Skip to content

Reshaping the future of sterilization: confronting the dilemma of EtO with the unquestionable rise of vH2O2

header-dem-abm-1

 

What if the undisputed champion of sterilization for over 50 years suddenly became a threat to both health and the environment? That’s exactly what happened.

This dramatic decision ignited a high-stakes, urgent search for a safer, more sustainable sterilization method, one that would address three crucial imperatives: ensuring patient safety, safeguarding public health, and securing product efficacy.

What’s really unfolding and what happens next? Cut through the noise and dive straight into the heart of it with our video podcast.

The crucial point is that replacing EtO means developing a new, tailored solution each time, because there is no one-size-fits-all approach to sterilization.

 

Let’s explore this scientific pursuit. Let’s start here, together.

 

The four-step process to transitioning from EtO

The transition from EtO to alternative methods is not simple, but it’s absolutely necessary. To navigate this complex shift, a clear, methodical process is essential:

  1. Assess the device’s intended use:  understanding how the device interacts with a patient directly determines whether sterilization is required. Devices in direct contact with the bloodstream or other sterile areas unequivocally require sterilization, whereas those that merely touch intact skin may only need validated cleaning and disinfection.
  2. Analyze the product design and materials:  each device is built differently; materials must be evaluated for sensitivity to heat, moisture, and chemicals. Manufacturing processes can also introduce residual stresses or chemicals that impact sterilization compatibility.
  3. Evaluate the sterilization options: a careful match between the device and the sterilization method is required to maintain safety and efficacy.
  4. Confirm post-sterilization functionality: the device must perform as intended after sterilization, with no degradation.

The industry's turning point: regulatory recognition

The FDA’s recognition of vH2O2 as an Established Category A sterilization method in January 2025 marks a pivotal turning point. This categorization positions vH2O2 as a legitimate, top-tier alternative to EtO, steam, and other traditional methods. Furthermore, ISO 22441:2022 provides specific requirements for the development, validation, and control of low-temperature vH2O2 sterilization processes for medical devices, and it is recognized in various pharmacopoeias.

While the European Medicines Agency (EMA) 2019 guideline does not yet include vH2O2, the Eudralex Annex 1 (2022) allows for alternative approaches with sufficient Quality Risk Management (QRM) justification, explicitly stating that EtO should only be used when no other method is practical.

The industry's turning point: regulatory recognition

The FDA’s recognition of vH2O2 as an Established Category A sterilization method in January 2025 marks a pivotal turning point. This categorization positions vH2O2 as a legitimate, top-tier alternative to EtO, steam, and other traditional methods. Furthermore, ISO 22441:2022 provides specific requirements for the development, validation, and control of low-temperature vH2O2 sterilization processes for medical devices, and it is recognized in various pharmacopoeias.

While the European Medicines Agency (EMA) 2019 guideline does not yet include vH2O2, the Eudralex Annex 1 (2022) allows for alternative approaches with sufficient Quality Risk Management (QRM) justification, explicitly stating that EtO should only be used when no other method is practical.

Alternatives to Ethylene Oxide: Moist Heat and Vaporized Hydrogen Peroxide

The primary alternatives to EtO, particularly for pharmaceutical and medical device sterilization, are Moist Heat and Vaporized Hydrogen Peroxide (vH2O2).

1. Moist Heat Sterilization

Moist Heat, or saturated steam sterilization, is often the most common and well-understood pharmaceutical sterilization process. It is generally preferred when material compatibility is allowed due to its robust nature and lower risk of impacting materials compared to other methods like ionizing radiation, which can introduce radiolysis impurities.

However, its applicability is constrained by temperature and humidity sensitivities of device materials. Many polymers used in medical devices, for example, cannot withstand temperatures above approximately 50°C, or their coatings may be negatively impacted by high humidity, rendering moist heat unsuitable. For such temperature-sensitive products, alternative low-temperature modalities become essential.

In this article, we’ll dive into the drama behind the transition and explore how vH2O2 is positioning itself as the solution to this high-stakes dilemma.

heat-sterilization

 

Polygon 5

2. Vaporized Hydrogen Peroxide: the clear winner in the EtO dilemma


vH2O2 has emerged as a particularly valid and increasingly recognized alternative to EtO for heat and moisture-sensitive devices. Developed in the 1970s, vH2O2 technology offers a "cold sterilization process" that serves as a non-toxic alternative to EtO and formaldehyde.
Advantages of vH2O2:

Low-temperature processing:

vH2O2 can sterilize effectively at temperatures as low as 4°C, with typical operating ranges between 24-38°C. This significantly reduces thermal stress and potential damage to heat-sensitive materials that cannot tolerate traditional high-temperature sterilization methods.

Broad-spectrum efficacy:

vH2O2 is sporicidal, bactericidal, fungicidal, and virucidal, demonstrating high efficacy against a wide range of microorganisms, including those residing in seams and joints. When used for the sterilization process, it consistently achieves a minimum 1 × 10−6 Sterility Assurance Level (SAL).

 

Environmental profile ("Green"):

vH2O2 is considered a "Green" sterilization modality because its active vapor breaks down into benign byproducts: oxygen and water vapor. This eliminates the dangerous emissions associated with EtO.




 Material compatibility:

vH2O2 exhibits excellent compatibility with a wide range of metal and polymeric materials. It is suitable for diverse products, including general surgical instruments, endoscopes, implants with electronics, pharmaceutical containers, and pre-filled syringes.

 

Challenges and limitations of vH2O2

Despite its advantages, vH2O2 also presents specific challenges that require careful consideration in process development:

Material Incompatibility:

the primary limitation of vH2O2 is its incompatibility with cellulosic materials. Cellulose degrades hydrogen peroxide gas, compromising sterilization efficacy. Additionally, certain uncoated reactive metals, such as copper and brass, may react with vH2O2, leading to surface degradation or discoloration. These issues necessitate careful material selection for devices and, critically, for primary packaging.

Vapor Penetration deficiencies:

while vH2O2  generally permeates materials well, difficulties can arise in sterilizing long lumen devices or densely packed loads. Poor cycle development that neglects factors like dew point changes, gas concentration, and saturation levels can lead to inadequate penetration and non-conformances.

Other Factors:

other considerations for vH2O2 include potential H2O2 residues (though significantly less problematic than EtO), and the impact on adhesives used in device manufacturing.

 

Addressing challenges: the role of Deep Vacuum processing

To mitigate the limitations of vH2O2, particularly concerning penetration and residue management, deep vacuum processing is identified as a primary or preferred method to replace EtO. 

  •    • Enhanced Penetration: For complex devices, especially those with long lumens or intricate geometries, and for densely packed loads, achieving effective sterilant penetration can be challenging in atmospheric conditions. Deep vacuum processing significantly aids in overcoming these penetration deficiencies by creating a pressure differential that facilitates the diffusion of hydrogen peroxide vapor into difficult-to-reach areas and internal lumens. Early work on vH2O2 demonstrated success with a "deep vacuum vH2O2 process", supporting its role in ensuring comprehensive sterilization.
  •    
       •     Efficient Residue Management    : vH2O2 inherently offers a cleaner process compared to EtO, as its breakdown products are benign oxygen and water vapor. The application of a deep vacuum during or after the vH2O2 cycle further enhances the removal of any residual vapor and its breakdown products, ensuring that devices are free from problematic residues and substantially decreasing or eliminating the need for extensive post-sterilization aeration typically associated with EtO.

The integration of deep vacuum processing with vH2O2 offers a scientifically sound solution to enhance sterilant penetration into challenging device geometries and facilitates the efficient removal of benign byproducts, further establishing vH2O2 as a safe, effective, and environmentally responsible choice for the future of medical device sterilization. 

However addressing the inherent challenges of vH2O2, while ensuring effective penetration in complex devices, requires meticulous process development.

Ready to see it in action? Two real cases

Hemodialysis tubing sets

For Hemodialysis tubing sets

are extremely long and narrow. That makes sterilization a huge challenge. Using deep vacuum H₂O₂, it is possible to achieve uniform distribution, full sterility, and a total cycle time far shorter than an EtO process, which can take multiple days due to aeration.

prefilled syringes

For prefilled syringes in Tyvek® blister packs

when a heat-sensitive drug products is contained in a PFS, it is possible to achieve sterility, keeping hydrogen peroxide residues below 1 ppm in the packaging, and ensured zero residue in the drug product. That shows us that H₂O₂ can meet even stringent pharma standards while protecting delicate formulations.

Fedegari's mission: guiding the industry through a crucial transition

The transition from EtO to vH2O2  is a critical challenge, and an incredible opportunity at the same time, that must be met head-on. At Fedegari, we are committed to helping medical device manufacturers navigate this crucial shift with confidence.

Our experts guide you through the evolving regulatory landscape, ensuring compliance and providing the insights you need to choose the right sterilization technology. We then work with you to develop a strategic transition plan, tailored to your specific needs and products.

The future of patient safety and product efficacy depends on making the right choices today. The industry cannot afford to wait any longer.

We guide companies through a confident and strategic transition to safer sterilization technologies. The future of collective well-being depends on this too.

 

 

Don't wait for the change to catch you off guard.

Contact us and prepare your organization for this critical transition in sterilization, turning it into an opportunity to innovate.

________________________________________

 

Fill out the form for more information