ASTM Preps Clean By Design Guidelines for Mid

Credit: Westend61/Getty Images Clean by Design guidelines—ASTM E55.03—are being

Credit: Westend61/Getty Images

Clean by Design guidelines—ASTM E55.03—are being drafted now with an anticipated mid-year release date. A second, updated edition is expected in 2024.

The goal of this completely new standard is to aid a step-change in production efficiency by increasing bioprocessing capacity while reducing cleaning time, cost, water, energy, and chemical usage.

"CIP cleaning time savings of more than 50%, and water and energy savings of 50–80%, are typical and dramatically increase productivity and capacity," Richard Hall, mechanical engineer, Rattiinox, and technical lead of the ASTM E55.03 Clean-by-Design task force, tells GEN.

Equipment design hazards make clean in place (CIP) cleaning methods inefficient and questionably robust, and "overkill CIP wreaks havoc with soft-parts, requiring excessive maintenance to avoid cross contamination," Hall says.

Unlike some standards, this one aims for clarity. It features graphics to illustrate CIP cleanability hazards and data to support science- and risk-based decisions.

ASTM E55.03 Clean by Design calls on equipment manufacturers to make CIP cleanability a priority. Its many points include:

In adapting this standard, Hall advises pharmaceutical manufacturers to:

The Clean by Design task group has 57 members, including 23 users, 13 engineering companies, 11 consultants, five suppliers, and the rest regulatory bodies and ASTM. Thirty-five members are from 13 different European countries and 22 are from the United States.

"The goal of this standard is to help new, highly efficient, stainless-steel multi-use systems compete more effectively with other (environmentally questionable) technologies and low-cost competitors," Hall says.

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ASTM Preps Clean By Design Guidelines for Mid