Aseptic Facility Design
Hixson designs cGMP aseptic processing facilities for sterile fill/finish, aseptic vialing, prefilled syringes, ophthalmics, and biologics with FDA, EU GMP Annex 1, and PIC/S alignment.
Hixson provides integrated Aseptic Processing System Design Services for pharmaceutical and biotech manufacturers that need reliable, compliant, and scalable sterile production environments. From cleanroom classification and unidirectional flow HVAC to RABS, isolators, clean utilities, and validation-supporting documentation, our multidisciplinary teams help reduce regulatory risk while advancing projects from concept through construction administration.

Integrated design and engineering services for sterile, compliant, and efficient aseptic manufacturing environments.
Hixson designs cGMP aseptic processing facilities for sterile fill/finish, aseptic vialing, prefilled syringes, ophthalmics, and biologics with FDA, EU GMP Annex 1, and PIC/S alignment.
Multidisciplinary teams support pharma and biotech clients from URS definition through construction documents and administration, integrating clean utilities, HVAC, pressurization, finishes, and validation-supporting documentation.
Pre-engineered cleanroom modules, skid-mounted process units, and modular fit-outs help clients accelerate speed-to-market while preserving regulatory predictability and capacity flexibility.
Hixson designs biologics manufacturing environments for mAbs, vaccines, recombinant proteins, blood products, and biosimilars, including upstream suites, downstream purification, fill/finish, clean utilities, and containment.
Primary filling, bottling, and packaging line engineering includes aseptic filling, precision dosing, line balancing, equipment selection, controls integration, and downstream packaging coordination.
Controls and automation services support URS and FDS development, PLC and HMI programming, network design, FAT/SAT, startup, commissioning, and integration with regulated process systems.

Hixson begins by clarifying the URS, product characteristics, throughput goals, regulatory expectations, containment needs, and operational constraints that shape the aseptic processing system and supporting facility infrastructure.
See how disciplined project delivery helps complex regulated manufacturers move from concept to compliant operations.
Hixson brings integrated technical depth to complex regulated manufacturing environments.
Decades of architecture and engineering experience support complex pharma, biotech, and cGMP projects.
Twenty in-house technical disciplines coordinate architecture, process, utilities, automation, and compliance together.
Designs account for FDA, EU GMP Annex 1, PIC/S, IQ, OQ, and PQ needs.
Specialized expertise helps clients identify process, contamination, utility, and constructability risks early.
Experienced leaders guide integrated technical project delivery.

Manager, Plumbing Systems & Fire Protection Engineering
John oversees the department responsible for the design and engineering of plumbing systems and fire protection engineering for a variety of project types, including new construction, building utility upgrades, utility capacity analyses, and process line additions. John and his team work with a range of systems, including domestic water, process water, hot water production, direct contact water heaters, high pressure/rinse water, compressed air, natural gas, sanitary drainage, process drainage, central sanitation systems, fire pumps, and fire sprinkler systems.

Manager, Controls & Automation Engineering
As the Manager of Hixson's Controls & Automation department, Craig guides the team responsible for designing, implementing, and commissioning advanced control systems and automation solutions. His responsibilities include overseeing the development of automation strategies that streamline manufacturing processes, enhance operational efficiency, and ensure seamless integration of new and existing systems.

Manager, Process Engineering
Warren leads the team providing processing design services, process optimization studies, and process commissioning and FAT, SAT, and IQ activities. He advises on waste, energy, and GHG emissions reductions, and conducts safety and dust evaluations, including PSM/HAZOP. His expertise spans all food and beverage sectors including fluid, dried and cultured dairy products, processed meat, flavors, and prepared foods. Warren is also on the IDFA Food Safety Committee and actively participates in the 3A, SSI steering committee, and work groups.

Manager, Civil Engineering
In his role as Manager of Civil Engineering, Steve leads the team responsible for the planning, design, and engineering of roads, stormwater hydraulics and modeling, and onsite utilities. On project work, Steve is responsible for civil site project design, specifications, technical design, and project coordination with the client, government regulatory bodies, outside consultants, and contractors. As a senior staff member with our firm, Steve also serves as a mentor to newer associates.

Vice President & Director, Project Management Services
Chris, a Hixson officer and member of the Board of Directors, oversees Hixson’s Project Management, Cost Estimating, and Construction Administration departments. Chris also serves in a project management role, leading teams consisting of representatives from the client, Hixson, contractors, and vendors to effective project completion. Chris assumes overall responsibility for development of project delivery strategies, coordination of all Hixson disciplines, and facilitating effective communication and management to focus resources on delivering high-quality projects on time and within budget.

Manager, Mechanical Engineering
Dave brings more than three decades of experience to his role as the Manager of Hixson’s Mechanical Engineering Department. His work has included the design and project management of new facilities, as well as modification of existing facilities for high technology and food processing industries. At a corporate level, Dave is a member of Hixson’s Dairy and Beverage Industry team, which works to continuously improve the value Hixson offers to the dairy industry through development of our knowledge base, services and capabilities.

Manager, Electrical Engineering
Kyle serves as the Manager of Hixson’s Electrical Engineering department. In this role, he oversees the team responsible for the creation and delivery of electrical designs. This includes the design of high, medium, and low voltage power distribution, lighting, telecommunications, and fire alarm systems. Kyle brings more than 15 years of experience in electrical consulting and design to his role. Areas in which Kyle specializes include electrically hazardous area classification, high- and medium-voltage power distribution, protective relaying, arc flash studies, harmonics analysis, cogeneration design, emergency systems design, and complex laboratory designs.

Senior Vice President, and Director, Mechanical & Electrical Engineering
Scott, an officer of the firm, leads the teams responsible for mechanical and electrical project tasks and design, specifications, technical content, consultation during equipment selection and installation and systems start-up assistance. In addition, Scott also serves as the Quality Assurance Manager, overseeing the firm’s commitment to quality. Over Scott’s more than three decades of experience, he has worked on greenfield, brownfield, and renovation projects for food & beverage plants in all sectors, labs, pharma & biotech facilities, and workplace projects.

Manager, Manufacturing Engineering
In his role as Manager of Hixson’s Manufacturing Engineering department, Scott leads the team responsible for project consulting and coordination between client, vendor, and internal disciplines within Hixson for overall manufacturing processes, functionality, equipment, and layouts. These team members develop process flow diagrams, equipment lists, and preliminary utility requirements, as well as develop equipment layouts that range from high level master planning to detailed construction documents. In addition to this role, Scott is a member of Hixson’s Meat Industry advisory team, focusing on technologies related to the meat and plant protein industry.

Director of Architecture
Derek is the Director of Hixson’s Architecture department. In this role, Derek leads the teams who design projects for our Food & Beverage, Pharma & Biotech, Laboratory, and Workplace clients. Previously, Derek served as the Manager of Hixson’s Process Layout department, where he directed the team that plays a critical coordination role in the overall development of process models and the 3D equipment model management process. Prior to these management roles, Derek, who began his career with Hixson in 2008, served as a Project Architect.
Aseptic Processing System Design Services plan the facility, equipment, utilities, controls, and documentation needed to manufacture sterile products while minimizing contamination risk. Hixson’s work can include cleanroom layouts, ISO classifications, personnel and material flows, RABS or isolator integration, unidirectional flow HVAC, clean utilities, environmental monitoring considerations, and validation-supporting design deliverables.
Connect with Hixson’s integrated engineering and design specialists.
Certified culture supporting experienced project teams.
Ranked No. 178 by Interior Design magazine.
Recognized in key architecture and engineering sectors.
Tell Hixson about your product, process, facility goals, and compliance requirements. Our team will help identify the right next steps for your aseptic design project.
For immediate assistance, feel free to give us a direct call at +1 513-241-1230. You can also send us a quick email at info@hixson-inc.com.
For immediate assistance, feel free to give us a direct call at +1 513-241-1230. You can also send us a quick email at info@hixson-inc.com.