Question 1

What is EtO (Ethylene Oxide) Sterilization?

Accepted Answer

EtO (Ethylene Oxide) sterilization is a low-temperature process (~45°C) that uses Ethylene Oxide gas and inert gases to eliminate microorganisms like bacteria, viruses, and fungi. It is widely used for sterilizing medical devices, pharmaceutical products, surgical instruments, and sensitive materials that cannot withstand high heat or moisture.

Question 2

What kind of products can be sterile by EtO (Ethylene Oxide)?

Accepted Answer

EtO sterilization is suitable for a wide range of heat- and moisture-sensitive products, including:

• Medical devices – Catheters, surgical instruments, syringes, and implants
 • Pharmaceutical products – Active Pharmaceutical Ingredients (APIs), drug delivery systems, and packaging materials
 • Disposable healthcare products – Surgical gowns, masks, and gloves
 • Electronics and plastic components – Pacemakers, sensors, and tubing
 • Laboratory equipment – Petri dishes, pipettes, and culture media
 • Complex materials – Products made from plastics, polymers, and multi-layer packaging

EtO's ability to penetrate packaging and complex structures makes it ideal for sterilizing products that are sensitive to heat, moisture, or radiation.

Question 3

How long is the shelf life of EtO sterilized products?

Accepted Answer

The shelf life of EtO sterilized products depends on factors such as the type of material, packaging, and storage conditions. When properly packaged and stored in a controlled environment, EtO sterilized products can maintain sterility for 1 to 5 years or even longer, as long as the packaging remains intact and undamaged.

Question 4

What are the acceptable limits for EtO residue in sterilized products?

Accepted Answer

The acceptable limits for EtO residue in sterilized products are regulated by international standards such as ISO 10993-7. The limits depend on the type of product and its intended use:

• For devices with limited exposure (≤24 hours): ≤4 mg of EtO and ≤9 mg of ethylene chlorohydrin (ECH) per day.
 • For devices with prolonged exposure (24 hours to 30 days): ≤0.1 mg of EtO and ≤2 mg of ECH per day.
 • For devices with permanent exposure (>30 days): ≤0.05 mg of EtO and ≤0.25 mg of ECH per day.

Strict adherence to these limits ensures product safety and regulatory compliance.

Question 5

What is the acceptable primary and secondary packaging for each category of EtO sterilized products?

Accepted Answer

1. Primary Packaging – Direct contact with the product, providing a sterile barrier and protection from contamination.
2. Secondary Packaging – Provides additional protection during handling, storage, and transportation without direct contact with the product.

✅ Acceptable Packaging for Each Category:

Using PPE bags and HDPE containers for pharmaceutical APIs ensures that the product remains sterile, protected from contamination, and compliant with regulatory guidelines.

Question 6

What information is required to request a quotation for the EtO sterilization process?

Accepted Answer

Steris Surgical Solutions requires following information:

To provide an accurate quotation for the EtO sterilization process, the following information is typically required:
 • Product Details – Type of product, material composition, and dimensions.
 • Quantity – Number of units to be sterilized per batch or cycle.
 • Packaging Type – Details of primary and secondary packaging (e.g., PPE bags, HDPE containers).
 • Sterilization Requirements – Desired sterility assurance level (SAL) and any specific standards (e.g., ISO 11135).
 • Residual Limits – Acceptable EtO and ethylene chlorohydrin (ECH) residue levels.
 • Turnaround Time – Expected processing time and delivery schedule.
 • Special Handling Instructions – Temperature sensitivity, storage conditions, or other unique requirements.

Providing detailed information helps ensure an accurate quote and a smooth sterilization process.

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