The Importance of Concept Design Review in Manufacturing Facility Development

A concept design review is a fundamental phase in the development of a biopharmaceutical manufacturing facility. This review provides a valuable opportunity to assess the layout of the facility and understand how the flow of personnel and materials will function within the space. By transitioning high-level ideas about processes, quality standards, and business objectives into a tangible design, the concept design review becomes a crucial step in ensuring that a facility meets both operational and regulatory requirements. 

What is Concept Design Review? 

A concept design review is the process of transforming abstract ideas about manufacturing processes and quality requirements into a visual blueprint. It allows subject matter experts (SMEs) and project stakeholders to evaluate the proposed design and ensure that all technical, regulatory, and operational needs are addressed early in the planning process. According to the ISPE Commissioning and Qualification Baseline Guide, the design review is a formal, documented, and systematic examination aimed at identifying potential issues and offering solutions. 

Defining Requirements for Facility Design 

Before creating conceptual drawings, it is essential to define the high-level project requirements. For start-up companies, these requirements often balance immediate needs with future development goals, all while adhering to the necessary regulatory guidelines. Regulatory bodies such as the FDA (21 CFR 211) and Eudralex Volume 4, Annex 1 provide standards that guide the facility design, even though a concept design review itself is not a regulatory requirement. Conducting a review based on these standards is considered best practice to prevent costly design revisions and construction delays. 

Reviewing the Facility Design: Key Considerations 

Once the initial concept design is ready, it is time for SMEs to evaluate it thoroughly. This process involves assessing the suitability of various areas, including labs, production suites, utility areas, common spaces, and cleanrooms. A particular focus is placed on the layout’s efficiency in supporting the flow of personnel and material into and out of critical areas. 

A significant aspect of this review is ensuring that cleanrooms and anterooms are designed to comply with GMP operations. This includes proper personnel entry protocols, such as locker rooms for gowning and controlled access to production areas. Cleanroom integrity is also maintained by ensuring the design includes appropriate airlocks and pressurization systems to prevent contamination. 

ISO Standards and Airflow Considerations 

Critical to the design review is the classification of Controlled Non-Classified and Classified areas (such as production suites) per ISO 14464. These areas must be marked with their intended air cleanliness level to ensure proper design flow, both for material and personnel entry. For areas like cleanrooms, the design should incorporate positive pressure in critical areas and negative pressure in support areas, following industry standards for contamination control. 

For high-risk operations, such as high-potency manufacturing, containment cleanroom designs that use pressure bubbles, sinks are essential. The FDA has clarified that these designs are crucial for safeguarding both product quality and personnel safety. 

Cleanroom Design and Regulatory Compliance 

Cleanroom classification and the control of airborne particulates are key aspects of the concept design review. Regulatory guidelines from both the FDA and the EU outline specific requirements for cleanroom grades and monitoring procedures. The EU enforces strict rules for transitioning between Grade C and Grade B environments, and airlocks must meet the same classification as the production room they lead into. 

Understanding the type of product being manufactured also influences cleanroom design. For instance: 

• Sterile products such as high-potency drugs or cell and gene therapies may require specialized designs. 

• The use of single-use systems or isolator-based filling equipment could dictate the layout of production areas. 

Achieving “Right First Time” with Concept Design Reviews 

The concept design review is a crucial phase for conducting a technical analysis, identifying potential risks, and addressing challenges early in the process. By pinpointing design concerns and resolving them promptly, the project can proceed smoothly, ensuring that key milestones are met on time and within budget. The approach follows a “Right First Time” methodology, which is crucial for avoiding costly redesigns and delays. 

Mitigating Risks and Ensuring Quality by Design 

By performing a thorough review at the conceptual stage, the project team can develop mitigation strategies, implement corrective actions, and maintain a quality by design approach throughout the facility buildout. This not only streamlines the design and construction process but also guarantees that the facility is designed to meet regulatory requirements and quality standards from the outset. 

Partner with BioBoston Consulting for Expert Facility Design Guidance 

At BioBoston Consulting, we specialize in providing expert advice and project management support during the concept design review process for biopharmaceutical manufacturing facilities. Our team of experienced professionals will guide you through the complexities of facility design, ensuring compliance with regulatory standards and achieving operational excellence. Whether you are a start-up or an established company, we can help you navigate the design and build process, minimizing risks and ensuring that your project is a success. 

Ready to start your facility design on the right foot? Contact BioBoston Consulting today to schedule a consultation and ensure your manufacturing facility meets both your business and regulatory needs.