ABSTRACT
This chapter discusses the regulatory expectations along with industry trends pertaining to residue removal in Cleanroom Environments. The take home message from the study is that drug product may cause residue issues and, in some cases, should be considered in a site's residue removal plan. Testing residue removal products and effectiveness can be conducted outside of the cleanroom in a laboratory and may be valuable means to save resources. The results of the in situ case study indicate the use of detergents as cleaning agents for residue removal and bioburden reduction is superior to WFI when heavy disinfectant residue is present. Start off less conservative and increase frequency based on visual observations The objective of routine residue removal is to give the cleanroom surfaces a cleaner and more pristine image. Cleanroom curtains should be rinsed for visible residue removal after each application of disinfectant or sporicidal agents.
