Quality control is an essential requirement forthe medical grade products. FDAregistration and ISO 13485certification are required to run an industry otherwise the industry would notbe able to sell its medical roducts. FDAregistration is required for the commercial distribution of the products.FDAhas a quality management systems and a complete list of standards.
Formanufacturing and launching the product, all these standards must be fulfilled.Materialsterilization is the basic aspect of these standards. It is found thatconventional polypropylene is unsuitable for the gamma irradiationsterilization at high doses. It results into increased brittleness, a reductionin its mechanical properties and discoloration 2. For polypropylene,autoclave is a suitable method of sterilization. Now a days, medical gradeplastics have reduced the requirement of sterilization.Somequality and facility certificates are in Pakistan: 3· FDA registration · ISO 13485· ISO 9001· ISO 11137· ISO 1113Syringesare inspected time to time to ensure the size, shape and the consistencyspecifications.
Visual inspection method is the primary test method. However,more rigorous measurements are also performed. Measuring equipment are used tocheck legth, width and thickness of the component pieces. Hypodermic syringeproduction is strictly controlled by the United States government, specificallythe Food and Drug Administration (FDA). They have a complete list of specifications to which every manufacturermust comply. They perform inspections of every company to ensure that they arefollowing good manufacturing practices, handling complaints appropriately, andkeeping adequate records related to design and production. Additionally,individual manufacturers have their own product requirements.
41. Surgical masks are also tested to ensure the proper filtration of bacteria.A test is performed “bacterialfiltration efficiency in vitro” 5.in this method, the masks are testedfor the bacterial filtration via staphylococcus aureus as challenged organism.A bacterial challenge aerosol is passed through the test specimen at a flowrate of 28 L/min, allowing evaluation of filtration efficiencies of the mask.
Ahigher bacterial filtration efficiency percentage indicates the betterprotection for specialists from bacterial diseases.