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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A BioPhorum member only deliverable, the BioPhorum Commercialization workstream has developed a conceptual facility design that deliberately disrupts conventions for flow, segregation and cleanroom classification.
Risk-based strategies to support revalidation and the assessment of requirements to maintain the validated state of equipment, process and facilities used for commercial and clinical manufacturing
This paper describes risk-based alternative strategies for defending the suitability of equipment and facilities requiring revalidation. These robust and risk-assessed approaches include real-time review, routine monitoring and in-/at-line alarms and measurements to help identify what data and testing are critical to assure the continued validated state of the equipment.