First edition · October 2026
From system selection to production use: documented decisions for single-use systems
A 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.
24 chapters · 6 parts
6 appendices
24 tools per language
PDF + Word + Excel
ITA / ENG
The guide
Each 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.
The toolkit
12 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.
Single-use or stainless steel?Compare options, constraints and evidence before assigning scores.
Scale transferConnect oxygen demand, mixing, measurement and process conditions.
An unreconciled TFF balanceDistinguish concentration, mass recovery, samples and quantities still to explain.
A new assembly or materialReview the configuration, contact conditions, applicable studies and evidence gaps.
A connection or supplier changeDocument sterile boundaries, interventions, impacts and actions before use.
TL-001 · WORDProject boundary, intended use and responsibility brief
TL-002 · WORDVerifiable URS and interface specification
TL-003 · EXCELTechnology option and evidence comparison
TL-004 · EXCELRisk, control and residual evidence register
TL-005 · EXCELBioreactor capability and oxygen-demand comparison
TL-006 · EXCELMixing study and homogeneity data assessment
TL-007 · WORDMeasurement and control strategy specification
TL-008 · WORDScale transfer study protocol
TL-009 · EXCELAssembly BOM and contact exposure inventory
TL-010 · EXCELTransfer, hold time and volume balance planner
TL-011 · EXCELTFF operating calculation and mass balance review
TL-012 · WORDFilter validation and integrity test strategy
TL-013 · WORDExtractables evidence and study plan
TL-014 · EXCELStudy applicability and specialist assessment matrix
TL-015 · WORDIntegrity verification protocol and result disposition
TL-016 · WORDSterilisation evidence and compatibility review
TL-017 · EXCELRequirement, qualification and operating evidence matrix
TL-018 · WORDConnection, intervention and aseptic process evidence plan
TL-019 · EXCELIncoming lot, storage, expiry and use register
TL-020 · WORDBatch evidence review and continued verification plan
TL-021 · WORDSupplier due diligence and quality agreement brief
TL-022 · EXCELChange impact, comparability and action register
TL-023 · WORDDeviation and product impact investigation
TL-024 · EXCELLifecycle cost and supply scenario comparison
Sources and site decisions
A 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.
The 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&L matrix supports review of study applicability and does not replace specialist toxicological assessment.
