Cleanroom Technology
Are current cleanroom standards sufficient for cell and gene therapy?
A (QA Manager): No. Cell therapies are living products. ISO 5 is baseline, but we need real-time microbial monitoring, not just post-process settling plates.
B (Engineer): Robotics are the answer. Human operators are the primary contamination source. Fully automated aseptic filling is expensive but necessary.
C (CFO): ROI is brutal. A single cleanroom retrofit costs millions. We’ll only do it if the FDA mandates it.
D (Regulatory): The EU GMP Annex 1 already pushes for Continuous Monitoring. US firms will have to follow to export. Prepare your CAPEX now.
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