一家大型製藥公司
一個靈活的ISO 7生物技術實驗室的案例研究，強調可持續性、生物安全協定，並通過智慧暖通空調系統和LED照明集成降低能耗。
1.項目背景
一家全球十大製藥公司計畫擴大其無菌生產能力；單克隆抗躰（mAbs）和預充式注射器. A new Grade A / ISO Class 5 cleanroom suite was required, fully compliant with EU GMP Annex 1 (2022 revision) and FDA cGMP.
2. Scope of Cleanroom Equipment
Our scope included the complete engineering, supply, installation, and qualification of all core cleanroom equipment:
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HVAC & Filtration: Redundant AHUs with HEPA/ULPA terminals (99.997% @ 0.3 µm), unidirectional airflow units (UDAFs) over filling line.
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Modular Cleanroom Panels: Hardwall, chemical‑resistant panels with air‑tight doors, pass‑through chambers, and interlocked airlocks.
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Containment Equipment: Downflow booths (DFB) for HPAPI weighing, Class II B2 biosafety cabinets, bag‑in/bag‑out (BIBO) housings.
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Environmental Monitoring System (EMS): Real‑time particle counters, differential pressure sensors, temperature/humidity probes, integrated with SCADA.
3. Key Achievements
| Parameter | 結果 |
|---|---|
| Cleanroom Area | 1,800 m²； （A、B、C、D級區域） |
| Air Change Rates | A級：0.45 m/s單向； B級：40&ndash； 60 ACH |
| Pressure Cascade | +45 Pa (Grade A) to +15 Pa (Grade D) |
| Validation | All IQ/OQ/PQ completed in 10 months |
| Regulatory Outcome | Passed EMA and FDA pre‑approval inspections with zero critical findings |
4. Unique Value Delivered
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Energy Efficiency: 25% lower HVAC power consumption via VFD fans and demand‑control logic.
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Modular Expandability: Future filling line addition possible without disrupting existing operations.
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Operator Safety: ； OEB全封閉 Level 4 化合物。
5. Conclusion
The project delivered a fully compliant, energy‑efficient, and scalable cleanroom equipment solution, enabling the client to launch a new injectable product line 3 months ahead of schedule.
