Service 13 / 27 · Pharmaceutical Water & Clean Utility Systems
Engineering Reliable Pharmaceutical Water Systems from Generation to Distribution.
Pharmaceutical water is engineered as a complete train, from raw water assessment and pretreatment through RO, EDI and, where applicable, WFI generation, to storage, distribution loops and points of use. Capacity, water balance, sanitization concept and monitoring strategy are defined together with the process, quality and HVAC teams. Clean utilities such as pure steam, compressed air and process gases are coordinated on the same technical basis.
Engineering phases
Where this service fits
05 / 09 phases in scope
- 01Feasibilitynot in scope
- 02Conceptnot in scope
- 03Basic EngineeringIn scope
- 04Detailed EngineeringIn scope
- 05ProcurementIn scope
- 06Constructionnot in scope
- 07CommissioningIn scope
- 08ValidationIn scope
- 09Operationnot in scope
Scope
What the service covers
- 01Raw water assessment and pretreatment concept
- 02RO, double-pass RO, EDI, PW and, where applicable, WFI generation
- 03Storage tanks, recirculation loops, sanitary piping and point-of-use distribution
- 04Clean utilities: clean and pure steam, compressed air, process gases and vacuum, as applicable
- 05Monitoring, instrumentation, automation interfaces and commissioning and qualification support
Method
From inputs to deliverables
INInputs
06 items- I01Raw water source and available analysis
- I02Product portfolio and dosage forms
- I03Required water grades and consumption profile
- I04Points of use and operating schedule
- I05Target markets and quality requirements defined by the client
- I06Site, building and utility constraints
WORKActivities
06 items- W01Demand profiling and capacity calculation
- W02Treatment and generation train selection
- W03Storage and distribution loop design
- W04Sanitization and monitoring concept
- W05Equipment specification and vendor technical review
- W06CQV planning support
OUTDeliverables
08 items- D-13.01URS support
- D-13.02Basis of design and capacity calculation
- D-13.03Water balance and PFDs
- D-13.04P&IDs and equipment datasheets
- D-13.05Equipment and system specifications
- D-13.06Layouts, utility routing and pipe sizing
- D-13.07BOQ and vendor technical comparison
- D-13.08CQV support documentation
Technical detail
Systems we engineer
Contents · 07
01 / 07
Water Treatment
Pretreatment is sized from the raw water quality so that downstream generation equipment operates within its design limits.
- Raw water assessment
- Pretreatment
- Filtration
- Softening
- Activated carbon
- Chemical dosing where applicable
02 / 07
Water Generation
The generation train is selected against the water grades, capacity and quality requirements defined for the project.
- Reverse osmosis — RO
- Double-pass RO where the feed quality requires it
- EDI
- Purified water — PW
- Water for injection — WFI where applicable
03 / 07
Storage & Distribution
Storage and distribution are designed to maintain water quality from the tank to every point of use.
- Storage tanks
- Distribution loops
- Pumps
- Heat exchangers
- Sanitary piping
- Point-of-use distribution
- Recirculation
- Thermal or chemical sanitization concepts
04 / 07
Clean Utilities
Clean utilities are defined by their use in the process and coordinated with the water system, HVAC and production equipment.
- Pure steam
- Clean steam
- Compressed air
- Process gases
- Vacuum
- CIP-related utilities
05 / 07
Automation & Monitoring
Instrumentation and alarms are specified so that system performance can be monitored and trended during operation.
- Conductivity
- TOC
- Flow
- Temperature
- Pressure
- Sampling points and instrument calibration planning
- PLC / SCADA coordination
- Alarm philosophy
- Monitoring strategy
06 / 07
Engineering Deliverables
Documentation is prepared to support design review, procurement, installation and qualification.
- URS support
- Basis of design
- Capacity calculation
- Water balance
- PFD
- P&ID
- Equipment datasheets
- Equipment specifications
- Layout
- Utility routing
- Pipe sizing
- BOQ
- Vendor technical comparison
07 / 07
CQV
Qualification activities are planned with the client quality team and aligned with the project validation approach.
- DQ
- FAT
- SAT
- Commissioning
- IQ
- OQ
- PQ
Treatment train
Typical water system train
A generic arrangement for illustration; the actual train is defined per project from the raw water quality and the required water grades.
01 / 10RAW WATER
Raw water
The source is assessed from available analyses and seasonal variation, because its quality sets the whole treatment train.
Select a step to read what it involves.
RAW WATER
Raw water
The source is assessed from available analyses and seasonal variation, because its quality sets the whole treatment train.
PRETREATMENT
Pretreatment
Filtration, softening, activated carbon and dosing where needed protect the RO membranes from fouling, scaling and oxidants.
RO
Reverse osmosis
Single- or double-pass RO, selected from the feed quality, removes the bulk of dissolved solids.
EDI
EDI polishing
Continuous electrodeionization polishes the RO permeate to the conductivity targeted for the project.
PW
Purified water
Product water is monitored against the quality attributes defined for the project before it enters storage.
WFIBranch
Water for injection
Where the products require it, WFI is generated from purified water, with its own storage and hot distribution.
CLEAN STEAMBranch
Clean / pure steam
Where required, a clean or pure steam generator fed from purified water serves sterilization and process equipment.
STORAGE
Storage
Sanitary storage tanks, sized from the water balance, buffer generation against peak demand.
DISTRIBUTION LOOP
Distribution loop
A continuously recirculating sanitary loop, with a defined sanitization concept, avoids stagnant water.
POINTS OF USE
Points of use
Each outlet is located, sized and detailed for its process demand, sampling and minimal dead legs.
Interactive engineering model
Explore how the engineering fits together.
Pharmaceutical water journey
Select a stage to see its purpose, engineering considerations, monitoring points and typical deliverables.
Main treatment train
Raw water
Purpose
Defines the feed the whole train is designed around: source, variability and the constituents the pretreatment must address.
Engineering considerations
- Raw water analysis and seasonal variation
- Supply pressure and continuity
- Break tank and backflow protection
Monitoring points
- FTFlow
- PTPressure
- CTConductivity
Typical deliverables
- Raw water basis of design
- Water balance (feed side)
Illustrative, generic arrangement. The actual train, grades and monitoring are defined per project; no design values are shown.
Deliverables
Typical documents and outputs
- D-13.01URS support
- D-13.02Basis of design and capacity calculation
- D-13.03Water balance and PFDs
- D-13.04P&IDs and equipment datasheets
- D-13.05Equipment and system specifications
- D-13.06Layouts, utility routing and pipe sizing
- D-13.07BOQ and vendor technical comparison
- D-13.08CQV support documentation
Services
Related services
- 06
Process Utilities
Steam, air, gases, water and drainage systems sized and specified for regulated production.
- 08
Qualification & Validation (CQV)
Documented evidence that facilities, utilities and equipment perform as intended.
- 10
Procurement & Vendor Management
Technical specifications, bid evaluation and vendor oversight through FAT and installation.
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