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Standard for class 100000 dust-free workshop for production of medical masks [detailed description]


   Due to the epidemic, this year's most popular is probably the medical mask, which is still in a difficult state. In the environment of short supply, many enterprises have also joined in the production of masks, and some small black heart workshops have also joined in, but this black workshop will definitely be checked, because their production environment is not up to standard, and the masks have not been sterilized.

   So, what are the environmental requirements for mask production? What is the workflow like? How is the mask material transported? Wait for a series of questions, Aijia Xiaobian below for you to answer questions!

Technical(圖1)

1. About medical masks

1. According to the classification catalog of medical devices, medical masks are divided into surgical masks and protective masks, both of which are class II medical devices.

2. According to the guiding principles for the technical review of the registration of medical mask products issued by the State Administration, the products are generally divided into medical protective mask, medical surgical mask and disposable medical mask based on their intended use and scope of application.

Note: according to the latest classification of medical devices, disposable medical masks are classified as 141400, which belong to the protective articles for medical personnel and are class II medical devices.

Since the medical mask belongs to class II medical devices, all its production processes must be carried out in accordance with the regulations. After the completion of design and development, production samples (the process of production samples shall meet the GMP conditions) are required to be sent for registration inspection, preparation of registration data, product registration, and the technical requirements of products prepared in accordance with the administrative measures for registration of medical devices are also submitted.

II. Production environment and requirements of respirator

Medical devices are divided into three categories, and masks are classified into two categories.

It is a compulsory requirement of the state that the production environment of medical masks must be a clean room of 100000 level or above. Standard: dust free and sterile. Some masks with special requirements must be produced at constant thermometer humidity.

Technical(圖2)

< strong > standard for class 300000 and 100000 dust-free workshops

100000 level high clean and dust-free workshop: it refers to the clean level, which can be understood as the dust-free room, but the dust-free room also needs air change. The air changed in needs to be purified in the purification room and then sent to the dust-free room. 100000 level requires air change 15-19 times per hour, and the air purification time after complete air change shall not exceed 40 minutes.

1. purification workshop principle

Generally, three filtration sections, i.e. primary filtration, medium filtration and high-efficiency filtration, are required. Air flow → primary purification → humidification section → heating section → surface hot section → surface cold section → medium efficiency purification → fan air supply → pipe → high efficiency purification air outlet → blowing dust and bacteria and other particles into the room → return air shutter → primary purification. The above processes can be repeated to achieve the purification purpose.

2. 100000 level purification workshop standard

When there is no special requirement for temperature and humidity in the 100000 class clean room, it is better to wear clean work clothes without comfortable feeling. The temperature is generally controlled at 20-22 ℃ in winter and 20-22 ℃ in summer 24 ~ 26 ℃, fluctuation ± 2 ℃; the humidity of clean room in winter is controlled at 30-50%, and in summer is controlled at 50-70%.

Standard 1: the maximum allowable number of particles ≥ 0.5 μ m shall not exceed 3.5 million, and the number of particles ≥ 5 μ m shall not exceed 20000.

Standard II: the maximum allowable number of microorganisms, the number of floating bacteria shall not exceed 500 / M; the number of settling bacteria shall not exceed 10 / Petri dish.

Standard 3: differential pressure. The pressure difference between clean rooms of the same cleanliness level shall be the same. The pressure difference between adjacent clean rooms of different cleanliness levels shall be ≥ 5pa, and between clean rooms and non clean rooms shall be ≥ 10Pa (mainly to ensure that the air flows from the clean area to the non clean area and avoid air backflow).

Design of grade 400, 100000 dust-free workshop

1. Power distribution

The general illuminance value of the main production rooms in the clean room (area) should be ≥ 300lx; the illuminance value of auxiliary rooms, personnel purification and material purification rooms, airlocks, corridors, etc. should be 200 ~ 300lx.

2. Noise control

1. During the dynamic test, the noise level in the class 10000 clean room shall not exceed 70dba.

2. During the static test, the noise level of the ten thousand level turbulent clean room should not be greater than 60 DBA.

3. Air distribution

The main air supply methods of 100000 class clean room are: 1. Air supply from local orifice ceiling; 2. Air supply from ceiling with diffusion plate high efficiency air filter; 3. Air supply from upper side wall.

The main air return methods used in class 100000 clean rooms are: 1. Air return is arranged at the lower part of one side wall; 2. When corridor air return is adopted, the air return is arranged uniformly in the corridor or centralized at the end of the corridor

Air speed of air supply outlet (M / s): 1. Orifice 3-5; 2. Side air supply outlet: (1) attaching jet 2-5 (2) the return air of the lower part of the same side wall is 1.5-2.5, and the return air of the lower part of the opposite side wall is 1.0-1.5.

Air speed at the air return port (M / s): 1. The air return of the clean room shall not be greater than 2; 2. The air return in the corridor shall not be greater than 4.

Technical(圖3)

   v. personnel in and out of the dust-free workshop

From dressing & gt; & gt; hand washing & disinfection / buffering & gt; & gt; wind drenching & gt; & gt; clean corridor & gt; & gt; Every clean workshop must be dust-free.

Technical(圖4)

  < strong > 6. Logistics of dust-free workshop: < strong >

1. Production process of medical cup type protective mask

Select raw material & gt; & gt; hot press & gt; & gt; make outer mask & gt; & gt; weld trimming & gt; & gt; print mask label & gt; & gt; Air valve drilling & gt; & gt; bridge welding & gt; & gt; manual / machine sticking inner bridge & gt; & gt; welding ear band & gt; & gt; welding air valve & gt; & gt; Internal packaging workshop & gt; & gt; external integrated packaging & gt; & gt; inventory / shipment

2. Material transportation process

From the initial selection of raw materials to the final forming of inner package, the whole process must be dust-free and sterile. Workshop layout should be reasonable, pay attention to smooth process flow, smooth connection between the upper and lower processes, short and straight transportation distance, and avoid detour and round-trip transportation as much as possible. Production process and room layout of mask in 100000 level purification workshop (D level purification workshop):

VII. Standard operation procedures for personnel entering and leaving 100000 level purification workshop

1. Purpose

Establish standard operation procedures for the entry and exit of 100000 level clean area personnel to ensure that the clean area is not polluted by personnel.

2. Scope

Access of 100000 level clean area personnel in the workshop, including production and operation personnel, maintenance personnel and management personnel.

3. Responsibility

3.1 all personnel entering and leaving the 100000 level clean area shall be responsible for this operation procedure.

3.2 the team leader and site quality controller in the clean area shall be responsible for supervision and inspection.

4. Content

4.1 enter the door of the production workshop and put down your rain gear and articles at the specified position.

4.2 change slippers. At the shoe changing place, sit on the shoe stool, take off the household shoes, put them into the shoe cabinet, rotate 180 degrees, and take out your own slippers on the upper part of the shoe cabinet.

4.3 change work clothes. Enter the general work area office, take off the casual clothes of employees and change into work clothes.

4.4 wash hands. Wash hands according to the hand washing process.

Four point five Change work shoes. Enter the door of the shoe changing room, sit on the horizontal stool, face the door, take off the slippers, put the slippers into the lower layer of the shoe cabinet, take out your work shoes from the upper layer of the shoe cabinet, and sit and rotate 180 degrees to put on your back to the door.

4.6 wash hands and dry.

4.6.1 moisten your hands and hands to your wrist 10cm on the sink, wash with detergent, and make the skin of 10cm on hands and wrists full of froth and rub for about 15 seconds.

4.6.2 rinse your hands with water, wash the foam on your hands, turn your hands up and down, and rub until they are not creamy. 4.6.3 use eyes to check whether hands are clean.

4.6.4 extend the palm to 8-10cm under the drying cell phone, dry the hand until it is dry.

Four point seven Change into clean underwear. Take off the work clothes and put them into the personal locker. Take off the work cap, work clothes and work pants with personal number from the hook on the wall of the change room and put them on. Put them on from top to bottom, i.e. first put on hat, mask, then coat, then pants. Pay attention to tie the top into the trouser belt, put the hair into the hat, and check whether the clothes and hats are neat.

4.8 wash hands and disinfect.

4.8.1 moisten your hands and hands to your wrist 10cm on the sink, wash with detergent, and make the skin of 10cm on hands and wrists full of froth and rub for about 15 seconds.

4.8.2 rinse your hands with water, wash the foam on your hands, turn your hands up and down, and rub until they are not creamy. 4.8.3 use eyes to check whether hands are clean.

4.8.4 disinfection. Immerse the hands on the wrist 10 cm into the chlorine containing disinfectant for 30 seconds.

4.8.4 extend the palm to 8-10cm under the drying cell phone, dry the hand until it is dry.

4.9 wear one-piece clothes. Take the one-piece suit with personal number out of the wardrobe and put it on in the order from bottom to top. Pay attention that the one-piece suit is not allowed to touch the ground.

4.10 hand disinfection. Push the door into the buffer chamber, put your hands under the automatic spray sprayer with 75% ethanol, disinfect the spray, shake your hands, and let the alcohol dry.

4.11 enter clean area. Open the buffer room door and enter the clean area.

4.12 personnel leaving the clean area shall follow the reverse procedure of entering the clean area. Pay attention to the order from bottom to top when undressing.

Four point one three External visitors must be approved by the factory, under the guidance and supervision of the workshop management personnel, and enter and exit the clean area according to the specified procedures. Visitors must strictly abide by the management regulations of the workshop clean area. During the production of clean workshop, visitors are not allowed to enter.



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