Axenic System is one of the leading company engaged in architectural
designing, planning, installation, commissioning of HVAC and Turnkey
construction for cleanroom projects
Cell & Gene Therapy
Table of Contents
ABOUT CELL & GENE THERAPY
AXENIC SYSTEMS (established in 1995) functionally designs, builds and installs top-of-the-line cleanrooms to meet the requirements of the CELL & GENE THERAPY. Our CELL & GENE THERAPY cleanrooms can meet any classification requirements and are preferably suited for this application.
Cell and gene therapy are two new practices in the healthcare industry, but they’re rapidly growing to efficiently treat life-threatening conditions in a safer, more targeted, and less-invasive way.
As forms of regenerative medicine, cell and gene therapies include extracting cells, protein, or genetic material (DNA) from the patient (or a donor), modifying the sample to deliver a highly personalized treatment, then reinjecting the sample into the patient. Although these are comparatively new therapies, many healthcare providers are confident that they’ll offer longer-lasting effects than traditional ones.
The procedure of treating patients with cell and gene therapies has started in several countries, and it’s already saved many lives. However, there is several research still to be done within this industry. As recognition for these treatments continues to grow, and as healthcare experts continue their research, cleanrooms are required to ensure manufacturing, safe testing, and distribution practices.
CELL & GENE THERAPY CLEANROOM STANDARDS
Cell and gene therapies involve more complex production procedures than earlier biological medicines. They use genetic engineering, cellular engineering, growth, and purification — all procedures that must be carried out in a controlled environment to ensure reliable, safe, and repeatable results.
Therefore, most cell and gene therapy cleanrooms adhere to strict 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 make sure no more than 3,520 μm allowable particles per cubic meter.
- ISO Class 6 cell and gene therapy cleanrooms need just a bit less filtration, needing at least 150 air changes per hour and 25% ceiling coverage to make sure no more than 35,200 μm allowable particles per cubic meter.
For maximum control in cell and gene therapy applications, AXENIC SYSTEMS designs, manufactures, and installs two kinds of modular cleanrooms: Hardwall and Rigidwall.
- Hardwall cleanrooms offer the supreme level of environmental control in terms of humidity, static, pressure, and contamination.
- Rigidwall cleanrooms can encounter similar strict standards, but offer a cleaner, professional aesthetic.
ADDITIONAL CELL & GENE THERAPY CLEANROOM FEATURES
To further meet the requirements of cell and gene therapy cleanrooms, other functioning features may be installed, including:
- Hazardous material storage
- Gowning rooms
- 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
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