Gamma Indicator Dots

Sterile indicating labels for quality assurance

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

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Gamma dots are a vital tool in ensuring the efficacy of gamma radiation sterilization, widely used in healthcare, pharmaceutical, and medical device industries. These small, adhesive-backed labels change color upon exposure to gamma radiation, providing a clear visual confirmation that sterilization has been successfully completed. This feature is crucial for maintaining product safety and adherence to stringent industry standards. Our gamma dots are not only sensitive to radiation but also equipped with advanced ink and UV protection technologies to prevent false readings from sunlight exposure. By choosing our gamma dots, you gain a reliable method for verifying sterilization processes, enhancing safety and compliance in your operations.

  • Radiation Sensitivity: Gamma dots are sensitive to gamma radiation, a type of ionizing radiation, and can detect even low levels of exposure.
  • Passive Operation: Gamma dots do not require a power source or external equipment for operation. They are passive devices that respond to radiation exposure without active monitoring.
  • Color Change Indicator: When exposed to gamma radiation, gamma dots typically undergo a color change. The extent of color change is proportional to the radiation dose received.
  • Permanent Record: The color change in gamma dots is usually permanent, providing a visual and permanent record of radiation exposure levels.
  • Dose-Response Relationship: Gamma dots are designed to have a known and predictable dose-response relationship, allowing users to estimate the radiation dose based on the extent of color change.
  • Small Size: Gamma dots are often very small, making them easy to place in various locations where radiation exposure needs to be monitored.
  • Dose Range: Gamma dots are available in various dose ranges to cover different applications, from low-dose monitoring to high-dose radiation environments.
  • Color Change: Gamma dots may change color to varying degrees, depending on the manufacturer and the specific model. Users can choose gamma dots with a color change that is easily distinguishable and suits their needs.
  • Calibration: Gamma dots may be calibrated for specific radiation energy levels or sources, ensuring accuracy in radiation dose assessment.
  • Shape and Form: Gamma dots can come in different shapes and forms, such as dots, strips, or labels, to accommodate various monitoring requirements and applications.
  • Radiation Sterilization Validation: Medical devices and products that are sensitive to heat or chemicals are often sterilized using gamma radiation. Gamma dots can be used to validate and verify the effectiveness of the sterilization process. By placing gamma dots in different locations within a sterilization chamber or alongside medical products, manufacturers can monitor and confirm that the specified radiation dose is delivered to ensure proper sterilization.
  • Dose Mapping and Uniformity: Ensuring uniform radiation dose distribution is critical in radiation sterilization. Gamma dots can be strategically placed in containers, packaging, or within the load to create dose maps. These maps help assess whether the entire batch of medical devices received the required dose, ensuring consistency and product safety.
  • Quality Assurance and Batch Release: Manufacturers use gamma dots to verify that a specific dose of gamma radiation has been delivered to medical devices during sterilization. This verification is crucial for quality assurance and batch release processes, ensuring that products meet regulatory requirements and are safe for use in clinical settings.
  • Dosimetry Services: Dosimetry service providers offer gamma dot dosimetry as a service to medical device manufacturers and healthcare facilities. They use gamma dots to measure radiation doses during sterilization processes, providing accurate and reliable dose verification reports, which are essential for regulatory compliance and product certification.
  • Radiation Safety Training: In medical device manufacturing and healthcare settings, gamma dots can be used for radiation safety training and education. Staff members can observe the color change in gamma dots when exposed to radiation, helping them understand the importance of proper handling and safety precautions in areas where gamma radiation is used.
  • Product Development and Testing: During the development of new medical devices and materials, gamma dots can be used in research and testing to assess the effects of gamma radiation exposure on product performance, integrity, and materials compatibility.
  • Regulatory Compliance: Many regulatory agencies require medical device manufacturers to validate and document the radiation sterilization process. Gamma dots serve as a critical tool for demonstrating compliance with regulatory standards, such as those set by the U.S. Food and Drug Administration (FDA).
  • Radiation Dosimetry for Healthcare Equipment: In addition to sterilization, gamma dots may be used to verify radiation doses delivered by healthcare equipment, such as linear accelerators used in radiation therapy. This ensures the accuracy and safety of radiation treatments for patients.
  • Research and Development in Radiopharmaceuticals: In the field of radiopharmaceutical development, gamma dots may be used for radiation dosimetry to measure and monitor radiation doses in research experiments and clinical trials.

1. What are gamma dots?

Gamma dots are small, circular labels or indicators that are used to verify exposure to gamma radiation during the sterilization process. They change color when exposed to gamma radiation, providing a visual confirmation of sterilization.

2. Why are gamma dots important?

They provide a simple and effective way to ensure that medical equipment, pharmaceuticals, and other products have been adequately exposed to gamma radiation for sterilization purposes.

3. How do gamma dots work?

Gamma dots contain a radiation-sensitive material that changes color when exposed to a specific dose of gamma radiation. This color change indicates that the item has undergone the sterilization process.

4. What types of products are gamma dots used with?

They are commonly used with medical devices, surgical instruments, pharmaceuticals, and any other products that require gamma sterilization for safe use.

5. Can gamma dots indicate the level of radiation exposure?

Some gamma dots are designed to indicate whether the product has received the minimum required dose of radiation, while others can provide more detailed information about the level of exposure.

6. Are gamma dots safe to use on all materials?

They are generally safe for use on most materials, but it’s important to check compatibility, especially with sensitive or reactive materials.

7. How are gamma dots applied to products?

They are typically applied like stickers on the product or its packaging before undergoing the gamma sterilization process.

8. Can gamma dots withstand other sterilization processes?

Gamma dots are specifically designed for gamma sterilization. Exposure to other sterilization methods, like autoclaving or ethylene oxide, might not trigger the color change and could potentially damage the dots.

9. How should products with gamma dots be stored?

Store products with gamma dots in a cool, dry place away from direct sunlight and extreme temperatures to preserve the integrity of the dots until use.

10. Are there any regulatory considerations for using gamma dots?

In industries like healthcare and pharmaceuticals, there may be specific regulatory standards for sterilization and the use of indicators like gamma dots. It’s important to ensure that your use of gamma dots complies with these regulations.

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Gamma Indicator Dots

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

Designed with a specific material that alters color when exposed to gamma radiation, these labels provide a clear and reliable method for verifying sterilization in medical and pharmaceutical applications.

Gamma Indicating

Designed with a specific material that alters color when exposed to gamma radiation, these labels provide a clear and reliable method for verifying sterilization in medical and pharmaceutical applications.

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