PDA Letter Article

How to Qualify Your Disinfectants

by Michael Hodgkinson, Orvera Scientific

spraybottle

Setting up a sound program for qualification of disinfectants is a critical component of any contamination control program in a facility manufacturing sterile drug products (1). Yet subtle changes in a facility and its environmental control performance are often overlooked. This oversight can lead to qualification documentation that does not fully support the program over time.

The following is a framework for managing disinfectant qualification over the lifecycle of a program that takes into account subtle changes, ensuring effective disinfectant qualification.

Members can read the full article in the November/December 2019 PDA Letter (PDF)