After surgical mask respirators have been fabricated, it is necessary to conduct tests on them to confirm that they are safe to use in a variety of settings. They are required to pass each of the following five examinations:
- The effectiveness of bacterial filtration in vitro (BFE). An aerosol containing staphylococcus aureus germs is fired at the surgical face mask at a rate of 28.3 liters per minute for this test to be effective. This makes certain that the surgical face mask can capture the specified number of microorganisms.
- The effectiveness of particle filtration. This test, which is also known as the latex particle challenge, involves spraying an aerosol of polystyrene microspheres in order to determine whether or not the mask is capable of filtering particles of the size that it is intended to filter.
- The resistance to the breath Testing the mask’s breathing resistance involves blasting a flow of air at it and then measuring the difference in air pressure on both sides of the mask. This is done to guarantee that the mask will maintain its form and have enough ventilation when the user breathes in and out of it.
- Resistance to being splashed. In tests of splash resistance, surgical face mask respirators are subjected to being sprayed with simulated blood at pressures comparable to that of a human’s blood in order to verify that the fluid is unable to pass through the mask and contaminate the user.
- Flammability. The flammability of surgical mask respirators is evaluated by lighting them on fire and observing how quickly they ignite and how long it takes for the material to completely burn. This is done since various components of an operating theatre have the potential to readily start a fire. All three levels of the ASTM standard, 1 through 3, must meet the requirements for Class 1 flame resistance.
Is It Possible for Any Manufacturer to Also Be a Manufacturer of Surgical mask respirators?
It is conceivable for a generic producer, such as a garment factory, to transition into the production of surgical mask respirators; however, there are a lot of obstacles that need to be cleared out first. In addition, the procedure does not take place overnight since several organizations and bodies need to provide their stamp of approval for the items. Among the challenges that must be overcome are the following:
Navigating Test and Certification Standards Organizations
A corporation has to be aware of the complex network of testing organizations and certification authorities, as well as who among those organizations can provide particular services to the company. After protection criteria for the end, users of items like masks have been established by government agencies such as the FDA, NIOSH, and OSHA, and organizations like the ISO and NFPA establish performance standards based on these protection needs. Then, organizations that specialize in testing methodologies, such as the ASTM, UL, or AATCC, develop defined procedures to guarantee that a product is risk-free. When a corporation wishes to prove that a certain item meets certain safety standards, it sends samples of that item to a certification organization like CE or UL. That organization either tests the item on its own or contracts with an authorized third-party testing facility.
The results of the tests are compared by engineers to the performance standards, and if the product satisfies both sets of criteria, the organization places its seal of approval on it to demonstrate that it is risk-free. There is a close connection between all of these organizations; workers of certifying authorities, producers, and end users of the goods all serve on the boards of directors of organizations that develop standards.
For a new manufacturer to produce masks or respirators that meet industry standards, they need to be able to successfully negotiate the complex web of organizations that are involved in the production of their particular product.
Managing the procedures of the government
Surgical mask respirators need to be approved by the FDA, which under pre-pandemic conditions might be a time-consuming procedure. This is particularly true for first-time companies who have never been through the approval process before. In spite of this, the Food and Drug Administration (FDA) has lately made it easier for some businesses to get authorizations for the urgent use of surgical mask respirators. Additionally, it is open to collaborating with firms that are transitioning from other product lines.
Being familiar with the requirements that must be met while producing a product
The testing that a product will go through is something that the manufacturer has to be aware of in order to produce the product with consistent results and guarantee that it is safe for the consumer. A recall is a very worst thing that can happen to a company that manufactures safety products because it ruins its reputation. Customers for personal protective equipment (PPE) may be tough to acquire since they have a tendency to adhere to tried-and-true items, particularly when it might quite literally mean that their lives are on the line. Visit http://signaturecareconnect.com/how-are-surgical-masks-made/ to read about How are surgical masks made?
Competition against huge enterprises
Smaller firms in this sector, such as those in the automotive industry, have been purchased by and merged with bigger corporations like Honeywell over the course of the last decade or so. Surgical mask respirators and respirators are highly specialized goods that may be manufactured with more ease by bigger organizations that have prior expertise in this industry. Larger corporations can produce them more cheaply since, in part, they are easier to create; as a result, they can sell their goods at a cheaper price. In addition, the polymers that are used in the production of masks are often proprietary formulations.
Navigating the political systems of other countries
In the aftermath of the coronavirus epidemic or in a scenario analogous to it, there are rules and government entities that need to be handled by manufacturers that have the explicit goal of selling their products to Chinese customers.
Acquiring necessary materials
During the early stages of the pandemic, there was a scarcity of mask material, particularly melt-blown cloth. Because of the necessity to create a product that is both constant and exceedingly accurate, it might take several months to construct and install a single melt-blow machine. Because of this, it was difficult for makers of melt-blown fabric to scale up, which led to shortages of masks manufactured from this fabric and caused prices to rise. The large worldwide demand for masks made from this fabric also caused price spikes. If the output does not expand in a greater number of nations, then this can occur again. Click here to read about the Face covering exemption card.