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Sterilization Validation

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Sterilization Validation & Monitoring System. Based on NLPButton Technology ... Critical Functional Characteristics. Cycle Specification with Load Assignment ... – PowerPoint PPT presentation

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Title: Sterilization Validation


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)

Hygrochrons (temperature/humidity suitable for
EO sterilization/Intrinsically safe)
Thermochrons (temperature)
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 FDAs 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-loggers 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 1,000s 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 Characteristics Logging 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 Requirements Pareto 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 FDAs 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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