Sterilization Validation & Monitoring System Based on NLPButton Technology
description
Transcript of Sterilization Validation & Monitoring System Based on NLPButton Technology
Sterilization Validation & Monitoring System
Based on NLPButton Technology
Application for Steam Sterilization
Presented byOPULUS
2006
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
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
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
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
NLPButton-T Data-LoggerFeature Value/ DescriptionIdentification Universally Unique 64- bit rgistration numberMaterial 305 SS Stainless Steels + SS Protective
CasingSize 17.35 mm (0.68" diameter) x 5.89 mm (0.23"
thickness)Up to 10 Bar, Resistant to shock, dust, andresistant to acid, alkaline, & organic solvents8- bit:± 0.5 C11- bit: ±0.0625 C
Operating range for temperature logging
0 … +125 C
PyroPad Stainless Steel Capsule for protection of the data- loggers
Up to 140 psi (10 bar) & 145C
Temperature Accuracy after calibration
±0.1 C
Calibration uncertainty of measurement (NIST traceable)
≤ 0.08 C
8192 (8- bit reading), or4096 (16- bit reading)
Sampling rate 1 sec … 273 hoursPassword protection Two- level password protectionCommunication 15.4 … 125kbits per second using 1- Wire
protocolImmediately, orUser- defined delay, orTemperature alarm (High and/or Low)
Battery life time Up to 9 years/depending on usage definition
Mission started by
Pressure & Chemical Rating
Resolution for temperature logging
Maximum number of measurements
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
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)
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
Critical Functional CharacteristicsCycle Specification with Load Assignment
• Cycle Specification
Critical Functional CharacteristicsLogger Positional Assignment
• Logger Positional Specifiation
Critical Functional Characteristics
Logging Data Security
Documentation RequirementsSummary of The Results
Documentation Requirements SQC/SPC
Documentation Requirements Temperature Control Chart Characteristics Including Load
Analysis in Selected Sterilizer
Documentation Requirements Pareto Analysis of Measurement Distribution of The Sensors
According to 3D Positions
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
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