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Ethylene Oxide Sterilisation Training - The Process

Ethylene Oxide Sterilization Training - The Components

Part 1 – Introduction

  • Overview of why Ethylene Oxide (EO) is used.
  • Brief History on EO and sterilisation.
  • Implications of using EO.
  • What can we sterilize with EO.

Part 2 – Ethylene Oxide Gas Appreciation

  • Properties of EO.
  • How EO is handled.
  • Process In Built Safety.
  • EO monitoring.
  • Explosion triangle appreciation.
  • Different gas mixtures.

Part 3 – EO Sterilisation Cycle Appreciation

  • Achieving sterility.
  • Sterilisation cycle stages.
  • Methods of preconditioning.
  • Methods of degassing.

Part 4 – Meeting the Standards

  • Control and Monitoring.
  • System control architecture.
  • Design and Installation Requirements.
  • 21CFR Part 11.

Part 5 – Notes on Steam and Humidity

  • Steam Under Vacuum.
  • Dew Point and Humidity.

Part 6 – Process Qualification

  • Regulatory Standards.
  • Validation Overview.
  • Validation Life Cycle.
  • Implications of 21CFR Part 11.

Part 7(a) – Mechanical and Electrical Components and Installation

  • ATEX Review.
  • Local and National Requirements.
  • Insurance Requirements.
  • ATEX / Ex electrical equipment.
  • Intrinsic Safety.
  • Explosion / flame protection.

Part 7(b) – Mechanical and Electrical Components and Installation

  • Electrical Installation requirements
  • Mechanical equipment with Ethylene Oxide
  • Mechanical Installation requirements
  • Typical process safety interlocks
  • Maintaining the process

Part 8 – Cycle / Product Qualification

  • Regulatory Standards
  • Key Sterility components
  • Qualification methods
  • Maintaining cycle / product qualification

Part 9 – Process Key Components

  • Sterilisation Chamber.
  • Doors and interlocks.
  • Vacuum System.
  • Preconditioning Equipment.
  • Degassing Equipment.
  • Service Equipment.
  • Deluge.
  • Safety monitoring.

Part 10 - Process Summary and Installation

  • Summarizing the Process.
  • Typical Installation Costs.
  • Typical Running Costs.
  • Typical personnel levels.
  • Installation time schedules.
  • Operation Time Schedules.
  • Typical Operating Procedures.
 
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Sterilisation Training Leaflet (PDF) Control & Monitoring