cGMP Facility Architecture & Engineering
Pharmaceutical Cleanroom Design, Start to Startup
Hixson designs cGMP cleanrooms for sterile fill/finish, biologics, cell and gene therapy and oral solid dose across North America.
- ISO Class 5-8 cleanrooms with pressurization and flow design
- Clean utilities: WFI, USP purified water, clean steam, pure gases
- Design documents that support IQ/OQ/PQ validation
Designing cGMP spaces since 1948, with 20 in-house technical disciplines.
Prefer to talk? Call 513-241-1230
Talk to a cGMP design team
Tell us about your cleanroom project. A Hixson team member will follow up to discuss scope and next steps.
Why manufacturers bring cleanroom projects to Hixson
One team, 20 disciplines
Architecture, process, HVAC, electrical, plumbing, controls, structural and civil all sit in house, so your cleanroom design stays coordinated.
Built for regulators
We design to cGMP expectations and align sterile work with FDA, EU GMP Annex 1 and PIC/S guidance.
Validation-ready documents
Our design and construction documentation supports your IQ/OQ/PQ validation effort.
Process and building together
Cleanroom layout follows real material, personnel and product flow, not just square footage.
Through construction
Project management, cost estimating and construction administration are in house, from URS through startup.
Deep experience
Hixson has designed cGMP spaces for over 75 years for pharma, biotech and lab clients.
What our pharmaceutical cleanroom design covers
Hixson multi-disciplinary teams support your project from defining the URS through design, construction documentation and construction administration. We plan classified zones, gowning and airlocks, pressure cascades and unidirectional flow so your suites work for both product protection and daily operations.
We also handle the systems behind the walls: HVAC and pressurization, clean utilities, cGMP-compliant finishes, and the containment and monitoring that sterile and biologic products require.
- ISO Class 5 critical zones with appropriate background classifications
- RABS and isolator integration, plus biosafety cabinets
- Sterile fill/finish, aseptic vialing, prefilled syringes and ophthalmics
- Biologics: bioreactor suites, chromatography, UF/DF, lyophilization
- Cell and gene therapy: viral vector, CAR-T, plasmid DNA, BSL-2 containment
- Oral solid dose and controlled environment design
- Clean utilities: WFI, USP purified water, clean steam, pure gases
- Modular cGMP: pre-engineered cleanroom modules and skid-mounted units
- Environmental monitoring program and media fill support
- QA/QC and analytical lab integration next to production
Trusted by science and technology clients
“our customers would rate the service we deliver as excellent.”
“support and efforts to help get the facility back up and running, stating that Hixson's authentic leadership just confirms why we enjoy working with you all and gratefully appreciate your efforts.”
What happens after you reach out
We listen to your scope
Share your product, classifications, site and drivers. We ask the questions that shape a real cleanroom scope.
We map the approach
Our team outlines the disciplines, deliverables and phases your project needs, from master plan to construction documents.
You get a proposal
We send a written scope and fee proposal so you can compare it against your capital plan.
Frequently asked questions
How is pharmaceutical cleanroom design priced?
Fees depend on scope, classification levels, square footage and which of our disciplines you need. We prepare a written proposal after a scoping conversation.
Do you handle the construction too?
No. Hixson provides design and construction administration. We do not perform general contracting or construction labor, and we do not sell process equipment.
Which cleanroom classifications do you design?
We design ISO Class 5, 6, 7 and 8 environments, including ISO 5 critical zones with appropriate background classifications, RABS, isolators and BSL-2 containment.
Can you work on an existing facility instead of a new build?
Yes. We work on greenfield plants, expansions, retrofits and modular fit-outs of tenant cGMP space.
Where do you work?
Hixson serves clients across North America, including the United States and Canada. Our office is in Cincinnati, Ohio.
Will your documents support validation?
Yes. Our design and construction documentation is prepared to support IQ/OQ/PQ validation, with alignment to FDA, EU GMP Annex 1 and PIC/S for aseptic work.
Ready to scope your cleanroom project?
Tell us about your product, classification needs and schedule. A Hixson cGMP design lead will get back to you to talk through scope and next steps.
- ISO Class 5-8 cleanrooms with pressurization and flow design
- Clean utilities: WFI, USP purified water, clean steam, pure gases
- Design documents that support IQ/OQ/PQ validation
Prefer to talk? Call 513-241-1230