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

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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

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NLPButton-T Data-Logger
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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

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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)

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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

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Critical Functional CharacteristicsCycle
Specification with Load Assignment

• Cycle Specification

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Critical Functional CharacteristicsLogger
Positional Assignment

• Logger Positional Specifiation

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Critical Functional Characteristics Logging Data
Security
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Documentation RequirementsSummary of The Results
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Documentation Requirements SQC/SPC
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Documentation Requirements Temperature Control
Chart Characteristics Including Load Analysis in
Selected Sterilizer
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Documentation Requirements Pareto Analysis of
Measurement Distribution of The SensorsAccording
to 3D Positions
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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

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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