Complete Guide of the Processes Involved in Face Mask Manufacturing

Surgical masks, N95 masks, and KN95 masks are always in limited supply (The N95 equivalent of China). The majority of people believe that the methods involved in making a face mask by a face mask manufacturer are highly complicated, which is why there is a scarcity. As a result, it's critical to understand the mechanisms required for mask manufacturing.

Face mask manufacturing processes

1. Combining: Three distinct non-woven textiles were layered neatly together by the laminator above on the production line's permanent support. A trumpet-shaped feeding port is located here, and a string of wires is continuously fed into the laminating machine through the trumpet.

 
2. Stitch: When wearing the mask, the nose clip must be pinched to the bridge of the nose in order for the mask to be secure and the protective effect to be maintained. The wire must be matched and conveyed down one side of the non-woven fabric, then the next edge must be rolled, the back must be stitched, and the wire must be stitched in.

 
3. Folding mask: Masks for adults are all the same size. It is ensured that different persons have the appropriate size needs in order to wrap the nose, lips, and chin to the maximum extent possible. It must then be flattened using a roller machine to create a crease for improved processing in future procedures. After that, it's trimmed down to a single mask unit.

4. Strengthen: This stage necessitates the use of additional non-woven fabric to press-fit the mask's edges. The excess non-woven fabric unites the single mask bodies that were cut in the previous stage at this point, so we must separate them once more.
Fixing the ear loop: It is vital to use adhesives at the four corners of the mask to improve the binding strength of the rope and the mask body. It is mechanically transferred during the pressing process. Hang the ear rope from the heat pressing equipment and adhere it to the mask with an adhesive.

5. Disinfecting: The mask will invariably become contaminated by germs during the entire manufacturing process, including not only the machine's processing contact but also the touch of many artificial linkages. Face mask manufacturer is aware of this. If it's just a regular mask, it doesn't need to be sterilised, but medical treatment necessitates the use of a ring. The steriliser for oxygen ethane (EO) has been sterilised. To achieve the goal of sterilisation, the mask was placed in an atmosphere containing 400 mg/L of ethylene oxide, and the hydroxyl group was alkylated to render the microbial macromolecules inactive. 

Only medical masks made using the above procedure use high-melt melt-blown non-woven textiles for filter materials, electric treatment to promote electrostatic adsorption, disinfection with ethylene oxide after manufacture, and ethylene oxide analysis after 7 days. Masks made with this procedure is a certified, non-hazardous medical mask that can be used to prevent the spread of the new Covid variants.

Certifications and evaluation needed by the 3 ply surgical mask manufacturer

Infectious agents can be spread in a variety of ways during surgical operations in operating rooms and other medical facilities. The nose and mouth are two of the most common ways for germs to spread. A person discharges little and large volumes of secretions from the mucous membranes through the mouth and nose while breathing, speaking, coughing, or sneezing. These droplets evaporate fast, leaving nuclei floating in mid-air. If the nuclei are small enough, they can move via the air to a vulnerable spot like an open operating wound or sterile equipment, or they can be breathed. As a result, every medical facility purchases surgical masks from a reputable 3 ply surgical mask factory to be sure of its guaranteed protection.

BIS Certification

This accreditation guarantees that the product's quality is preserved at all times. This BIS Certification comes with a plethora of advantages. Here are a few examples:

• Before use, verifies the quality to ensure that it is usable.
  
• Examining the product’s authenticity, safety, and purity.
• Quality assurance.
• Winning consumer trust.
• Implementing an ambitious edge.
• Quality assurance will traverse into more sellouts.

Furthermore, the government has mandated that all producers obtain a BIS licence and ISI-marked masks before shipping to HLL or any other government entity.

Evaluation of surgical mask in Europe

Surgical masks must be CE-marked and meet the standards of EN 14683: Medical face masks - Requirements and test procedures in Europe.

 

Surgical masks are defined as medical devices that cover the mouth, nose, and chin to provide a barrier that prevents infectious agents from spreading from hospital workers to patients.

In terms of performance, the mask is examined as a finished product and must meet a variety of requirements.

The results of the following tests are used to categorise the masks.:

• bacterial filtration efficiency (BFE)
• breathability (delta P)
• splash resistance (synthetic blood)
• microbial cleanliness
• biocompatibility

Because surgical masks are class I medical devices, the manufacturer must conduct a risk analysis and, if necessary, further testing to comply with the European Medical Device Regulation 2017/745.

There are no specifications regarding barriers against inert particles.

Evaluation of face masks in the USA

Surgical masks are classified as medical device class 2 by the FDA, which governs all medical equipment in the United States. The FDA has created rules that manufacturers must follow to obtain a licence to sell certain medical devices on the market. Surgical masks, operations, isolation, dental interventions, and laser treatments all fall within these guidelines. Furthermore, the FDA strongly advises that a 3 ply surgical mask factory explicitly states the product's intended usage on the label. The FDA also requires that filtering efficiency be measured for inert particles (latex) and that fire tests be performed.

 

The performances of the materials composing the 3ply surgical mask are evaluated by five tests:

• bacterial filtration efficiency
• breathability (delta P)
• splash resistance
• particle filtration efficiency
• fire test According to the results, the masks are classified into three levels.

Facts About a Good Face Mask Factory

A good face mask factory sells millions of masks of various specifications to various outlets and e-stores in India as well as in international countries. In the current scenario, masks are used as preventive equipment against the COVID-19 fiasco as well as protection against dust, pollen, smoke and particles that are fatal to enter the respiratory tract. So, selling masks in India as well as overseas has steady output. So, if you are planning on opening a new venture for selling masks, it is the best time to do so. So, we have tried our best to give you a game plan. Let us see what they are:

 
Budget: Always keep to your budget, capital investment, marketing and advertising, and, most importantly, a contingency plan in case you lose money in the first quarter. Continuously tapping your budget line is a good idea because it will work as a backbone for expansion in different departments.

 
Registration Act: Whatever course you choose, you must register your company as a private limited company, a public limited company, or a proprietorship plan with the Ministry of Corporate Affairs.

 
Great Infrastructure: To set up machinery, equipment, labourers, and personnel to manufacture masks using the correct raw materials, you'll need a legal place (office space with no legal conflicts with the government). We require a consistent supply of polypropylene, just like we do for N95 masks (a material that has high efficiency, is perfect for particle filtration and has been approved by CDC).

 
Machinery: Instead of renting out machinery, you should buy it to ensure a proper flow of your manufactured masks.

 
Requirements: Each mask must pass a series of tests to determine its level of protection. Medical face masks are classified as medical equipment and are subject to national laws. Regulations will lay out the legal requirements for ensuring that medical face masks provide the bare minimum of protection against the threats they are meant to guard against. The mentioned performance standards list specific requirements by classification. Like:

• Registration and approval
• Classification designations
• Marking and labelling
• Particulate Filtration Efficiency (PFE)
• Bacterial Filtration Efficiency (BFE)
• Differential pressure (breathability)
• Blood penetration resistance
• Flammability
• Microbial cleanliness
• Biocompatibility

Quality Check: Examine the product or material to see if there is a compelling rationale to continue with product development. It will save you time and money by eliminating the need for unneeded testing. A complete test, including a test report and authorisation that is ready for certification and, as a result, for usage after the Covid-19 epidemic. To ensure improved efficiency, a competent face mask factory would subject its masks to frequent quality checks.

 
Marketing channels: A brief view of market statistics is a great way to know the demand and needs of the common masses.