PyroButton-SQL/S for Optimal Sterilization Process Management
Introduction
PyroButton-SQL/S integrates Self-powered data-logger measurements with SQL database, application modules, and Decision Support Sub-system. The product is suitable for the sterilization process management of both steam and Ethylene Oxide gas sterilization. The program can be upgraded for dry heat sterilization & depyrogenation.
The benefits of a single integrated solution include:
- Consistent sterilization process validation
- Integration & comparative analysis of multiple sterilizers
- Consistent product validation
- Consistent Performance Qualification & re-qualification
- Scalable and modular implementation
- Effective & efficient OOS, OOT, & CAPA compliance
- Highest Return-On-Investment
The following application modules are included in PyroButton-SQL/S: Sterilization, Clean Room, Facilities, Process, & Container/Closure.
PyroButton-SQL/S is the only out-of-the-box solution product that encompasses Self-powered data-logger operations & SQL based information management in compliance of the FDA Guideline on "
for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Products."
Key Benefits to the User
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Sterilization process specification relative to:
- Temperature
- Pressure
- % RH (as applicable)
- Load quantity
- Specification SOP
- Bioburden
- Temperature Sensor Pattern mapping
- Calibration & maintenance support
- Re-qualification (scheduled & unscheduled) support
- Heat distribution mapping
- Heat penetration relative to heat load analysis
- Thermal monitoring & diagrams outputs
- Humidity monitoring & diagrams (as applicable)
- Effects of loading on thermal input analysis
- Container/closure validation studies relative to heat & humidity loads
- Process SOP effects
- Events management
System Requirements
- Pentium compatible 500 MHz
- 64 MB RAM (128 MB recommended)
- CD drive for installation
- Mouse
- 800x600 display resolution, 256 color (1024x768 resolution with High Color is recommended)
- 100 MB free hard disk space
- Windows 2000 or XP operating system
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