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Ethylene Oxide (EtO/EO) Sterilization

Small-batch, quick-turn, in-house EtO sterilization delivers rapid processing in as little as XX weeks standard (24 hour expedited) without compromising quality or compliance.

Overcoming Today’s EtO Sterilization Challenges

While EtO sterilization remains one of the most popular sterilization methods, it’s not without challenges. Today’s medical device manufacturers too often must contend with changing regulatory requirements to lower and long lead times due to capacity constraints.

At LSO, our chambers are always open and with our small-batch EtO method, we are well positioned to remain compliant with new emissions constraints in the next few years.

What Is Ethylene Oxide (EtO) sterilization?

 

Ethylene Oxide (EtO) sterilization leverages a colorless gas that functions at relatively low temperatures. This approach currently stands out as the predominant sterilization technique for medical devices. Products are enclosed within a secure chamber where they are exposed to EtO gas. EtO inactivates microorganisms through alkylation of their molecular structures and genetic material. EtO has excellent compatibility with an array of materials, ranging from plastics and metals to glass.

Who Is Using EtO?

Ethylene oxide sterilization is particularly effective for devices that are unable to tolerate high heat and radiation. It is widely used for pacemakers, surgical kits, syringes, and catheters. This method is beneficial for sterilizing a broad range of materials including plastics, resins, metals, glass, and multi-layer packaging. As a surface sterilant, EtO is unable to travel past hermetic seals and gas-tight fittings.

How Does EtO Work?

At LSO, we utilize a total of  six (4 LSO West, 2 LSO East) in-house 3M™ STERI-VAC™ STERILIZER/AEROTOR GS8XL machines with ‘All-In-One’ cycles. During the 1-8 hour (4 hour standard) customizable cycle times, pre-conditioning, sterilization, and aeration are performed in-chamber. Temperatures can range from 37-55 degrees C to suit different material requirements while meeting ISO 11135-2014 standards and conforming to all regulatory requirements (EPA OSHA, SCAQMD, AAMI) for quality and safety.

Why LSO?

In addition to ‘always open’ capacity, we offer professional expertise with our in-house microbiologist, maintain the highest levels of compliance <link> and certification <link>, and have successfully helped over 1,000 clients process XXXXX cycles and YYYYYY validations and counting <insert counters>. In addition to this extensive experience, we streamline your sterilization process for ease and efficiency with:

Full EtO Validation

Comprehensive packages for regulatory compliance.

Flexible Sterilization Cycles

From fractional to full cycles with EtO residual testing.

Robust Qualification

Secure with 2X qualification.

Choice of PCDs

Tailored to your sterilization needs.

What Standards Apply?

Several standards specifically address medical device sterilization by providing guidelines to support sterilization processes safety and efficacy. Some of the key standards include:

 
  • ISO 11135: Outlines requirements and guidance for the validation and routine control of ethylene oxide sterilization processes for medical devices.
  • ISO 11137: Focuses on sterilization of healthcare products using radiation and includes guidance on validation and routine control of the process.
  • ISO 17665: Specifies requirements for the development, validation, and routine control of a moist heat sterilization process for medical devices.

These standards are crucial for effective sterilization of medical devices, which in turn ensures patient safety and regulatory compliance. Depending on your geographic location and markets you operate in, additional standards may be enforced by local regulatory organizations and authorities. It’s important to thoroughly research all applicable standards or consult with an industry professional experienced in the regulatory landscape. Their expertise can provide valuable insights and guidance in following specific requirements relevant to your region and verify that your sterilization processes meet industry standards.

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