Participation in a project team embarking on the design and construction of a new pharma facility is both challenging and rewarding in equal measure. There are endless opportunities for innovation, learning and improvement but at the same time, a balance between innovation, cost and compliance must be maintained — and this often leads to challenging cross-functional discussions and tough decisions.
The design phase for a new facility is critical as it’s the only opportunity for all stakeholders and end-users to significantly influence the facility design and ensure it meets their requirements for optimum process layout in addition to including the critical design elements required for efficiency, contamination control and containment.
Build a diverse team
The SME group involved in the facility design should be cross-functional. In addition to architects and engineers, the team should include end-users such as operations and quality personnel who can represent the requirements of their functions but also maintain a pragmatic approach to project time and budget. The goal should be the delivery of a final facility design that meets the expectations of regulatory guidelines and incorporates features to fully support the manufacturing of safe, efficacious drugs. Also, the design should satisfy end-user requirements and provide appropriate conditions for facility personnel.
The EU regulatory guidelines presented in Eudralex, chapter 3, “Premises and Equipment,” provide guidance on the general requirements for heating, ventilation, drains and other systems and features that are necessary for the provision of a controlled manufacturing environment that is suitable for medicinal product production. A 2015 revision included guidance relating to the application of appropriate facility design in the prevention of cross-contamination.
The FDA Code of Federal Regulations (CFR) Part 211 also outlines the minimum good manufacturing practices for building and facilities in subpart C. This section outlines requirements for design and construction features, lighting, ventilation, air filtration, air heating and cooling, plumbing, sewage and refuse, sanitization and maintenance. All of these must be considered during facility design if seeking FDA approval. Although the FDA doesn’t include a requirement for a contamination control strategy as outlined in the EU guidance, the control of contamination is an inherent FDA requirement for multi-product facilities.
To get the maximum benefit from the facility design process, the road map for design approval should be defined at the beginning of the process, providing structure to the review process and allowing time for cross-functional meetings where all stakeholders and end-users can walk through the layout drawings and highlight areas of concern. The SME group must be given the opportunity to review, challenge and assess the design for usability and operability, as well as its ability to provide protection to the drugs being manufactured.
Keep quality in mind
From a quality perspective, specific emphasis should be placed on the proposed flow of people, equipment, materials, product and waste through the facility, providing a design that will minimize cross-contamination and offer adequate product protection and the appropriate level of containment. Quality risk management is essential for providing a structured approach to facility design review as it provides a mechanism for documenting risks and actions identified during the review and provides justification, based on risk, for any changes required in the design.
Newer technologies such as building information modeling and virtual reality can be useful tools to communicate and display the facility design to help end-users and stakeholders gain a better understanding of how the facility will look and feel post-construction. These technologies can display the design in a more tangible way than traditional 2D drawings and although more costly to implement, may provide savings later in the process.
Collaborative approaches to pharma facility design provide the design team with an opportunity to receive cross-functional end-user feedback, and identify cross-contamination risks and design weaknesses before construction has even started. This way, changes that will enhance operability, usability and compliance can be made when the cost of change is much lower.
