Transcript What is a NLPButton data

Sterilization Validation & Monitoring
System
Based on NLPButton Technology
Application for Steam Sterilization
Presented by
OPULUS
2006
What is a NLPButton data-logger?
Anatomy of NLPButton data-loggers
(actual size) Hygrochrons
Thermochrons
(temperature/humidity
suitable for EO
sterilization/Intrinsically safe)
(temperature)
Li-Battery
Microprocessor
Capacitive humidity sensor
Quartz clock
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-Logger
Feature
Identification
Material
Size
Pressure & Chemical Rating
Resolution for temperature logging
Operating range for temperature
logging
PyroPad Stainless Steel Capsule for
protection of the data-loggers
Temperature Accuracy after
calibration
Calibration uncertainty of
measurement (NIST traceable)
Maximum number of measurements
Sampling rate
Password protection
Communication
Mission started by
Battery life time
Value/Description
Universally Unique 64-bit rgistration number
305 SS Stainless Steels + SS Protective
Casing
17.35 mm (0.68" diameter) x 5.89 mm (0.23"
thickness)
Up to 10 Bar, Resistant to shock, dust, and
resistant to acid, alkaline, & organic solvents
8-bit:± 0.5 C
11-bit: ±0.0625 C
0 … +125 C
Up to 140 psi (10 bar) & 145C
±0.1 C
≤ 0.08 C
8192 (8-bit reading), or
4096 (16-bit reading)
1 sec … 273 hours
Two-level password protection
15.4 … 125kbits per second using 1-Wire
protocol
Immediately, or
User-defined delay, or
Temperature alarm (High and/or Low)
Up to 9 years/depending on usage definition
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 Characteristics
Sterilization Validation, Control, & Management
• Database setup
– Applicable SOP
– Sterilizer
Dimensions
– Specification limits
– Bioburden limits
– Cycle events
– Area classification
(e.g., ISO 14644-1)
Critical Functional Characteristics
Data-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 Characteristics
Cycle Specification with Load Assignment
• Cycle
Specification
Critical Functional Characteristics
Logger Positional Assignment
• Logger Positional
Specifiation
Critical Functional Characteristics
Logging Data Security
Documentation Requirements
Summary 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