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