Service 04 / 18 · Cleanroom Design
Controlled Environments. Engineered for the Process.
Cleanroom design starts from the process and the cleanliness grade each operation requires. Room classification, pressure cascades, airlocks and gowning are laid out as one system, together with wall, ceiling and floor construction. Designs are prepared with consideration for applicable international GMP guidelines and project-specific regulatory requirements.
Engineering phases
Where this service fits
06 / 09 phases in scope
- 01Feasibilitynot in scope
- 02ConceptIn scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05Procurementnot in scope
- 06ConstructionIn scope
- 07CommissioningIn scope
- 08ValidationIn scope
- 09Operationnot in scope
Scope
What the service covers
- 01Classification strategy and cleanliness-grade mapping
- 02Pressure cascade and airlock design
- 03Personnel, material and waste flows
- 04Wall, ceiling, door and flooring systems
- 05Pass boxes and material transfer points
- 06Environmental monitoring coordination
Method
From inputs to deliverables
INInputs
05 items- I01Process description and product exposure steps
- I02Equipment list and layout
- I03Target markets and applicable GMP guidelines
- I04Product and personnel protection needs
- I05Concept layout and zoning
WORKActivities
05 items- W01Grade assignment per operation
- W02Zoning and pressure cascade definition
- W03Flow separation and airlock planning
- W04Finish and construction-system selection
- W05Coordination with HVAC and monitoring design
OUTDeliverables
05 items- D-04.01Cleanroom classification and pressure cascade drawings
- D-04.02Personnel, material and waste flow drawings
- D-04.03Room data sheets
- D-04.04Cleanroom wall, ceiling, door and floor specifications
- D-04.05Environmental monitoring point layout input
Technical detail
How the controlled environment is built up
Contents · 04
01 / 04
Classification & zoning
- Classification strategy
- Room zoning
- Airlocks
- Pass boxes
- Pressure cascade
02 / 04
Flows
- Personnel flow
- Material flow
- Waste flow
03 / 04
Contamination control & finishes
- Surface materials
- Ceiling systems
- Wall systems
- Doors
- Cleanability of details and junctions
04 / 04
Monitoring
- Environmental monitoring coordination
- Sampling and sensor point locations
- Pressure indication at room entries
- Interfaces with BMS and EMS
Cleanrooms & HVAC
Airflow Is Part of the Process.
Explore how a cleanroom suite is organised: cleanliness grades, pressure relationships and the separate routes for people and materials.
01 / 04 — Z-GRAD
Grade / Zone
Each room is assigned a cleanliness grade from the process risk it carries.
- Grade B — process room
- Grade C — airlocks and wash room
- Grade D — gowning
- CNC — controlled, not classified corridor
Showing layer: Grade / Zone
Swipe to see the whole plan
Deliverables
Typical documents and outputs
- D-04.01Cleanroom classification and pressure cascade drawings
- D-04.02Personnel, material and waste flow drawings
- D-04.03Room data sheets
- D-04.04Cleanroom wall, ceiling, door and floor specifications
- D-04.05Environmental monitoring point layout input
Services
Related services
- 08
Qualification & Validation (CQV)
Documented evidence that facilities, utilities and equipment perform as intended.
Yes. Upgrades usually start with a review of the current zoning, pressure cascade and air handling against the process, followed by a phased design that keeps requalification in view.
From the first layout. Zoning, personnel and material flows, pressure relationships and utilities are hard to change once the design is fixed, so compliance considerations should shape the concept rather than be checked after it.
Next step
Planning a pharmaceutical project?
Share the product type, the current stage and the main constraints. We will respond with a proposed scope and next steps.
+20 101 171 1700