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. Client Requirements

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

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

• Precision Environmental Control: Temperature stability at $21\pm 1^{\circ }C$, 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 Filter Ceiling Modules: Terminal HEPA filters (99.997% @ 0.3 µm) with leak-tested housings.

• 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.

• Interlocking Air-Tight Doors: With magnetic gaskets and vision panels.

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

C. Containment and Safety Equipment

• Biosafety Cabinets (BSC Class II Type B2): 100% exhaust units connected to dedicated containment ducts.

• 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)

• Real-time sensors for particle count, differential pressure, temp/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 (Design Qualification): Verified ISO class, material compatibility, and airflow simulations.

• IQ (Installation Qualification): Verified utility connections, filter integrity, and component certification.

• 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.

Result: The facility passed regulatory inspection with zero major observations, and achieved ISO 14644-1 Class 5 (at rest/in operation) for critical zones.

6. Project Outcome

• Completion Time: 14 months (on schedule)

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

• Energy Efficiency: 28% reduction in HVAC energy consumption compared to conventional designs

• Operational Readiness: Successful commissioning of 8 HPAPI containment suites

The client now operates a flexible, safe, and compliant research laboratory, accelerating its oncology pipeline with minimized cross-contamination risk.

7. Conclusion

This case study demonstrates that for multinational pharmaceutical R&D projects, engineered cleanroom equipment—not just construction—is the cornerstone of regulatory compliance and operational excellence. By integrating modular hardwall systems, precision HVAC, and real-time monitoring, the project met all scientific, safety, and scalability requirements.