Quality control is an essential requirement for
the medical grade products. FDA
registration and ISO 13485
certification are required to run an industry otherwise the industry would not
be able to sell its medical roducts. FDA
registration is required for the commercial distribution of the products.FDA
has a quality management systems and a complete list of standards. For
manufacturing and launching the product, all these standards must be fulfilled.
sterilization is the basic aspect of these standards. It is found that
conventional polypropylene is unsuitable for the gamma irradiation
sterilization at high doses. It results into increased brittleness, a reduction
in its mechanical properties and discoloration 2. For polypropylene,
autoclave is a suitable method of sterilization. Now a days, medical grade
plastics have reduced the requirement of sterilization.
quality and facility certificates are in Pakistan: 3
are inspected time to time to ensure the size, shape and the consistency
specifications. Visual inspection method is the primary test method. However,
more rigorous measurements are also performed. Measuring equipment are used to
check legth, width and thickness of the component pieces.
production is strictly controlled by the United States government, specifically
the Food and Drug Administration (FDA). They have a complete list of specifications to which every manufacturer
must comply. They perform inspections of every company to ensure that they are
following good manufacturing practices, handling complaints appropriately, and
keeping adequate records related to design and production. Additionally,
individual manufacturers have their own product requirements. 4
Surgical masks are also tested to ensure the proper filtration of bacteria.
A test is performed “bacterial
filtration efficiency in vitro” 5.in this method, the masks are tested
for the bacterial filtration via staphylococcus aureus as challenged organism.
A bacterial challenge aerosol is passed through the test specimen at a flow
rate of 28 L/min, allowing evaluation of filtration efficiencies of the mask. A
higher bacterial filtration efficiency percentage indicates the better
protection for specialists from bacterial diseases.