Miles Capper, Pharma Application Specialist at Crane Saunders, attended the ISPE Nordic Cleaning and Sterilization Conference in Helsinki (June 15-17). One message was consistent across regulators, end users, and suppliers:

The biggest risks in cleaning and sterilization are determined at the design stage—not during validation.

From Compliance to Defensible Decisions

The industry is moving away from “tick box” compliance toward more risk based and justifiable approaches. Regulators are increasingly focused on whether decisions are logical, representative, and clearly documented.

A recurring theme was that data alone is no longer enough. It must be backed by sound, defensible rationale. For project delivery, this reframes how risk is managed:

Risk is reduced by the quality of design decisions, not the volume of documentation.

Cleanability is a Critical Design Input

A consistent theme was that cleanability must be engineered in from the outset. Common validation challenges such as poor sampling access or undefined worst-case conditions often originate in early design stages.

The impact is measurable:

• Dead legs significantly increase cleaning time and complexity
• Poor geometry directly increases validation complexity and operational risk

Once built, these issues are difficult to correct without redesign, rework, or extended validation effort.

Designing for cleanability early is one of the most effective levers for reducing risk in complex projects.

Cleaning performance defines capacity

Cleaning is no longer just a validation consideration. It is a constraint on capacity.

Industry examples highlighted that:

• A significant portion of purified water consumption is driven by CIP
• Cleaning can be a major contributor to lost productive time in biologics facilities

At the same time, optimised systems have shown:

• Meaningful reductions in water and chemical usage
• Significant reductions in cycle time, with cleaning moving from multi day processes to less than 24 hours

This reinforces a critical point:

Designing for cleanability enables capacity and directly improves operational efficiency.

Annex 1 reinforces design accountability

Annex 1 expectations, including sterile boundary integrity, PUPSIT, and defined testing strategies, are driving the need for solutions that are built into system design.

Systems must now be:

• Designed with access to worst case locations
• Configured to enable repeatable and verifiable testing

This increases the importance of design quality and clarity of specification.