Perusahaan farmasi besar
Studi kasus tentang laboratorium biotek ISO 7 yang fleksibel yang menekankan keberlanjutan, protokol keamanan biologis, dan pengurangan konsumsi energi melalui sistem HVAC cerdas 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 Lampiran GMP UE 1 (Revisi 2022) & nbsp; dan 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 Penyaringan: & nbsp; AHU redundant dengan terminal HEPA / ULPA (99,997% @ 0,3 & mikro; m), unit aliran udara satu arah (UDAFs) di jalur 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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Peralatan penahanan: & nbsp; Booth Downflow (DFB) untuk menimbang HPAPI, Kelas II B2 lemari keamanan biologis, tas-in / tas-out (BIBO) perumahan.
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Environmental Monitoring System (EMS): Real‑time particle counters, differential pressure sensors, temperature/humidity probes, integrated with SCADA.
3. Pencapaian Utama
| Parameter | Result |
|---|---|
| Ruang bersih | 1,800 m² (Grade A, B, C, D zones) |
| Air Change Rates | Grade A: 0.45 m/s unidirectional; Grade B: 40–60 ACH |
| tekanan Cascade | +45 Pa (Kelas A) hingga +15 Pa (Kelas D) |
| Validation | All IQ/OQ/PQ completed in 10 months |
| Regulatory Outcome | Passed EMA and FDA pre‑approval inspections with zero critical findings |
4. Nilai Unik Dikirimkan
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Efisiensi Energi: & nbsp; Konsumsi daya HVAC 25% lebih rendah melalui kipas VFD dan logika kontrol permintaan.
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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. Kesimpulan
Proyek ini memberikan solusi peralatan ruang bersih yang sepenuhnya sesuai, hemat energi, dan dapat diskalakan, memungkinkan klien untuk meluncurkan lini produk suntik baru 3 bulan lebih awal dari jadwal.
