Applications Gamma Sterilization Indicator Labels

Gamma Sterilization Indicator Labels

Ensuring Sterilization Confidence

Gamma sterilization indicator labels are visual chemical indicators used to show the sterilization of medical devices, pharmaceuticals, and other products using gamma radiation. Our gamma sterilization indicator label contains radiation-sensitive ink that undergoes a visible change when exposed to a specific dose of gamma radiation. The label is attached to the product, serving as a visual confirmation that the item received the required sterilizing dose. Our ink irreversibly changes color from yellow to red depending on the dose exposure. 

Gamma sterilization indicator labels are essential for quality control purposes and ensure that medical devices and pharmaceutical products have undergone the necessary sterilization process. They provide a visible and easily identifiable confirmation that the items have been exposed to the appropriate level of gamma radiation, reducing the risk of contamination and ensuring product safety. Our labels play a critical role in healthcare, pharmaceuticals, biotechnology, and medical device manufacturing, where sterility is paramount. They help maintain the integrity and safety of products by clearly indicating that they have undergone the necessary sterilization process and are ready for use.

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CleanMark - Gamma Labels

Product Resources

Why Choose CleanMark Gamma Sterilization Indicator Labels

  • Reliability: We manufacture our labels to meet high expectations commensurate with our service industries. They provide a clear and visible indication of whether an item has undergone the gamma sterilization process, giving you confidence in the sterilization's effectiveness.
  • Compliance: Our gamma sterilization indicator labels comply with relevant industry regulations and standards, including those set by regulatory bodies like the FDA or ISO. By using our labels, you can ensure that your sterilization processes meet the necessary compliance requirements.

  • Quality Assurance: Our gamma sterilization indicator labels undergo rigorous testing and quality control processes. We strive to deliver labels that consistently perform as intended, providing you with peace of mind regarding the accuracy and reliability of the sterilization indication.

  • Traceability: Our labels can feature unique identification codes or serial numbers, allowing for traceability and easy record-keeping for your inventory management systems.

  • Straightforward Interpretation: Our gamma sterilization indicator labels highlight clear instructions and quickly interpretable visual indicators. 

  • Durable and Resilient: Our labels are specifically engineered to withstand the rigors of gamma radiation and the sterilization process. They resist fading, damage, moisture, and other environmental factors ensuring that the label remains intact and legible throughout its intended lifespan.

  • Easy Application and Removal: Our gamma sterilization indicator labels feature a strong adhesive backing for secure application on various surfaces. They are also designed for easy removal, if required, without leaving residue or causing damage to the item.

  • Expertise and Support: We have extensive expertise in sterilization indicators and can provide guidance and support in selecting the most suitable labels for your specific requirements. Our knowledgeable team is available to assist you throughout the process.

Gamma Sterilization Indicator Label Options

CleanMark’s gamma sterilization indicator labels feature a chemical ribbon built into the construction of the label. This radiation sensitive label material permanently changes color from yellow (unexposed) to red when exposed to a gamma beam dosage in order to help distinguish a sterile product from one that is not. CleanMark’s gamma sterilization indicator labels combine this sterile process indicating ribbon with a thermal transfer printable, print-on-demand label that eliminates the need for a separate label and gamma sterilization indicating dots or tape.

Gamma Sterilization 
Indicator Applied Labels

A strip of radiation sensitive material is placed along the edge of the label to provide enough space for printed information.

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CleanMark - Gamma Applied Labels

Auto Applied Gamma Sterilization Indicator Label Dots

A small square of radiation sensitive material can be applied anywhere on the label to to accommodate intricate label designs.

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CleanMark - Auto Applied Gamma Dots

Gamma Sterilization 
Indicator Label Dots

A roll containing 5000 .5” squares of radiation sensitive material for applications where users want to hand apply dots to their packaging.

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CleanMark - Gamma Dots

Direct Gamma Sterilization 
Indicator Label Printing

Radiation sensitive ink is printed on the edge of the label so that text can be used to help indicate when sterilization has occurred.

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CleanMark - Direct Gamma Printing Labels

Custom Made Gamma Sterilization Indicator Labels

Our gamma 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. 

Form Factor

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

Construction Type

Available in rolls or sheets, piggyback and label set constructions

Topcoat finish

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

Printing Options

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

Adhesive Grade

Pick from permanent, semi-removable and removable adhesives

Sterile Indicating

Utilize chemical indicators that fit your sterilization processing method

Printing Capability

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

Material Selection

Select from multiple forms of premium face stocks, plastic cores and liners

Surface Resistance

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

Find The Right Gamma Sterilization Indicator Labels

In order to find gamma 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 sterile labels that are engineered for your application. Our aim is to make this quick and easy for you. 

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Label features
  • 8+ hour sunlight protection
  • Type 1 11140-1 compliant process indicator 
  • Distinct color change for sunlight vs. gamma radiation
Applications of gamma sterilization indicator labels
  • Medical Devices: Gamma sterilization indicator labels are widely used in the healthcare industry to indicate that medical devices and instruments have undergone sterilization, ensuring their safety for patient use. Pharmaceutical Products: Labels are applied to pharmaceutical packaging, including vials, ampules, blister packs, and bottles, to signify that the contents received appropriate levels of gamma radiation. 
  • Laboratory Equipment: Gamma sterilization indicator labels are used on laboratory equipment, such as glassware, Petri dishes, pipettes, and culture media, to indicate that they have undergone the sterilization process.
  • Biotechnology Products: Gamma sterilization indicator labels are applied to various biotechnology products, including cell culture media, enzymes, reagents, and diagnostic kits, to ensure their sterility and prevent microbial contamination.
  • Food and Beverage Industry: Certain food products, such as spices, herbs, and dried ingredients, are sometimes sterilized using gamma radiation. The labels indicate that these products have undergone sterilization to enhance food safety and extend shelf life.
  • Cosmetics and Personal Care Products: Some cosmetics, toiletries, and personal care products, particularly those with high water content or prone to microbial growth, may undergo gamma sterilization. Our gamma sterilization indicator labels denote that these products underwent process sterilization.
  • Veterinary Medicine: Gamma sterilization indicator labels are applied to veterinary medical devices, equipment, and pharmaceuticals to indicate sterilization occurred, ensuring safety and efficacy for animal use.
  • Research and Development: Research institutions and laboratories utilize gamma sterilization indicator labels on experimental equipment, biological samples, and other research materials to ensure sterility and prevent cross-contamination.
  • Aerospace and Defense: Certain components and materials used in the aerospace and defense industries require sterilization to meet stringent quality and safety standards. Gamma sterilization indicator labels signify the completion of the sterilization process.
  • Industrial Applications: In industrial settings, specific products or components used in manufacturing processes, such as semiconductors, optics, and precision instruments, undergo gamma sterilization. 
Application spotlight
CleanMark - Gamma Labels Application Spotlight

Before working with CleanMark, a customer suffered from extensive lead times, poor customer service, and an inability to consistently supply products from their previous vendors. The labels in this application are for pharmaceutical product packaging lines requiring a large 6 x 8 auto-applied label piggybacked with a more minor 3 x 2 label system. These label combinations identify bottle contents, lot, batch and line numbers, customer PO#, shipping address, and proof of sterilization by gamma radiation. CleanMark’s superior customer service and ability to deliver all of their needs for label quality and greatly improved lead times led them to forgo their previous vendor and shift to CleanMark as their #1 supplier. 

Design considerations
  • Gamma Radiation Resistance: Gamma sterilization indicator labels should withstand the high-energy gamma radiation used in the sterilization process. They should exhibit excellent resistance to radiation-induced degradation or fading, ensuring the label remains visible and legible after exposure.
  • Color Change or Visual Indicator: The label should have a clear and easily recognizable visual indicator that undergoes a noticeable change upon exposure to the sterilization dose. This color change or visual transformation indicates radiation exposure for the label and the affixed item.
  • Dose Sensitivity: The label's visual indicator must calibrate to a specific dose of gamma radiation used in the sterilization process. It should accurately reflect whether the item has received the required sterilizing dose or if it falls outside the specified range.
  • Clear Readability: The label should provide clear and legible information even after exposure to gamma radiation. The label's text, symbols, or indicators should remain visible and identifiable to ensure straightforward interpretation and verification.
  • Adhesive Quality: The label should feature a strong adhesive backing that adheres securely to different surfaces, including packaging materials, medical devices, or other objects. It should withstand sterilization conditions, maintaining its position throughout the process and subsequent handling.
  • Durability: Gamma sterilization labels should be resistant to physical damage, moisture, chemicals, and other environmental factors that they may encounter during storage, transportation, or use. 
  • Regulatory Compliance: Gamma sterilization indicator labels must meet relevant industry standards, regulations, and guidelines. Look for labels that comply with international standards and regulations specific to the intended application, such as those set by regulatory bodies like the FDA or ISO.
  • Traceability: Labels with unique identification codes or serial numbers allow for traceability and tracking of sterilization processes, enabling easy record-keeping, inventory management, and quality control.
  • Easy Application and Removal: The label should be designed for convenient application on different surfaces and easy removal, if required, without leaving residue or causing damage to the affixed item.

  1. Do your labels need to be clean and sterile?

    • Clean = free of particulate matter

    • Sterile = free of microbial contamination

  2. Is proof of process sterilization required or desired?

  3. 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?

  4. 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?

  5. What are the dimensions and size 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?

Each of the questions listed above will influence the type of label construction we would suggest for your particular application. 

Frequently asked questions
  1. What are gamma sterilization indicating labels?

    • Gamma sterilization-indicating labels undergo a visible color change or other visual indication when exposed to gamma radiation. They provide visual evidence of gamma sterilization.

  2. How does gamma sterilization indicating labels work?

    • Gamma sterilization-indicating labels contain chemicals or indicators that react to the gamma radiation during sterilization. This reaction results in a noticeable color change or other visual indication, indicating that the sterilization process has occurred.

  3. Why should I use gamma sterilization indicating labels?

    • Gamma sterilization indicating labels offer a reliable and convenient method to verify that items have undergone sterilization. They provide assurance of sterilization effectiveness, compliance with regulations, and proper record-keeping for quality control purposes.

  4. Are gamma sterilization indicating labels compliant with industry standards?

    • Yes, our gamma sterilization indicates labels meet industry standards and regulatory requirements. 

  5. How accurate are gamma sterilization indicating labels?

    • Gamma sterilization indicating labels indicate exposure to gamma radiation and the completion of the sterilization process. However, following our color guide to interpret and use the labels correctly is essential.

  6. Are gamma sterilization-indicating labels useful for multiple sterilization cycles?

    • No, our gamma sterilization indicating labels are designed for single-use only. 

  7. Are gamma sterilization-indicating labels durable?

    • Yes, gamma sterilization-indicating labels are durable and resilient. They withstand the effects of gamma radiation, physical handling, moisture, and environmental conditions.

  8. Are gamma sterilization-indicating labels customizable?

    • Some manufacturers offer customization options for gamma sterilization indicating labels. You may include unique identifiers, logos, or specific label information depending on the manufacturer's capabilities.

  9. How should you store gamma sterilization indicating labels?

    • They should be stored in a cool, dry place away from direct sunlight and other potential radiation sources. Follow our manufacturer's recommendations for proper storage conditions to maintain their Along the electromagnetic spectrum, gamma rays, beta, and X-Ray UVC radiation are all classified under the ionizing radiation family on the spectrum. The primary differences between the three are their wavelength and frequency concerning their energy output.

  10. Are you irradiation indicating labels sensitive to direct exposure to sunlight?

    • Yes, as direct sunlight emits radiation and can trigger the indicator, this long-standing problem has been mitigated with our improved protective layer.

  11. If my irradiation requirements are outside your specified detection range, do you have any other products that fit my needs?

    • Yes, we work with you to develop custom indicators for your detection limit needs.

  12. What does a premature color shift indicate?

    • Because ionizing irradiation indicates labels are sensitive to direct sunlight, when exposed, the labels will often trigger red and give a false signal to the users.

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

    • We have a two-level verification program where raw materials are tested at an independent third-party testing facility and an internal release check before shipping to ensure the highest consistency and product quality.

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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