Expert cGMP Facility Design for Biopharmaceutical and Sterile Manufacturing
Genesis delivers comprehensive architectural and engineering solutions for state-of-the-art cGMP facility design. Our expertise spans biopharmaceutical facilities specializing in oncological products and sterile injectables.
Efficient cGMP Workflow with “Linear Factory” Layout
To optimize workflow and minimize cross-contamination risks, our cGMP facility designs follow a “Linear Factory” organizational concept, optimizing cGMP workflow and minimizing cross-contamination risks. This approach seamlessly integrates pharmaceutical manufacturing areas dedicated to oncological products and sterile injectables, a spacious warehouse, advanced laboratories, administrative offices, and essential utility spaces (CUB), all connected by a central corridor spine.
Aesthetically Pleasing & Functional cGMP Facility Design
Furthermore, our design approach prioritizes both aesthetics and functionality. For instance, by relocating stair towers to the exterior, we enhance the visual appeal and usability of the manufacturing block. Additionally, the use of refined materials creates a welcoming environment. Dedicated spaces for offices, break rooms, training, and visitor entrances further improve the workplace experience.
Enhanced Aseptic Manufacturing Capabilities for Sterile Injectables
Moreover, our cGMP facility designs for sterile injectables incorporate cutting-edge aseptic manufacturing capabilities. We integrate new filling lines for vials, syringes, and IV bags, ensuring sterile production. Our flexible designs accommodate both RABS and isolator technologies, along with terminal sterilization for bag products. To further enhance sterility, we also incorporate sterile supplies processing, including autoclaves, dry heat ovens, and advanced washing facilities.
Regulatory Strategies & Technical Expertise for cGMP Compliance
Genesis provides in-depth expertise on regulatory strategies to ensure cGMP compliance throughout the process. We develop cGMP flow diagrams, design HVAC systems tailored for pharmaceutical manufacturing, and provide structural designs. We also ensure the implementation of critical clean utilities like WFI (Water for Injection), Clean Steam, and CDA (Clean Dry Air), adhering to the highest industry standards.