What are the Quality Highlights of Biopharmaceutical Cleanroom Engineering?
创建于06.05
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.
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%.
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.
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%.
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.
VI. Quality Highlight - Drainage System Section
316L stainless steel pipelines, trap depth ≥50mm. Floor drains feature cleanroom-type air-tight designs. Drainage slope ≥2%, equipped with online COD monitors.
VII. Quality Highlight - Fire Protection and Smoke Exhaust Section
Specialized smoke exhaust fans (operating ≥280℃ for 1 hour), damper opening time (0-90°) ≤15s. Exhaust capacity ≥60m³/min·m², interlocked with clean air conditioning systems for automatic switchover during fires.
VIII. Quality Highlight - Lighting Installation Section
Recessed LED cleanroom fixtures (IP65 rating), surface flatness ≤0.2mm. Luminous flux maintenance ≥90% (30,000h), color temperature 4000K±150K. Sealed with medical-grade silicone at color steel plate joints.
IX. Quality Highlight - Sterilization and Cleaning Equipment Section
VHP sterilizers achieve ≥6log reduction, residual H₂O₂ ≤1ppm. Pass-through boxes feature dual-door interlocks and UV sterilization. Class A laminar flow hoods maintain 0.45±0.1m/s airflow velocity with ≤15% uniformity.
X. Quality Highlight - Laboratory Ventilation Systems
VAV (Variable Air Volume) control response time ≤1s. Fume hood face velocity 0.5±0.1m/s, makeup air ≥90% of exhaust volume. Toxic gas emissions ≤1/100 TLV, with emergency exhaust systems.
XI. Quality Highlight - Laboratory Furniture
Full stainless steel workbenches (304 grade), load capacity ≥300kg/m², acid/alkali resistant (pH 1-13). Cabinet doors auto-close at ≤15° angle. Non-shedding accessories with sealed joints.
Quality management in biopharmaceutical cleanroom engineering must span the entire project lifecycle. Through rigorous DQ/IQ/OQ/PQ validation, each system achieves zero defects, zero contamination, zero deviation quality objectives, ensuring reliable safeguards for pharmaceutical production safety.
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