{"product_id":"single-use-bioprocess-systems-gmp-guide","title":"Single-Use \u0026 Bioprocess Systems: Practical GMP Guide (First Edition + Toolkit)","description":"\u003cdiv class=\"gxsu-product\" style=\"font-family:Arial,sans-serif;color:#253348;line-height:1.65\"\u003e\n\u003cdiv style=\"background:#11162F;color:#fff;border-left:6px solid #176B4B;border-radius:14px;padding:30px;margin-bottom:24px\"\u003e\u003cp style=\"color:#A1E2C1;font-size:12px;letter-spacing:1.4px;text-transform:uppercase;margin:0 0 12px\"\u003eFirst edition · October 2026\u003c\/p\u003e\u003ch2 style=\"color:#fff;font-size:28px;line-height:1.22;margin:0 0 16px\"\u003eFrom system selection to production use: documented decisions for single-use systems\u003c\/h2\u003e\u003cp style=\"color:#D9EDE3\"\u003eA practical route to specifying, assessing and integrating single-use systems into bioprocessing. The guide connects requirements, performance, fluid paths, materials, integrity, qualification and lifecycle management, with worked cases carried through into Word and Excel templates.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:8px\"\u003e\n\u003cspan style=\"padding:6px 11px;border:1px solid #607088;border-radius:20px;font-size:13px;color:#fff\"\u003e24 chapters · 6 parts\u003c\/span\u003e\n\u003cspan style=\"padding:6px 11px;border:1px solid #607088;border-radius:20px;font-size:13px;color:#fff\"\u003e6 appendices\u003c\/span\u003e\n\u003cspan style=\"padding:6px 11px;border:1px solid #607088;border-radius:20px;font-size:13px;color:#fff\"\u003e24 tools per language\u003c\/span\u003e\n\u003cspan style=\"padding:6px 11px;border:1px solid #607088;border-radius:20px;font-size:13px;color:#fff\"\u003ePDF + Word + Excel\u003c\/span\u003e\n\u003cspan style=\"padding:6px 11px;border:1px solid #607088;border-radius:20px;font-size:13px;color:#fff\"\u003eITA \/ ENG\u003c\/span\u003e\n\u003c\/div\u003e\u003c\/div\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:14px;margin-bottom:26px\"\u003e\n\u003cdiv style=\"flex:1 1 260px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:10px;padding:20px\"\u003e\u003ch3 style=\"color:#14573E;margin:0 0 10px\"\u003eThe guide\u003c\/h3\u003e\u003cp style=\"margin:0\"\u003eEach chapter starts with a concrete decision and develops mechanisms, criteria, evidence, responsibilities and review points. Cases follow bioreactors, mixing, transfers, TFF, connections and component management. Navigable contents, bookmarks and source references support quick consultation.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 260px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:10px;padding:20px\"\u003e\u003ch3 style=\"color:#14573E;margin:0 0 10px\"\u003eThe toolkit\u003c\/h3\u003e\u003cp style=\"margin:0\"\u003e12 Word and 12 Excel tools per language, with instructions, a clean template and a separate completed example. You receive 24 individual modules and two complete masters containing the same tools. Masters provide an additional reference format: there are still 24 distinct tools.\u003c\/p\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ch3 style=\"color:#11162F;font-size:23px\"\u003eSix connected routes\u003c\/h3\u003e\u003col\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eChoices and requirements: boundaries, responsibilities, URS, technology comparison and risk management.\u003c\/li\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eProcess and performance: bioreactors, oxygen transfer, mixing, measurement, controls and scale transfer.\u003c\/li\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eFluid path and downstream processing: assemblies, product contact, transfers, hold times, TFF and filtration.\u003c\/li\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eMaterials, integrity and sterilisation: extractables and leachables, study applicability, testing and compatibility.\u003c\/li\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eQualification and integration: traceability, connections, aseptic process evidence, receipt, use and continued verification.\u003c\/li\u003e\n\u003cli style=\"margin:0 0 10px\"\u003eLifecycle and procurement: suppliers, quality agreements, changes, deviations, lifecycle cost and supply continuity.\u003c\/li\u003e\n\u003c\/ol\u003e\n\u003ch3 style=\"color:#11162F;font-size:23px\"\u003eWhen to use it\u003c\/h3\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\n\u003cdiv style=\"flex:1 1 235px;border:1px solid #D5E2DA;padding:16px;border-radius:8px\"\u003e\u003cstrong\u003eSingle-use or stainless steel?\u003c\/strong\u003e\u003cp style=\"margin:7px 0 0\"\u003eCompare options, constraints and evidence before assigning scores.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 235px;border:1px solid #D5E2DA;padding:16px;border-radius:8px\"\u003e\u003cstrong\u003eScale transfer\u003c\/strong\u003e\u003cp style=\"margin:7px 0 0\"\u003eConnect oxygen demand, mixing, measurement and process conditions.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 235px;border:1px solid #D5E2DA;padding:16px;border-radius:8px\"\u003e\u003cstrong\u003eAn unreconciled TFF balance\u003c\/strong\u003e\u003cp style=\"margin:7px 0 0\"\u003eDistinguish concentration, mass recovery, samples and quantities still to explain.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 235px;border:1px solid #D5E2DA;padding:16px;border-radius:8px\"\u003e\u003cstrong\u003eA new assembly or material\u003c\/strong\u003e\u003cp style=\"margin:7px 0 0\"\u003eReview the configuration, contact conditions, applicable studies and evidence gaps.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 235px;border:1px solid #D5E2DA;padding:16px;border-radius:8px\"\u003e\u003cstrong\u003eA connection or supplier change\u003c\/strong\u003e\u003cp style=\"margin:7px 0 0\"\u003eDocument sterile boundaries, interventions, impacts and actions before use.\u003c\/p\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003ch3 style=\"color:#11162F;font-size:23px;margin-top:30px\"\u003eThe 24 editable tools\u003c\/h3\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:9px\"\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-001 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eProject boundary, intended use and responsibility brief\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-002 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eVerifiable URS and interface specification\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-003 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eTechnology option and evidence comparison\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-004 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eRisk, control and residual evidence register\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-005 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eBioreactor capability and oxygen-demand comparison\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-006 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eMixing study and homogeneity data assessment\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-007 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eMeasurement and control strategy specification\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-008 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eScale transfer study protocol\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-009 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eAssembly BOM and contact exposure inventory\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-010 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eTransfer, hold time and volume balance planner\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-011 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eTFF operating calculation and mass balance review\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-012 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eFilter validation and integrity test strategy\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-013 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eExtractables evidence and study plan\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-014 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eStudy applicability and specialist assessment matrix\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-015 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eIntegrity verification protocol and result disposition\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-016 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eSterilisation evidence and compatibility review\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-017 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eRequirement, qualification and operating evidence matrix\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-018 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eConnection, intervention and aseptic process evidence plan\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-019 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eIncoming lot, storage, expiry and use register\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-020 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eBatch evidence review and continued verification plan\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-021 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eSupplier due diligence and quality agreement brief\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-022 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eChange impact, comparability and action register\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-023 · WORD\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eDeviation and product impact investigation\u003c\/div\u003e\u003c\/div\u003e\n\u003cdiv style=\"flex:1 1 230px;background:#F7F8F6;border:1px solid #D5E2DA;border-radius:8px;padding:13px\"\u003e\u003cspan style=\"font-size:11px;color:#14573E;font-weight:700\"\u003eTL-024 · EXCEL\u003c\/span\u003e\u003cdiv style=\"font-weight:600\"\u003eLifecycle cost and supply scenario comparison\u003c\/div\u003e\u003c\/div\u003e\n\u003c\/div\u003e\n\u003cdiv style=\"border-left:4px solid #176B4B;background:#F7F8F6;padding:20px;margin:28px 0\"\u003e\u003ch3 style=\"margin:0 0 8px;color:#14573E\"\u003eSources and site decisions\u003c\/h3\u003e\u003cp style=\"margin:0\"\u003eA register of 49 references records status and use limitations as of 10 October 2026. Applicable requirements, guidance, technical standards, drafts and GuideGxP recommendations remain distinct. Public standard information does not replace consultation of the complete normative text. Site limits and criteria require a relevant approved basis.\u003c\/p\u003e\u003c\/div\u003e\n\u003cdiv style=\"background:#EAF4ED;padding:22px;border-radius:12px;margin:26px 0\"\u003e\u003ch3 style=\"margin:0;color:#11162F\"\u003eRead the free preview\u003c\/h3\u003e\u003cp\u003eDownload the actual opening pages of the Italian or English edition: cover, edition information, contents and the start of the guide. The preview retains the complete PDF’s layout and page numbers.\u003c\/p\u003e\u003cdiv style=\"display:flex;flex-wrap:wrap;gap:10px\"\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Single_Use_Bioprocess_Preview_2026_ITA.pdf?v=1791686118\" style=\"display:inline-block;background:#11162F;color:white;padding:12px 18px;border-radius:6px;text-decoration:none;font-weight:600\"\u003eFree preview — Italian (PDF)\u003c\/a\u003e\n\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/GuideGxP_Single_Use_Bioprocess_Preview_2026_ENG.pdf?v=1791686118\" style=\"display:inline-block;background:#11162F;color:white;padding:12px 18px;border-radius:6px;text-decoration:none;font-weight:600\"\u003eFree preview — English (PDF)\u003c\/a\u003e\n\u003c\/div\u003e\u003c\/div\u003e\n\u003ch3 style=\"color:#11162F;font-size:23px\"\u003eWhat you receive\u003c\/h3\u003e\u003cdl\u003e\n\u003cdt style=\"font-weight:700;color:#14573E;margin-top:12px\"\u003eFormat\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eA4 PDF guide; 24 editable modules and 2 complete Word\/Excel masters in your selected language.\u003c\/dd\u003e\n\u003cdt style=\"font-weight:700;color:#14573E;margin-top:12px\"\u003eLanguages\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eThe guide, preview and toolkit are available only in Italian and English. Select ITA or ENG before purchase.\u003c\/dd\u003e\n\u003cdt style=\"font-weight:700;color:#14573E;margin-top:12px\"\u003eDelivery\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eDigital product delivered as a ZIP archive for the purchased variant. No physical shipping.\u003c\/dd\u003e\n\u003cdt style=\"font-weight:700;color:#14573E;margin-top:12px\"\u003eEdition\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eRev 1.0 · October 2026 · evidence cut-off 10 October 2026.\u003c\/dd\u003e\n\u003cdt style=\"font-weight:700;color:#14573E;margin-top:12px\"\u003eReaders\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eEngineering, CQV, QA, QC, production, maintenance, technical procurement and project owners.\u003c\/dd\u003e\n\u003cdt style=\"font-weight:700;margin-top:12px\"\u003ePDF\u003c\/dt\u003e\u003cdd style=\"margin:4px 0 0\"\u003eITA: 204 pages · ENG: 198 pages\u003c\/dd\u003e\n\u003c\/dl\u003e\u003cp style=\"font-size:13px;color:#55616E;margin:24px 0\"\u003eThe principal scope is human medicinal-product manufacture. Tools require adaptation to the process and site criteria; calculations and checklists do not automatically approve a system or batch. The E\u0026amp;L matrix supports review of study applicability and does not replace specialist toxicological assessment.\u003c\/p\u003e\n\u003cdiv style=\"background:#11162F;color:#fff;border-radius:12px;padding:24px\"\u003e\u003ch3 style=\"color:#fff;margin:0\"\u003eWorking on a single-use or bioprocess project?\u003c\/h3\u003e\u003cp style=\"color:#D9EDE3\"\u003eDescribe the system, project stage and decision you need to address.\u003c\/p\u003e\u003ca href=\"https:\/\/www.guidegxp.com\/pages\/expert-support?area=single-use-bioprocess\u0026amp;source=product-single-use-bioprocess-guide\u0026amp;cta=product-page\" style=\"display:inline-block;background:#176B4B;color:#fff;padding:12px 18px;border-radius:6px;text-decoration:none;font-weight:600\"\u003eRequest specialist support\u003c\/a\u003e\u003c\/div\u003e\u003c\/div\u003e\n","brand":"GuideGxP","offers":[{"title":"ITA - Italiano","offer_id":63878156353866,"sku":"SU-2026-ITA","price":199.0,"currency_code":"EUR","in_stock":true},{"title":"ENG - English","offer_id":63878162612554,"sku":"SU-2026-ENG","price":199.0,"currency_code":"EUR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0955\/3320\/3786\/files\/Mockup3DdiguidaGxP.png?v=1791703980","url":"https:\/\/www.guidegxp.com\/products\/single-use-bioprocess-systems-gmp-guide","provider":"GuideGxP","version":"1.0","type":"link"}