Applications Ethylene Oxide (EtO) Sterilization Indicator Labels

Ethylene Oxide (EtO) Sterilization Indicator Labels

An EtO label for sterilization is a specialized label used to validate and indicate that items or equipment have undergone a sterilization process using ethylene oxide (EtO). Ethylene oxide is a commonly used gas for sterilization in various industries, including healthcare, pharmaceuticals, and laboratories. EtO labels serve as a visual indicator to confirm that the ethylene oxide sterilization process has been effectively completed. These labels typically incorporate color-changing indicators or other visual cues that react to the EtO sterilization process, indicating successful sterilization. The purpose of EtO sterilization indicator labels is to ensure that sterilized items meet the necessary standards for safety and efficacy. These labels play a critical role in maintaining the integrity of sterile products, protecting patients from potential infections, and complying with regulatory requirements. When applied to packaging, wraps, pouches, or containers, EtO sterilization indicator labels provide a quick and convenient way to verify the completion of the sterilization process. By checking the color change or other indicators on the label, healthcare professionals or sterile processing personnel can easily confirm if an item has been properly sterilized using ethylene oxide.

It's important to note that EtO sterilization indicator labels are single-use indicators and should not be reused or relied upon for multiple sterilization cycles. They are designed to provide a one-time visual validation of the sterilization process. Overall, EtO labels for sterilization play a crucial role in ensuring the safety and efficacy of sterilized items by providing a clear and reliable indication of successful ethylene oxide sterilization.

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CleanMark - Ethylene Oxide Labels (ETO)
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Product Resources

Why Choose Our Ethylene Oxide (EtO) Indicator Labels

  • Accurate Sterilization Validation: Our EtO sterilization indicator labels are designed to provide accurate and reliable validation of sterilization processes. With these labels, you can confidently verify that your equipment, instruments, or medical devices have been properly sterilized using ethylene oxide. This ensures the safety and effectiveness of your sterilization practices.

  • Compliance with Regulatory Standards: Compliance with regulatory standards is essential for sterilization processes. Our EtO indicator labels meet the latest industry regulations and guidelines, enabling you to fulfill your legal obligations effortlessly. By using our labels, you demonstrate your commitment to maintaining the highest sterilization and patient safety standards.

  • Clear and Visible Results: Our EtO sterilization indicator labels offer clear and easily visible results, quickly confirming successful sterilization. These labels incorporate color-changing indicators that react to the ethylene oxide sterilization process, indicating whether the items have been adequately sterilized. This visual clarity promotes efficiency and minimizes the risk of errors or reprocessing.

  • Durable and Reliable: Our EtO sterilization indicator labels are constructed from durable materials to withstand sterilization cycles. They are resistant to moisture, heat, and chemicals, ensuring they remain intact and legible throughout sterilization. You can use our labels to maintain their effectiveness and accuracy, ensuring consistent sterilization validation.

  • Easy Integration into Workflow: Our EtO sterilization indicator labels are designed for seamless integration into your sterilization workflow. They can be easily applied to various surfaces, such as packaging, wraps, pouches, or containers, without compromising the sterility of the items. Incorporating our labels into your process is hassle-free, saving you time and effort.

  • Customizable Options: We understand that every organization has unique requirements. That's why we offer customizable options for our ethylene oxide indicating labels. You can add your company logo, specific instructions, or additional safety information to the labels, ensuring they align perfectly with your safety protocols and brand identity.

Ethylene Oxide (EtO) Sterilization Indicator Label Options

Ethylene oxide (EtO) sterilization indicator labels are class 1 indicators manufactured in compliance with ISO 11140 that qualitatively identify processed and unprocessed equipment post-exposure to EtO. EtO sterilization process indicators are EtO-sensitive labels that undergo a significant color change from purple to green upon exposure to an ethylene oxide concentration of 450 mg/L. In addition to achieving this concentration, green's chromatic intensity depends on other factors such as equipment preconditioning, EtO/CO2 ratio, sterilization parameters (e.g., duration, RH%, temperature), and water vapor injection. CleanMark’s EtO labels combine this sterile process indicating ribbon with a thermal transfer printable, custom print-on-demand label, and EtO indicating dots.

EtO Sterilization Indicator 
Applied Labels

Our label-on-label manufacturing capabilities automates the manual process of hand applying ethylene oxide dots to primary and secondary packaging.

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CleanMark - ETO Applied Labels

Auto Applied EtO Sterilization Indicator 

Small strip ribbons and/or dots are applied to strategically select areas of the labels that leaves critical space for you label text content on any given sample or batch.

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CleanMark - Auto Applied Ethylene Oxide (ETO) Labels

EtO Sterilization Indicator Dots

Our ribbon dot rolls are backed with a pressure-sensitive adhesive label that are easily applied to most surfaces and items that need to undergo ethylene oxide sterilization.

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CleanMark - Ethylene Oxide (ETO) Dots

Direct EtO Sterilization Indicator 

Direct custom printing of EtO-sensitive material on the page with clear readable instructions embedded in the label that is tunable to your unique specification requirements.

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CleanMark - ETO Label Printing

Custom Made Ethylene Oxide (EtO) Sterilization Indicator Labels

Our ethylene oxide (EtO) sterilization indicator labels are fully customizable to satisfy a wide range of technical requirements. We are here to understand your needs end-to-end to develop a complete label construction unique to your application.

Construction Type

Available in rolls or sheets, piggyback and label set constructions

Topcoat Finish

Choose from a variety of matte, gloss and semi-gloss topcoat selections

Form Factor

Die cut and tailor your labels to fit practically any dimension or containers, products and packaging

Adhesive Grade

Pick from permanent, semi-removable and removable adhesives

Sterile Indicating

Utilize chemical indicators that fit your sterilization processing method

Printing Options

Compatible with thermal transfer, direct thermal, inkjet and standard laser printers

Printing Capability

Labels can be fully printed, partially printed, blank or hand writeable

Material Selection

Select from multiple forms of premium facestocks, plastic cores and liners

Surface Resistance

Can provide material that exhibits chemical, moisture, UV and temperature resistance

Find The Right Ethylene Oxide (EtO) Sterilization Indicator Labels

In order to find EtO sterilization indicator labels that perform and properly satisfy your quality standards, it is important to partner with a label expert familiar with a wide array of controlled environment applications. Our team has extensive experience working with companies involved with advanced research and manufacturing. We can work in tandem with your technical team to design, prototype and manufacture EtO sterilization indicator labels that are engineered for your application. Our aim is to make this quick and easy for you. 

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Label features
Ethylene Oxide (ETO) Indicating Label Features Color Transition
  • Permanent purple to green color change on exposure to EO gas
  • ISO compliant type 1 process indicator
  • 450 mg/L at 54°C from 50 - 70% RH for 20 minutes
Applications of ethylene oxide sterilization indicator labels
  • Healthcare Facilities: Ethylene oxide is widely used for sterilizing medical devices, surgical instruments, and other healthcare equipment. Indicator labels are applied to packaging, wraps, or containers to verify that these items have undergone proper sterilization using EtO. Healthcare facilities, including hospitals, clinics, and dental offices, rely on these labels to ensure patient safety.
  • Pharmaceutical Industry: Pharmaceutical companies often use ethylene oxide for sterilizing drug containers, vials, syringes, and other packaging materials. Ethylene oxide sterilization indicator labels confirm that the sterilization process has been completed, meeting regulatory requirements and ensuring product safety.
  • Laboratory and Research Settings: Laboratories working with sensitive materials, including biological samples or laboratory glassware, may employ ethylene oxide for sterilization. Indicator labels validate the sterilization process, ensuring that equipment or items are free from contaminants and ready for use.
  • Manufacturing and Industrial Facilities: In certain manufacturing processes, ethylene oxide is used for sterilizing or decontaminating equipment, machinery, or components. Ethylene oxide sterilization indicator labels help ensure that these items have undergone the required sterilization process and are safe to use or handle.
  • Packaging and Transportation: Ethylene oxide sterilization indicator labels can also be used in the packaging and transporting of items requiring sterilization. These labels provide a visual indication that the packaged products have been properly sterilized, instilling confidence in end-users or consumers regarding the safety and quality of the contents.

  • Hazardous Material Handling: Ethylene oxide is classified as hazardous due to its flammability and potential health risks. Indicator labels warn personnel about the presence of ethylene oxide in containers, tanks, or storage areas, ensuring that proper precautions are taken during handling, storage, and transportation.
Design considerations

Auto-Applied EtO Sterilization Indicating Dots 

CleanMark EtO labels can also be manufactured with precision-applied EtO indicator dots to assist with sterilization processing. Our label-on-label processing automates the manual hand application of gamma dots to primary and secondary packaging. This eliminates an often labor-intensive process and replaces it with a more efficient method to mark items sterilized with ethylene oxide.

EtO Sterilization Indicator Applied Labels 

CleanMark gamma labels can be produced with an integrated chemical indicator strip or dot to provide a sleek, uniform way to identify, track, and help distinguish sterilized medical equipment from non-sterilized. We apply a thin strip of ethylene oxide-sensitive material to the outer rim of one side of the label to provide sufficient space to print your required information. Our EtO labels can be manufactured blank or preprinted. CleanMark can also print your company’s logo, product name, and other static content while leaving space on the label for your team to print on-demand data like lot numbers and expiration dates.

EtO Sterilization Indicator Dots

Our standard EtO sterilization indicator labels are self-adhesive dots that undergo an irreversible color change via EtO sterilization. The dots undergo a clear and distinct color change from purple to green upon activation. These dots qualitatively verify processed vs. unprocessed products and packaging. Our dots manually apply directly to most items, constructed to be automated, or included in a formal label (see below).

EtO Sterilization Indicator Label Printing

For advanced labeling requirements requiring specialized messaging or images, we have expanded our capabilities better to match your quality needs via direct EtO label printing. On-demand, we provide high-quality direct-to-page printing of our EtO-sensitive material that sustains clear activation and legible instructions embedded directly into the page. 

Find the Right Label Solution

Responsible for sterilizing more than 20 billion medical devices and tooling yearly, ethylene oxide (EtO) has a profound footprint and invaluable role in protecting us from harmful biological pathogens. With thousands of healthcare and other laboratory facilities relying heavily on EtO to sterilize billions of devices, ensuring that each piece has met the requirements for safe usage is paramount in protecting millions of patients from the real risks of infectious diseases. At CleanMark, our EtO indicating labels aid in ensuring successful sterilization by qualitatively identifying processed vs. unprocessed equipment that undergoes this form of sterilization. We will work with your technical team to design, prototype, and manufacture engineered autoclave labels for your application. We aim to make this quick and easy for you. A great place to start is by requesting samples and then discussing your project with our team.

Auto Applied EtO Sterilization Indicator Dots 

  • Do your labels need to be clean and sterile?
    • Clean = free of particulate matter
    • Sterile = free of microbial contamination
  • Is proof of process sterilization required or desired?
  • What type of sterilization are you performing?
    • Is box level proof sufficient evidence or is itemized level proof required?
    • How or where should such evidence be present on the label for clear viewing?
  • What information is needed on the label?
    • Who is going to read the label?
    • Does it require tracking and/or tracing capabilities?
    • Are there specific regulatory requirements that need to be present on the label?
    • Do you need to maximize information content on the label?
    • What colors are needed?
  • What is the size and dimensions of the container being used?
    • Is this going on a box or smaller vial?
    • Does the label need to lie flat with it wrapped around?
    • Is the surface flat or curved?
Frequently asked questions
  1. What is sterilization indicating technology (SIT)? 

    • Our indicating technologies are an easy visual guide that allows operators, stakeholders, and any other vested parties to verify their products have undergone sterilization. 

  2. How does ethylene oxide (EtO) compare to vaporized hydrogen peroxide (H2O2) and air plasma sterilization methods?

    • EtO sterilization is a low-temperature technique to sterilize heat and moisture-sensitive tools. A known carcinogenic, EtO requires significant exposure periods often exceeding 8+ hours. However, EtO is far more common and has a greater penetration depth than H2O2. Like EtO sterilization, vaporized hydrogen peroxide is a low-temperature, vacuum-sealed method used to sterilize equipment. As an alternative to EtO, H2O2 is less toxic, and the sterilization process is completed in minutes vs. hours but has less penetration depth. Air plasma is vaporized H2O2 that is ionized to the plasma state via an amplified electric field at normal atmospheric conditions. Plasma is another EtO alternative, generally the cheapest to run per cycle. 

  3. EtO Indicating labels are ethylene oxide sensitive labels that undergo a dynamic color change from purple to green upon exposure. The chromatic intensity of green is contingent on several processing factors, such as equipment preconditioning, EtO/CO2 ratio, sterilization parameters (e.g., duration, RH%, temperature), and water vapor injection. We offer various label options, including stand-alone self-applied labels, custom label integration, and direct on-label printing.

  4. How do I know my products have undergone ethylene oxide sterilization?

    • We apply an indicator ink to any of our labels that will undergo a distinct color change upon appropriate exposure to EtO gas. Our indicator will turn from dark purple to green. 

  5. On what types of surfaces can indicators be placed?

    • With several options for adhesive, cutouts, and form factors, we can place labels on plastic, corrugated cardboard, glass, stainless steel, etc. 

  6. Can you direct print on the labels?

    • Yes! And we also offer printed indicator label options for our customers. This will provide clear instructions for the user with minimal explanation.

  7. How are your products verified to work as intended?

    • Our ethylene oxide indicating labels are third-party verified before market release. 

What Our Customers Say

"The CleanMark team was informative about the different materials and print processes. They were able to quickly get me samples to test as well as pre-production proofs to verify label size, orientation and color. They fulfilled on their promise to decrease my delivery time while improving print quality."

— Ernie Schrepfer, Associate Director of Quality Access Biologicals
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