Although several industries and trades require PPE gears for their employees, medical applications seek critical attention. Even more so, when the world is battling against the deadly Corona Virus.
The increasing demand for PPE, particularly masks, body covers, and eyewear is a good sign for the trade. Likewise, it is probably a good time to make an entry into the trade, since the demand is high and the supply is low.
But, what does it takes to start a PPE manufacturing unit?
Ensuring Health & Safety GuidelinesThe very first thing about PPE products is- they need to be clean and hygienic. Particularly, the pieces that are used by healthcare personnel need to be ultra-clean before they are put to use. In light of the latest healthcare emergency, the COVID-19 Pandemic, the need is even more imminent. Therefore, the manufacturing facility needs to be disinfected and cleaned in compliance with the health and safety guidelines.
The way forward is by learning about the guidelines laid by the government agencies. Usually, the workers would require to wear PPE gears, to ensure their own safety. Of course, if the workers stay fit and healthy, the products thus manufactured are also likely to be free from contaminants. Some manufacturing units are also installed with air curtains to keep out the contaminants from the facilities. The idea is to keep the facility as hygienic as possible for manufacturing medical grade PPE kits.
Complying With The Quality Parameters
Apart from in-house hygiene, the products that are to be manufactured also need to pass through various quality standards. For example, face masks usually need to comply with pM 2.5 standards that are meant to protect against air pollution. Likewise, the masks used by healthcare professionals need to comply with N95 standards. In short, the end-use of the PPE kit decides the quality parameters.
Before setting up a manufacturing plant for PPE products, it is important to learn about suitable quality standards. Apart from the local standards, the products also need to comply with the standards of the target market. So, if a manufacturing unit is supplying to a healthcare facility in Norway, it would require to pass the quality inspection according to EU norms. And this is in combination with the quality standards set by the local authorities of the factory.
Setting Up The Machinery
The next thing is setting up the machinery. Depending upon the type of product the type of machinery varies. For example, manufacturing a 2 ply surgical mask would require filament spinning, laying of the fibers, binding the fibers, and then attaching the accessories. All of these processes are carried out in separate machines.
Furthermore, the machines for the aforementioned processes also vary with quality standards and structural needs. For example, the binding process alone can include spun bonding, needle punching, chemical bonding, etc. The type of bonding/binding machinery to be used depends on the end-use and customer requirement.
Besides, a factory also needs a continuous supply of electricity to ensure uninterrupted production. Installing a diesel generator, for example, maybe a good idea to curb the energy needs during blackouts and brownouts. One can visit site of a reputed manufacturer to tally their energy needs. Adding up the total machinery load and then matching up with the power production of the generator is a good way to decide which one to buy for supporting the manufacturing process.
Another important thing to ensure is the correct floor plan for the manufacturing unit. Some procedures may need more attention than others. Therefore, it is crucial to have a floor plan that allows easy access to the parts that need more attention. At the same time, it is also important to maintain a plan that reduces the delays between one process to another.
Quality Assurance & Certification
Second, to the health and safety, and even before production is commenced at full swing, it is necessary to ensure the quality of the products. And it is not just for one batch or a lot, but instead for the complete procedure of manufacturing. A buyer would never believe a quality report from the manufacturer, alone. They would require the report and the shipment be submitted along with third-party certification.
When it comes to PPE kits, quality standards are pretty stringent. After all, the products play an important role in the health and safety of the wearer. Any defect in the product can have severe repercussions. Several certification agencies, mostly private, are at work to help the manufacturers keep up with the quality standards. These agencies can conduct inspections and audits to identify the shortcomings in the quality standards, and can also help redesign the process. So, as to achieve the desired quality matrix.
Maintaining The Production With Quality
In the end, it is at the manufacturer’s disposal to maintain the production along with ensuring the desired quality. Usually, the manufacturers outsource several tasks in the manufacturing process before making the delivery. For example, the PPE garments and accessories for healthcare applications need to be coated with anti-bacterial and anti-pathogenic materials. It is quite an easy way to outsource these processes than to carry them out in the house.
Setting up a PPE manufacturing unit is similar to any other production facility. That being said, the difference lies at the extra caution needed for maintaining the high-grade medical standards. PPE garments and accessories are the only layers of protection between life and death. Therefore, any discrepancy in the manufacturing procedure can prove to be fatal for the user.
Along with ensuring the quality standards, it is important to fulfill the legal obligations as well. Consult with a legal attorney to help get through the formalities of getting into the trade. Conforming with the legal procedures can help avoid any future problems and issues. Rest assured, a business in PPE manufacturing is sure to gain success in the coming years, particularly for the early entrants.
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