STERILIZATION EQUIPMENT VALIDATION CHECKLIST

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--- DOCUMENT CONTROL & PLANNING ---
[ ] Validation Protocol Number
[ ] Protocol Creation Date
[ ] Protocol Review Date
[ ] Document Status (Draft/Approved/Revoked) (Draft, Approved, Revoked)
[ ] Document Scope & Objectives
[ ] Approved Protocol Document (PDF)
[ ] Validation Phase (Planning/Execution/Reporting) (Planning, Execution, Reporting)
[ ] Deviation Handling Procedure Reference
[ ] Protocol Approver Signature

--- EQUIPMENT IDENTIFICATION & DESCRIPTION ---
[ ] Equipment Name
[ ] Manufacturer
[ ] Model Number
[ ] Serial Number
[ ] Detailed Equipment Description (including configuration)
[ ] Capacity (e.g., number of trays)
[ ] Cycle Type(s) Validated (e.g., Gravity, Steam Flush, Vacuum) (Gravity, Steam Flush, Vacuum, Other (Specify in Long Text))
[ ] Equipment Photos/Diagrams
[ ] Any known modifications to the standard equipment configuration

--- PERSONNEL & TRAINING ---
[ ] Number of Personnel Involved in Validation
[ ] Validation Personnel Roles (Validation Lead, Equipment Operator, Quality Assurance, Facility Management)
[ ] Brief Description of Personnel Training (e.g., manufacturer training, SOP review)
[ ] Date of Personnel Training
[ ] Attach Training Certificates/Records
[ ] Competency Assessment Performed? (Yes, No)
[ ] Details of Competency Assessment (if applicable)
[ ] Signature of Validation Personnel (Confirmation of Training and Competency)

--- VALIDATION PROTOCOL DEVELOPMENT ---
[ ] Protocol Purpose and Scope
[ ] Reference Documents (e.g., SOPs, Manufacturer's Instructions)
[ ] Number of Validation Runs
[ ] Validation Method (e.g., Release, Non-release) (Release, Non-Release)
[ ] Types of Indicators Used (e.g., Biological, Chemical) (Biological Indicators, Chemical Indicators, Class 1 Chemical Indicators, Class 1 Rapid Readout Indicators, Class 2 Chemical Indicators)
[ ] Date Protocol Prepared
[ ] Acceptance Criteria – Sterility Assurance Level (SAL) (10^-6, 10^-3, Other (Specify))
[ ] Specify 'Other' SAL, if applicable
[ ] Prepared By

--- PRE-VALIDATION EQUIPMENT CHECKS ---
[ ] Equipment Serial Number
[ ] Date of Last Preventative Maintenance
[ ] Time of Equipment Startup for Pre-Validation Check
[ ] Voltage Reading (Input)
[ ] Pressure Reading (Initial)
[ ] Equipment Cycle Type (e.g., Gravity, Steam Flush, Vacuum) (Gravity, Steam Flush, Vacuum, Other)
[ ] Description of Pre-Validation Checks Performed
[ ] Visual Inspection - Equipment Condition (Excellent, Good, Fair, Poor)
[ ] Technician Signature - Pre-Validation Check Completion

--- VALIDATION RUNS – BIOLOGICAL INDICATORS (BIS) ---
[ ] BI Lot Number
[ ] Date of BI Exposure
[ ] Time of BI Exposure
[ ] BI Incubation Temperature (°C)
[ ] BI Incubation Time (hours)
[ ] BI Result – Positive/Negative (Positive, Negative)
[ ] BI Result Comments (e.g., unusual growth, etc.)
[ ] Upload BI Result Image/Documentation
[ ] BI Type (e.g., Spore Disc, Strip) (Spore Disc, Spore Strip, Spore Suspension)

--- VALIDATION RUNS – CHEMICAL INDICATORS (CIS) ---
[ ] Cycle Number
[ ] Chemical Indicator Type Used (e.g., MSD, Dye, Integrator) (MSD, Dye, Integrator, Other (Specify in LONG_TEXT))
[ ] If 'Other' indicator type selected, please specify:
[ ] Number of Chemical Indicators Used
[ ] Indicator Placement (e.g., Inside, Outside, Top, Bottom) (Inside, Outside, Top, Bottom, Other (Specify in LONG_TEXT))
[ ] If 'Other' indicator placement selected, please specify:
[ ] Time Indicator Observed (Initial)
[ ] Time Indicator Observed (Final)
[ ] Photo/Scan of Chemical Indicator Post-Cycle
[ ] Indicator Result (Based on Manufacturer Instructions) (Passed, Failed, Uncertain/Unreadable)

--- DATA ANALYSIS & EVALUATION ---
[ ] BI Spore Count (CFU/mL)
[ ] Incubation Temperature (°C)
[ ] Incubation Time (hours)
[ ] BI Result (Positive/Negative) (Positive, Negative)
[ ] CI Result (Passed/Failed) (Passed, Failed)
[ ] Summary of Data Analysis
[ ] Acceptance Criteria Met? (Yes, No)
[ ] Detailed Explanation of Results and Justification (if applicable)
[ ] Attach Raw Data Files (e.g., data logs, instrument printouts)

--- DEVIATION HANDLING & CORRECTIVE ACTIONS ---
[ ] Description of Deviation
[ ] Severity of Deviation (Minor, Moderate, Major) (Minor, Moderate, Major)
[ ] Root Cause Analysis
[ ] Corrective Action(s) Implemented
[ ] Date Corrective Action Implemented
[ ] Effectiveness Verification of Corrective Action
[ ] Verification Status (Satisfactory, Unsatisfactory) (Satisfactory, Unsatisfactory)
[ ] Signature of Person Implementing Corrective Action

--- VALIDATION REPORT & DOCUMENTATION ---
[ ] Report Summary & Conclusion
[ ] Validation Protocol Document
[ ] Raw Data Files (BI & CI Results)
[ ] Number of Validation Cycles Completed
[ ] Deviations Encountered (Select all that apply) (None, Parameter Out of Range, Equipment Malfunction, Documentation Error, Other (Specify in Long Text))
[ ] Detailed Description of Deviations & Corrective Actions (If Applicable)
[ ] Report Completion Date
[ ] Validation Lead Signature
[ ] Report Approval Status (Approved, Rejected, Pending Review)

--- EQUIPMENT RELOCATION/MAINTENANCE/REPAIR VALIDATION ---
[ ] Description of Relocation/Maintenance/Repair Performed
[ ] Reason for Relocation/Maintenance/Repair (Routine Maintenance, Equipment Repair, Equipment Relocation, Software Update, Other (Specify in Long Text))
[ ] Date of Relocation/Maintenance/Repair
[ ] Time of Relocation/Maintenance/Repair (Start)
[ ] Cycle Number on Which Validation was Performed
[ ] Pre-Relocation/Maintenance/Repair Equipment Log/Service Records
[ ] Software Version (if applicable)
[ ] Detailed Description of Post-Maintenance/Repair Checks
[ ] Technician Signature - Verification of Work Completion

--- PERIODIC REVALIDATION ---
[ ] Date of Revalidation
[ ] Reason for Revalidation (e.g., Time-based, Equipment Modification, Deviation) (Time-based (Scheduled), Equipment Modification, Process Change, Deviation Identified, Other (Specify))
[ ] Brief Description of Revalidation Activities Performed
[ ] Biological Indicator (BI) Records
[ ] Chemical Indicator (CI) Records
[ ] Number of BI Strips Used
[ ] BI Results: All Positive/Negative? (All Negative, All Positive, Mixed Results (Specify))
[ ] Explanation/Details of any Deviation from Expected Results (if applicable)
[ ] Reviewer Signature

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