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SES202 - Clean by Design - for Efficiency and Sustainability

‐ Jan 29, 2024 2:45pm

An introduction to the ASTM E55.11 Clean by Design work item for the specification, manufacture and test of pharmaceutical and biopharmaceutical manufacturing systems that are rapidly and robustly CIP-cleanable.

The adoption of the simple CbD approach offers improved manufacturing efficiencies due to reduced cleaning times and dramatically reduced water usage. The water used for cleaning is generally produced by distillation, so energy usage is also reduced pro rata.

Efficiency data for 41 facilities is included in the presentation (including the current lengthy cleaning times), together with energy usage for one bioprocessing facility (41.7% of total energy used is to produce and heat water for CIP cleaning).

Current overkill CIP cycles using aggressive chemicals result in deterioration of "soft parts" which can cause contamination/cross-contamination issues - or result in substantial maintenance time, cost and residues.

Clean by Design started as a checklist of technical recommendations, but much of the content is now based on ensuring users clearly state what they require to equipment manufacturers.