Un grande istituto di ricerca scientifica

1. Panoramica del progetto

A large scientific research institute—comprising multiple departments such as molecular biology, nanotechnology, advanced materials, and pharmaceutical sciences—initiated a major infrastructure upgrade to centralize its high‑containment and high‑sensitivity research capabilities. The institute required a flexible, scalable cleanroom facility capable of supporting diverse research activities ranging from coltura cellulare e produzione di vettori virali to nanofabrication and analytical chemistry.

Unlike a single‑owner pharmaceutical company, the institute hosts dozens of independent research groups, each with varying cleanliness, safety, and equipment requirements. The primary challenge was to design a shared cleanroom equipment ecosystem that could serve multiple users without cross‑interference, while maintaining compliance with institutional biosafety levels (BSL‑2 and BSL‑3) and ISO 14644 standards.

2. Client Requirements

• Multi‑User Flexibility: Cleanroom zones that can be reconfigured for different research protocols (e.g., sterile cell work one week, nanoparticle synthesis the next).

• Segregated Containment: Isolated modules for BSL‑2, BSL‑3, and low‑humidity nanofabrication processes, each with dedicated HVAC and airlock systems.

• Alta affidabilità & Tempo di funzionamento: 24/7/365 operation with redundant cleanroom equipment to avoid research downtime.

• Energy Efficiency: Given the large footprint (3,500 m²), the institute demanded low‑energy cleanroom HVAC and filtration solutions.

• Formazione & Accessibilità: Equipment interfaces designed for easy operation by rotating students, postdocs, and visiting scientists.

3. Cleanroom Equipment Engineering Solution

Il nostro team di ingegneri ha consegnato un pacchetto di attrezzature centralizzate per sale pulite  su misura per un ambiente di ricerca multi-tenant:

A. Zoned HVAC and Filtration

• Dedicated AHU per cleanroom class:  Unità di trattamento dell'aria separate per ISO  Class 5, Classe  6, e classe  7 zone.

• HEPA/ULPA filter banks: Ceiling‑mounted filter modules with adjustable airflow for research‑grade unidirectional or non‑unidirectional patterns.

• Ventilazione a bassa velocità in low‑turbulence zones (e.g., for electron microscopy prep).

B. Modular Cleanroom Architecture

• Pannelli a parete rigida smontabili:  Consente la riconfigurazione dei layout di laboratorio senza modifiche strutturali.

• Color‑coded modular walls: Visual differentiation of cleanliness levels (e.g., white = ISO 7, blue = ISO 6, yellow = BSL‑3).

• Autoclavi a passaggio interbloccati e serbatoi chimici: For safe material transfer between containment levels.

C. Shared Containment and Process Equipment

• Classe multipla   Tipo II   Armadi di biosicurezza A2 (BSC):  Ognuno dotato di monitoraggio individuale ma collegato a un pleno di scarico comune.

• Portable glovebox isolators: For oxygen/moisture‑sensitive materials research.

• Centralized vacuum and gas systems:  Azoto, argon e aria secca pulita di ultra-alta purezza distribuiti tramite collettori in acciaio inossidabile.

D. Central Monitoring & Access Control

• Room‑by‑room EMS/BMS: Real‑time pressure, particle count, temp, RH, and door interlock status.

• RFID‑based access system: Restricts users to authorized cleanroom classes and records usage for billing/accountability.

• Visual alarm beacons at each entry for rapid pressure‑cascade failure notification.

4. Key Engineering Challenges & Solutions

5. Validation & Compliance

Tutte le attrezzature della sala pulita sono state qualificate per ISO 14644‑1:2015  esigenze istituzionali di biosicurezza:

• DQ: Simulated multi‑user scenarios (e.g., simultaneous cell culture and nanoparticle synthesis).

• IQ: Verified utility connections, filter certifications, and equipment mounting.

• OQ: Tested air change rates (20–60 ACH depending on class), pressure cascades, and recovery time (<15 min to ISO Class 5).

• PQ: Three months of dynamic monitoring with actual research protocols, including microbial air sampling.

Risultato:  L'istituto ha ottenuto la certificazione operativa completa con zero cross‑contamination events during the validation period.

6. Project Outcome

• Cleanroom Area:  3,500  m² (ISO 5: 400  m² , ISO 6: 1,200  m² , ISO 7: 1,900  m²)

• Capacità utente:  Fino a 150 ricercatori al giorno in 28 moduli di laboratorio indipendenti

• Energy Savings: 32% reduction in HVAC energy via variable‑speed fans and demand‑controlled ventilation

• Utilization Rate: >85% within six months of opening, accommodating 12 research groups from 4 faculties

The research institute now operates a truly shared, high‑performance cleanroom core facility, enabling cross‑disciplinary projects that were previously impossible due to contamination or containment conflicts.

7. Conclusion

Per i grandi istituti di ricerca scientifica, l'ingegneria delle attrezzature per sale pulite deve dare priorità a flexibility, segregation, and user‑centric design far more than in a dedicated pharmaceutical facility. This project demonstrates that with zoned HVAC, modular hardwall architecture, and centralized monitoring, a single cleanroom complex can safely serve hundreds of researchers across BSL‑2, BSL‑3, and nanofabrication disciplines—while maintaining ISO Class 5 integrity and energy efficiency.