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Ethylene Oxide (EO or ETO) Sterilization for Pharmaceutical Products

Ethylene Oxide (EO) offers a wide range of material compatibility except for moisture- and temperature-sensitive materials.

Ethylene Oxide (EO) offers a wide range of material compatibility except for moisture- and temperature-sensitive materials.

For manufacturers whose products are particularly radiation sensitive, EO can be an effective sterilization modality.

Applications include:

  • External sterilization of pre-filled syringes, vials, or cartridges, where the goal is that EO does not reach the pharmaceutical product
  • Sterilization of bulk active pharmaceutical ingredients (API)
  • Sterilization of drug-device products
  • DNA removal

Benefits include:

  • Sterilization at low temperatures, ensuring the integrity of both the product and packaging
  • Effective sterilization of a broad range of polymers, resins, natural materials, and metals as well as dual drug-device combination products that require external contact surface sterilization
  • Consistently meets product and regulatory requirements
  • Allows for the release of products directly after processing which results in fast turn times to help get product to market rapidly

The authors of this white paper guide readers through the use of a developmental chamber for Process Definition in adherence with ISO 11135:2014.
Our goal is to develop and maintain the most effective sterilisation processes for your products, bringing them to market in the fastest, most efficient and...
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