Pharmaceutical Water & WFI Systems
From required quality to control during operation.
Generation, loops, sampling and qualification: connect each engineering decision to water use and the evidence you need to build.
What decision are you working on?
18 articles across 6 topics. Choose what you need now.
Which water does your process need?
Connect each use to the required quality. Define demand, requirements and risks before choosing the system.
Water Quality & Intended Use Matrix, URS and QRM template.
How do you choose the generation technology?
Start with feedwater and compare pretreatment, membranes and distillation in the site context.
Generation Technology Comparison and Design Basis & Capacity Calculator.
How do you maintain quality up to the point of use?
Connect the tank, loop, materials and sanitisation strategy to operating conditions.
Design Review Checklist and equipment, P&ID and point-of-use register.
What should you measure, where and how?
Build a coherent strategy covering sampling, microbiology, TOC, conductivity and system data.
Sampling Plan & Point Rationale and Monitoring, Alarm & Trending tool.
Which tests support system suitability?
Organise the transition from installation to qualification evidence, including sanitisation.
FAT/SAT and IQ/OQ/PQ protocols, plus a sanitisation and microbiological control template.
How do you manage issues, changes and suppliers?
Address recurring problems, biofilm and rouging. Consider periodic review, retrofit, service and lifecycle cost.
Templates for biofilm and rouging, periodic review, retrofit and bid evaluation.
Available editions: Italian and EnglishRead the free sampleSample in ItalianStructure your water project, from design basis to periodic review.
A PDF guide and 18 Word and Excel tools connecting water quality, engineering decisions, qualification and lifecycle management.
Define quality, capacity and requirementsWork on intended use, URS, design basis and system demand.
Document design and supplier selectionCompare technologies, review the design and evaluate bids against explicit criteria.
Organise qualification and operational controlStructure protocols, sampling plans, sanitisation and investigations.
Download after payment · Future updates included
Choose the Italian or English edition on the product page.
Explore all 18 included tools
- Project Brief
- Water Quality & Intended Use Matrix
- System URS
- Design Basis & Capacity Calculator
- QRM & Critical Control Point
- Generation Technology Comparison
- Design Review Checklist
- Equipment, P&ID & POU Register
- Vendor Bid Evaluation
- FAT / SAT & Commissioning
- IQ / OQ / PQ Protocol Set
- Requirements Traceability Matrix
- Sampling Plan & Point Rationale
- Monitoring, Alarm & Trending
- Sanitisation & Microbiological Control
- Lifecycle & Periodic Review Planner
- Deviation, Biofilm & Rouging
- Change Impact & Retrofit
Adapt the editable documents to your system, risks and site criteria.
Working on a PW/WFI project or a loop problem?
Tell us about water quality, configuration and objectives: new installation, capacity, qualification, biofilm, sanitisation or retrofit.
Describe your projectWe help you find the right expertise.
GuideGxP collects your request, assesses your needs and recommends the professional or company best suited to finding a solution for your case.
- 01Describe the system, objective and project stage.
- 02We assess the expertise required and geographic area.
- 03We suggest a contact suited to your needs.
