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Droplets vs dryness and the requirement for equipment post-cleaning

19 June 2023
Drug Substance
Droplets vs dryness and the requirement for equipment post-cleaning
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470 downloads

The pharmaceutical and biotech industries are being asked to deliver medicines at faster speeds and lower costs, and to continue to improve compliance to ensure the safety and efficacy of the drugs produced.

Health agencies require that equipment is drained/dried following cleaning and before use or storage. Residual moisture following the cleaning of a system is one factor that should be properly addressed, as there is no need to fully dry a clean piece of equipment before the next use. However, any residual moisture should be justified not to impact the equipment’s cleanliness before use. Therefore, droplets of residual water following cleaning can be considered acceptable, and complete dryness is not required if the equipment is being stored for short periods. Equipment that is to be stored for long periods should either be stored in a bacterial-static solution or be visually dry to ensure microbial control.

This paper provides practical considerations and strategies for protecting cleaned equipment. It provides a justification and rationale for the acceptability of residual moisture following cleaning for routine reuse of equipment while promoting a post-cleaning condition of ‘drained’ after cleaning or ‘dry’ for process equipment intended for long-term storage. It also discusses the factors that contribute to residual water post-cleaning and the considerations, supporting rationale, and justifications to rationalize and justify what levels of residual water may be acceptable.

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