How to Control Manufacturing Process？

COVID-19 has highlighted how infectious diseases can spread at alarming rates and paralyse entire societies. Diagnostic testing is one of many effective tools that can be used to help prevent disease proliferation. Diagnostic tests depend on reliable medical devices that produce consistent results for each test. Manufacturing process control is especially critical when producing medical devices. Incorporating surface quality specifications for materials used in medical device design enables manufacturers to make products that perform consistently in the field and provide reliable test results. Polymeric testing devices such as diagnostic slides or microplates are handled, cut, cleaned, and coated during their assembly. Each of these steps has the potential to affect the caliber of products; quantitative control of these steps during the manufacturing process ensures the quality and reliability of these devices. Effective diagnostic testing methodologies are predicated on consistent, predictable behaviour of body fluids as they interact with the surface of a device. This frequently requires cleaning, surface treatment, and perhaps coating. These surfaces need to be prepared to a consistent level of chemical cleanliness and composition. Lateral flow assays (LFAs) are an example of products that need consistent, predictable wetting properties. Enzyme-linked immunosorbent assays (ELISAs), which are used to test for COVID-19, are one type of LFA. ELISA tests depend on capillary flow between two closely spaced surfaces. Reliable capillary flow requires surfaces that are reproducibly clean on a molecular level. Even a monomolecular layer of a contaminant can impede this capillary flow and cause device failure. Capillary flow and vacuum deposited coatings Hydrophilic coatings facilitate successful capillary flow. A common method of applying these coatings to diagnostic plates is through vacuum deposition processes. Physical vapor deposition (PVD) and chemical vapor deposition (CVD) are two of the vacuum deposition methods used to apply these molecularly thin coatings on surfaces. Consistently applied coatings drive consistent wetting behaviors and, therefore, achieve reliable testing results.COVID-19 has highlighted how infectious diseases can spread at alarming rates and paralyse entire societies. Diagnostic testing is one of many effective tools that can be used to help prevent disease proliferation. Diagnostic tests depend on reliable medical devices that produce consistent results for each test.