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Expert Aseptic Processing System Design Services

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.

Aseptic processing cleanroom design

Our Aseptic Processing System Services

Integrated design and engineering services for sterile, compliant, and efficient aseptic manufacturing environments.

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.

Pharma Biotech Design

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.

Modular cGMP Design

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.

Biologics Facility Design

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.

Filling Line Engineering

Primary filling, bottling, and packaging line engineering includes aseptic filling, precision dosing, line balancing, equipment selection, controls integration, and downstream packaging coordination.

Controls Automation

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.

Engineers reviewing aseptic facility plans

Our Aseptic Design Process

Define Requirements And Risk Drivers

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.

Map Process And Facility Flows

Engineer Critical Systems

Document Compliance And Validation Support

Support Construction And Commissioning

Trusted By Industry

Project Experience

See how disciplined project delivery helps complex regulated manufacturers move from concept to compliant operations.

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis

"Very cool place with nice employees."

RaiderGreg
RaiderGreg

"Love it."

Zachary Waas
Zachary Waas

"Great Group of people. Thank You for supporting Special Olympics!"

Rebekah Travis
Rebekah Travis
The Hixson Difference

Why Choose Hixson?

Hixson brings integrated technical depth to complex regulated manufacturing environments.

75+ Years

Decades of architecture and engineering experience support complex pharma, biotech, and cGMP projects.

Integrated Teams

Twenty in-house technical disciplines coordinate architecture, process, utilities, automation, and compliance together.

Regulatory Focus

Designs account for FDA, EU GMP Annex 1, PIC/S, IQ, OQ, and PQ needs.

Risk Reduction

Specialized expertise helps clients identify process, contamination, utility, and constructability risks early.

Meet The Project Leaders

Experienced leaders guide integrated technical project delivery.

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John Brockmeier P.E.

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.

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Craig Cheevers

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.

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Warren Green, P.E.

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.

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Steve Guyer, P.E.

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.

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Chris Jarc, P.E., PMP, LEED AP

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.

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Dave Klenk

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.

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Kyle McAllister

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.

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Scott McGlamery, P.E.

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.

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Scott Wever

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.

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Derek Wojcikowski

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.

Frequently Asked Questions

What are Aseptic Processing System Design Services?

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.

What types of aseptic facilities does Hixson design?

Which regulations and standards guide aseptic processing design?

Can Hixson help with RABS and isolator integration?

Does aseptic design include clean utilities?

Can an existing facility be retrofitted for aseptic processing?

What deliverables are typically included in an aseptic design project?

How early should Hixson be involved in an aseptic project?

Still Have Aseptic Design Questions?

Connect with Hixson’s integrated engineering and design specialists.

Certified & Recognized

Awards and Recognition

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Great Place To Work

Certified culture supporting experienced project teams.

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Rising Giants

Ranked No. 178 by Interior Design magazine.

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Top Sector Firm

Recognized in key architecture and engineering sectors.

Plan Your Aseptic Processing Project

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.

Contact Us Today

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.