Critical Utilities Systems
Define utility quality from the process it serves.
Connect intended use, contamination risks and point-of-use requirements. Design, qualify and manage clean steam, compressed air, process gases and vacuum through their lifecycle.
Operational guide + toolkitPDF + 24 Word and Excel tools · in Italian or English€199,00See the package
What decision are you working on?
12 articles across 6 decision areas. Choose what you need now.
What quality must the utility deliver?
Connect intended use, product contact and contamination risks to verifiable requirements and point-of-use specifications.
TL-001 Project briefTL-002 Utility and point-of-use inventoryTL-003 Product-contact and criticality risk assessmentTL-004 User requirements specificationTL-005 Quality specification and acceptance basisTL-007 Peak demand and capacity
How will steam reach the user in the required condition?
Connect generation and distribution to drainage, physical steam quality, condensate testing and the process interface.
TL-008 Steam design reviewTL-009 Steam sampling protocolTL-010 Steam results register
Which supply and quality strategy suits the process?
Define particles, moisture, oil, purity and microbiological controls. Assess the complete path from the supplier to the point of use.
TL-011 Air and gas design reviewTL-012 Air and gas sampling protocolTL-013 Air and gas results registerTL-014 Terminal filtration and integrity
How do you preserve and demonstrate quality at each use?
Design distribution, filtration, pressure control and vacuum interfaces. Connect sensors, alarms and records to decisions.
TL-006 Boundary and interface recordTL-015 Pressure, flow and dew-point measurement basisTL-020 Alarm and data reviewTL-021 Trends and excursions
Which evidence demonstrates fitness for use?
Trace requirements through DQ, FAT, SAT and qualification. Use representative sampling and suitable test methods at relevant user points.
TL-017 FAT/SAT plan and recordTL-018 DQ/IQ/OQ/PQ planTL-019 Requirements traceability matrix
How do you resolve failures and select a supplier?
Investigate excursions, maintain reliability and assess retrofit. Compare supply scope, service, energy and lifecycle cost.
TL-016 Technical bid comparisonTL-022 Maintenance, calibration and periodic reviewTL-023 Change, incident and return to serviceTL-024 Lifecycle cost and energy
Digital product: A4 PDF, Word and Excel files
From generation to point of use: requirements, tests and decisions for critical utilities
Critical Utilities in GMP: Practical Guide (First Edition + Toolkit)
A practical route to specifying, qualifying and maintaining clean-steam, compressed-air and process-gas systems. The guide connects design choices, point-of-use quality, sampling, data, deviations and lifecycle management, with examples carried through into editable templates.
What you get
- PDFA4 PDF guide: 24 chapters in six parts, integrated cases and appendices.
- Word12 editable Word templates: URS, protocols, checklists, specifications and reports.
- Excel12 macro-free Excel tools: quality registers, capacity, measurement bases, trends, bid comparison and TCO.
Requirements grounded in actual useConnect product contact with point-of-use specifications, the URS and acceptance testing.
A method for sampling and qualityClean steam, air and gases: link risks, methods and results to actual operating conditions.
Traceable decisions throughout the lifecycleQualification, alarms, trends, maintenance and return to service, with documents to adapt to your site.
File language: Italian or English, one language per purchase.
Digital delivery: download after payment, with no physical shipping.
Choose the Italian or English edition on the product page.
Explore all 24 included tools
01Requirements and utility strategy
- TL-001Project briefWord
- TL-002Utility and point-of-use inventoryExcel
- TL-003Product-contact and criticality risk assessmentExcel
- TL-004User requirements specificationWord
- TL-005Quality specification and acceptance basisExcel
- TL-007Peak demand and capacityExcel
02Clean steam systems
- TL-008Steam design reviewWord
- TL-009Steam sampling protocolWord
- TL-010Steam results registerExcel
03Compressed air and process gases
- TL-011Air and gas design reviewWord
- TL-012Air and gas sampling protocolWord
- TL-013Air and gas results registerExcel
- TL-014Terminal filtration and integrityWord
04Distribution, monitoring and control
- TL-006Boundary and interface recordWord
- TL-015Pressure, flow and dew-point measurement basisExcel
- TL-020Alarm and data reviewWord
- TL-021Trends and excursionsExcel
05Qualification and quality testing
- TL-017FAT/SAT plan and recordWord
- TL-018DQ/IQ/OQ/PQ planWord
- TL-019Requirements traceability matrixExcel
06Lifecycle and procurement
- TL-016Technical bid comparisonExcel
- TL-022Maintenance, calibration and periodic reviewExcel
- TL-023Change, incident and return to serviceWord
- TL-024Lifecycle cost and energyExcel
The same TL codes identify each tool in the Italian and English editions.
Adapt the editable documents to your system, risks and site criteria.
A critical utility project or a quality problem to resolve?
Describe the utility, process contact, point of use and project stage: URS, steam quality, compressed air, process gases, distribution, monitoring, qualification or recurring failures.
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 your situation.
- 01Describe the system, objective and project stage.
- 02We assess the expertise required and geographic area.
- 03We suggest a contact suited to your needs.
