Automated User Interface Design for HEPA FilterRecertification

摘要

In the pharmaceutical manufacturing industry, there is a need to create an aseptic environment. Part of creating an aseptic environment is having HEPA filters installed and working properly. Many regulatory agencies, including the Federal Drug Administration (FDA) require strict controls over the factors that allow for a manufacturing facility to be aseptic. One of these factors is the use of High Efficiency Particle Air (HEPA) filters. The HEPA filters must be certified or recertified. This occurs as frequently as monthly, but in some cases six months are allowed. This paper addressed the process for recording and storing information for the HEPA filter recertification trials using an automated user interface system.