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ALVEDA SOLUTIONS

Solution 01 / 07

Pharmaceutical Manufacturing Facility

A manufacturing facility is decided long before it is drawn. ALVEDA SOLUTIONS starts from the product portfolio, the dosage forms and the capacity, and carries those decisions through every discipline until the plant is ready for qualification.

Discuss your facilitySee the engineering path
Glass facade of a modern pharmaceutical facility at dusk, with stainless-steel process vessels visible inside

The problem and its context

Most cost and schedule problems in a new plant trace back to the first months: a layout fixed before the process was understood, HVAC sized after the architecture was frozen, or utilities added one request at a time.

A facility that has to satisfy a regulatory authority also has to work as a production system. Room sizes, material and personnel routes, equipment access and future expansion are part of the same design question as air classification and pressure relationships.

Typical pressure points

  • Capacity and product mix not yet translated into equipment, rooms and shifts
  • Cross-contamination risk between products that share areas or utilities
  • Disciplines designing in sequence instead of against one design basis
  • Qualification planned at the end rather than built into the design

What the solution involves

  1. 01

    Converting the product portfolio and capacity into a process and equipment basis

  2. 02

    Zoning the plant by cleanliness grade, with segregated personnel, material and waste routes

  3. 03

    HVAC zoning, air-change and pressure concepts matched to each room’s function

  4. 04

    Utility, purified water and clean-utility load schedules sized from the process

  5. 05

    Coordinated engineering packages ready for tender and construction

  6. 06

    A qualification approach defined alongside the design, not after it

Engineering path

The service disciplines involved, in the order the project needs them. Each step links to the full service description.

  1. 01Feasibility study and capacity basisProduct mix, capacity and site options become a costed starting point.
  2. 02Concept planning and master layoutBlock layout, phasing and expansion space before detailed design starts.
  3. 03GMP zoning and personnel/material flowClean zones, airlocks and one-directional routes set on the layout.
  4. 04Pharmaceutical process engineeringProcess flow, equipment list and room requirements derived from the product.
  5. 05Basic engineering and design basisOne coordinated design basis that every discipline works from.
  6. 06Cleanroom design and classificationRoom grades, finishes and envelope details aligned with the zoning.
  7. 07Pharmaceutical HVAC engineeringAir handling, filtration and pressure regimes for each zone.
  8. 08Process and clean utilitiesCompressed air, steam, chilled water and other services sized from the load schedule.
  9. 09Purified water generation and distributionWater grades and loop design matched to the products and the pharmacopoeia applied.
  10. 10Detailed engineering for constructionTender and construction drawings, specifications and schedules.
  11. 11GMP design reviewDesign reviewed against the agreed project regulatory basis at each stage.
  12. 12Commissioning, qualification and validationA CQV plan that traces requirements from design through to qualified operation.
  13. 13Project management and delivery controlSchedule, cost and interfaces held together from design to handover.

Deliverables and design basis

Typical deliverables

  • Feasibility and capacity basis report
  • Design basis and user requirement inputs
  • Process flow diagrams and equipment list
  • Zoning, flow and room data sheets
  • HVAC zoning and pressure concept
  • Utility and water load schedules
  • Tender and construction packages
  • Commissioning and qualification plan

Key design-basis considerations

  • Dosage forms, product mix and batch sizes
  • Target markets and the agreed project regulatory basis
  • Product potency, cross-contamination risk and segregation needs
  • Expansion and future product lines
  • Site climate, available utilities and local codes

Classification, pressure relationships and containment are set by the project regulatory basis and the process risk.

How the regulatory design basis is set

Related sectors

Next step

Planning this type of facility?

Share the product, the capacity and where the project stands. An engineer will reply with a proposed engineering path.

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