Salt Lake City, Utah
A purpose-built controlled environment.
5,200 ft² bringing research and development, quality control and manufacturing together under one roof — designed around controlled material and personnel flow, contamination-control practices and continuous environmental monitoring.
At a glance
Everything a regulated product needs, in one building.
The facility was built by HealthTech Wound Care, a Levaris company, to develop and manufacture human cell and tissue-based products, including the DermaBind® product family. Its integrated design supports consistent manufacturing, product development, process improvement and future expansion — and it is now available to partners.
5,200ft²
Total facility footprint
2,600ft²
Modular ISO 7 / ISO 8 cleanroom space
ISO 5
Hood-level aseptic processing
2,600ft²
QC, R&D and material-prep workspace
13485
Quality management system aligned with ISO 13485
Cleanrooms
ISO 7 and ISO 8 cleanrooms, with ISO 5 processing.
2,600 ft² of modular cleanroom space classified to ISO 7 and ISO 8, with ISO 5 biosafety cabinets for aseptic, open-product work. Modular construction means the space can be reconfigured as programs change.
ISO 5
Biosafety cabinets / hoods for aseptic handling of open product — the cleanest working zone in the facility (comparable to the former Class 100).
ISO 7
Classified processing space surrounding critical operations (comparable to the former Class 10,000).
ISO 8
Classified support and transition space for gowning, staging and material preparation (comparable to the former Class 100,000).
Equipment
Production-ready equipment, already qualified for our own products.
A highlight of what’s on site. The complete equipment list is available on request.
| Equipment | Environment | Used for |
|---|---|---|
| Class II biosafety cabinets | ISO 5 inside ISO 7 | Aseptic processing and handling of open product |
| Production-scale lyophilizer (freeze dryer) | Cleanroom suite | Freeze-drying for stability and room-temperature shelf life |
| QC laboratory instruments | QC lab | In-process and release testing support |
| R&D laboratory | R&D lab | Formulation, feasibility and process development |
| Environmental monitoring | Facility-wide | Continuous monitoring of controlled spaces |
Lyophilization on site.
Freeze-drying removes water while preserving a product’s structure, improving stability and shelf life. Partners with moisture-sensitive biologics, peptides and specialty products can use the same capability without sourcing a separate lyophilization vendor.
Lyophilization servicesLaboratories
2,600 ft² for QC, R&D and material preparation.
Dedicated laboratory space sits alongside the cleanroom suite, so development, testing and production stay connected — and technology transfer happens down the hall, not across the country.
Environmental controls
Contamination control is designed in, not added on.
Our own products are human cells, tissues and cellular and tissue-based products, so the facility’s layout and practices were built for that standard from day one.
- Controlled material and personnel flow
- Gowning and contamination-control practices
- Continuous environmental monitoring of controlled spaces
- Quality management system aligned with ISO 13485
- Processes designed to meet applicable FDA requirements, including 21 CFR Part 1271
Our team
The people who run it for our own products.
Partners don’t just rent space. They work with the scientists, quality professionals, production staff and commercial team who operate the platform every day.
Scientists
Formulation, process development and technology transfer.
Quality & regulatory
Document control, QC testing, release and regulatory guidance.
Production
Trained cleanroom technicians and production management.
Commercial
Sales, distribution, reimbursement and customer support.
Tell us what you’re building.
We’ll respond to schedule a confidential discovery call — or an in-person or virtual tour of the Salt Lake City facility.