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ALVEDA SOLUTIONS

Solution 04 / 07

Pharmaceutical Water / PW / WFI

Water is the most used material in most pharmaceutical plants and one of the hardest systems to correct once it is running. ALVEDA SOLUTIONS engineers PW and WFI systems from the feed-water analysis and the points of use, to the pharmacopoeia that applies to the project.

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Glass facade of a modern pharmaceutical facility at dusk, with stainless-steel process vessels visible inside

The problem and its context

A water system is a process in its own right: pretreatment, generation, storage, distribution, sanitisation and sampling all affect microbial control. Problems usually appear as dead legs, low velocities, temperature drift or loops that cannot be sanitised without interrupting production.

The required water grades, the generation technology and the sanitisation method all depend on the products, the dosage forms and the pharmacopoeia selected in the project regulatory basis.

Typical pressure points

  • Feed water that varies by season or source
  • Peak demand at points of use that the loop was not sized for
  • Dead legs, poor drainability and hard-to-sanitise branches
  • Expanding an existing loop without losing its qualified state

What the solution involves

  1. 01

    Water demand profile built from every point of use and its grade

  2. 02

    Pretreatment and generation selection based on the feed water and the required grades

  3. 03

    Storage and distribution loop design for velocity, temperature and drainability

  4. 04

    Sanitisation approach: hot, ozone or chemical, as the system requires

  5. 05

    Hygienic piping, instrumentation and sampling points

  6. 06

    Qualification of generation, storage and distribution against the design basis

Engineering path

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

  1. 01PW and WFI system engineeringGrades, demand profile, generation technology and loop concept.
  2. 02Water system design basisUser requirements, feed-water data and the design basis agreed before sizing.
  3. 03Clean steam and supporting utilitiesHeating, cooling and clean steam interfaces for generation and sanitisation.
  4. 04Hygienic process pipingLoop routing, slopes, drainability and dead-leg control in the piping design.
  5. 05Detailed water system engineeringP&IDs, isometrics, specifications and tender packages.
  6. 06Water system procurement supportTechnical evaluation of generation and distribution packages.
  7. 07Installation and construction supportSite supervision of hygienic installation, welding records and testing.
  8. 08Water system qualificationCommissioning, qualification and the sampling plan for the qualification phases.

Deliverables and design basis

Typical deliverables

  • Water demand and point-of-use schedule
  • Water system user requirement inputs and design basis
  • Process flow and P&ID drawings
  • Loop hydraulic and thermal calculations
  • Piping layout and isometric drawings
  • Technical bid evaluation
  • Commissioning and qualification plan with sampling approach

Key design-basis considerations

  • Water grades required by each product and process step
  • Feed-water quality and its seasonal variation
  • Peak and average demand at each point of use
  • Generation technology permitted by the pharmacopoeia applied
  • Sanitisation method and operating temperature

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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