Gamma Indicator Labels

Sterile indicating labels for quality assurance

Elevate the safety and reliability of your sterilization processes with our Gamma Indicator Labels, engineered to provide visual confirmation of successful gamma radiation sterilization. Trusted across healthcare, pharmaceutical, and medical device industries, our gamma indicating labels offer a vital tool for ensuring product safety and adherence to the highest industry standards.

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Product Information

Explore how our labels can satisfy your requirements

Gamma indicating labels are a critical component in the gamma sterilization process, widely relied upon in sectors such as healthcare, pharmaceuticals, and medical device manufacturing. These specialized labels, equipped with radiation-sensitive materials, undergo a distinct color change when exposed to gamma radiation, providing immediate and clear confirmation of successful sterilization. This reliable visual cue is crucial for ensuring product safety and sterility, helping to maintain compliance with rigorous industry standards. Our gamma indicating labels, enhanced with advanced ink and UV protection technologies, are designed to ensure accuracy in the sterilization confirmation process, making them an indispensable tool for any operation where gamma sterilization is utilized. Choose our gamma indicating labels for their precision and reliability, ensuring your products meet the highest standards of safety and sterility.

  • Radiation Sensitivity: Gamma indicating labels are sensitive to gamma radiation, which is a form of ionizing radiation. They change color or display a visual indication when exposed to gamma radiation.
  • Immediate Response: These labels provide a near-instantaneous visual response to gamma radiation exposure, allowing users to quickly assess radiation levels and take appropriate safety measures.
  • Passive Operation: Gamma indicating labels are passive devices that do not require external power sources or equipment for operation. They provide a simple and cost-effective means of radiation monitoring.
  • Permanent Record: The color change or visual indication on gamma indicating labels is typically permanent, providing a long-term record of radiation exposure levels.
  • Dose-Response Relationship: Gamma indicating labels are designed to have a known and predictable dose-response relationship, enabling users to estimate the radiation dose received based on the extent of color change or visual indication.
  • Self-Adhesive: These labels are often self-adhesive, making them easy to apply to surfaces, containers, or equipment where radiation monitoring is needed.
  • Dose Range: Gamma indicating labels are available in various dose ranges to cover different applications, from low-dose monitoring to high-dose radiation environments.
  • Color Change: Gamma indicating labels may change color to varying degrees based on the radiation dose received. Users can choose labels with color changes that are easily distinguishable and suit their needs.
  • Calibration: Some gamma indicating labels may be calibrated for specific radiation energy levels or sources, ensuring accuracy in radiation dose assessment.
  • Adhesive Type: Users may have the option to choose from different adhesive types, including permanent adhesives or removable adhesives, depending on their specific labeling needs.
  • Color and Finish: Labels may come in different colors and finishes (e.g., matte or glossy) to accommodate specific labeling requirements, including color-coding or visual identification.
  • Barcode and QR Code Printing: Gamma indicating labels can offer the option to print barcodes, QR codes, or other data matrix codes for inventory management, tracking, and traceability purposes.
  • Custom Printing: Customers can often order custom-printed gamma indicating labels with specific information, such as sample details, storage conditions, and identification data.
  • Variable Data Printing: Labels can be customized with variable data printing, allowing for unique information on each label, such as sample identifiers, lot numbers, or expiration dates.
  • Print Method Compatibility: We can make gamma indicating labels that are compatible with direct thermal printers, thermal transfer printers, laser printers, and inkjet printers.
  • Size and Shape: Gamma indicating labels may come in various sizes and shapes to accommodate different labeling needs and surfaces.
  • Sterilization Process Validation: Gamma indicating labels are applied to medical device packaging or within sterilization containers before undergoing gamma radiation sterilization. These labels serve as indicators to validate that the prescribed radiation dose has been delivered to ensure the sterilization process's effectiveness.
  • Dose Mapping and Uniformity: Gamma indicating labels are strategically placed within sterilization loads, containers, or packaging to create dose maps. These maps help assess whether the entire batch of medical devices received a uniform radiation dose, ensuring consistency and sterility throughout the load.
  • Quality Control and Batch Release: Manufacturers use gamma indicating labels to verify that the specified radiation dose has been delivered during sterilization. This verification is essential for quality control processes and batch release, ensuring that medical devices meet regulatory requirements and are safe for clinical use.
  • Dosimetry Services: Dosimetry service providers offer gamma indicating labels as part of their services to medical device manufacturers. These labels are used to measure and confirm the radiation dose delivered during sterilization, providing accurate dose verification reports for regulatory compliance and product certification.
  • Radiation Sterility Assurance: In applications where maintaining sterility is critical, such as in the production of implantable medical devices or surgical instruments, gamma indicating labels play a crucial role in ensuring that devices remain sterile and free from microbial contamination.
  • Regulatory Compliance: Regulatory agencies, such as the U.S. Food and Drug Administration (FDA) and the International Organization for Standardization (ISO), require medical device manufacturers to demonstrate the effectiveness of their sterilization processes. Gamma indicating labels help manufacturers comply with these regulatory requirements.
  • Documentation and Traceability: Gamma indicating labels provide a visual and permanent record of the sterilization process, allowing for documentation and traceability of each batch of medical devices, including the date of sterilization and radiation dose received.
  • Supplier Audits and Inspections: During supplier audits and inspections, gamma indicating labels may be reviewed to verify that the sterilization process is properly monitored and documented, ensuring product quality and safety.
  • Research and Development: Gamma indicating labels can be used in research and development projects involving the development and testing of new sterilization methods and techniques for medical devices.

1. What are gamma indicating labels?

Gamma indicating labels are specialized labels that change color when exposed to gamma radiation, commonly used to verify that medical equipment, pharmaceuticals, and other sensitive products have undergone gamma sterilization.

2. Why are gamma indicating labels used?

They provide a visual confirmation that a product has been exposed to gamma radiation, ensuring compliance with sterilization protocols and enhancing safety in medical and pharmaceutical applications.

3. How do gamma indicating labels work?

These labels contain chemicals that react to gamma radiation. Upon sufficient exposure, a color change occurs, signaling that the item has been subjected to the sterilization process.

4. Are the color changes in gamma indicating labels reversible?

No, the color change is permanent and provides a lasting record of gamma radiation exposure, which is crucial for quality control and compliance purposes.

5. What types of products typically use gamma indicating labels?

They are widely used on medical devices, surgical instruments, certain pharmaceuticals, and any other products requiring sterile packaging and gamma sterilization.

6. How accurate are gamma indicating labels?

These labels are designed to be highly accurate and reliable, but it’s important to use them as directed and within their specified exposure range for accurate results.

7. Can these labels indicate the amount of radiation exposure?

Some gamma indicating labels are designed to indicate that a minimum necessary dose has been received, while others can provide more detailed information about the level of exposure.

8. How should gamma indicating labels be stored before use?

Store them in a cool, dry, dark place to prevent premature or accidental activation. Follow the manufacturer's specific storage recommendations.

9. Are there different types of gamma indicating labels for different radiation doses?

Yes, different labels may be calibrated for different radiation doses. It’s important to choose a label appropriate for the specific gamma sterilization process used.

10. Are there regulatory standards for using gamma indicating labels?

In industries such as healthcare and pharmaceuticals, there may be regulations governing the use of sterilization indicators. Ensure that the labels you use comply with relevant industry standards and regulations.

Why Choose CleanMark

Quality, Customization, and Speed at Your Service


Expert Guidance

Get the perfect label solution with advice from our team. We’re here to help every step of the way.


Custom Solutions

Drawing on extensive experience and diverse material options, we create labels that are tailor-made for you.


Seamless Integration

Set up your labels quickly and easily. They’re designed to fit right into your printing and application systems.


Swift Production

Need labels fast? Count on us for quick 4-day delivery, even for complex orders.


Adaptive Scalability

Your business changes, and so can your labels. We can easily adjust designs and production as you grow.

Why Choose CleanMark

Quality, Customization, and Speed at Your Service

Precision in Every Dimension

Our Label Design Process Focuses On 3 Key Areas


We assess and select the optimal adhesive to ensure reliable bonding and removal suited to a range of substrates and application scenarios.


Our design process involves optimizing release and peel values for seamless integration with both manual and machine applied label processes.


We ensure compatibility with your printing systems and application conditions so that your labels remain legible over time.


Find the Right
Gamma Indicator Labels

Evaluate our label samples in your environment to assess their performance under your specific conditions. This will help you feel sure about choosing the right labels for your needs. We have many kinds of labels and can send you samples quickly to help you decide.

Additional options for Gamma Indicator Labels

Gamma Indicator Dots

Gamma indicator dots are small, color-changing indicators used to confirm exposure to gamma radiation, typically utilized in sterilization and medical packaging processes.

Gamma Dots

Gamma dots are small, color-changing indicators used to confirm exposure to gamma radiation, typically utilized in sterilization and medical packaging processes.

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 at Access Biologicals