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.

Choosing the Right Face Mask: 3 Things to Know

 

Rhysley

Protection is always preferred over preference. In today's scenario where on the one hand, we have a pandemic raging, with an effective vaccine still a distance away, safety is everyone's concern. There are various kinds of masks available in the market, and all masks are not the same. Keeping all the safety factors in mind for facial protection, one must ensure that the masks must satisfy the standards.

 

Choosing the Right Mask

It is primarily regarded that an ASTM rated mask is the right mask. The ASTM ratings make the process of choosing the right mask quite simple. One can select an ASTM-rated mask that gives the best protection, peace of mind and is perfect. When you are buying a mask, look for the ASTM Level 1/2/3 on the face mask package. Be careful. All face masks are not ASTM rated, making it imperative to make this critical check before buying a face mask.

What is ASTM?

Founded in 1898, ASTM International is one of the world's most extensive international standards developing organizations.  ASTM International develops and publishes technical standards for many products, materials, services, and systems. Worldwide, more than 12,800 ASTM standards are in use for safety and quality across a wide variety of industries and services worldwide, including ASTM F2100-11. Most of the healthcare organizations globally adopt ASTM recommendations to implement best practices. Since 2012, ASTM F2100-11 has been the standard for medical face masks.

Understanding ASTM Protection Levels

ASTM has a process in place to evaluate several characteristics, including sub-micron particulate filtration (PFE), bacterial filtration efficiency (BFE), differential pressure, and flame spread, and that determine whether a mask is of Level 1, 2, or 3. The primary difference between the three ASTM Protection levels is in the mask's resistance to penetration by synthetic blood. The minimum resistance pressure in a Level 3 mask is double that of a Level 1 mask.

 

• ASTM Protection Level 1: 

• This is for a low risk of fluid exposure.
• Low-Level Protection
• They are generally used for short procedures and exams that don't involve aerosols, spray, or fluid.
• ASTM Protection Level 2: 
• This is for moderate risk of fluid exposure
• Moderate Level Protection
• For low or moderate levels of aerosols, spray, or fluids.
• ASTM Protection Level 3: 
• Maximum Level Protection
• For high levels of aerosols, spray, and fluid.
• For high risk of fluid exposure 

US Food and Drug Administration, or simply FDA, is the organization that regulates medical devices in the USA. The standards have been drafted by the FDA, which serves as a benchmark for manufacturers to receive a license to sell their products in the market. These same standards also apply to surgical masks and other medical devices. FDA prescribes the measurement of filtration efficiency regarding inert particles and fire tests. 

ASTM F2100-11 is the standard specification for the performance of the material used in medical face masks.  The masks are classified into three levels. The performances of the materials composing the masks are evaluated by five tests - like bacterial filtration efficiency, splash resistance, breathability, particle filtration efficiency, and flammability test.

So, how will I know how each mask is rated?

In order to determine the rating of the face mask, one needs to simply look for ASTM Level 1, 2, or 3 on the package of the face mask. Since all face masks are not ASTM-rated, it's important to check before you choose to buy the mask. In order to ensure that one is getting the proper level of protection, it is worth the effort to find face masks that carry the ASTM rating.

How Are Face Mask Tested

Once the masks are manufactured, they should be tested to ensure their safety when used under different scenarios. All the masks are subjected to five related tests that they have to pass. 

1. Bacterial Filtration Efficiency in Vitro (BFE) – Test ASTM F2101

The effectiveness of a surgical mask is measured by its Bacterial Filtration Efficiency (BFE). The BFE test is performed on filtration materials, covers, fabrics, and devices designed to provide protection against biological aerosols. This test is a measure of a material's resistance to bacterial penetration. This test measures the percentage of bacteria larger than 3 microns filtered out by the mask. Staphylococcus aureus is the challenge material used to conduct the test. As part of the test procedure, aerosol with Staphylococcus Aureus bacteria is shot at the mask at 28.3 liters per minute. The effectiveness of the mask is measured in terms of the percentage of filtration efficiency. The percentage is calculated by dividing the total volume of the aerosol by the volume of the aerosol droplets blocked. The filtration efficiency depends on the size and number of the bacteria blocked and the amount of airflow. 

2. Particulate Filtration Efficiency (PFE) – Test ASTM F2299

PFE is another important parameter to measure the effectiveness of the mask. The Particle Filtration Efficiency test evaluates the nonviable particle retention or filtration efficiency of filter media at sub-micron levels. This test is performed on face masks and all filter material that allows only one cubic foot per minute (CFM) fluid flow to pass through it. This test for measuring the PFE is also known as the latex particle challenge. During the test, aerosol of polystyrene microspheres or latex is sprayed on the mask and the percentage of particles larger than 1 micron blocked by the mask is measured. 

3. Breathing resistance – Test MIL-M-36954 C: ΔP

Breathing resistance is measured to ensure that the mask retains its shape and has proper ventilation while the wearer breathes through it. The test aims to calculate the resistance to airflow of the face mask. It is tested by shooting a flow of air at the mask and then measuring the difference in air pressure on both sides of the mask. The breathing resistance is defined as the pressure difference divided by the surface area of the mask. When the breathing resistance is lower, the comfort level of the user is better. A differential pressure of less than 40 (Type I and II) and less than 60 (Type IIR) is required for surgical masks. The breathing resistance depends on a series of parameters such as the nature of the textile, the number of layers, thickness and the applied finish. 

4. Fluid Resistance – Test ASTM F1862

Fluid resistance, also known as the splash resistance test, is a synthetic blood resistance test for determining a fluid’s ability to act as a barrier to blood-borne pathogens. This test method offers a procedure for evaluating medical face mask resistance to synthetic blood penetration where a small volume about 2 ml of synthetic blood is passed at a high velocity of 80 mmHg, 120 mmHg, or 160 mmHg. It is useful in measuring the penetration resistance performance of medical face masks and ranking their performance. Medical face masks are used to prevent liquid penetration from the splashing of all kinds of body fluids, blood, and other potentially infectious materials. Depending on the visual evidence of synthetic blood penetration, the face mask passes or fails the test. 

5. Flammability – Test 16 CFR Part 1610: Flame Spread

The importance of the flammability test can be realized from the fact that there can be several flammable elements in a room that can easily cause and catch fire. The face masks are tested for their flammability by exposing it to a flame and then measuring how slowly it catches fire and how much time the material takes to burn. All three ASTM levels 1, 2, and 3 require the masks to be Class 1 flame resistant. 

ASTM F2100-11: Standard Specification for Performance of Materials Used in Medical Face Masks 

The table below summarizes the specific data required in order to be labeled an ASTM performance mask. 

TEST	LEVEL 1 BARRIER	LEVEL 2 BARRIER	LEVEL 3 BARRIER
ASTM F1862(Fluid Resistance in mmHg)	80	120	160
MIL-M-36954 C:  Delta P, ΔP mm H20/cm2(Breathability)	< 4	< 5	< 5
ASTM F2101: BFE (Filtration 3μm)	≥ 95%	≥ 98%	≥ 98%
ASTM F2299: PFE (Filtration 1μm)	≥ 95% @ 0.1 micron	≥ 98% @ 0.1 micron	≥ 98% @ 0.1 micron
16 CFR Part 1610: Flame Spread (Flammability)	Class 1	Class 1	Class 1

 

Does an ASTM-rated face mask provide all the protection I need?

In the healthcare environment, choosing the appropriate face mask is crucial in minimizing the spread of infectious diseases. However, choosing the correct mask is not a cakewalk considering the different options, prices, and brands that are available in the market. ASTM International is considered as one of the largest standards for the testing of face masks. 

ASTM rated masks protect one’s nose and mouth against splashes and sprays of blood and other bodily fluids, as well as bacteria and particulate matter of the sizes. Having said all that, it must be noted that the face masks do not provide respiratory protection against airborne diseases. For that purpose, a respirator such as N95, N99 is required.

Respiratory Protection During Outbreaks: Respirators versus Surgical Masks

Respirators versus Surgical Masks

Consistent use of respirators improves protection against respiratory illness

In these times of the Corona pandemic, one of the foremost strategies are to protect medical professionals from getting infected by patients. One can achieve it by consistent use of respirators that block the infectious particles and viruses, thereby reducing respiratory infections. 

In a healthcare environment, N95 filtering facepiece respirators (FFRs) and surgical masks are the two most commonly used devices. As there is a shortage of N95 respirators now, it becomes imperative to understand the difference between surgical masks and the N95 respirators to have access to proper protection. 

FFRs are designed to protect the healthcare professional and surgical masks are designed for patient

N95 respirators

When we talk about the healthcare environment, respirators have been designed to protect the medical professionals, and surgical masks have been designed to protect the patients. N95 respirators block at least 95% of particles from inhaled air. The filtering facepiece respirators (FFRs) are regulated by the National Institute for Occupational Safety and Health (NIOSH), which is a part of the Centers for Disease Control and Prevention (CDC) within the U.S. Department of Health and Human Services. NIOSH has laid down stringent test conditions to measure the minimum filtration efficiency based on which the FFRs are categorized. To provide the expected protection levels, the FFRs must seal the wearer's face preventing air leaks. FFR acts as a physical barrier between the wearer's face and contaminated hands or gloves.

Surgical masks

On the contrary, surgical masks have not been designed to protect the wearer from airborne hazards. At best, they can only limit the spread of infectious particles expelled by the wearer. Surgical masks can protect a sterile area surrounding a surgical incision from contamination by particles expelled by the wearer that can be in the form of sneezes or coughs. Surgical masks act as a physical barrier to protect the wearer from sprays, splashes, or contact with contaminated hands. Surgical masks are not governed by stringent conditions on minimum filtration efficiency and they are loose fitting in nature.

N95 respirators offer greater protection than surgical masks if worn properly - Scientific studies 

The current COVID-19 pandemic has restarted the debate on which device should be the minimum level protection in the healthcare facilities - N95 FFRs or surgical masks. One should keep this fact in mind that respirators have been designed so as to reduce the wearer’s exposure to airborne particles. Respirators do not make any claims with respect to disease prevention. Properly fitted and worn N95 masks have a minimum filtration efficiency of 95%. Greater protection against aerosols is achieved by FFRs in comparison with surgical masks in the laboratory studies, however, the clinical studies have been inconclusive.

Thus during the time of crisis and mask shortage, it becomes very important to prioritize the distribution of N95 masks and limit their usage for protection against aerosols. Once the shortage ceases and the supply chain is back to normal, facilities with a respiratory protection program must follow the CDC and Occupational Safety and Health Administration (OSHA) guidelines. These guidelines and procedures have been described in detail in the Hospital Respiratory Protection Program Toolkit.

 

surgical masks v/s N95 respirators

There have been discussions on the comparative the ability of respirators against surgical masks to protect medical professionals against influenza virus that was published in the Journal of the American Medical Association’s article, “N95 Respirators versus Medical Masks for Preventing Influenza Among Health Care Personnel: A Randomized Clinical Trial (ResPECT)”. No significant difference was reported, when a number of incidence of laboratory-confirmed influenza was compared among outpatient health care personnel, participants on trial with surgical masks v/s N95 respirators. ResPECT was conducted at a randomly selected 137 outpatient study sites at seven U.S. medical centers between September 2011 and May 2015, followed by a final follow-up in June 2016. The aim of ResPECT was to measure the effectiveness of an intervention under routine clinical conditions. One limitation of the study was that although the FDA has cleared 500 N95 FFR models and 200 surgical masks, ResPECT studied only two  N95 respirators and medical mask models. It would not be correct to generalize about the protectiveness of other models on the basis of these two models. Due to the absence of performance requirements for surgical masks regarding environmental aerosol filtration capability and no requirement of fit testing, less than 1% of surgical masks were cleared by the FDA. 

Personal protective equipment worn inconsistently by healthcare professionals reduces protection

There has been a constant debate over the use of respirators versus surgical masks by healthcare professionals. The main bone of contention in this debate is that the PPEs including the respiratory protection cannot protect the users effectively if they are not used consistently in a proper manner. 

Healthcare professionals have been reported to be inconsistently using personal protective equipment, substantially leading to reduced protection. More than 12 observational studies have proved that healthcare professionals are not using protective equipment frequently and are not removing the respirators correctly. They have been seen to take off their respirators when they should be wearing them or have been observed not to wear them at all when required. 

Authors conducting trials in ResPECT found that only 35% of medical professionals either never used surgical masks or respirators or used sometimes. This led to the conclusion that this incomplete adherence to the use of surgical masks or respirators had caused unprotected exposures, thereby leading to an increase in the probability of discovering no differences.

Adherence to infection control can be increased with observation, metrics, training, and reinforcing safety culture

The ResPECT study conducted among healthcare professionals could not definitively prove whether there was any practical difference in the protection provided by surgical masks v/s N95 respirators. However, the study emphasized an important opportunity for prevention.  This was the enhancement of the safety culture, which would improve adherence to infection control recommendations. 

One must realize that understanding and addressing the core reasons for non-compliance will go a long way to improve the safety culture. The compliance of proper PPE usage improves depending on the level of health risk the worker perceives, such as exposure to influenza v/s tuberculosis (TB) or the Ebola virus. Hence, to ensure consistent compliance, a safety culture emphasizing daily worker safety and training must be established. The behavior leading to non-compliance can be corrected with training, making observations, collecting metrics, and reinforcing the safety culture. The Hospital Respiratory Protection Program Toolkit issued by NIOSH details this belief that routine compliance increases preparedness during a public health emergency.  

Healthcare professionals will have to follow the two main steps when they are formulating and implementing respiratory protection program policies. Firstly, they have to be aware of the best practices and secondly, strike the right balance between their own safety and factors associated with patient care. 

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Face Mask Types and Their Differences: Surgical, FFP1, FFP2, FFP3 and More

The only thing certain about this pandemic is that we have to get used to wearing masks for the foreseeable future. Until there is a vaccine for COVID-19, the best way to protect yourself and others is by wearing a mask. This means it is important to understand the different types of masks in the market so that you pick the right one for your needs. There is a heated debate about face masks and its effectiveness. The use of face masks is highly encouraged by all countries around the world and this is why it is best to know about different types of face masks available and how they differ from one another. Before you buy a face mask, it helps to know what you are buying and how it will help you.

Let us discuss the different types of masks in the market including the FFP3 mask and FFP2 mask, non-medical fabric masks and surgical face mask. Listed below are the main types of masks available today. 

•      Fabric hygiene masks for non-medical use

•      Surgical masks

•      PPE masks (FFP1, FFP2, and FFP3 masks)

•      N95 and KN95 masks

•      Filtering masks

Fabric hygiene masks for non-medical use

The best feature of fabric masks is that they are washable and re-usable. They are ideal for non-medical use and are not certified. There was a time when there was a huge demand for masks but the supply was scarce. This is when a lot of firms converted their production lines to manufacture hygiene masks. The mask will cover your mouth and nose but you also need to maintain a distance of at least two meters from others even when wearing the mask. The mask is not a medical-grade but will help prevent the spread of the virus. It will filter out most droplets expelled from the mouth and nose. 

Many countries recommend people to wear some sort of protection even if it is non-medical grade. It is a low form of protection that will work as a barrier against the spread of the virus. It will also reduce the waste associated with disposable masks and gloves.

Surgical masks

Surgical masks are more effective than fabric masks. They are commonly used and are available in blue color. They protect patients from potential contact with viruses and bacteria exhaled by the wearer. These masks filter the air expelled from the mouth and nose. It has a filtration efficiency of 95% and is considered ideal for limiting the spread of saliva droplets that are expelled when you talk, sneeze or cough. 

Surgical masks are used by medical professionals as they are ideal for preventing the spread of the virus through the air. It is important to follow social distancing when wearing the mask. The mask should fit well and it must completely cover the mouth and nose. They are only for single-use and should be thrown away after about four hours of use.

PPE masks (FFP1, FFP2, and FFP3 masks)

PPE (personal protective equipment) is worn by medical staff in the hospitals and it provides a very high filtration level. It is much more efficient when it comes to filtering for inhaled and exhaled air than surgical masks. FFP means filtering facepiece and it shows that the mask has met the EN 149-2001 standard. It is the minimum performance criteria for structural stability, breath-ability, biocompatibility, and efficiency. FFP has a numbering system that shows the filtration efficiency of the devices. 

An FFP1 mask has a limited filtering capacity and will only filter out large particles. They are not suitable for protecting the wearer from harmful microparticles which carry the virus. FFP2 has a slightly higher filtration efficiency for airborne particles which is around 92% and FFP3 has 98%. The most effective masks are valveless FFP2 and FFP3 masks because they offer maximum protection for the wearer and others. A valve will expel the wearer’s exhaled air without filtering it which is why it is not recommended by those who have symptoms. 

The drawback of the FFP3 mask is that it has a high level of filtering and layering which makes the wearer uncomfortable when worn for a long period of time. The mask also has a limited lifespan and they are designed to provide protection for six hours, after which they need to be disposed of. 

N95 and KN95 masks 

N95 and KN95 masks are similar to FFP2 make and they offer a high level of protection to medical professionals. These ratings of N95 with respirator and KN95 with respirator are certified to Chinese and American standards which are similar but not the same as European mask standards. For the efficiency of the respirator, they need to carry the CE mark. It means that the mask has been tested for efficiency and meets the EU standards. Hence, if the mask has a CE mark, its efficiency is equal to FFP2 masks. 

Filtering masks 

The filtering mask has high comfort and filtration efficiency and is manufactured with the latest technology. It is reusable and is made out of three fabrics. The mask provides 95% filtration efficiency for fine particles and bacteria. The three layers form a mechanical barrier against the microparticles and protect the wearer and those around them. It has replaceable filters that last 12 hours and is a dust protector. 

After wearing the mask for 12 hours, you do not need to replace the mask but replace the filter. The mask can be washed in warm water with soap. It is available in different colors and patterns and offers a high level of protection. It has a long life and reduces waste associated with single-use masks.

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