Incorporated Air Filter ETO Sterilization Machine For Ethylene Oxide Gas Sterilization

EO PROCESSING STEPS

• Preconditioning/conditioning
  • Exposure to RH and temperature
  • Ensure uniformity of these conditions
• Sterilization cycle
  • Exposure to EO gas
• Aeration
  • Dissipation of remaining gases

DECISIVE PROCESS PARAMETERS

• Gas concentration >400mg/L
• Temperature ~100 – 140ºC
• Relative humidity ~35 – 80%
• Exposure (dwell) time 2 – 10 hours

DEEP VACUUM CYCLE

SHALLOW VACUUM CYCLE

FACTORS AFFECTING CYCLE SUCCESS

• Bioburden
• Product/package properties
• Loading configuration
• Cycle parameters

DETERMINE THE STANDARD

• AMI/ISO 11135-01 4ed

“Sterilization of health care products – Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices”

• Europe – EN 550

EO VALIDATION OVERVIEW

• Process development
• Product compatibility
• Commissioning
• PQ – Physical
• PQ – Microbiological
• Certification
• Revalidation

PROCESS CONTROL

• Must assure that validated process parameters are met
  • Temperature
  • RH
  • Gas concentration
• Biological indicators are used to demonstrate lethality
• Microprocessors are used to control process

RELEASE MECHANISMS

• Documentation showing that processing specification are met
• Successful results of tests
  • Sterility of BI
  • EO residues
  • Packaging
  • Pyrogens

PARAMETRIC RELEASE

• BIs not used in release
• Validation more involved
• Routine control more rigorous
• AAMI TIR20:2001 “Parametric release for ethylene oxide sterilization”

PRODUCT COMPATIBILITY

• Post sterilization testing for
  • Device functionality
  • Package integrity and strength
  • Residue dissipation rates
  • Impact of re-sterilization