QUALITECH covers all the key areas to undertake effective cleaning of equipment and to validate the cleaning process:

– Cleaning actions/chemistry involved, optimising cleaning processes and the use of cleaning agents

– The design of equipment for ease of cleaning (includes hygienic engineering principles)

– The use/types of Clean-in-Place (CIP) and Clean-Out-of-Place (COP) systems

– Control and removal of rouge in hot systems

– Methods available for sampling and detecting/quantifying residues, included a detailed presentation on the use of Total Organic Carbon (TOC) detection methods in detecting and quantifying residues present after cleaning.

– How to establish maximum acceptable levels of material carryover for active ingredients (large and small molecules) and cleaning agents, and how to set limits for swab areas and rinse solutions (incorporates all EMA guidance on health based exposure limits [HBELs])

– The use of a matrix approach to cleaning validation where multiple products are involved

– Key validation considerations and validation documentation requirements (includes risk based approach to the qualification of cleaning equipment

– Alternative technology – avoiding the need for cleaning validation, e.g. disposables