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

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

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 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 Characteristics Docking 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 Characteristics Sterilization 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 Characteristics Data-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 Characteristics Cycle Specification with Load Assignment Cycle Specification

11. Critical Functional Characteristics Logger Positional Assignment Logger Positional Specifiation

12. Critical Functional Characteristics Logging Data Security

13. Documentation Requirements Summary of The Results

14. Documentation Requirements SQC/SPC

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

16. Documentation Requirements Pareto Analysis of Measurement Distribution of The Sensors According 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