production site to the safety exit, the tortuous personnel purification route should not be passed. Net entrances should not be used as safe exits.

The door of the safety exit cannot be locked and should be able to be opened from the inside.

One way is to install a fixed glass door with tools such as axes and hammers on the side, so that you can break out of the door in an emergency.

The second method is that the door is plugged in from the inside, and it can only be opened from the inside, but its tightness is poor.

The third method is to have a door that is not inserted or locked outside, and there are two layers of plastic film inside, which can prevent people from entering in normal times, and break the film in an emergency. This method is relatively simple.

5. Fire exit

Windowless workshops should be equipped with doors or windows at appropriate locations as fire exits for firefighters to enter. When the distance between doors and windows is greater than 80m, a fire exit should also be set up at the appropriate position of the outer wall, with a width of not less than 750mm and a height of not less than 1800mm, and with obvious signs.

6. Door opening direction

According to the 'Design Specifications for Clean WorkshopDoors to the outside (including safety doors) should be opened outward, that is, in the direction of evacuation.

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