Cell & Gene Therapy CLEANROOMS
About Cell & Gene Therapy
Cell and gene therapy are two fairly new practices in the healthcare industry, but they’re quickly evolving to effectively treat life-threatening conditions in a safer, more targeted, and less-invasive way.
As forms of regenerative medicine, cell and gene therapies involve extracting cells, protein, or genetic material (DNA) from the patient (or a donor), altering the sample to provide a highly personalized treatment, then reinjecting the sample into the patient. Although these are relatively new therapies, many healthcare providers are hopeful that they’ll offer longer-lasting effects than traditional ones.
The process of treating patients with cell and gene therapies has started in multiple countries, and it’s already saved many lives. However, there’s also much research still to be done within this industry. As recognition for these treatments continues to grow, and as healthcare specialists continue their research, cleanrooms are needed to ensure safe testing, manufacturing, and distribution practices.
Cell & Gene Therapy Cleanroom Standards
Cell and gene therapies require more complex production processes than previous biological medicines. They use cellular engineering, genetic engineering, growth, and purification — all processes that must be carried out in a controlled environment to ensure safe, reliable, and repeatable results.
Therefore, most cell and gene therapy cleanrooms adhere to stringent cleanliness standards, usually either ISO Class 5 or 6 (Federal 209E Class 100-1,000).
- ISO Class 5 cell and gene therapy cleanrooms must have at least 240 air changes per hour and 35% ceiling coverage to ensure no more than 3,520 μm allowed particles per cubic meter.
- ISO Class 6 cell and gene therapy cleanrooms need just a tad less filtration, requiring at least 150 air changes per hour and 25% ceiling coverage to ensure no more than 35,200 μm allowed particles per cubic meter.
For maximum control in cell and gene therapy applications, Angstrom Technology designs, manufactures, and installs two types of modular cleanrooms: HardWall and RigidWall.
- HardWall cleanrooms offer the greatest level of environmental control in terms of static, humidity, pressure, and contamination.
- RigidWall cleanrooms can meet similar stringent standards, but offer a cleaner, professional aesthetic.
We can construct both types as free-standing structures or within existing buildings.
Additional Cell & Gene Therapy Cleanroom Features
To further meet the needs of cell and gene therapy cleanrooms, other operational features may be installed, including:
- Gowning rooms
- Hazardous material storage
- Cryostorage and vaporized hydrogen peroxide (VHP) staging areas
- Laminar airflow systems
- Multi-stage HEPA and ULPA filtration systems
- Standard, flow-through, LED strips, and other lighting options