When biopharmaceutical manufacturers need more production capacity, the focus often turns to new facilities, additional equipment or expanded production lines. However, significant untapped capacity may already exist within existing operations.
The constraint is often not production itself, but the time between batches.
Cleaning and disinfection directly influence equipment availability, changeover times and overall throughput, but they are still widely treated as compliance requirements rather than operational processes that can be optimised. As manufacturers look to maximise existing assets before making major capital investments, this perspective is beginning to change.
Increasingly, cleaning is being recognised as an opportunity to improve manufacturing performance by challenging long-standing assumptions.
Looking beyond compliance
Cleaning programmes are typically established early in a facility’s lifecycle and, once validated, are rarely revisited. As products, equipment and manufacturing priorities evolve, this can leave organisations relying on processes that are no longer fit for purpose.
Without regular reassessment, conservative cycle times, precautionary steps and operating parameters can become embedded in routine operations. At the same time, valuable operational data is often overlooked because validation is treated as the end of process development rather than the start of continuous improvement.
These legacy practices reduce equipment availability and quietly constrain manufacturing capacity.
Common examples include:
- Cleaning cycles that are longer than necessary, such as extended rinse times, redundant wash steps or conservative hold times that have never been re-evaluated.
- Operating conditions that are more conservative than required, such as higher temperatures or chemical concentrations that consume additional resources without improving cleaning performance.
- Overly cautious validation strategies, including conservative acceptance criteria and extensive sampling plans that increase effort while adding little value.
- Greater use of water, energy and cleaning agents, increasing both operating costs and environmental impact.
Current regulatory guidance, including ICH Q7, ICH Q9(R1) and EU GMP Annex 15, supports science and risk-based approaches to cleaning validation rather than prescriptive methods.
Organisations that develop a strong understanding of their processes and use operational data to justify decisions can often streamline cleaning and validation activities while maintaining compliance, improving equipment utilisation and increasing manufacturing throughput.
Finding the hidden capacity
Inefficient cleaning, over-cleaning and overly conservative validation often share the same root cause: decisions based on habit rather than evidence. A useful starting point is to ask a question: Which elements of our cleaning process are genuinely required to manage risk, and which have never been challenged?
Answering that question requires collaboration and a data-driven approach. The goal is not to impact cleaning standards, but to eliminate activities that add time without improving product quality or compliance.
The impact can be significant. In one manufacturing facility, two identical pieces of equipment producing the same product followed different cleaning procedures. By reviewing the processes, removing unnecessary steps and standardising the approach, the site increased annual manufacturing capacity by approximately 15% (equivalent to several additional production batches) without investing in new equipment or expanding the facility.
This example demonstrates that hidden capacity often already exists and simply needs to be uncovered through systematic evaluation of cleaning processes.
Building optimisation into the facility lifecycle
Cleaning optimisation delivers the greatest benefits when it is considered throughout the facility lifecycle rather than as a one-off improvement project. Manufacturers can create more efficient, adaptable operations by focusing on four key areas:
Design for cleanability
Consider cleaning requirements during equipment selection and facility design to minimise dead legs, improve drainage and reduce manual intervention throughout the equipment lifecycle.
Use operational data
Monitor cleaning performance to identify which process parameters genuinely influence cleaning efficacy and where unnecessary variability or inefficiency exists.
Adopt risk-based decision-making
Replace historical assumptions with evidence-based approaches that align cleaning and validation activities with actual process risk while maintaining regulatory compliance.
Embed continuous improvement
Treat cleaning as an evolving manufacturing process, using cross-functional collaboration and digital technologies to identify further optimisation opportunities over time.
These practices transform cleaning from a fixed operational requirement into a measurable contributor to manufacturing performance, helping facilities improve throughput without additional capital investment.
A competitive advantage hidden in plain sight
As biologics manufacturing becomes more flexible and production schedules more dynamic, rapid equipment turnaround will increasingly influence operational performance. Facilities that continue to treat cleaning solely as a compliance activity risk overlooking one of the most accessible opportunities to improve throughput. Those that approach cleaning as a process to be designed, measured and continuously refined will be better positioned to maximize existing assets before considering major capital investment.
Cleaning and disinfection will always be fundamental to protecting product quality and patient safety. Increasingly, however, they are also becoming strategic tools for improving operational performance. For many biopharma manufacturers, the next opportunity to increase capacity may already exist within their facilities, waiting to be unlocked with a fresh look at the cleaning process.
Author: Georgios Koukoulas, Global Technical Consulting Manager, Ecolab
