Process Engineering

EwingCole has earned a national reputation for designing cGMP-compliant manufacturing facilities that meet both FDA and EU regulatory requirements.

We design facilities that support a wide range of production types, including cell culture, cell banking, blood processing, solid and liquid dosage, parenteral, transdermal, topical, and vaccines. Each space is tailored to client needs while ensuring compliance, cleanability, and long-term performance.

Our areas of specialization include:

• cGMP Manufacturing Facilities

• CAR-T Cell Therapy

• Blood Processing Facilities

• Discovery and Development Laboratories

• Clinical and Anatomic Pathology Laboratories

• QA/QC Laboratories

Development labs must support a wide range of activities, from research and pilot-scale testing to QA/QC and analytical functions. EwingCole designs flexible lab environments with modular layouts, accessible utilities, and clear adjacencies between research, workplace, and support spaces. Our planning addresses equipment-intensive workflows, acoustics, natural light, and lab-office visibility to promote safety and collaboration. MEP systems are engineered for precision, energy efficiency, and redundancy to minimize downtime and contamination risk. In both cGMP and non-cGMP spaces, we integrate Building Automation Systems and environmental monitoring to maintain critical parameters. Our process leads to lab environments that are both high-performing and responsive to changing research needs.

Aseptic fill/finish operations require exceptional coordination between cleanroom design, process equipment, and regulatory protocols. EwingCole has designed facilities for sterile drug production that incorporate liquid filtration, aseptic filling, and secondary packaging within ISO-classified environments. We understand the requirements for both RABS and isolator systems and support clients in developing appropriate gowning, material flow, and validation strategies. Our design process includes cleanroom zoning, integration of automated filling lines, and clean utility systems like Clean Steam, WFI, and CIP/SIP. We also provide QA/QC lab spaces to support in-process control and regulatory compliance. With every project, our goal is to streamline sterile production while maintaining product integrity and regulatory alignment.

Cell and gene therapy facilities require a design strategy that supports evolving science, strict regulatory control, and highly specialized infrastructure. EwingCole plans and designs modular suites that allow clients to scale from clinical trials to commercial production while minimizing risk of cross-contamination. Our approach includes dedicated cleanrooms for blood processing, cell culture, and extraction, each with appropriate directional airflow, biosafety containment, and cryogenic storage. We size systems for heat-generating equipment like freezers and incubators, and integrate CO₂ and liquid nitrogen where needed. Special attention is paid to workflow, from material quarantine and waste disposal to personnel movement and clean zone transitions. The result is a compliant, adaptable facility that supports innovation in advanced therapy manufacturing.

EwingCole has a proven track record in designing facilities that support the development and production of medical devices, diagnostics, and delivery systems. These environments must balance precision manufacturing with adaptability to new technologies like miniaturization, 3D printing, and automation. Our projects include pilot plants, cleanrooms, warehousing, and workplace areas—all designed to meet cGMP standards and life safety codes. We focus on modular layouts, streamlined shop floors, and infrastructure that supports rapid scale-up and integration of outsourcing strategies. Clean utility systems, flexible equipment zones, and forward-thinking space planning allow facilities to evolve with the market. From feasibility through commissioning, we design to help clients accelerate time to market without compromising quality.

Manufacturing semisolid pharmaceuticals—such as creams, ointments, gels, and pastes—requires precise control over complex, multi-phase processes. EwingCole designs facilities that ensure consistency, stability, and compliance by addressing critical parameters like temperature, mixing, flow rates, and cleanability.

We integrate validated CIP/WIP systems, specialized equipment layouts, and simulation-based planning to optimize workflows and streamline production. Our approach results in scalable, adaptable environments ready to support evolving formulations and technologies.

Designing high purity water systems for biopharmaceutical manufacturing requires a deep understanding of cGMP processes and regulatory standards for water grades, including RO/DI, Purified Water (PW), and Water for Injection (WFI). Based on the characteristics of incoming water, EwingCole engineers select and integrate appropriate preprocessing technologies—such as multimedia filtration, activated carbon, water softening, reverse osmosis, ion exchange, UV light, ozone treatment, and cartridge filtration—to meet purity specifications. For parenteral drug production and other applications requiring USP WFI, we design systems utilizing Multi-Effect Distillation (MED) or Vapor Compression Distillation for reliable, large-scale output.

Our team uses advanced hydraulic modeling tools to accurately size storage, pumps, and distribution networks for PW and WFI systems. We design complete loop systems—including hot, cold, and ambient configurations—with sanitization strategies tailored to each facility’s process needs. These systems may include return-to-tank and return-to-pump configurations, point-of-use heat exchangers, and plant-wide water balancing. EwingCole delivers high-performing water infrastructure that ensures purity, reliability, and long-term compliance across a wide range of manufacturing environments.

EwingCole has extensive experience designing safe, code-compliant systems for the handling, storage, and distribution of solvents and other hazardous materials used in biopharmaceutical manufacturing. Our multidisciplinary team—including process, electrical, structural, and fire protection engineers—works closely with clients to understand their solvent requirements and apply the latest NFPA, OSHA, and Factory Mutual guidelines. Early planning focuses on identifying material types, quantities, hazard classifications, fire ratings (NFPA 30), and electrical area classifications (NFPA 497), as well as building code allowances for flammable material limits.

We design systems to address critical fire and explosion risks, particularly during loading, unloading, and transfer operations. Proper grounding systems are essential to prevent static discharge, with electrical resistance kept below 10 ohms as defined by NFPA 77 and API RP 2003. These principles also guide our approach to downstream waste collection and vapor control. Our team has designed regenerative thermal oxidizers (RTOs), distillation systems, and solvent recovery technologies—including azeotrope separation—based on detailed mass balance analyses to ensure safety, compliance, and operational efficiency throughout the entire solvent lifecycle.