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Sterilization Validation & Monitoring System Based on NLPButton Technology

Sterilization Validation & Monitoring System Based on NLPButton Technology. Application for Steam Sterilization Presented by OPULUS 2006. What is a NLPButton data-logger?. Hygrochrons (temperature/humidity suitable for EO sterilization/Intrinsically safe). Thermochrons (temperature).

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Sterilization Validation & Monitoring System Based on NLPButton Technology

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  1. Sterilization Validation & Monitoring System Based on NLPButton Technology Application for Steam Sterilization Presented by OPULUS 2006

  2. What is a NLPButton data-logger? Hygrochrons (temperature/humidity suitable for EO sterilization/Intrinsically safe) Thermochrons (temperature) Anatomy of NLPButton data-loggers (actual size) Li-Battery Microprocessor Humidity sensor inlet, covered by Gore-Tex Capacitive humidity sensor Quartz clock

  3. Content • Steam Sterilization Validation & Monitoring System Components • Regulatory Considerations • Major Performance Characteristics • Critical Functional Characteristics • Documentation Requirements • Support & Maintenance • Cost of Ownership • Benefits to the User

  4. Steam Sterilization Validation & Monitoring System Components • Thermochron data-logger • Certificate of Calibration • Docking Station for Programming/Data download • Integrating Software • SOP (Standard Operating Procedure) • SCORM Compatible Competency Training • IQ-OQ-PQ protocol for compliance verification • 21 CFR Part 11 protocol for compliance verification

  5. Regulatory Considerations • Compliance with US FDA Requirements: • 21 CFR Part 11 Compliance: The Steam Sterilization Validation & Monitoring System is 21 CFR Part 11 Compliant • IQ-OQ-PQ Verification Protocols are Included • 21 CFR Part 11 Verification Protocols are Included • SOP (Standard Operating Procedure) are Included • SOP Competency Training: Web-enabled SCORM (DoD supported protocol) Compatible SOP Competency Training is Available • Complies with FDA’s “Guidance for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Products" http://www.fda.gov/cder/guidance/cmc2.pdf • Calibration: each data-logger’s Calibration is Traceable to NIST Reference Standard

  6. NLPButton-T Data-Logger

  7. Major Performance CharacteristicsDocking Station for iButton Programming/Data download • iButton docking station for parallel programming/data down-load of the data-logger is available in various sizes to hold 8, or 16, or 32, or 50, or 100 iButtons • The iButtons can be chained through a single Batch No. of multiple docking stations for parallel programming of 1,000’s of iButtons • RS232, USB, & parallel interfaces are supported

  8. Critical Functional CharacteristicsSterilization Validation, Control, & Management • Database setup • Applicable SOP • Sterilizer Dimensions • Specification limits • Bioburden limits • Cycle events • Area classification (e.g., ISO 14644-1)

  9. Critical Functional CharacteristicsData-Logger Control & Management • Data-logger Management • SOP assignment • Specification data • Automatic registration of logger events • Calibration specification • Calibration scheduling • Custom property option (e.g., BI application) • Sensor integrity verification • Attrition verification & optimization

  10. Critical Functional CharacteristicsCycle Specification with Load Assignment • Cycle Specification

  11. Critical Functional CharacteristicsLogger Positional Assignment • Logger Positional Specifiation

  12. Critical Functional CharacteristicsLogging Data Security

  13. Documentation RequirementsSummary of The Results

  14. Documentation Requirements SQC/SPC

  15. Documentation Requirements Temperature Control Chart Characteristics Including Load Analysis in Selected Sterilizer

  16. Documentation RequirementsPareto Analysis of Measurement Distribution of The SensorsAccording to 3D Positions

  17. Support & Maintenance • 24/7 On-line Web Access for Interactive Support • NIST Compliant Calibration Service • IQ-OQ-PQ protocol verification • On-site or Web-supported • 21 CFR Part 11 compliance verification • On-site or Web-supported via Intelligent Decision Tree • SOP templates – 24/7 On-line Web access • SCORM – 24/7 On-line Web, desktop, or enterprise training

  18. Benefits to the User • Low Purchase Cost • Best in Class Price to Performance Ratio • Total Solution with Full Regulatory Compliance • Certificate of Calibration • SOP • SCORM Compatible Training • Complies with FDA’s “Guidance for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Products“ • Ensures Best Sterilization Practices

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