Clinical Stage and High-Volume Production Vaccine Cleanrooms

Until recently, vaccines were something we focused on for our toddlers or if we were traveling to unique parts of the world. AdvanceTEC’s cleanroom integration and design build platform is being leveraged for full scale up of multiple vaccine manufacturing facilities. Harnessing our 3D BIM to Build technology and integrated project delivery methodology, global technology leaders have embraced AdvanceTEC for their experience in vaccine cleanroom projects.

Typical Vaccine Cleanroom Considerations

Vaccines are said to be one of the trickiest things in science to create.  Your cleanroom should be the easy part.  Vaccine cleanrooms are purpose built facilities customized to the unique processes they enable.  While every vaccine approach  cleanroom is different, there are common cleanroom considerations that span the applications and technology platforms:
Vaccine Cleanroom Design Considerations
  • MAL (Material Airlocks) / PAL (Personnel Airlocks)
  • Door interlocking and personnel flow patterns
  • Pressure cascades
  • Process equipment configuration and access
  • HVAC configurations and air flow segregation
  • Down flow booths or LAF (laminar air flow) modules
  • Low wall returns
  • Process distribution
  • Environmental monitoring
  • ISO classification, temperature & humidity
  • Viewing, monitoring, security cameras
  • Gowning and cleaning protocols
Vaccine Facility and Systems Experience
  • N+1 redundant utilities
  • Bioreactors
  • Process utility panels & distribution hook-ups
  • WFI (Water for Injection) generation and distribution
  • VHP (Vapor Hydrogen Peroxide)
  • BMS (Building Management System) controls and door interlocks
  • Environmental monitoring equipment (viable and nonviable particle counters)
  • Analytical equipment

Common Vaccine Cleanroom Specifications

Vaccine cleanrooms are comprised of various ISO performance classifications ranging from ISO 4 (Class 10) zones, to ISO 5 (Class 100), ISO 6 (Class 1,000), ISO 7 (Class 10,000), ISO 8 (Class 100,000) backgrounds and CNC (Controlled Non-Classified) support zones.  Critical supporting infrastructure such as N+1 redundancy across critical utilities, in-line analytical testing labs, environmental chambers, and process utilities common aspects of AdvanceTEC’s integrated project delivery.  Specifications for vaccine cleanrooms vary based on process requirements.

Provided below are typical specifications:
ISO Classification
  • ISO 4 – (Class 10) – 300-540 ACPH
  • ISO 5 – (Class 100) – 240-480 ACPH
  • ISO 6 – (Class 1,000) – 150-240 ACPH
  • ISO 7 – (Class 10,000) – 60-90  ACPH
  • ISO 8 – (Class 100,000) – 5-48 ACPH
European Standard
  • Grade A
  • Grade B
  • Grade C
  • Grade D
  • Controlled Non-Classified (CNC)

Important Vaccine Regulatory Considerations

There are various regulatory agencies to be considered for new vaccine cleanroom facilities depending on the technology platform and end market.
  • Good Manufacturing Practices (GMP)
  • US Food and Drug Administration (FDA)
  • World Health Organization (WHO)
  • National Institute of Health (NIH)
  • Office for Human Research Protections (OHRP)
  • Center for Biologics Evaluation and Research (CBER)
  • Regulations under Code of Federal Regulations (CFR)
  • European Medical Agency (EMA)

Cleanroom IP

AdvanceTEC is the industry leading design & build cleanroom and process integration provider where experts with decades of segment experience apply the latest digital tools and technologies to deliver outstanding outcomes for customers. 

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