New Facility Design and Expansions
At SAGE, we leverage our extensive expertise in highly regulated environments to lead comprehensive facility design and expansion projects. We guide our clients through every critical phase of development—from initial feasibility studies and conceptual layouts to detailed design and construction execution. Our team excels at navigating the complex intersection of advanced process engineering, custom equipment integration, and stringent regulatory compliance, ensuring your new or expanding facility is built upon a resilient foundation of operational excellence.
When operations outgrow their existing footprints, scaling from clinical to commercial manufacturing requires meticulous strategic planning. Working collaboratively as an extension of your team, we develop optimized facility concepts that seamlessly integrate strict aseptic manufacturing and specialized safety requirements into robust pre-design packages. We manage the entire specification and procurement lifecycle for critical process and quality control equipment, generating precise Facility User Requirements (URS), spatial layouts, and performance specifications that align perfectly with your complex capacity goals.
Acting as the Owner’s Representative, we provide authoritative oversight from the detailed design phase straight through to project tendering and execution. We ensure that every architectural and engineering decision strictly adheres to global regulatory standards while mitigating the risks inherent in large-scale capital expansions. By proactively managing specialized vendor coordination and safeguarding the integrity of the design, we position our clients to successfully consolidate their operations, seamlessly launch new capabilities, and achieve sustainable commercial growth.
Key Projects
Equipment & Facility Engineering
Concept Design
- Capacity and Spatial Analysis, GMP Concept design for new allergen facility, including greenfield and brownfield layouts
Process Flow
- Process flow mapping, new facility block layout, new facility optimization / required architectural modifications for meal delivery kit provider
Equipment & Facility Engineering
Facility Segregation
- Cytotoxic Oncology products filling suite with closed/active Restricted-Access Barrier System (RABS) constructed in a new building expansion with facility segregation
Line Layout
- Filling Suite layout for filling and closing machines enclosed in an aseptic isolator, integrated with a secondary packaging line in adjacent unclassified area
Equipment & Facility Engineering
Suite Design
- Suite design for 30,000 sq. ft. of blending, granulation and compression
Compliance & Validation
Laboratory
- Conceptual designs of biology testing laboratory area and gowning rooms to meet current GMP
Compliance & Validation
Improvement
- Engineering Services provider representing the Client through the Core & Shell and Tenant Improvement phases of the Solid Dose Nutraceutical facility construction
Conversion
- Project Manager for conversion of non-GMP space into GMP compliant, including install of manufacturing equipment, terminal HEPA, GMP finishes, chiller, and modifications to existing AHU
Project Management
Construction
- Project Manager (Equipment) and development of facility concept for brown field construction project
Clean Room
- Project Manager for construction of clean room space for radiotherapeutics operations; vendor management and owner’s representative during construction phase