Case study 01 / 03
Sample Project — Oral Solid Dosage Facility
This sample shows how an oral solid dosage facility could be taken from a product and capacity brief through concept design, detailed engineering, and qualification. The scenario assumes a new building for granulation, compression, coating, and primary packaging.
This is a sample case study. It shows how ALVEDA presents project work; it does not describe a completed ALVEDA project, and it names no client, location, date or measured result.
Fact sheet
CS-01- Country
- To be confirmed
- Sector
- Oral solid dosage
- Facility type
- Tablet and capsule manufacturing facility
- Scope
- Concept to qualification
- Status
- Sample content
Services in scope
- 01Feasibility & StrategyTesting the technical and commercial case before capital is committed.
- 02Master Planning & Concept EngineeringZoning, flows and phasing fixed early, while changes are still inexpensive.
- 03Facility & Architectural DesignPharmaceutical architecture shaped by the process, the people and the flows between them.
- 05HVAC EngineeringAir systems designed for cleanliness, pressure, temperature and humidity control.
- 08Qualification & Validation (CQV)Documented evidence that facilities, utilities and equipment perform as intended.
Challenges
- 01
Dust containment and cross-contamination control between granulation, compression, and coating suites.
- 02
Separate personnel, material, and waste flows within a constrained building footprint.
- 03
Humidity control for moisture-sensitive products, with AHU zoning that keeps the pressure cascade stable during door openings.
Engineering approach
- Step 01
Define the URS and room data sheets with production and quality stakeholders before the layout is frozen.
- Step 02
Zone the plan by cleanliness grade, then set the pressure cascade, airlocks, and gowning sequence to suit the process.
- Step 03
Coordinate architecture, HVAC, process utilities, and dust extraction in one BIM model, with clash detection at each design stage.
- Step 04
Structure DQ, IQ, OQ, and PQ protocols under a validation master plan (VMP), each traced back to the URS.
Intended outcome
The approach is designed to give the owner a layout, an engineering package, and a qualification route that align from the first design review. It is aimed at limiting late rework between design, construction, and validation.
Stated as design intent. A sample case study reports no measured result.
Gallery
Illustrative photography — these are not images of a completed ALVEDA project.
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.
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