Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

eResidue Software


eResidue is a new cloud-based version (www.eResidue.com) of the CD-based version of RESIDUE. It is designed for calculating limits for actives and cleaning agents in drug product manufacturing. Enhanced capabilites include calculating limits based on health-based values (ADE/PDE) in addtion to dose-based values, as well as determining the more stringent of the two. A second enhancement is the optional use of a default  value for the limit per surface area, in addtion to the optional use of a limit in the next product. A third enhancement involves new product entry screens for cleaning agents, topical drug products and transdermal patches. Finally, the most important enhancement is speed of calculations (particularly important for those of you with 25 or more products in one calculation). eResidue is Part 11 compliant. It is available on a yearly subscription basis, with tiers based on the number of users, the number of products, and the number of equipment items. The original disk-based RESIDUE software is no longer being sold.