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This is all you need to know about building the N95 mask dust-free workshop factory

Industrial modular Clean Room time:2021/02/02 09:51:49 click:612

There are three categories of medical equipment, masks belongs to the category of medical devices, whether medical cup type respirator, or disposable surgical masks, their production environment must be clean grade level 100000 (GMP said: D clean workshop) or above Dust-free production workshop, this is a national mandatory requirements, production environment must be clean, sterile, masks have special requirements must be produced under the constant temperature and humidity range specified.

This is all you need to know about building the N95 mask dust-free workshop factory

One hundred thousand grade dust-free workshop standard

Grade one hundred thousand high clean and dust-free workshop: refers to the clean level, which can be understood as the dust-free room, but the dust-free room also needs ventilation. The air changed in needs to be purified by the purification room, and then sent to the dust-free room. Class 100000 requires 15-19 ventilation times per hour, and the air purification time after complete ventilation is no more than 40 minutes.

Two, the principle of purification workshop

Generally after the first effect filter, in effect filter, high efficiency filter and other three segments and airflow to effect at the beginning of purification, humidification section - heating section - table hot section to table cooling section, the effect of purifying - fan air - pipe to efficiently purify tuyere, blow into the room to go at the beginning of the dust particles such as bacteria - return air shutters - effective purification, repeat the above process can achieve purification.

Four basic elements of a mask factory:

1. Licensing/third party testing

2. Dust-free workshop

3. The raw materials

4. Mask/packing/sterilizer

The general process of setting up a mask factory:

Three hundred thousand grade dust-free workshop design

1. The distribution

The general illumination value of the main production room in the clean room (area) should be N300LX; The illumination value of auxiliary studio, personnel and material purification room, air lock room, corridor and so on should be 200~ 300LXO

2. Noise control

1. When dynamic testing, the noise level in A ten-thouson-level clean room should not exceed 7 Pa A.

2. When static test, the noise level of ten-thousand grade turbulence clean room should not be greater than 6 pPa A.

3. Air distribution

Air supply modes are mainly used in class 100,000 clean rooms: 1. Air supply through local orifice ceiling; 2. Ceilings with diffuse plate HEPA filter for air supply; 3. Three air supply modes, such as upper side wall air supply.

The main air return mode used in class 100,000 clean room is: 1. The lower part of the unilateral wall is arranged with the air return port; 2. 2. When the corridor return air is used, evenly arrange the return air outlet in the corridor or centrally set the return air outlet at the end of the corridor.

Air outlet wind speed (m/s) : 1. ORIFATE PLATE ORIFATE 3-5; 2. Side air supply outlet :(1) Attach jet 2 ~ 5; (2) The return air at the lower part of the non-attached jet wall on the same side is 1.5 ~ 2.5, and the return air at the lower part of the opposite wall is 1.0 ~ 1.5.

Return air outlet wind speed (m/s) : 1. Clean room return air outlet is not more than 2; 2. The return air outlet in the corridor should not be greater than 4.