Syarikat farmaseutikal besar
Kajian kes mengenai makmal bioteknologi ISO 7 yang fleksibel yang menekankan kemampanan, protokol keselamatan bio, dan pengurangan penggunaan tenaga melalui sistem HVAC pintar dan integrasi pencahayaan 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 dan Penapisan:Perkhidmatan: AHU berlebihan dengan terminal HEPA / ULPA (99.997% @ 0.3 & mikro; m), unit aliran udara satu arah (UDAFs) di atas barisan pengisian.
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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 | Result |
|---|---|
| Kawasan Bilik Bersih | 1,800 m² (Grade A, B, C, D zones) |
| Air Change Rates | Gred A: 0.45 m/s satu arah; Gred B: 40 & ndash; 60 ACH |
| Kaskad tekanan | +45 Pa (Gred A) kepada +15 Pa (Gred 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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Kecekapan Tenaga:Perkhidmatan: Penggunaan kuasa HVAC yang lebih rendah 25% melalui kipas VFD dan logik kawalan permintaan.
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Modular Expandability: Future filling line addition possible without disrupting existing operations.
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Operator Safety:Perkhidmatan: Pengendalian penuh untuk OEB Level 4 sebatian.
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.
