Discipline 01

Architecture & GMP layout

Space planning, cleanroom construction, wall/ceiling/floor systems, doors and pass-throughs, and the flows that keep contamination out.

Space planning, cleanroom construction, wall/ceiling/floor systems, doors and pass-throughs, and flows that keep contamination out. We design the envelope around the process.

  1. 01ArchitectureEnvelope, roof plant, access(this discipline)
  2. 02HVAC
  3. 03Electrical
  4. 04Utilities / Plumbing
  5. 05Fire Fighting
  6. 06CleanroomsGMP zoning, flows, classification(this discipline)
  7. 07Automation / BMS
  8. 08Process Equipments
Where this discipline sits in the facility model

GMP layout & flows

Zoned around the process.

Every room is zoned to its cleanliness grade and HVAC class, with defined temperature and humidity limits and a pressure cascade that keeps air moving from clean to less clean.

ZoneConditions
Grade D22 ± 3 °C · RH not more than 55%
Grade C22 ± 3 °C · RH not more than 55%
ComfortNot more than 27 °C
  • Isolator-based filling

    Powder and liquid filling take place in isolators within a Grade C room.

  • Graded support rooms

    Preparation, washing and process rooms zoned by product exposure.

  • Comfort & technical zones

    Packing, stores and corridors comfort-cooled; technical areas ventilated.

HVAC and pressure-differential zoning layout for an aseptic production and packing area, with rooms coloured by cleanliness grade and arrows showing the pressure cascade.
HVAC and pressure-differential zoning layout: aseptic production and packing.

Let’s design it right.

From the first concept sketch to an issued-for-construction package, Agon designs pharmaceutical facilities that meet the highest international standards. We would welcome the conversation.