큰 제약 회사
스마트 HVAC 시스템과 LED 조명 통합을 통해 지속 가능성, 생물 안전 프로토콜 및 에너지 소비 감소를 강조하는 유연한 ISO 7 바이오 테크 연구소에 대한 사례 연구.
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. 클린룸 장비의 범위
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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콘테인먼트 장비: & nbsp;HPAPI 무게를 위한 다운플로우 부스 (DFB), 클래스 II B2 생물 안전 캐비넷, 백인/백아웃 (BIBO) 하우징.
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Environmental Monitoring System (EMS): Real‑time particle counters, differential pressure sensors, temperature/humidity probes, integrated with SCADA.
3. Key Achievements
| 매개 변수 | 결과 |
|---|---|
| Cleanroom Area | 1,800 m² (등급 A, B, C, D 지역) |
| 공기 변화 속도 | Grade A: 0.45 m/s unidirectional; Grade B: 40–60 ACH |
| Pressure Cascade | +45 Pa (등급 A) +15 Pa (등급 D) |
| Validation | 모든 IQ / OQ / PQ 10 개월 안에 완료 |
| Regulatory Outcome | Passed EMA and FDA pre‑approval inspections with zero critical findings |
4. 배달된 독특한 가치
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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: & nbsp;OEB를 위한 완전한 컨테인터 Level 4 화합물.
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.
