شركة صيدلانية كبيرة
دراسة حالة حول مختبر مرن للتكنولوجيا الحيوية ISO 7 يؤكد على الاستدامة وبروتوكولات السلامة الحيوية وخفض استهلاك الطاقة من خلال أنظمة HVAC الذكية ودمج إضاءة LED.
1. Project Background
A global top‑10 pharmaceutical company planned to expand its aseptic manufacturing capacity for monoclonal antibodies (mAbs) and prefilled syringes. 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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نظام المراقبة البيئية (EMS): Real‑time particle counters, differential pressure sensors, temperature/humidity probes, integrated with SCADA.
3. Key Achievements
| Parameter | Result |
|---|---|
| منطقة الغرف النظيفة | 1,800 m² ؛ (الصف أ، ب، ج، مناطق د) |
| معدلات تغيير الهواء | Grade A: 0.45 m/s unidirectional; Grade B: 40–60 ACH |
| سلسلة الضغط | +45 Pa (الدرجة A) إلى +15 Pa (الصف 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: Full containment for OEB Level 4 compounds.
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.
