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:

  • Reducing the number of connections to vessels
  • Choosing process piping for real service flow
  • Flushing bioprocessing vessels as soon as they are empty
  • Defining “dry” and how it is measured
  • Avoiding dead legs in utilities and connecting pipework
  • Selecting components and instruments that can be cleaned robustly and quickly with minimal maintenance
  • Using hygienic pads rather than nozzles on vessels
  • Ensuring direct CIP spray impingement on residues in vessel components without thru-flow capability (instruments, vent valves, etc.)
  • Sizing tank bottom valves for good drainability and ensuring full CIP flow available from satellite valves for downstream cleaning

In adapting this standard, Hall advises pharmaceutical manufacturers to:

  • “Involve your engineers, cleaning, cleaning validation, operations and maintenance experts when developing the user requirement specification (USR).
  • “Clearly define CIP-cleanability targets in terms of time, water and energy usage in the equipment/facility USR.
  • “Ensure the equipment supplier understands the critical effect of CIP-cleanability hazards and that you understand where those hazards exist and how the supplier plans to reduce their effects.
  • “Specify a cleanability test during the supplier factory acceptance test for equipment using real or suitable surrogate residues. Note that the riboflavin spray test is a coverage—not a cleanability—test.”

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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