Commercial 503B Compounding Cleanrooms

The innovation of personalized medicine, compounded to an individual’s health needs has been a revolution in medicine over the last decade.  AdvanceTEC is focused on serving leading clients in the 503B Compounding segment who are held to stringent cGMP (Current Good Manufacturing Practices) and FDA inspections and compliance. Clinical or commercial scale compounders in the 503B segment benefit from AdvanceTEC’s cleanroom integration and total performance delivery.  AdvanceTEC’s unique Open Market, Zero Compromises offering to 503B is a customer centric approach that provides certainty of cost, schedule and total performance for you.  

Common 503B Compounding Cleanroom Considerations

While there are variations in terms of scale, layout, and total output needs from one 503B cleanroom to another, there are also common cleanroom considerations we see serving this market.
503B Compounding Cleanroom Design Considerations
  • Airflow arrangements
  • Pressurization cascades
  • HVAC configurations
  • Low wall air returns
  • Temperature, humidity and particle control
  • Gowning and cleaning protocols

Common 503B Compounding Cleanroom Specifications

Specification for 503B pharmaceutical compounding cleanrooms vary based on process requirements.  Typical 503B compounding facilities perform their requirements in and ISO Class 5 (Class 100) zone or control area, ISO 7 (Class 10,000) cleanroom background, and a gown room / anteroom of either ISO 7 or ISO 8.

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 503B Compounding Regulatory Considerations

In the US, 503B compounding facilities are regulated by the US Food and Drug Administration (FDA) with oversite through its related organizations, including:
  • Good Manufacturing Practices (GMP)
  • US Food and Drug Administration (FDA)
  • The Drug Quality and Security Act (DQSA)
  • United States Pharmacopeia (USP)
  • The Drug Enforcement Administration (DEA)
  • 21 CFR Part 210: Current Good Manufacturing Practice in Manufacturing Processing, Packing, or Holding of Drugs
  • 21 CFR Part 211: Current Good Manufacturing Practice for Finished Pharmaceutical

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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