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What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering?

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What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering?

June 5, 2025
último caso de la compañía sobre What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering?
Biopharmaceutical cleanroom engineering is a critical systems engineering that ensures sterile, dust-free, and contamination-free environments for drug production. Its quality highlights are reflected in comprehensive process control from design through construction to maintenance, with each subsystem meeting stringent GMP (Good Manufacturing Practice) requirements.
The following details the quality highlights of biopharmaceutical cleanroom engineering across eleven core sections:
I. Quality Highlight - Ventilation Duct Section
Utilizes 316L stainless steel material with inner-wall electropolishing Ra≤0.5μm. All welds undergo TIG welding and endoscopic inspection. Pipeline installation slope ≥0.5%, equipped with online particle monitoring ports, compliant with ISO 14644-1 Class 5 standards.
último caso de la compañía sobre What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering? 0
II. Quality Highlight - HVAC System Section
Three-stage filtration system (G4+F8+H13), temperature-humidity control accuracy ±0.5℃/±3%RH, pressure differential gradient ≥15Pa. Incorporates variable frequency control energy-saving technology reducing annual energy consumption by over 25%.
último caso de la compañía sobre What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering? 1
III. Quality Highlight - Cleanroom Envelope Structure Section
Double-layer hollow tempered glass viewports, specialized R-corner treatment for color steel plate joints. All transitions feature arc designs (R≥50mm). Flooring utilizes 2mm thick PVC seamless welding with wear resistance coefficient ≥0.55.
último caso de la compañía sobre What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering? 2
IV. Quality Highlight - Process Water Supply Section
Employs double-tube sheet heat exchangers for Water-for-Injection preparation. TOC≤500ppb, conductivity≤1.3μS/cm, equipped with SIP (Steam-in-Place) systems. Circulation flow velocity ≥1.5m/s, pipeline slope ≥1%.
último caso de la compañía sobre What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering? 3
V. Quality Highlight - Electrical System Section
Dedicated LED lighting for clean areas (≥300lux), emergency power transfer time ≤0.5s. All cables installed in stainless steel conduits, ground resistance ≤1Ω, with surge protection devices.
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