{"product_id":"guida-cleanroom-hvac-gmp","title":"Operational Guide to Cleanrooms \u0026 HVAC Systems in GMP Facilities (First Edition + Toolkit)","description":"\u003cdiv style=\"font-family:-apple-system,BlinkMacSystemFont,'Segoe UI',Roboto,Helvetica,Arial,sans-serif;color:#2B3D52;line-height:1.65\"\u003e\u003cdiv style=\"background:#0A1320;border-radius:14px;padding:34px 30px 30px 30px;color:#ffffff;margin-bottom:26px\"\u003e\u003cdiv style=\"display:inline-block;background:#A9CDF2;color:#0A1320;font-size:12px;font-weight:700;letter-spacing:1.6px;text-transform:uppercase;padding:6px 12px;border-radius:4px;margin-bottom:16px\"\u003eFirst edition \u0026middot; Regulatory cut-off 30 August 2026\u003c\/div\u003e\u003ch3 style=\"margin:0 0 12px 0;font-size:29px;line-height:1.25;color:#ffffff;font-weight:800\"\u003eDesign, build and qualify a cleanroom without borrowing somebody else's numbers\u003c\/h3\u003e\u003cp style=\"margin:0 0 20px 0;font-size:16px;color:#A9CDF2;max-width:660px\"\u003e248 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.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\u003cspan style=\"background:#13263C;color:#A9CDF2;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e248 pages (ENG) \u0026middot; 249 (ITA) \u0026middot; A4 PDF\u003c\/span\u003e\u003cspan style=\"background:#13263C;color:#A9CDF2;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e23 chapters in 6 parts\u003c\/span\u003e\u003cspan style=\"background:#13263C;color:#A9CDF2;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e19 editable tools per language\u003c\/span\u003e\u003cspan style=\"background:#13263C;color:#A9CDF2;font-size:13px;padding:7px 13px;border-radius:20px\"\u003eItalian and English\u003c\/span\u003e\u003cspan style=\"background:#13263C;color:#A9CDF2;font-size:13px;padding:7px 13px;border-radius:20px\"\u003e126 verified sources\u003c\/span\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:30px\"\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F8FC;border:1px solid #E2E9F2;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#1F5FBF;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe guide\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#2B3D52\"\u003e23 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.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F8FC;border:1px solid #E2E9F2;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#1F5FBF;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThe toolkit\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#2B3D52\"\u003e19 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.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 230px;background:#F5F8FC;border:1px solid #E2E9F2;border-radius:11px;padding:19px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#1F5FBF;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eLifetime updates\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#2B3D52\"\u003eThe 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.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:22px;margin:0 0 6px 0;color:#13263C\"\u003eThe 19 tools in the toolkit\u003c\/h3\u003e\u003cp style=\"margin:0 0 18px 0;font-size:15px;color:#5E7183;max-width:700px\"\u003eEvery 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.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:12px;margin-bottom:28px\"\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e01 \u0026middot; Cleanroom \u0026amp; HVAC Project Brief\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eFreezes scope, areas, site constraints, stakeholders and success criteria before the project starts off in the wrong direction.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e02 \u0026middot; Cleanroom \u0026amp; HVAC URS\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eUser requirements already drafted with ID, priority and acceptance criterion, ready for traceability.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e03 \u0026middot; Room Classification \u0026amp; Zoning Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eRoom by room: grade, activity, occupancy state and zone, with consistency checked by the sheet itself.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e04 \u0026middot; Contamination Risk \u0026amp; CCS Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eContamination sources, barriers and residual controls, in the form that feeds the Contamination Control Strategy.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e05 \u0026middot; Room Data Sheet Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eOne data sheet per room: parameters, tolerances and the source of each requirement, with operating values left to be defined.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e06 \u0026middot; Pressure Cascade \u0026amp; Airflow Design Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eChecks cascade consistency between adjacent rooms and documents the rationale behind every pressure differential.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e07 \u0026middot; HVAC Architecture Design Review\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eFormal design review of the architecture: air handling units, recirculation, zoning, redundancy and site interfaces.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e08 \u0026middot; HEPA Filter \u0026amp; Terminal Device Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eRegister of filters and terminal devices with classification, installation, installed filter system leakage test and due dates.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e09 \u0026middot; Cleanroom Architectural Design Review Checklist\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eFinishes, joints, penetrations, doors, interlocks and pass-boxes: the point-by-point review to run before site works begin.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e10 \u0026middot; HVAC \/ BMS \/ Instrument Register\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eInstruments, measuring points, GMP criticality and calibration plan in a single traceable register.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e11 \u0026middot; Vendor Technical Bid Evaluation \u0026amp; Supplier Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eWeighted criteria, knock-outs and automatic ranking to compare technical bids that are not comparable at a glance.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e12 \u0026middot; FAT \/ SAT \u0026amp; Commissioning Protocol\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eProtocol and report with explicit conditions for reusing commissioning evidence in qualification.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e13 \u0026middot; Cleanroom IQ \/ OQ \/ PQ Protocol Set\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eA complete protocol set with recording forms, deviation handling and conclusions ready to be signed.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e14 \u0026middot; Airflow Visualisation Study Protocol \u0026amp; Report\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eThe smoke study set up as a study: objective, conditions, recordings, evaluation criteria and a written conclusion.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e15 \u0026middot; Cleanroom Qualification Test Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eWhich tests, in which occupancy state, at which frequency and on which documented basis.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e16 \u0026middot; Requirements Traceability Matrix\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eCoverage calculated requirement by requirement, with an automatic list of everything that is not traced.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e17 \u0026middot; Maintenance, HEPA \u0026amp; Requalification Planner\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eMaintenance, integrity testing and periodic requalification planned, with due dates calculated by the sheet.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#185ABD;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eWORD\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e18 \u0026middot; Cleanroom Change Impact \u0026amp; Retrofit Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eAssesses the impact of changes and retrofits on qualified status and leaves the decision documented.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 250px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cspan style=\"display:inline-block;background:#1D6F42;color:#fff;font-size:10px;font-weight:700;letter-spacing:1px;padding:3px 7px;border-radius:3px;margin-bottom:8px\"\u003eEXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:700;font-size:15px;color:#13263C;margin-bottom:5px\"\u003e19 \u0026middot; Cleanroom Energy Optimisation Assessment\u003c\/div\u003e\u003cdiv style=\"font-size:14px;color:#5E7183\"\u003eStructures an energy reduction assessment without losing the contamination control rationale.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#13263C\"\u003eYou can use it tomorrow morning\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:28px\"\u003e\u003ctr style=\"background:#0A1320;color:#fff\"\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eThe situation\u003c\/th\u003e\u003cth style=\"text-align:left;padding:11px 13px\"\u003eWhat you use\u003c\/th\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eI have to write a URS for a new cleanroom\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart II \u0026mdash; Defining the project (ch. 5-7) + Tools 01 and 02\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eAn inspector asks why that room has those air change rates\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart III \u0026mdash; Designing (ch. 8-14) + Tools 05 and 06: the rationale with source, nature and scope\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eI have to decide the pressure cascade between adjacent rooms\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart III + Tool 06: differential consistency and a documented rationale room by room\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eA terminal filter has failed its integrity test\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart V \u0026mdash; Operating, maintaining, evolving (ch. 19-21) + Tools 08 and 17, plus the dedicated investigation sheet\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eThe smoke study shows recirculation above the critical point\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart IV \u0026mdash; Building and qualifying (ch. 15-18) + Tool 14 and the deviation investigation sheet\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eI keep getting recurring pressure alarms in one zone\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart V + Tools 06 and 10: differentials, instrumentation and trends before touching the set point\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eI have to evaluate three technical bids that are not comparable\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart III + Tool 11: weighted criteria, knock-outs and automatic ranking\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003eThe energy manager wants to reduce the air flow rate\u003c\/td\u003e\u003ctd style=\"padding:11px 13px;border-bottom:1px solid #E2E9F2\"\u003ePart V + Tools 19 and 18: savings assessed without losing the contamination rationale\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\u003cdiv style=\"background:#FDF6E3;border-left:4px solid #C9A227;border-radius:0 9px 9px 0;padding:20px 22px;margin-bottom:28px\"\u003e\u003cdiv style=\"font-weight:700;color:#7A5C00;font-size:15px;margin-bottom:9px\"\u003eRegulatory rigour, declared line by line\u003c\/div\u003e\u003cdiv style=\"font-size:14.5px;color:#4A4530\"\u003e\u003cp style=\"margin:0 0 11px 0\"\u003eAn eight-label system marks every statement in the volume \u0026mdash; 692 labels across 248 pages \u0026mdash; so you always know whether a sentence is an obligation, an expectation, a technical standard, good practice or the author's interpretation:\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong\u003e[REQUIREMENT]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[GUIDANCE]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[STANDARD]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[GOOD PRACTICE]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[QRM]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[GUIDEGXP]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[DRAFT]\u003c\/strong\u003e \u0026nbsp;\u003cstrong\u003e[NOT YET APPLICABLE \u0026mdash; from DD\/MM\/YYYY]\u003c\/strong\u003e\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003e\u003cstrong\u003eNo operating value is presented as universal.\u003c\/strong\u003e 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 \u0026laquo;20 air changes per hour of Annex 1\u0026raquo; \u0026mdash; which does not exist in Annex 1 \u0026mdash; and settles the confusion between filter classification and the installed filter system leakage test.\u003c\/p\u003e\u003cp style=\"margin:0 0 11px 0\"\u003eRegulatory cut-off at \u003cstrong\u003e30 August 2026\u003c\/strong\u003e, with a register of \u003cstrong\u003e126 verified sources\u003c\/strong\u003e giving edition, date and status. The text covers the withdrawal of \u003cstrong\u003eISO 14698-1 and -2 on 16 March 2026\u003c\/strong\u003e with no ISO replacement, the \u003cstrong\u003e2026\u003c\/strong\u003e editions of ISO 14644-13, -14 and -15, \u003cstrong\u003ePIC\/S PI 006-4\u003c\/strong\u003e published on 30 July 2026 and in force from \u003cstrong\u003e1 October 2026\u003c\/strong\u003e, and \u003cstrong\u003eISO\/DIS 14644-7\u003c\/strong\u003e at ballot.\u003c\/p\u003e\u003cp style=\"margin:0\"\u003eNo false urgency: texts that are not yet applicable are labelled as such with their date, drafts stay drafts, and no effective dates are invented.\u003c\/p\u003e\u003c\/div\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:22px;margin:0 0 12px 0;color:#13263C\"\u003eInside the guide\u003c\/h3\u003e\u003cdiv style=\"font-size:15px;color:#2B3D52;margin-bottom:28px\"\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart I \u0026mdash; Framework, strategy and governance (ch. 1-4).\u003c\/strong\u003e 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.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart II \u0026mdash; Defining the project (ch. 5-7).\u003c\/strong\u003e From the need to the project brief, room classification and zoning, user requirements and traceable acceptance criteria.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart III \u0026mdash; Designing (ch. 8-14).\u003c\/strong\u003e HVAC architecture, pressure cascade and airflow, filtration and terminal devices, layout and finishes, instrumentation and BMS, technical evaluation of suppliers.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart IV \u0026mdash; Building and qualifying (ch. 15-18).\u003c\/strong\u003e Commissioning, FAT and SAT, IQ\/OQ\/PQ, airflow visualisation, the qualification test matrix and requirements traceability.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart V \u0026mdash; Operating, maintaining, evolving (ch. 19-21).\u003c\/strong\u003e Maintenance, filter integrity testing, periodic requalification, change control and retrofit, energy optimisation.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePart VI \u0026mdash; Applying (ch. 22-23).\u003c\/strong\u003e 6 complete application scenarios and 46 inspection questions with the expected evidence and the red flags.\u003c\/p\u003e\u003cp style=\"margin:0 0 9px 0\"\u003e\u003cstrong style=\"color:#13263C\"\u003ePlus five appendices.\u003c\/strong\u003e 4 decision trees, 8 deviation investigation sheets, a 106-entry glossary, the register of 126 sources and a 30\/60\/90 roadmap.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F8FC;border:1px solid #E2E9F2;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\u003ch3 style=\"font-size:22px;margin:0 0 8px 0;color:#13263C\"\u003eRead 19 pages before you buy\u003c\/h3\u003e\u003cp style=\"margin:0 0 16px 0;font-size:15px;color:#5E7183;max-width:700px\"\u003eThe 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.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Cleanrooms_HVAC_GMP_Preview_1ed_ITA.pdf?v=1788196761\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#1F5FBF;color:#ffffff;font-weight:700;font-size:15px;text-decoration:none;padding:12px 22px;border-radius:6px\"\u003eFree preview \u0026mdash; Italian edition (PDF)\u003c\/a\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Cleanrooms_HVAC_GMP_Preview_1ed_ENG.pdf?v=1788196762\" target=\"_blank\" rel=\"noopener\" style=\"display:inline-block;background:#ffffff;color:#0A1320;border:1.5px solid #0A1320;font-weight:700;font-size:15px;text-decoration:none;padding:11px 21px;border-radius:6px\"\u003eFree preview \u0026mdash; English edition (PDF)\u003c\/a\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F8FC;border:1px solid #E2E9F2;border-radius:12px;padding:22px 24px;margin-bottom:28px\"\u003e\u003ch3 style=\"font-size:20px;margin:0 0 10px 0;color:#13263C\"\u003eWhere this guide ends and the ISO 14644-5 guide begins\u003c\/h3\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:14px\"\u003e\u003cdiv style=\"flex:1 1 260px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#1F5FBF;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eThis guide \u0026mdash; building and qualifying\u003c\/div\u003e\u003cdiv style=\"font-size:14.5px;color:#2B3D52\"\u003eDesign, HVAC, airflow, pressure cascade, filtration, commissioning, qualification and facility lifecycle: how a cleanroom is designed, built and qualified.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"flex:1 1 260px;background:#ffffff;border:1px solid #E2E9F2;border-radius:10px;padding:16px\"\u003e\u003cdiv style=\"font-size:12px;font-weight:700;color:#1F5FBF;letter-spacing:1.2px;text-transform:uppercase;margin-bottom:7px\"\u003eISO 14644-5 guide \u0026mdash; running it\u003c\/div\u003e\u003cdiv style=\"font-size:14.5px;color:#2B3D52\"\u003eSteady-state operations: impact assessment, the operations control programme, material and personnel flows, gowning, cleaning, maintenance and monitoring of a cleanroom already in use.\u003c\/div\u003e\u003c\/div\u003e\u003c\/div\u003e\u003cp style=\"margin:0 0 14px 0;font-size:14.5px;color:#2B3D52\"\u003eThey 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.\u003c\/p\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/products\/iso-14644-5-2025-cleanroom-operational-guide\" style=\"display:inline-block;background:#ffffff;color:#13263C;border:1.5px solid #13263C;font-weight:700;font-size:14.5px;text-decoration:none;padding:10px 20px;border-radius:6px\"\u003eSee the ISO 14644-5:2025 Operational Guide \u0026rarr;\u003c\/a\u003e\u003c\/div\u003e\u003ch3 style=\"font-size:22px;margin:0 0 14px 0;color:#13263C\"\u003eSpecifications\u003c\/h3\u003e\u003ctable style=\"width:100%;border-collapse:collapse;font-size:14.5px;margin-bottom:24px\"\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eFormat\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003eA4 PDF \u0026mdash; 248 pages (ENG edition) \u0026middot; 249 pages (ITA edition)\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eStructure\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003e23 chapters in six parts + five appendices\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eToolkit\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003e19 editable tools per language: 11 Excel workbooks and 8 Word documents\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eLanguages\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003eThe guide and the toolkit exist in two editions only, Italian and English, with an identical structure: choose the \u003cstrong\u003eITA - Italiano\u003c\/strong\u003e or \u003cstrong\u003eENG - English\u003c\/strong\u003e variant.\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eSources\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003eRegister of 126 verified sources with edition, date and status\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eRegulatory cut-off\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003e30 August 2026\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"background:#F5F8FC\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eDelivery\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003eImmediate download after purchase\u003c\/td\u003e\u003c\/tr\u003e\u003ctr style=\"\"\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2;width:34%;font-weight:600;color:#13263C\"\u003eLicence\u003c\/td\u003e\u003ctd style=\"padding:10px 13px;border-bottom:1px solid #E2E9F2\"\u003eIndividual and internal use within the purchasing company\u003c\/td\u003e\u003c\/tr\u003e\u003c\/table\u003e\u003cdiv style=\"background:#F5F8FC;border:1px solid #E2E9F2;border-radius:11px;padding:18px 21px;margin-bottom:24px;font-size:14.5px;color:#2B3D52\"\u003e\u003cstrong style=\"color:#13263C\"\u003eWho it is for.\u003c\/strong\u003e 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.\u003c\/div\u003e\u003cdiv style=\"background:#0A1320;border-radius:12px;padding:24px 26px;color:#fff;margin-bottom:20px\"\u003e\u003cdiv style=\"font-size:18px;font-weight:700;margin-bottom:8px;color:#ffffff\"\u003eWorking on a cleanroom project or an HVAC revamp?\u003c\/div\u003e\u003cdiv style=\"font-size:15px;color:#A9CDF2;margin-bottom:16px;max-width:640px\"\u003eDescribe 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.\u003c\/div\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/expert-support?area=cleanrooms-hvac\u0026amp;source=product-cleanrooms-hvac-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#A9CDF2;color:#0A1320;font-weight:700;font-size:15px;text-decoration:none;padding:11px 22px;border-radius:6px\"\u003eDescribe your project \u0026rarr;\u003c\/a\u003e\u003cdiv style=\"font-size:12.5px;color:#8FA6BD;margin-top:12px\"\u003eNo purchase required. Every request is reviewed before it is passed to any specialist.\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"background:#F5F8FC;border:1px solid #E2E9F2;border-radius:12px;padding:22px 24px;margin-bottom:24px\"\u003e\u003ch3 style=\"font-size:20px;margin:0 0 10px 0;color:#13263C\"\u003eDo you also need the operations side?\u003c\/h3\u003e\u003cp style=\"margin:0 0 16px 0;font-size:14.5px;color:#2B3D52;max-width:720px\"\u003eThis guide stops at release for use. Running a cleanroom that is already qualified \u0026mdash; impact assessment, the operations control programme, material and personnel flows, gowning, cleaning, maintenance and monitoring \u0026mdash; is the subject of the ISO 14644-5:2025 Operational Guide. The two guides together, with both toolkits, also exist as the \u003cstrong\u003eCleanroom Complete\u003c\/strong\u003e bundle at \u003cstrong\u003e\u0026euro;269.00\u003c\/strong\u003e instead of \u0026euro;308.00: 433 pages, 39 chapters and 31 editable tools, without a single chapter in common.\u003c\/p\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/products\/cleanroom-complete-bundle\" style=\"display:inline-block;background:#ffffff;color:#13263C;border:1.5px solid #13263C;font-weight:700;font-size:14.5px;text-decoration:none;padding:10px 20px;border-radius:6px\"\u003eSee the Cleanroom Complete bundle \u0026rarr;\u003c\/a\u003e\u003c\/div\u003e\u003cp style=\"font-size:12.5px;color:#8A93A0;margin:0\"\u003eGuideGxP 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.\u003c\/p\u003e\u003c\/div\u003e","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":63385892094282,"sku":null,"price":179.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":63385892127050,"sku":null,"price":179.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/00_cover.png?v=1788205510","url":"https:\/\/www.guidegxp.com\/products\/cleanroom-hvac-gmp-guide","provider":"GuideGxP","version":"1.0","type":"link"}