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AE Partnerships

United for Success: The Synergy Between AE Firms and Prefab cGMP Facility Providers
Designing and constructing a cGMP facility is a complex, resource-intensive undertaking. Assembling a team of experienced professionals, such as architects, engineers, contractors, and facility providers, is imperative. Prefabricated (prefab) offsite-built cGMP facilities have surged in popularity, offering advantages over conventional construction methods, including cost savings, shortened construction time, decreased waste, and enhanced flexibility. For a successful project outcome, fostering collaboration between architecture and engineering (AE) firms and prefab cGMP facility providers is indispensable. This article delves into how AE firms collaborate with prefab cGMP facility providers, like Germfree, to deliver facilities within budget and on schedule.
Project Alignment

AE firms and facility providers must align to the clients’ project goals and objectives to ensure timely, on-budget project completion. Effective communication and coordination are necessary throughout the project lifecycle. Regular meetings and updates guarantee everyone remains informed, allowing prompt resolution of any concerns or issues.

Risk management is another key element of project alignment. AE firms and facility providers must cooperate to identify potential risks and devise mitigation strategies. This may involve exploring alternative solutions or developing contingency plans to tackle unforeseen events.


The contracting process is a crucial aspect of collaboration between AE firms and prefab cGMP facility providers. A contract must clearly delineate each party’s roles and responsibilities and define the project scope, timeline, and budget. Provisions for change orders and dispute resolution should also be included.

A prevalent contracting approach in prefab construction is the design-build model, wherein the AE firm and facility provider collaborate as a single entity, taking responsibility for both design and construction. This model streamlines the contracting process and minimizes potential conflicts between parties. An AE firm directly contracting with a prefabricated cGMP facility provider on behalf of the client can offer several benefits, such as the AE firm’s design and construction management expertise and its provision of oversight and quality control during construction. However, it may come with additional overhead expenses, a longer construction timeline, and less control over the construction process.

An alternative approach is for the Client to contract directly with the cGMP facility provider, such as Germfree, a full-service solution provider capable of delivering turnkey prefabricated facilities. Germfree can provide infrastructure equipment, project management, procurement, equipment integration, commissioning, and qualification of facilities and equipment, and facility installation. Additionally, a client contracting directly with the facility provider can yield immediately recognizable cost savings, faster project delivery, and a more streamlined process. However, potential drawbacks include less client control over the design process and the need to hire additional professionals to ensure compliance with regulatory requirements.


Seamless collaboration between AE firms and prefab cGMP facility providers is critical to ensuring a facility meets client expectations and adheres to regulatory requirements. The collaboration process typically commences with a needs assessment and feasibility study. Both parties collaborate to identify project-specific requirements, such as facility size, layout, and functionality, using this information to develop a User Requirement Specification (URS) and conceptual design that fulfills the client’s needs and satisfies regulatory requirements.

Upon conceptual design approval, AE firms and facility providers join forces to finalize the design and develop construction documents. In this phase, collaboration is essential to optimize the design for prefab construction, involving the identification of components suitable for offsite prefabrication (e.g., HVAC systems or cleanrooms) and integrating them into the final design. Design precision with accurate scope delineation is critical to project success. BIM Model coordination should be utilized to minimize conflicts while construction progresses, in parallel, at both the client location and the prefab providers factory site.

Streamlining the Process

AE firms and prefab cGMP facility providers should establish a unified communication channel to exchange information and discuss progress throughout the project’s lifecycle. By leveraging their respective areas of expertise, these entities can navigate complexities, ensure integration, maintain project momentum, and achieve desired outcomes.

Germfree’s internal project management team helps streamline the project by providing a single point of contact for all systems associated with the cleanroom. This team is also capable of scheduling any on-site subcontractor support required to bring the cleanroom online.

If well scheduled and executed, prefabricated cleanroom facilities can be installed, commissioned and turned over to the Client months, if not years, faster than traditionally built facilities. The concurrent work happening at the prefabricated site and the final Client site is only recognizable through off-site built modular construction methods. Germfree’s vertical integration as well as our unique Design-Build process provides the schedule with a higher level of certainty than traditional built facilities, even taking the tumultuous supply chain issues seen in this post-COVID environment into account.

To accelerate project turnover on site, Germfree’s in-house Quality and CQV teams develop Factory/Site Acceptance Testing documentation, along with IQOQ/Commissioning during the build. This means the facility will be completely functional and tested at the factory site prior to shipping, a feature unique to Germfree’s solution. The Client and AE firm can use this documentation for the overall facility commissioning, expediting the overall turnover of the facility to the client.

Adapting to Evolving Industry Needs

As the landscape of cGMP facility construction continues to evolve, AE firms and prefab cGMP facility providers must stay informed of emerging trends and technologies to remain competitive. By maintaining an open dialogue and embracing collaboration, both parties can adapt to changing industry demands and deliver state-of-the-art facilities that meet and exceed client expectations.

Ultimately, the partnership between AE firms and prefab cGMP facility providers serves as the foundation for the successful execution of cGMP facility projects. Their collective expertise and commitment to collaboration contribute to the efficient delivery of high-quality facilities that fulfill clients’ needs and comply with stringent regulatory requirements. By continuing to refine and optimize their collaborative processes, AE firms and prefab cGMP facility providers can drive innovation and set new benchmarks for excellence in cGMP facility design and construction.


Successful cGMP facility projects hinge on collaboration between AE firms and prefab cGMP facility providers. Effective collaboration necessitates clear communication, project alignment, and a well-defined contracting process. By working in tandem, AE firms and facility providers can optimize designs for prefab construction, identify and mitigate risks, and ensure that the facility meets the client’s needs and regulatory requirements.

By synchronizing their efforts, AE firms and prefab cGMP facility providers can overcome challenges associated with the design and construction phases of the project. They can identify areas where prefab construction offers significant advantages and implement innovative solutions that cater to the client’s requirements. This collaborative approach fosters efficiency, minimizes risk, accelerates schedule, and ensures a high-quality facility that adheres to regulatory standards.