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.

Considerations for OEM N95 Mask Manufacturing

There are plenty of industries that are turning to mask making. According to medical professionals all over the world, N95 masks are the best mask available for regular use and also during emergencies. There is no such dearth of these N95 masks. However, given the current state of affairs, there could be insufficiency. So, if you want to increase your revenue and profit from government regulations and policies, you should partner with a manufacturer who specializes in OEM N95 masks where you can easily take care of designing, branding, marketing and sales.

Doesn't that sound fantastic? So, without further ado, here's a quick rundown of how these OEM manufacturers would manufacture using raw materials, conduct proper testing following NIOSH requirements, and more:

Manufacturing: Multiple layers of non-woven fabric specifically polypropylene, are used to make these N95 masks. The inner and exterior of the mask, which is made by spun bonding, are covered by these two external protecting layers of fabric. Spun bonding is a process that layers threads between 15 and 35 micrometres on a conveyor belt using nozzles blowing molten threads of a thermoplastic polymer (typically polypropylene) that pile up into a cloth as the belt moves down the line. Thermal, mechanical, or chemical procedures are then used to glue the fibres together. A needle woven non-woven layer is placed between the spun bonding layer and the non-woven layer to strengthen the mask's cohesion. The last layer is made up of a high-efficiency melt-down electret non-woven material that ensures maximum efficiency.

 

Testing: These N95 masks are now ready for testing, which is a time-consuming process. During the examinations, OEM face mask makers make certain that the created N95 masks are always above the certification threshold. The fewer rejections you have, the more money you'll make in marketing. Before being sent out for delivery, all OEM N95 masks must pass the following tests:

I. The sodium chloride aerosol spray contains charge neutralised particles with a median diameter of.3 microns. This is a particle penetration test.

II. A moderately high work rate is indicated by the airflow of 85 L per minute.

III. Exhalation resistance at 25 mm or below water column height pressure, as well as a breathing resistance test at 35 mm or below water column height pressure (A millimetre of water column height pressure is the pressure from one millimetre of water at 39 degrees F).

IV. At least 200 mg of aerosol loading, which clogs the mask with aerosol particles to simulate a high degree of exposure.

 

Sanitization: Under government rules, all machinery, equipment, lab tests, and masks are sanitised.

It is instantly distributed in boxes to delivery units once it has been approved by NIOSH, where you can quickly market and start selling to your clientele. The greatest advantage of OEM face mask makers is that they do not take credit for design, branding, marketing, or any marginal earnings. As a result, it's much easier to create the home of your dreams if it's already built and ready to sell.

How to protect from wildfire using masks?

Wildfire is an uncontrollable and unforeseen disaster brought on by the human race or natural climate change. However, certain regions of the world are prone to numerous wildfires and the inextricable link between the climatic changes in this part of the world and bigger fires is undeniable.

 

Apart from disrupting transportation, communications, power, and water supply, it has an immediate impact on air quality. If you live in a wild-fire prone areas, the CDC recommends wearing masks at all times during indoor and outdoor activities. A personal degree of protection, such as collaborating with a reputable N95 cup mask wholesaler, is an excellent option.

Types of masks to wear:

Procedural masks: Surgical masks are not to be confused with respirators such as N95 masks. The procedural masks harm the wearer by giving them a false sense of security and safety against air particulates.

 
Respirators: These respirators are divided into two types based on their way of operation: air supplying and air-purifying respirators (APRs). Because of their weight, air providing systems are only worn by firefighters and not by the general public, as they require special training to wear. Air purifying devices, on the other hand, have cartridges, filters, or canisters that may easily remove air contaminants before they reach the wearer's respiratory system. And depending on the contaminants it purifies it is again divided into 3 categories further:

 

• Particulate Respirator: As the name implies it filters particles - air, mist, and fumes – but not hazardous gases or vapors.
• Gas and Vapour Respirators: These respirators filter polluted gases and vapors from the air.
• Combination respirator: It is the combines the efficiency of particulate respirator and gas and vapor respirator, making it a piece of cumbersome equipment to use.

Non-powered APRs: Depending on the type of inlet covering, these are available in various types- half facepiece, full-facepiece, half mask, and quarter mask.

• Half-piece Respirator: It is the most common type and readily covers the nose, mouth, and chin. The distinguishing feature is that the entire covering acts as a filtering shield and is attached through straps. e.g.: N95 mask.
• Particulate Facepiece respirator: These are usually disposable items that can't be cleaned once they've become contaminated, soiled, or provide too much barrier for breathing.
• Elastomeric half-piece respirators: It is a reusable and non-disposable respirator with a thermoplastic facepiece that is held to the face by two head straps and one or more filters. This mask can be used again because it is readily cleaned. To provide maximum protection, make sure these filters and cartridges are cleaned and maintained properly.

The risks associated with a wildfire are significant. And there is no good proof that any one form of respirator is effective in combating this disaster. However, FHPR (filtering half-piece respirator) is the most commonly used respirator to filter out particles found in wood smoke particles. Also, look for a licensed N95 cup mask wholesaler who follows NIOSH's rigorous criteria.

Certification of respirators
A wearer has ample respirators to choose from. However, a certified respirator is a better choice than a non-certified one. A glance will assist you in choosing the proper mask:

• Respirators are subjected to NIOSH certification
• Non-respirators like procedural masks are not subjected to NIOSH certification
• TC Approval Number: TC (testing and certification) number must be provided on the packaging, if not present, that it is neither NIOSH certified nor can provide protection against wildfire hazards. TC is provided if the mask is manufactured after 2008.

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. 

For more information visit our website www.rhysley.org.

Differences Between KN95 Vs 3 Ply Disposable Face Masks: Which One Should You Wear?

As the year 2020 revolves around the terms Coronavirus and Covid-19, the world resorts to face masks to prevent the spread of the disease. Currently, there are different types of face masks available from the top face mask manufacturer & distributors in the market. For effective protection, it is important to choose the right one. Let us checkout the key uses and differences between KN95 and 3 Ply face masks to understand which one meets your requirements.

3 Ply Disposable Masks

3 Ply Disposable Face Mask

These sky blue hued masks are readily made available in the market by the face masksuppliers. The masks contain 3 layers and hence the name, 3 ply. According to FDA (Food & Drug Administration), these masks should be used by civilians and people under non-medical environment. These are cheap face masks and enable approximately 70-90% dust and germ filtration. So, when respirators are unavailable, it is better to put on 3 Ply face masks than nothing at all. According to tests, surgical or 3 Ply face masks are resistant to fluids. The masks do not come with a pressure seal. Last but not the least; 3 Ply masks are one time wear and should be properly disposed after every use. You should also be careful not to touch your face, nose and mouth when removing the mask. These face masks are easily accessible.

KN95 Face Masks 

Rhysley KN95 Masks

First of all, KN is the Chinese standard for masks. These masks are known to filter approximately > 95% of tiny particles (which is equivalent to 0.3 micron particles). These masks have a flow rate of 85L per minute.

Some additional features of KN95 masks as compared to 3 Ply or surgical masks are-

* Light Weight

KN95 masks are light and breathable. For this reason, these masks are an easy wear for long hours.

* Non-Allergic

According to tests, KN95 masks are non-toxic and non-irritating. These face masks are free from latex and hence can be worn by anyone and everyone.

* Easy To Wear

These masks come with a tip-shaped hanging ear design. For this reason, KN95 facemasks do not easily slip off from the ears. These masks come with a silicone adjustable nose clip. So, you can easily adjust the sealing. This protects the glasses from fogging when you wear a mask.

* Water Proof

These masks are safe to be worn even during monsoons. KN95 masks are resistant to water and humidity and hence offers added protection.

* Reusable

Face masks have become a necessary accessory. So whenever you go out or are in contact with other people, it is mandatory to wear a mask. KN95 masks make your life easy as you can reuse these face masks. Made from elastic fabric, these can be reused after handwash. Last but not the least, these face masks do not have any smell.

If N95 masks are not available, KN95 face masks may be used as an alternative. The difference between N95 and KN95 masks are considered subtle. It is important for everyone to wear face masks; whether the individual is a Covid-19 patient or not. So, choose your face mask wisely. For more information visit www.rhysley.org or call us @ 001-587-441-3737 or +91 89299 00031.