PDA Letter Article

Draft Annex 1 Separates Cleaning and Disinfection Is Your Microbiology Lab Ready?

by James Tucker, Ecolab Life Sciences

EU Flag Continent

The EU Annex 1 revision released at the end of last year featured many changes; one in particular addresses cleaning and disinfection. It has long been widely accepted that cleaning and disinfection are two distinct processes within the cleanroom environment. The segregation of these two processes is, for the first time, reinforced in the Annex.

Cleaning versus Disinfection

The objective of cleaning is to remove physical soiling that can lead to contamination. This is usually achieved via systems such as vacuums, detergent cleans, wet cleans with water for injection (WFI), isopropyl alcohol (IPA) or even dry cleans with wipes and mops. Disinfection, on the other hand, is designed to kill microorganisms. Disinfectants can be divided into distinct groups: sporicides and broad-spectrum disinfectants. Each consists of various chemistries offering different effects against each type of organism; however, they share a common goal to render the specific target group of microorganisms unable to proliferate.

Members can read the full article in the September 2018 PDA Letter (PDF)