某跨國製藥公司研究實驗室項目

1. Project Overview

A leading multinational pharmaceutical company embarked on a strategic initiative to establish a state-of-the-art research laboratory in [Location – e.g., Singapore, Boston, or Shanghai]. The facility was designed to support early-stage drug discovery, formulation development, and potency analysis for novel oncology and gene therapy products.

To meet stringent regulatory requirements (EU GMP, FDA cGMP, and ISO 14644), the company required a fully integrated cleanroom equipment solution capable of achieving ISO Class 5 to ISO Class 7 environments, with specialized containment for highly potent active pharmaceutical ingredients (HPAPIs).

2.客戶要求

• Strict Contamination Control: Prevention of cross-contamination between different research modules (e.g., cell culture, virology, and chemical synthesis).

• 高度封閉： Negative pressure suites with HEPA/ULPA filtration and pass-through systems for handling OEB Level 4 and 5 compounds.

• Precision Environmental Control: ； 溫度穩定性；$21\pm 1^{\circ }C$, relative humidity $45\pm 5\%$, and room pressure cascade from clean to dirty corridors.

• Modular Scalability: Ability to expand or reconfigure lab modules without major renovation.

• Data Integrity & Monitoring: Continuous monitoring of particle counts, differential pressure, and airflow velocity.

3. Cleanroom Equipment Engineering Solution

Our engineering team delivered a turnkey cleanroom equipment package comprising:

A. HVAC and Filtration Systems

• AHUs with Energy Recovery: Redundant air handling units with VFD-controlled fans.

• HEPA篩檢程式天花板模塊： ； 終端HEPA篩檢程式（99.997%@0.3微米），外殼經過洩漏測試。

• Unidirectional Airflow Units (UDAFs): Installed over biosafety cabinets and filling stations to maintain ISO Class 5 zones.

B. Modular Cleanroom Architecture

• Hardwall Modular Panels: Non-porous, chemical-resistant polyurethane or mineral core panels with rounded cove corners for easy cleaning.

• 聯鎖氣密門： With magnetic gaskets and vision panels.

• Pass-Through Chambers: Interlocked, HEPA-filtered pass-boxes for safe material transfer.

C.圍堵和安全設備

• 生物安全櫃（BSC II類B2型）： ； 100%排氣裝置連接到專用安全殼筦道。

• Powder Containment Hoods: Downflow booths (DFB) for weighing and dispensing HPAPIs.

• Bag-In/Bag-Out (BIBO) Filter Housings: For safe filter replacement without operator exposure.

D. Monitoring and Control System (BMS/EMS)

• 實时感測器 ； 用於顆粒計數、壓差、溫度/RH。

• Alarm and alert integration with the client’s central SCADA system.

• Data logging compliant with 21 CFR Part 11.

4. Key Engineering Challenges & Solutions

5. Validation & Compliance

All cleanroom equipment was installed and qualified according to V-model approach:

• DQ（設計鑒定）： ； 經過驗證的ISO等級、資料相容性和氣流類比。

• IQ (Installation Qualification): ； 已驗證的公用設施連接、篩檢程式完整性和組件認證。

• OQ (Operational Qualification): Tested airflow velocity, pressure cascade, particle counts (non-viable), and alarm functionality.

• PQ (Performance Qualification): Dynamic testing under simulated operational conditions, including aseptic media fills.

結果： ； 該設施通過了監管檢查，沒有出現任何重大觀察結果，並實現了；ISO 14644-1 5級（靜止/運行） ； 對於關鍵區域。

6. Project Outcome

• 完成時間： ； 14個月（按計畫）

• Cleanroom Area: 2,800 m² (including 12 modular labs and 4 support zones)

• 能源效率： ； 與傳統設計相比，暖通空調能耗降低28%

• 操作準備： ； 8個HPAPI密封套件成功調試

客戶現在經營一家；靈活、安全、合規 ； 研究實驗室，加快其腫瘤學研發行程，最大限度地降低交叉污染風險。

7. Conclusion

本案例研究表明，對於跨國製藥研發來說； D項目；engineered cleanroom equipment&mdash； 不僅僅是建築； 是監管合規和卓越運營的基石。 通過綜合模組化硬牆系統、精密暖通空調和即時監控，該項目滿足了所有科學、安全和可擴展性要求。