Project Background: In the mRNA vaccine stock solution workshop of a biopharmaceutical enterprise, there was a risk of cross-contamination between the logistics corridor and the Class B clean area. The original ordinary door could not meet GMP certification requirements:

• External dust entering the clean area during material transfer, affecting product quality

• Odor cross-contamination, resulting in a poor working environment for employees

• Slow door opening and closing, leading to prolonged exposure of materials to non-clean environments

Product Solution: Three-door interlocking high-speed clean door system with core configurations:

• Anti-static PVC curtain + double-layer sealing, preventing dust adsorption

• Three-door interlocking control, ensuring only one door opens at the same time

• Fast opening and closing at 0.8m/s, reducing exposure time during material transfer

Implementation Effect:

• The concentration of dust ≥0.5μm in the workshop was stably within 3500 particles/m³, 28% better than the EU GMP limit

• Isopropanol odor concentration decreased by 40%, and employee satisfaction was significantly improved

• Material transfer efficiency increased by 45%, successfully passing EU GMP certification