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Last modified: 2024-03-18 
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PyroButton Sterilization Process Management

PyroButton-SQL/S for Optimal Sterilization Process Management


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 "Guidance for the Industry for the Submission Documentation for Sterilization Process Validation in Application for Human and Veterinary Drug Products."

Key Benefits to the User
  • 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

  • Intel(R) Core i5 CPU
  • 4 GB RAM
  • DVD drive for installation
  • 1680x1050 display resolution, High Color
  • 22+ inch monitor
  • 2 GB HDD
  • Windows XP, Windows 7 (32/64bits), Windows 8 (32/64bits), Windows 10 (32/64bits)


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