Bundle · 2 guides + 2 toolkits
The cleanroom from blank sheet to production shift, in two volumes that never repeat each other
One guide takes the cleanroom from the project brief to release for use: design, HVAC, pressure cascade, filtration, commissioning and qualification. The other starts exactly there and governs the running facility: impact assessment, the operations control programme, flows, gowning, cleaning, maintenance and monitoring. Together: 433 pages, 39 chapters and 31 editable tools — without a single chapter in common.
433 pages · 2 A4 PDFs39 chapters31 editable toolsItalian and English editions€269.00 instead of €308.00
What the bundle contains
Volume 1 · Design and qualify
From the project brief and the URS through to periodic requalification: classification and zoning, HVAC architecture, pressure cascade and airflow, filtration and terminal devices, finishes and layout, instrumentation and BMS, technical evaluation of suppliers, commissioning, FAT and SAT, IQ/OQ/PQ, airflow visualisation, the qualification test matrix and requirements traceability, maintenance, change control and retrofit, energy optimisation.
249 pages ITA · 248 ENG23 chapters in 6 parts19 tools (11 Excel, 8 Word)List price €179.00
Volume 2 · Make it run
From the already qualified cleanroom onwards: the clause 6 impact assessment, the OCP document and its five supporting programmes, access authorisation, gowning and requalification, training, material and consumable flows, cleaning and disinfection with in-situ validation, maintenance permits and restoration, monitoring of effectiveness, deviations and CAPA, inspection readiness.
184 pages ITA · 185 ENG16 chapters in 5 parts12 tools (7 Excel, 5 Word)List price €129.00
Where one ends and the other begins
The boundary is not an editorial choice: it is release for use. Row by row, the question you are asking and the volume that answers it.
| The question | The volume that answers it |
|---|
| How many air changes for this room, and on what documented rationale? | Cleanroom & HVAC — design (Part III) + Tools 05 and 06 |
| How do I set the pressure cascade between adjacent rooms and demonstrate it? | Cleanroom & HVAC — Tool 06, Pressure Cascade & Airflow Design Matrix |
| What goes into the IQ/OQ/PQ set and the airflow visualisation protocol? | Cleanroom & HVAC — Part IV + Tools 13 and 14 |
| Which periodic requalification tests, in which occupancy state and at what frequency? | Cleanroom & HVAC — Tools 15 and 17 |
| How do I formalise the operations control programme required by ISO 14644-5:2025? | ISO 14644-5 — Part II + Tool 03, the OCP Template |
| Who is authorised to enter, with which gowning and which requalification? | ISO 14644-5 — Part III + Tools 06, 07 and 08 |
| How do I bring in a new consumable, and with what suitability assessment? | ISO 14644-5 — Part IV + Tool 09 |
| Maintenance in the area: work permit, restoration, return to service? | ISO 14644-5 — Part IV + Tool 11 |
| A change in the area: operational impact assessment, change control or facility requalification? | Both of them — the only point where the two volumes touch: ISO 14644-5 gives the twin decision track, the HVAC guide tells you when you go back into qualification (Tool 18) |
Why this bundle is not a pack of two similar products
The two guides do not overlap by construction, not by accident. The design guide stops at release for use: once the cleanroom is qualified and released, its job is done. The operations guide starts exactly there and assumes a cleanroom that is already qualified. None of the 39 chapters answers the same question as another, and none of the 31 tools duplicates another tool.
That is why the bundle makes sense: you are not buying the same content twice at a discount, you are buying the two halves of a lifecycle that hand over to each other at one precise point. Whoever has only the first is left without the governance of the running facility; whoever has only the second is left without the design rationale when an inspector asks why that room has those parameters.
Read 35 pages of the two volumes before you buy
Each volume has its own free preview. 19 pages from the Cleanroom & HVAC guide: the complete table of contents with page numbers, the section on air change rates, the section on filtration and one complete application scenario. 16 pages from the ISO 14644-5 guide: the Regulatory Status Box, the full table of contents, what the standard actually says and a table of inspection questions. These are real pages of the editions, not sales summaries.
Volume 1 — Cleanroom & HVAC · 19 pages
Volume 2 — ISO 14644-5 Cleanroom Operations · 16 pages
The total, and what you save
433
pages in total (249+184 ITA · 248+185 ENG)
39
chapters (23 + 16), plus 11 appendices
31
editable tools (19 + 12): 18 Excel and 13 Word
€39.00
saved against the separate list price
Bought separately, the two guides cost €179.00 + €129.00 = €308.00. The bundle costs €269.00: the same content, the same two complete toolkits, €39.00 less. Nothing is cut or reduced compared with the two individual products.
Specifications
| Format | 2 A4 PDFs — 433 pages in total (ITA edition: 249 + 184 · ENG edition: 248 + 185) |
| Structure | 39 chapters (23 + 16) + 11 appendices (5 + 6) |
| Toolkit | 31 editable tools (19 + 12): 18 Excel workbooks with formulas, drop-down menus and dashboards, and 13 Word documents with model text already written |
| Languages | Guides and toolkits exist in two editions, Italian and English, with an identical structure. Select the ITA - Italiano or ENG - English variant before purchase |
| Price | €269.00 instead of €308.00 at separate list price |
| Delivery | Immediate download after purchase |
| Licence | Individual and internal use within the purchasing company |
| Updates | When either guide is revised, you receive the updated version from your order link at no extra cost |
Who it is for. QA and Heads of Quality, Sterility Assurance, Validation and CQV, Engineering and Facility, HVAC and Cleanroom Engineers, Project Managers, Cleanroom and Production Managers, QC Microbiology, Automation and BMS/EMS, maintenance, energy managers, procurement, Qualified Persons, consultants, EPCM firms and contractors. It is the package for anyone covering the full cleanroom lifecycle, or taking a new facility from design to first batch.
Working on a cleanroom project, an HVAC revamp or a contamination control programme?
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.
GuideGxP guides do not replace official regulations (EU GMP, EMA, FDA, WHO, PIC/S, ICH, ISO, EN, IEST, pharmacopoeias): they are operational support tools, and the user remains responsible for applying the regulations in force in their own corporate context. Operational parameters — air change rates, pressure differentials, frequencies, thresholds, durations — have no universal value and must be defined and justified by the site. Digital product: no physical shipment.
