Due to the epidemic, the hottest thing this year must be medical masks, which are still in short supply. Under the environment of insufficient supply, many companies have also joined the industry in the production of masks, and some black-hearted small processing workshops have also joined, but this black workshop will definitely be investigated because their production environment is not up to standard and the masks are not sterilized .
So, what are the environmental requirements for the production of masks? What is the work flow like? How is the mask material transported? Wait for a series of questions, here are answers for everyone!
Mask production
1. About medical masks
1. According to the Medical Device Classification Catalog, medical masks are divided into surgical masks and protective masks, which are all second-class medical devices.
2. According to the “Guiding Principles for the Technical Review of Medical Mask Product Registration” by the National Bureau, based on the intended use and scope of the product, it is generally divided into medical protective masks, medical surgical masks and disposable medical masks.
Note: According to the latest classification of medical devices, single-use medical masks are classified under the number 141400, which are protective equipment for medical personnel and are second-class medical devices.
Since the medical mask is a second-class medical device, all its production processes must be carried out in accordance with regulations. After the design and development are completed, production samples are required (the process of production samples should meet the requirements of GMP), send registration inspection, prepare registration materials, perform product registration, and submit the product technical requirements prepared in accordance with the “Medical Device Registration Management Measures” .
Second, the mask production environment and requirements
There are three types of medical devices, and masks belong to the second type of medical devices.
The state mandates that the production environment of medical masks must be a class 100,000 clean room or a clean workshop. The standard: dust-free and sterile. Some masks with special requirements must be produced under constant thermometer humidity.
Mask production environment
Standards for Class 100,000 Cleanrooms
Class 100,000 high-clean dust-free workshop: Refers to the clean level, which can be understood as a clean room, but the clean room also needs to be ventilated. The air that has been changed in needs to be purified through a clean room and then sent to the clean room. Class 100,000 requires 15-19 ventilations per hour, and the air purification time after full ventilation does not exceed 40 minutes.
Purification workshop principle
Generally, it has to go through three filtering sections: primary effect filtration, intermediate effect filtration, and high efficiency filtration. Airflow → primary effect purification → humidification section → heating section → surface heating section → surface cooling section → intermediate efficiency purification → fan air supply → pipeline → high efficiency Purification air outlet → blowing into the room to take away particles such as dust bacteria → return air shutters → primary effect purification Repeat the above process to achieve the purpose of purification.
2. Standard of 100,000 class purification workshop
When there is no special requirement for temperature and humidity in the Class 100,000 clean room, it is advisable to wear clean work clothes without producing a comfortable feeling. The temperature is generally controlled between 20-22 ° C in winter and 24-26 ° C in summer, with fluctuations of ± 2 ° C. Winter clean room humidity Controlled at 30-50%, summer clean room humidity is controlled at 50-70%.
Standard one : The maximum number of particles allowed for dust particles ≥ 0.5 micron does not exceed 3.5 million, and the number of particles ≥ 5 microns does not exceed 20,000.
Standard two : the maximum allowable number of microorganisms, the number of planktonic bacteria does not exceed 500 / m; the number of sedimentary bacteria does not exceed 10 / culture dish.
Standard three : differential pressure. The pressure difference between clean rooms of the same cleanliness level is the same. The pressure difference between adjacent clean rooms of different cleanliness levels must be ≥5Pa, and the cleanroom and non-clean rooms must be ≥10Pa. Clean area to avoid airflow.
dust-free workshop
Design of 40,000-level dust-free workshop
Power distribution
The general illumination value of the main production room in the clean room (area) should be ≥300Lx; the illumination value of the auxiliary studio, personnel purification and material purification room, air lock room, corridor, etc. should be 200 ~ 300Lx.
2. Noise control
1. During dynamic testing, the noise level in a 10,000-degree clean room should not exceed 70 dBA.
2. During static test, the noise level of 10,000-level turbulent clean room should not be greater than 60 dBA.
3. Airflow organization
The main air supply methods for 100,000-class clean rooms are : 1. partial perforated ceiling air supply; 2. high-efficiency air filter ceiling diffuser with diffuser plate; 3. upper side wall air supply.
The main air return method used in the 100,000-class clean room is : 1. the air return opening is arranged under the single side wall; 2. when the corridor air return is adopted, the air return opening is evenly arranged in the corridor or the air return opening is concentratedly arranged at the end of the corridor.
Air velocity at the air outlet (m / s) : 1. Orifice orifices 3 to 5; 2. Side air outlet: (1) attached jets 2 to 5; (2) non-attached jets with the return air 1.5 to the lower part of the side wall 2.5, return to the lower part of the opposite wall 1.0 ~ 1.5.
Wind speed at the return air outlet (m / s) : 1. The clean room return air outlet is not greater than 2; 2. The return air outlet in the corridor is not greater than 4.
V. Personnel entering and leaving the clean room
From changing clothes >> hand washing disinfection / buffering >> wind shower disinfection >> clean corridor >> each clean workshop must be dust-free.
The process of entering the clean room
6. Logistics aspects of the clean room:
1. Production process of medical cup-shaped protective mask
Selection of raw materials >> Hot pressing shaping >> Manufacture of outer masks >> Welding trimmings >> Marking of printed masks >> Breathing valve punching >> Nose bridge welding >> Manual / machine pasting inner nose bridge >> Welding ear bands> > Welding Breathing Valves >> Finished Inner Packaging Workshop >> External Integrated Packaging >> Storage / Shipping
2. Material transportation process
From the initial selection of raw materials to the final molding of the inner package, the entire process must be dust-free and aseptic. The layout of the workshop should be reasonable, the process flow should be smooth, the connection between the upper and lower procedures should be smooth, and the transportation distance should be short and straight. Avoid detours and round-trip transportation as much as possible. 100,000-level purification workshop (D-level purification workshop) mask production process and room layout:
The process of material transportation
Standard operating procedures for personnel entering and exiting 100,000-level purification workshops
1. Purpose
Establish standard operating procedures for personnel in and out of Class 100,000 clean areas to ensure that clean areas are not contaminated by personnel.
2. area
The entry and exit of the 100,000-level clean area personnel in the workshop, including production operators, maintenance personnel and management personnel.
3. Liability
3.1 All personnel entering and leaving the Class 100,000 clean area shall be responsible for this operation procedure.
3.2 The team leader of the clean area and the site quality controller are 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 bench, take off your home shoes, put it in the shoe cabinet, rotate it 180 degrees, take out your own slippers on the upper layer of the shoe cabinet and put them on.
4.3 Change work clothes. Enter the general workspace office, take off the employee’s casual clothes, and change into work clothes.
4.4 Wash your hands. Wash your hands according to the hand washing procedure.
4.5 Change work shoes. Enter the doorway of the shoe room, sit on the horizontal bench, face the door, remove 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 back and put it back outside the door.
4.6 Wash and dry hands.
4.6.1 Wet hands with water in the sink to 10cm above the wrist, and wash with detergent to fill the skin of 10cm on the hand and wrist with foam and rub for about 15 seconds.
4.6.2 Rinse your hands with water, rinse off the foam on your hands, flip your hands up and down, and rub until you don’t feel greasy.
4.6.3 Check with your eyes whether your hands are clean.
4.6.4 Extend your palm to 8-10cm under the hand dryer, and dry your hands until it is dry.
4.7 Change to clean underwear. Take off the work clothes and put them in the personal locker. Take off the work hat, work clothes, and work pants containing the personal number from the wall hook of a locker room. Wear them in order from top to bottom, that is, first wear a hat, a mask, then a coat, and then pants. Pay attention to piercing the top into the trousers’ belt, and inserting the hair into the cap, and check whether the cap is neat.
4.8 Wash and disinfect hands.
4.8.1 Wet hands in the sink with water to 10cm above the wrist, and wash with detergent, so that the skin of 10cm on the hand and wrist are filled with foam, and rub for about 15 seconds.
4.8.2 Rinse your hands with water, rinse off the foam on your hands, flip your hands up and down, and rub until you don’t feel greasy.
4.8.3 Check with your eyes whether your hands are clean.
4.8.4 Disinfection. Soak your hands to the wrist 10cm into the disinfectant containing chlorine for 30 seconds.
4.8.4 Extend your palm to 8-10cm under the hand dryer and dry your hands until it is dry.
4.9 Wear a jumpsuit. Take out the body suit containing the personal number from the closet, and put it on in order from bottom to top, taking care not to allow the body suit to touch the ground.
4.10 Hand disinfection. Push the door into the buffer room, put your hands under the automatic induction sprayer equipped with 75% ethanol, spray disinfect, and shake your hands to let the ethanol dry.
4.11 Enter the clean area. Open the buffer room door and enter the clean area.
4.12 Personnel shall go out of the clean area according to the reverse procedure of entering the clean area. Please pay attention to the order from bottom to top when undressing.
4.13 Foreign visitors must enter and leave the clean area according to the prescribed procedures with the consent of the factory and under the guidance and supervision of workshop management personnel. Visitors from outside must strictly abide by the management regulations of the clean area of the workshop. During the production of the clean workshop, outside visitors are not allowed to enter.