Mediclue Technology Pvt. Ltd.
CSSDISO 11135WHO TRS 1019EN 1422EU MDR 2017/745

Pharma Fully Automatic ETO Sterilizer

Low-temp ethylene oxide cycle for heat-sensitive devices. WHO TRS 1019 aligned.

Mediclue Pharma ETO Sterilizers are engineered for validated terminal sterilization of heat-sensitive pharmaceutical packaging and medical devices. Operating at 37°C–55°C, ethylene oxide penetrates complex device geometries and multilayer packaging that steam sterilization cannot reach.

Key Features

  • Low-temperature cycle 37°C–55°C for heat-sensitive loads
  • WHO TRS 1019 and ISO 11135 aligned validation protocol
  • Automatic ETO injection, cycle control and aeration
  • Catalytic abatement unit for ETO emission control
  • Residual gas monitoring with alarm
  • Full electronic cycle record for regulatory submission

Applications

  • 01Heat-sensitive medical device sterilization
  • 02Pharmaceutical packaging component sterilization
  • 03Single-use device manufacturer terminal sterilization
  • 04Contract sterilization facilities

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Related Technical Resources

CSSDThe Role of ETO Sterilizers in Modern CSSD SetupWhy ethylene oxide remains indispensable for heat-sensitive instrument loads, and how to design exha…Read article →

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