Cleaning Validation for Biologics

Published on: 
Andrew Walsh
BioPharm International, BioPharm International-10-15-2015, Volume 2015 eBook, Issue 2

Can alternative approaches to the permitted/acceptable daily exposure be justified?

BioPharm International

eBooks Volume 28, Issue 14  

Many pharmaceutical companies have adopted the permitted daily exposure (PDE), or acceptable daily exposure (ADE), to set cleaning validation limits. Some regulatory agencies now require its use, but some companies continue to argue against it, particularly biologics manufacturers. Critics of the approach argue that protein molecules are denatured or degraded by their cleaning processes, and that alternate approaches should be used.   Read this article and other articles in


BioPharm International

's 2015