Assess cleaning-agent residues
Consider the selection and removal of cleaning agents.
CV-REQ-000028
Cleaning validation guide (GUI-0028)§ 12.1
TOPIC EXPLORER
Detergents
Cleaning-agent selection and the evidence supporting residue removal.
1 connected reference
Practical guidance
PIC/S Publishes PI 006-4: A New Qualification and Validation Recommendation Takes Effect in October
PIC/S has published PI 006-4, the revised Recommendations on Qualification and Validation, superseding the 2007 PI 006-3 and entering into force on 1 October 2026. Cleaning validation now occupies a full chapter, with HBEL-driven scope, explicit limits on visual inspection and a clear position against continued test-until-clean practice.
ASTM E3470-25: Cleaning Risk Management Gets a Dedicated Method Standard
ASTM International has published E3470-25, a first-edition guide on using FMECA and HACCP/HARPC to identify, analyse and control risk in pharmaceutical and medical device cleaning processes. It is the method layer that E3106 required but did not fully specify.
Cleaning Validation Meets Waste Treatment: A Study of SGLT-2 Inhibitor Residues
A NIPER-Ahmedabad group pairs a validated RP-HPLC surface-residue method for three SGLT-2 inhibitors with a detoxification strategy for the resulting cleaning waste.