Cleaning, CIP & SIP Systems
From equipment and residues to a justified cleaning strategy.
Connect cleaning requirements, hygienic design, CIP, SIP and process data. Build the evidence for qualification, cleaning validation and control throughout the lifecycle.
Operational guide + toolkitPDF + 24 Word and Excel tools · in Italian or English€199,00See the package
What decision are you working on?
12 articles across 6 decision areas. Choose what you need now.
What must your cleaning strategy demonstrate?
Start with equipment, products and residues. Connect intended use, HBEL and process risks to requirements and an evidence-based strategy.
CS-TK-01–04Project Brief and RACI MatrixEquipment, Surface and Residue RegisterCleaning and SIP Risk AssessmentCIP/SIP URS
How will cleaning reach the product-contact surfaces?
Compare skid architecture, supply and return. Evaluate drainability, cleaning devices and coverage without confusing coverage with cleaning effectiveness.
CS-TK-05–08CIP Hydraulic Calculator — Velocity, Reynolds, Wall Shear, Flow and VolumeDead-Leg and Drainability RegisterHygienic Design Review ChecklistSpray Coverage Test Protocol (Riboflavin)
How will steam reach and sterilise the defined system?
Connect the sterile boundary to steam distribution, air removal and condensate control. Develop cycles and qualify the evidence at relevant cold spots.
CS-TK-09–12Saturated Steam and F₀ Lethality CalculatorSIP Design and Sterile Boundary ChecklistSIP Cycle Development and Qualification ProtocolSIP Temperature Mapping Data Analysis
Which parameters and records support the decision?
Control recipes, routing and interlocks. Relate conductivity, TOC, temperature and flow to their actual measurement purpose and justified limits.
CS-TK-13–16Recipe, Sequence and Interlock Functional SpecificationInstrument and Calibration RegisterCIP/SIP Data Integrity and Audit Trail AssessmentRinse Endpoint Trending (Conductivity/TOC)
Which evidence proves system and cleaning suitability?
Trace URS through FAT, SAT and qualification. Establish a residue acceptance and sampling strategy with suitable methods and recovery evidence.
CS-TK-17–20C&Q Plan and FAT/SAT/IQ/OQ/PQ FrameworkRequirements Traceability MatrixCleaning PQ Protocol — Cleaning Validation InterfaceQualification Report and Release for Use
How do you resolve failures and choose a supplier?
Investigate recurring problems, assess changes and justify return to service. Compare technical capability, documentation, service and lifecycle cost.
CS-TK-21–24CIP/SIP Deviation Investigation and CAPAMaintenance, Periodic Review and Requalification PlannerRFP Checklist and Supplier ResponsibilitiesTechnical Bid Evaluation and TCO
Digital product: A4 PDF, Word and Excel files
Turn cleaning and sterilisation requirements into documented, verifiable CIP and SIP systems.
Operational Guide to Cleaning, CIP & SIP Systems in GMP
A PDF guide in 24 chapters and 24 Word and Excel tools covering the full lifecycle of CIP and SIP systems: requirements and cleaning strategy, hygienic design and hydraulics, SIP cycles, automation and monitoring, qualification and the cleaning validation interface, troubleshooting and suppliers.
What you get
- PDFA4 PDF guide: 24 chapters in six parts, integrated cases and appendices.
- Word12 editable Word templates: URS, protocols, checklists, specifications and reports.
- Excel12 macro-free Excel tools: registers, hydraulic and F₀ lethality calculators, mapping data analysis and TCO.
Justified requirements and strategyFrom equipment, surfaces and residues to the URS and risk assessment, with traceability to FAT, SAT and qualification.
Coverage and SIP cycles with methodHygienic design, dead legs and drainability, riboflavin coverage testing and SIP temperature mapping: spray coverage alone does not demonstrate cleaning effectiveness.
Recipes and data under controlRecipes and interlocks, instrumentation and audit trails, rinse endpoint trending and deviation investigation: residue limits stay with cleaning validation.
File language: Italian or English, one language per purchase.
Digital delivery: download after payment, nothing is shipped. When the texts change, you receive the revised guide and toolkit at no extra cost.
Choose the Italian or English edition on the product page.
Explore all 24 included tools
01Requirements and cleaning strategy
- CS-TK-01Project Brief and RACI MatrixWord
- CS-TK-02Equipment, Surface and Residue RegisterExcel
- CS-TK-03Cleaning and SIP Risk AssessmentExcel
- CS-TK-04CIP/SIP URSWord
02CIP design and hygienic engineering
- CS-TK-05CIP Hydraulic Calculator — Velocity, Reynolds, Wall Shear, Flow and VolumeExcel
- CS-TK-06Dead-Leg and Drainability RegisterExcel
- CS-TK-07Hygienic Design Review ChecklistWord
- CS-TK-08Spray Coverage Test Protocol (Riboflavin)Word
03SIP and thermal process control
- CS-TK-09Saturated Steam and F₀ Lethality CalculatorExcel
- CS-TK-10SIP Design and Sterile Boundary ChecklistWord
- CS-TK-11SIP Cycle Development and Qualification ProtocolWord
- CS-TK-12SIP Temperature Mapping Data AnalysisExcel
04Automation and process monitoring
- CS-TK-13Recipe, Sequence and Interlock Functional SpecificationWord
- CS-TK-14Instrument and Calibration RegisterExcel
- CS-TK-15CIP/SIP Data Integrity and Audit Trail AssessmentExcel
- CS-TK-16Rinse Endpoint Trending (Conductivity/TOC)Excel
05Qualification and cleaning validation
- CS-TK-17C&Q Plan and FAT/SAT/IQ/OQ/PQ FrameworkWord
- CS-TK-18Requirements Traceability MatrixExcel
- CS-TK-19Cleaning PQ Protocol — Cleaning Validation InterfaceWord
- CS-TK-20Qualification Report and Release for UseWord
06Lifecycle and procurement
- CS-TK-21CIP/SIP Deviation Investigation and CAPAWord
- CS-TK-22Maintenance, Periodic Review and Requalification PlannerExcel
- CS-TK-23RFP Checklist and Supplier ResponsibilitiesWord
- CS-TK-24Technical Bid Evaluation and TCOExcel
English edition titles. The Italian edition uses the same CS-TK codes with Italian titles.
Adapt the editable documents to your system, risks and site criteria.
A cleaning, CIP or SIP project to develop?
Describe the equipment, products, residues and project stage: requirements, cycle development, HBEL, hygienic design, automation, validation or recurring failures.
Describe your projectWe help you find the right expertise.
GuideGxP collects your request, assesses your needs and recommends the professional or company best suited to your situation.
- 01Describe the system, objective and project stage.
- 02We assess the expertise required and geographic area.
- 03We suggest a contact suited to your needs.
