Большая фармацевтическая компания
Тематическое исследование гибкой биотехнологической лаборатории ISO 7 с акцентом на устойчивость, протоколы биобезопасности и снижение энергопотребления через интеллектуальные системы HVAC и интеграцию светодиодного освещения.
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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Контейнерное оборудование: Кабины спуска (DFB) для взвешивания HPAPI, класс II B2 Шкафы для биобезопасности, корпусы для ввода/вывоза (BIBO).
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Environmental Monitoring System (EMS): Real‑time particle counters, differential pressure sensors, temperature/humidity probes, integrated with SCADA.
3. Ключевые достижения
| Parameter | Result |
|---|---|
| Cleanroom Area | 1,800 m² (Grade A, B, C, D zones) |
| Air Change Rates | Grade A: 0.45 m/s unidirectional; Grade B: 40–60 ACH |
| Pressure Cascade | +45 Pa (Grade A) to +15 Pa (Grade D) |
| Валидация | Все IQ/OQ/PQ завершены за 10 месяцев |
| Regulatory Outcome | Passed EMA and FDA pre‑approval inspections with zero critical findings |
4. Доставленная уникальная ценность
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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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Безопасность оператора: Полное содержание для OEB Level 4 соединения.
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.
