DETAIL INSTRUCTIONS TO PRODUCE A MEDICAL MASKS:
With the comlicated situation of the new coronavirus epidemic, the shortage of health’s protective in preventing and controlling in many areas of the world remains an urgent issue that needs to cope with. The diseased follow the rules of preventive hydroponic, preventive disease epidemic model requires that produce cannot get back as usual without masks and the lack of masks.
1. BASIC STRUCTURE AND FUNCTION OF A DISPOSABLE MEDICAL MASK
Formal medical mask include three layers of nonwoven. The inner layer is a common non-woven, mainly used to absorb moisture and moisture worn from user; the outer layer is a waterproof non-woven fabric, mainly used to isolate liquid sprayed by patient; the middle layer used for polypropylene-melted nonwoven fabric is processing by electret as a barrier against germs.
The most important material of a medical masks is a non-woven fabric that is melted with polypropylene after processing by electric *. It is important to remember these two keywords, as this is the key split to filter the new coronavirus.
* Filter of medical mask is Brown diffusion, trapping, inertial collision, gravity deposition and electrostatic adsorption. The first four factors are physical factors, meaning that the characteristics of nonwoven fabric are produced by the method of decay, the filtration percentage is about 35%; This is not right with the requirements of medical masks, we need to put electricity and let the fiber be charged and use static electricity to collect aerosol where the new coronavirus is located.
2. SPECIFICATIONS AND STANDARD REQUIREMENTS FOR MEDICAL MASKS
Common inspection standards for masks: (reference to China)
* EN 149 Respiratory protection device - Reduce half mask to protect against particles - Need marked
* EN 14683 Medical Mask pieces - Requirements and test methods
** Standard specification of ASTM F2100 for performance of materials used in medical masks
* CFR 42 Part 84 NIOSH Instructions on how to select and use respirators Requirements and test methods
•• GB2626 Respiratory protective equipment. Respirator for air particulate
3. MEDICAL MASK MANUFACTURING PROCESS
Inspection of input’s materials: materials (with 3-layer, 4-layer masks) for produce medical masks including: non-woven fabrics, activated carbon cloth (carbon) anti poison, antibacterial, waterproof, antibacterial filter cloth will be checked in appearance and physical characteristics before put into production.
Medical masks are manufactured using materials is some type of woven, knitted and non-woven. Today, most medical masks are made from nonwoven cloth. The technic for producing single-use nonwoven fabric is cheaper than that of woven and knitted fabric. Non-woven fabric helps protect the environment.
Process of making medical masks with automatic machines
Depending on whether you want to produce 3-layer or 4-layer medical masks, the input will be set up with the prices of placement of feed lots (roller, feeder) that are easy to manipulate. Each fabric (layer of mask) will correspond to a roll rack.
The fabric layers are pulled up and stacked into a long strip by the rollier system. It is also the types of masks that we often see with the outside surface (green eyes) that are waterproof and the inside (white) that absorbs water produced by the user during the steaming and talking process.
The layers of fabric are passed through the creasing roller system (water traps, semi-droplets). The inner pleats help retain water, while the exterior prevents the water from being kept on the surface for a long time.
Next, the roller (essentially the ultrasound heads rolled holes in the tank on the two sides of this strip) grout works to pull the strip away, just flattening the edges to create a tight and horizontal plane of the respirator.
In this process, the name, the mask code, also the tip of the ultrasonic welding roller is to quickly create on the surface.
The mask brace has also been provided with a system of provide, cutting according to the standard length and threaded into one of these two edges. This position will then rest on the nose of the wearer to keep the mask firmly in use.
The few layers are passed through the creasing roller system (water traps, droplets). Internal folds help retain water, outside prevents long-held water on the surface.
The cutting head with the blade mounted on the roller with the circumference of the face of the mask will do the job of dividing the strip into masks of a fixed size after each rotation of it. The cutting head will sand quickly, sand marks will be sharp.
Depending on the requirements of the mask shape, the number of layers, the type of a few, with no antibacterial to use and product standards of each export market. The solder mask ultrasonic body panel is designed with different roller surface (horn welding bottom).
With regular medical masks, a rectangular welding profile with four long-distance running lines running on four sides is created with a nonwoven ultrasonic welding machine.
More advanced types of medical masks (pictured below) have a more complex profile. Accordingly, the cutting edges on the cutting heads can be in the form of roller spinning fi on the menacing surface or die cutting structure type 2 (die cutting).
The higher the requirement, the more complex the mask making machine. Of course, the price of the machine and the manufacturing system, the cost of investment also increases.
The mask plates are according to the system of tape welding machines strapping, hemming. Preparing for welding on ultrasonic nonwoven welding machines. Depending on the speed and required output, the mask body panels can be moved directly to one welding head, covered or automatically divided into 2, 3 conveyors to 4, 6 ultrasonic welding beans (each side 2 head or 3 head) to ensure productivity.
The straps are independently fed, cut and welded on both sides. With a border-type mask, the double-sided border of the mask is folded, threaded and welded with the ultrasonic welding mask to help fast, accurate welding and ensure the quality of the strap.
Complete masks at the end of the transfer line are arranged in bundles, sterilized. Then the workers bagged and boxed, complete in cartons.
Inspection output: finished products are inspected in appearance, certainty of strap’s certainty, fringe, nose bar.
In addition, the manufacturing process also needs to ensure hygiene in processing and packaging, ensure the standards (TCVN 7312 2003) for dust masks and (TCVN 8389-1: 2010) for regular medical masks.
Process to ensure output quality:
3.3.1 The fact that the quality of filter materials for medical masks is difficult to control through convenient inspection methods, the standards of the production quality management system are the main means for enterprises to ensure their quality. The quantity of the product used for the purpose of the mask is therefore assessed based on the registration technology and the quality management system. Inspectors will pay attention to the production process and supply of antibacterial paper materials. Enterprises should control the antibacterial paper raw material of the product, check the origin and quality requirements of the material, and have a stable production and supply process to ensure product quality. In this process, a number of reliable testing equipment is used for testing. Raw material: It is necessary to check the sampling of non-woven raw materials, antibacterial paper materials, the sampling process will use sand sample machine with round and ladle to determine the weight of non-woven fabric, and also measure the waterproofing (spray assessment) and air permeability of the outer layer of the respirator and the moisture absorption of the inner layer. The breath factor is also determined whether the quality of the cloth can meet the requirements. And packing link: To determine whether the number of boxes is correct or not, the factory usually checks by simple weighing.
3.3.2 The safety and effectiveness of medical masks are just a few factors that play a decisive role. The proper use and wearing of the respirator also directly affects the protective effect. Therefore, all useful information to the customer should be clearly stated in the manual to avoid mask misuse and reduce the risk of cross-contamination. For example: indicate the method of wearing, identify the front and back of the mask, to show the use time, indicate the level of material’s fitler or related conductivity, etc. In addition, medical personnel do not fully understand the scope of application of different types of medical masks. The scope of masks should be clearly stated in the instructions and the training of health workers should be strengthened.
Aseptic medical masks are manufactured in clean factory conditions. Concentrated by the maximum number of dust particles allowed to be equal to or greater than 0.5 microns and the number of particles not exceeding 3.5 million, the number of particles greater than or equal to 5 microns cannot exceed 20,000. In addition, the maximum permitted number of microorganisms, the number of phytoplankton cannot exceed 500 per cubic meter; The number of sediment bacteria must not exceed 10. At the same time, the pressure difference between clean rooms of the same cleanliness level is the same. For different cleanliness, the pressure difference between adjacent clean rooms is> = 5Pa and between clean rooms and non-clean rooms is> = 10Pa. This is primarily to ensure that air flows from the clean area to the unclean area, and to prevent backflow. The temperature is usually controlled at 20-22 C in winter, 24-26 ° C in summer; fluctuating + - 2 "C. The humidity of the clean room in the winter is controlled at 30-50% and the humidity measurement of the clean room in the summer is controlled at 50-70%. When there is no special requirement It is recommended to wear a clean working shirt without creating a comfortable feeling.For the layout of functions, equipment and management requirements, please refer to Check Point Guide. for the Clean Room (District) of the Medical Device.
3.3.3 Medical mask quality check:
Medical masks may only be sell out after passing specific tests due to the characteristics of medical purposes. Inspection of disposable medical masks includes factory inspections and masks.
Factory inspection items should include at least the following items: exterior, structure and dimensions, caps, masks, indicators of birth and ethylene oxide residues (if ethyleneoxide sterilization is required.
Testing should be a product standard.