Sterilization Validation & Monitoring System Based on NLPButton TechnologyApplication for Steam Sterilization

Presented byOPULUS2006

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-BatteryQuartz clockCapacitive humidity sensorMicroprocessorHumidity sensor inlet, covered by Gore-Tex

ContentSteam Sterilization Validation & Monitoring System ComponentsRegulatory Considerations Major Performance CharacteristicsCritical Functional CharacteristicsDocumentation RequirementsSupport & MaintenanceCost of OwnershipBenefits to the User

Steam Sterilization Validation & Monitoring System ComponentsThermochron data-loggerCertificate of CalibrationDocking Station for Programming/Data downloadIntegrating SoftwareSOP (Standard Operating Procedure)SCORM Compatible Competency TrainingIQ-OQ-PQ protocol for compliance verification21 CFR Part 11 protocol for compliance verification

Regulatory ConsiderationsCompliance with US FDA Requirements:21 CFR Part 11 Compliance: The Steam Sterilization Validation & Monitoring System is 21 CFR Part 11 CompliantIQ-OQ-PQ Verification Protocols are Included21 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 AvailableComplies 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

NLPButton-T Data-Logger

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FeatureValue/Description

IdentificationUniversally Unique 64-bit rgistration number

Material305 SS Stainless Steels + SS Protective Casing

Size17.35 mm (0.68" diameter) x 5.89 mm (0.23" thickness)

Pressure & Chemical RatingUp to 10 Bar, Resistant to shock, dust, and

resistant to acid, alkaline, & organic solvents

Resolution for temperature logging8-bit: 0.5 C

11-bit: 0.0625 C

Operating range for temperature logging0 +125 C

PyroPad Stainless Steel Capsule for protection of the data-loggersUp to 140 psi (10 bar) & 145C

Temperature Accuracy after calibration0.1 C

Calibration uncertainty of measurement (NIST traceable) 0.08 C

Maximum number of measurements8192 (8-bit reading), or

4096 (16-bit reading)

Sampling rate1 sec 273 hours

Password protectionTwo-level password protection

Communication15.4 125kbits per second using 1-Wire protocol

Mission started byImmediately, or

User-defined delay, or

Temperature alarm (High and/or Low)

Battery life timeUp to 9 years/depending on usage definition

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Major Performance Characteristics Docking Station for iButton Programming/Data downloadiButton 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 iButtonsThe iButtons can be chained through a single Batch No. of multiple docking stations for parallel programming of 1,000s of iButtonsRS232, USB, & parallel interfaces are supported

Critical Functional CharacteristicsSterilization Validation, Control, & Management Database setupApplicable SOPSterilizer DimensionsSpecification limitsBioburden limitsCycle eventsArea classification (e.g., ISO 14644-1)

Critical Functional CharacteristicsData-Logger Control & ManagementData-logger ManagementSOP assignmentSpecification dataAutomatic registration of logger eventsCalibration specificationCalibration schedulingCustom property option (e.g., BI application)Sensor integrity verificationAttrition verification & optimization

Critical Functional CharacteristicsCycle Specification with Load AssignmentCycle Specification

Critical Functional CharacteristicsLogger Positional AssignmentLogger 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 SensorsAccording to 3D Positions

Support & Maintenance24/7 On-line Web Access for Interactive SupportNIST Compliant Calibration ServiceIQ-OQ-PQ protocol verification On-site or Web-supported21 CFR Part 11 compliance verificationOn-site or Web-supported via Intelligent Decision TreeSOP templates 24/7 On-line Web access SCORM 24/7 On-line Web, desktop, or enterprise training

Benefits to the UserLow Purchase CostBest in Class Price to Performance RatioTotal Solution with Full Regulatory ComplianceCertificate of CalibrationSOP SCORM Compatible TrainingComplies with FDAs Guidance for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug ProductsEnsures Best Sterilization Practices