First edition · Regulatory cut-off 30 August 2026
Design, build and qualify a cleanroom without borrowing somebody else's numbers
248 pages and 19 editable tools that follow the facility from the project brief to periodic requalification: HVAC, pressure cascade, filtration, airflow visualisation, commissioning and qualification. Every operating value carries its source, its nature and its scope. None of them is presented as universal.
248 pages (ENG) · 249 (ITA) · A4 PDF23 chapters in 6 parts19 editable tools per languageItalian and English126 verified sources
The guide
23 chapters in six parts that move from the requirement to the decision, and from the decision to the evidence that holds up in an inspection. 692 labels mark every statement: obligation, expectation, technical standard, good practice or a choice you have to justify.
The toolkit
19 editable tools per language: 11 Excel workbooks with real formulas, drop-down menus, conditional formatting and dashboards, and 8 Word documents with model text already written, revision history and approval tables.
Lifetime updates
The regulatory picture is moving: ISO/DIS 14644-7 is at ballot and PIC/S PI 006-4 comes into force on 1 October 2026. When the texts change you receive the revised guide and toolkit at no extra cost.
The 19 tools in the toolkit
Every tool exists in Italian and in English and comes out of the method described in the chapter that explains it. No operating limits are pre-loaded: air change rates, pressure differentials, velocities and acceptance criteria are placeholders you fill in with your own site rationale.
WORD01 · Cleanroom & HVAC Project Brief
Freezes scope, areas, site constraints, stakeholders and success criteria before the project starts off in the wrong direction.
WORD02 · Cleanroom & HVAC URS
User requirements already drafted with ID, priority and acceptance criterion, ready for traceability.
EXCEL03 · Room Classification & Zoning Matrix
Room by room: grade, activity, occupancy state and zone, with consistency checked by the sheet itself.
EXCEL04 · Contamination Risk & CCS Assessment
Contamination sources, barriers and residual controls, in the form that feeds the Contamination Control Strategy.
EXCEL05 · Room Data Sheet Register
One data sheet per room: parameters, tolerances and the source of each requirement, with operating values left to be defined.
EXCEL06 · Pressure Cascade & Airflow Design Matrix
Checks cascade consistency between adjacent rooms and documents the rationale behind every pressure differential.
WORD07 · HVAC Architecture Design Review
Formal design review of the architecture: air handling units, recirculation, zoning, redundancy and site interfaces.
EXCEL08 · HEPA Filter & Terminal Device Register
Register of filters and terminal devices with classification, installation, installed filter system leakage test and due dates.
WORD09 · Cleanroom Architectural Design Review Checklist
Finishes, joints, penetrations, doors, interlocks and pass-boxes: the point-by-point review to run before site works begin.
EXCEL10 · HVAC / BMS / Instrument Register
Instruments, measuring points, GMP criticality and calibration plan in a single traceable register.
EXCEL11 · Vendor Technical Bid Evaluation & Supplier Assessment
Weighted criteria, knock-outs and automatic ranking to compare technical bids that are not comparable at a glance.
WORD12 · FAT / SAT & Commissioning Protocol
Protocol and report with explicit conditions for reusing commissioning evidence in qualification.
WORD13 · Cleanroom IQ / OQ / PQ Protocol Set
A complete protocol set with recording forms, deviation handling and conclusions ready to be signed.
WORD14 · Airflow Visualisation Study Protocol & Report
The smoke study set up as a study: objective, conditions, recordings, evaluation criteria and a written conclusion.
EXCEL15 · Cleanroom Qualification Test Matrix
Which tests, in which occupancy state, at which frequency and on which documented basis.
EXCEL16 · Requirements Traceability Matrix
Coverage calculated requirement by requirement, with an automatic list of everything that is not traced.
EXCEL17 · Maintenance, HEPA & Requalification Planner
Maintenance, integrity testing and periodic requalification planned, with due dates calculated by the sheet.
WORD18 · Cleanroom Change Impact & Retrofit Assessment
Assesses the impact of changes and retrofits on qualified status and leaves the decision documented.
EXCEL19 · Cleanroom Energy Optimisation Assessment
Structures an energy reduction assessment without losing the contamination control rationale.
You can use it tomorrow morning
| The situation | What you use |
|---|
| I have to write a URS for a new cleanroom | Part II — Defining the project (ch. 5-7) + Tools 01 and 02 |
| An inspector asks why that room has those air change rates | Part III — Designing (ch. 8-14) + Tools 05 and 06: the rationale with source, nature and scope |
| I have to decide the pressure cascade between adjacent rooms | Part III + Tool 06: differential consistency and a documented rationale room by room |
| A terminal filter has failed its integrity test | Part V — Operating, maintaining, evolving (ch. 19-21) + Tools 08 and 17, plus the dedicated investigation sheet |
| The smoke study shows recirculation above the critical point | Part IV — Building and qualifying (ch. 15-18) + Tool 14 and the deviation investigation sheet |
| I keep getting recurring pressure alarms in one zone | Part V + Tools 06 and 10: differentials, instrumentation and trends before touching the set point |
| I have to evaluate three technical bids that are not comparable | Part III + Tool 11: weighted criteria, knock-outs and automatic ranking |
| The energy manager wants to reduce the air flow rate | Part V + Tools 19 and 18: savings assessed without losing the contamination rationale |
Regulatory rigour, declared line by line
An eight-label system marks every statement in the volume — 692 labels across 248 pages — so you always know whether a sentence is an obligation, an expectation, a technical standard, good practice or the author's interpretation:
[REQUIREMENT] [GUIDANCE] [STANDARD] [GOOD PRACTICE] [QRM] [GUIDEGXP] [DRAFT] [NOT YET APPLICABLE — from DD/MM/YYYY]
No operating value is presented as universal. Air change rates, pressure differentials, air velocities, temperatures, humidity, recovery time, frequencies and acceptance criteria always carry their source, nature and scope, and in the toolkit they remain placeholders to be defined. The guide documents, source by source, the myth of the «20 air changes per hour of Annex 1» — which does not exist in Annex 1 — and settles the confusion between filter classification and the installed filter system leakage test.
Regulatory cut-off at 30 August 2026, with a register of 126 verified sources giving edition, date and status. The text covers the withdrawal of ISO 14698-1 and -2 on 16 March 2026 with no ISO replacement, the 2026 editions of ISO 14644-13, -14 and -15, PIC/S PI 006-4 published on 30 July 2026 and in force from 1 October 2026, and ISO/DIS 14644-7 at ballot.
No false urgency: texts that are not yet applicable are labelled as such with their date, drafts stay drafts, and no effective dates are invented.
Inside the guide
Part I — Framework, strategy and governance (ch. 1-4). The regulatory and technical framework of the cleanroom, its place in the Contamination Control Strategy, project governance and the split of responsibilities between QA, Engineering and Validation.
Part II — Defining the project (ch. 5-7). From the need to the project brief, room classification and zoning, user requirements and traceable acceptance criteria.
Part III — Designing (ch. 8-14). HVAC architecture, pressure cascade and airflow, filtration and terminal devices, layout and finishes, instrumentation and BMS, technical evaluation of suppliers.
Part IV — Building and qualifying (ch. 15-18). Commissioning, FAT and SAT, IQ/OQ/PQ, airflow visualisation, the qualification test matrix and requirements traceability.
Part V — Operating, maintaining, evolving (ch. 19-21). Maintenance, filter integrity testing, periodic requalification, change control and retrofit, energy optimisation.
Part VI — Applying (ch. 22-23). 6 complete application scenarios and 46 inspection questions with the expected evidence and the red flags.
Plus five appendices. 4 decision trees, 8 deviation investigation sheets, a 106-entry glossary, the register of 126 sources and a 30/60/90 roadmap.
Read 19 pages before you buy
The free preview is 19 real pages of the edition, not a sales summary: the complete table of contents with page numbers, the section on air change rates, the section on filtration and one complete application scenario.
Where this guide ends and the ISO 14644-5 guide begins
This guide — building and qualifying
Design, HVAC, airflow, pressure cascade, filtration, commissioning, qualification and facility lifecycle: how a cleanroom is designed, built and qualified.
ISO 14644-5 guide — running it
Steady-state operations: impact assessment, the operations control programme, material and personnel flows, gowning, cleaning, maintenance and monitoring of a cleanroom already in use.
They are complementary and they do not overlap. If you are designing a new facility or requalifying an existing one, start here; if you are running a cleanroom that is already in operation, start there.
See the ISO 14644-5:2025 Operational Guide →Specifications
| Format | A4 PDF — 248 pages (ENG edition) · 249 pages (ITA edition) |
| Structure | 23 chapters in six parts + five appendices |
| Toolkit | 19 editable tools per language: 11 Excel workbooks and 8 Word documents |
| Languages | The guide and the toolkit exist in two editions only, Italian and English, with an identical structure: choose the ITA - Italiano or ENG - English variant. |
| Sources | Register of 126 verified sources with edition, date and status |
| Regulatory cut-off | 30 August 2026 |
| Delivery | Immediate download after purchase |
| Licence | Individual and internal use within the purchasing company |
Who it is for. QA and Sterility Assurance, Validation and CQV, Engineering and Facility, HVAC and Cleanroom Engineers, Project Managers, QC Microbiology, Automation and BMS/EMS, Data Integrity, Maintenance, Energy Managers, Procurement, Qualified Persons, consultants, EPCM firms and contractors. It is written for professionals: it does not explain what GMP is, it explains how decisions are made and documented.
Working on a cleanroom project or an HVAC revamp?
Describe the facility, the stage of the project and the support you are looking for. GuideGxP will review the request and, where appropriate, may put you in touch with a specialist matched to your technical needs and your geography.
Describe your project →No purchase required. Every request is reviewed before it is passed to any specialist.
Do you also need the operations side?
This guide stops at release for use. Running a cleanroom that is already qualified — impact assessment, the operations control programme, material and personnel flows, gowning, cleaning, maintenance and monitoring — is the subject of the ISO 14644-5:2025 Operational Guide. The two guides together, with both toolkits, also exist as the Cleanroom Complete bundle at €269.00 instead of €308.00: 433 pages, 39 chapters and 31 editable tools, without a single chapter in common.
See the Cleanroom Complete bundle →GuideGxP guides do not replace official regulations (EMA, EU GMP, ICH, PIC/S, ISO, EN, FDA, pharmacopoeias): they are operational support tools, and the user remains responsible for applying the regulations in force in their own corporate context. Digital product: no physical shipment.
