GOOD STORIES
Clean room validation is often underestimated in projects, leading to late-stage inclusion and extended timelines. To stay ahead of this challenge, we incorporated clean room validation into the project early on while supporting a Danish pharmaceutical company as they commenced the Basic Design (BD) phase for the rebuild of their clean room facility.
THE CHALLENGE
Clean room validation and maintaining alignment between validation activities and the overall project timeline is critical. However, delays and misalignment can disrupt schedules and have significant impacts on compliance, product quality, and safety.
In this project, the primary goal was to rebuild a clean room facility for a Danish pharmaceutical company, ensuring that it met stringent regulatory standards. As we progressed from the Basic Design (BD) phase to Detailed Design (DD), it was crucial to align our validation activities with the overall project timeline. Effective validation planning not only safeguards compliance but also minimizes potential delays, costs, and risks to product quality and patient safety.
The following section explores two possible scenarios: the ideal approach where validation is integrated from the beginning, and the typical challenges that arise when validation lags behind.
Validation activities, including planning as a major component, should begin early in the project life cycle and run concurrently with the project timeline from the Basic Design (BD) phase through to handover. This ensures that validation planning and design reviews are completed well in advance of construction. System and equipment qualification should follow the rebuild, culminating in validation reporting.
With a proactive validation track, the Emendo Engineering team can define qualification scopes, identify critical systems, and align activities with production and shutdown periods. This results in smoother qualification periods and more efficient renovations in active GMP environments.
Validation activities often lag behind schedule. In some cases, validation planning and design review may not begin until after construction is complete.
This delay can extend the project timeline, as the facility owner must wait for validation before handover. Moreover, such delays not only disrupt the project schedule but can also have significant repercussions on business costs, product quality, and patient safety if the built design does not meet regulatory requirements.
OUR APPROACH
To address these challenges, we collaborated with our client’s organization to involve stakeholders in the validation strategy early in the project lifecycle. This helped lay a strong foundation for the rebuild. By fostering cross-functional teamwork and promoting a proactive mindset towards front-end loading, we combined the client’s vision with their technical experts’ knowledge and our extensive understanding of Good Engineering Practice (GEP) and Good Manufacturing Practice (GMP). This approach allowed us to build a robust design that meets both client expectations and regulatory requirements.
Integrating the validation track from the outset allowed us to leverage GEP and GMP principles to influence the design during the BD phase—well before materials and equipment were procured or rebuild had commenced. Early involvement also enabled us to fulfill our client’s requests for timely inclusion of quality assurance and enhanced knowledge sharing, both of which have a direct impact on design.
RESULTS & FUTURE OUTLOOK
By adopting this approach during the BD phase, we gained valuable insights that will benefit the project during the DD and construction phases. Early knowledge sharing provided the opportunity to reflect on previous successes and avoid past mistakes, contributing to a more efficient design process.
Validation is often underestimated in projects, leading to late-stage inclusion and extended timelines. However, by prioritizing validation planning, as we did during the BD phase for Building & Utilities in this project, we are able to anticipate the scope of qualification and documentation well in advance, reducing uncertainties. This proactive approach helps prevent delays caused by outstanding validation activities that could otherwise hinder production readiness and impact business operations.
Looking ahead, we will continue to apply this approach in future projects—starting with the end in mind and aligning expectations with clients to find optimal solutions from the outset.
Early clean room validation during the Basic Design phase streamlined timelines and ensured regulatory alignment. If you want to avoid delays and ensure compliance in your clean room rebuild, we can help implement a similar approach.
Contact René Licht Bøtcher, Partner at Emendo Engineering, to see how we can support your project from the start.
HAVE A QUESTION
Clean room validation is the process of ensuring that a controlled environment meets regulatory standards for cleanliness, air quality, and operational integrity. It is critical in industries like pharmaceuticals and biotechnology, where maintaining product quality and patient safety depends on contamination control. Proper validation minimizes compliance risks and prevents costly operational delays.
Clean room validation should be integrated as early as the Basic Design (BD) phase of a facility project. Early validation planning helps align regulatory requirements with design choices, reduces the risk of non-compliance, and avoids costly delays that can occur when validation activities are left until after construction.
Delaying clean room validation can lead to extended project timelines, regulatory non-compliance, increased costs, and risks to product quality and patient safety. If validation is not considered early, redesigns or additional qualification steps may be required after construction, disrupting operations and delaying production readiness.
Early validation planning ensures that qualification scopes, system requirements, and regulatory expectations are addressed from the start. This proactive approach streamlines design processes, reduces project risks, and helps avoid bottlenecks during later stages such as commissioning and handover.
The Basic Design (BD) phase focuses on high-level planning, defining system requirements, and setting the project framework, including early validation activities. The Detailed Design (DD) phase involves specifying technical details, finalizing equipment selection, and preparing for construction and qualification. Integrating validation early across both phases ensures smoother project execution.
Alignment between validation activities and project timelines ensures that quality assurance measures are embedded in every project phase. This synchronization minimizes delays, supports compliance with Good Manufacturing Practice (GMP) standards, and ensures production readiness without compromising safety or product integrity.