RTI Biologics, Inc. (RTI) is a leading provider of sterile biological implants for surgeries around the world, with a commitment to advancing science, safety, and innovation. RTI prepares donated human tissue and bovine tissue for transplantation through extensive testing and screening, precision shaping and proprietary, validated sterilization processes. These allograft and xenograft implants are used in spine, sports medicine, orthopedic, dental, and other surgical specialties.
This new facility enhances their current campus by following the process for research and development, tissue processing and warehousing. By carefully isolating sensitive processing functions and zoning workgroups, the RS&H design team is able to provide a work efficient layout while eliminating cross-contamination risks.
Incorporating new Multipotent Adult Progenitor Cell technologies, the design team developed a cGMP processing area that supports ISO Class 8 pre and post process work areas and ISO Class 7 process and vialing suites. Strict attention to detail allows for the integration of accessible mechanical building support systems apart from clean finish areas in a sustainable coherent design.
The cGMP area includes lockers and gown in and out garb areas, tissue prep and transfer stations, process modules and anterooms to control pressurization, pass-through windows and transfer stations, product quality control, control rate, and liquid nitrogen freezer areas.
The R&D laboratories include tissue and cell culture laboratories, histology and cell biology, chemistry laboratories, and test laboratories. Technical services labs include debride suites, process areas, machine shop and freezer and refrigerator storage areas. Warehouse area includes bulk goods storage, incoming donor tissue process and storage areas, and quarantine areas. This project was a design-build delivery.
Architectural and structural documents were completed using BIM/Revit software.
“The cleanroom spaces required flexibility to support initially small volume manufacturing, with the ability to scale up rapidly as the new processes were fine-tuned and perfected. The RS&H team adapted well to these changes, and to the array of RTI personnel contributing to the design process. They provided a guiding hand and collaborated to lock down the design and translate it into a practical/constructible facility. In a nutshell, RS&H people were flexible, experienced, and personable. I have no hesitation in highly recommending RS&H for building-related design and construction services.” -Laurence Goodall, PE, Staff Engineering for Facilities, RTI Surgical