ABSTRACT
This chapter provides an overview of disinfection qualification testing and the considerations that must be addressed when designing and executing these studies. The terms “cleanroom disinfection qualification,” “disinfection validation,” and “cleaning validation” are often used in the pharmaceutical and aseptic manufacturing industries interchangeably. The major considerations and potential variables that must be addressed when considering the design and execution of a successful disinfection qualification study are outlined. As a result of the disinfection qualification studies, future trends that fall outside the pre-established disinfection program will allow facility staff to investigate and take appropriate corrective action. Validating that sterile, aseptic, and even non-sterile manufacturing environments are under microbial control as measured by a comprehensive and continuous environmental monitoring program. The ideal time in the product development lifecycle to conduct a disinfection qualification study is during the construction of the manufacturing facility.
