다국적 제약회사의 연구 실험실 프로젝트

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

• 엄격한 오염 통제: & nbsp;다른 연구 모듈 (예: 세포 배양, 바이러스 학 및 화학 합성) 간의 교차 오염 예방.

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

• 정밀 환경 통제: & nbsp;온도 안정성 $21\pm 1^{\circ }C$, 상대 습도 $45\pm 5\%$, and room pressure cascade from clean to dirty corridors.

• 모듈 확장 가능성: & nbsp;주요 개조 없이 실험실 모듈을 확장하거나 재구성할 수 있습니다.

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

3. Cleanroom Equipment Engineering Solution

우리의 엔지니어링 팀은 a 를 제공했습니다.턴키 클린룸 장비 패키지 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.

• 연결 공기 단단한 문: & nbsp;자기 가스켓과 비전 패널.

• 통행 방: Interlocked, HEPA-filtered pass-boxes for safe material transfer.

C. Containment and Safety Equipment

• 생물 안전 장 (BSC 종류 II 유형 B2): & nbsp;전용 콘테인먼트 전전용 배관에 연결된 100% 배기 단위.

• 분말 콘테인먼트 후드: Downflow booths (DFB) for weighing and dispensing HPAPIs.

• 가방 / 가방 아웃 (BIBO) 여과기 주택: For safe filter replacement without operator exposure.

D. Monitoring and Control System (BMS/EMS)

• 실시간 센서 & nbsp;입자 수, 차압, temp/RH를 위해.

• Alarm and alert integration & nbsp;고객’중앙 SCADA 시스템

• 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 (디자인 자격): & nbsp;ISO 클래스, 재료 호환성 및 공기 흐름 시뮬레이션을 검증했습니다.

• IQ (Installation Qualification): & nbsp;유틸리티 연결, 필터 무결성 및 구성 요소 인증 확인.

• OQ (운영 자격): & nbsp;공기 흐름 속도, 압력 카스케이드, 입자 수 (실행 불가능) 및 경보 기능을 테스트했습니다.

• 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)

• 클린룸 지역: & nbsp;2,800 m² (12개의 모듈 실험실 및 4개의 지원 구역을 포함하여)

• 에너지 효율성: & nbsp;전통적인 디자인에 비해 HVAC 에너지 소비를 28% 줄입니다.

• 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.