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Glossary Term
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Gamma Sterilization

Definition

Gamma sterilization is a method of sterilizing medical devices using high-energy gamma rays emitted from a radioactive isotope, typically cobalt-60. This process effectively kills microorganisms, including bacteria, viruses, and fungi, by disrupting their DNA, ensuring the sterility of the device.

Relevance to the MedTech Industry

Gamma sterilization ensures the sterility of medical devices and products with minimal impact on packaging or device geometry. It is widely used for single-use devices, offering a reliable and efficient method to meet sterility assurance requirements.

Additional Information & Related Terms

How Gamma Sterilization Works

  1. Source of Radiation: Cobalt-60 emits gamma rays that penetrate the medical device and its packaging.

  2. Radiation Exposure: Devices are exposed to controlled doses of gamma radiation, which destroys the DNA of microorganisms, rendering them non-viable.

  3. Dose Measurement: The dose of gamma radiation is carefully calibrated and monitored to ensure effective sterilization without compromising the material or functionality of the device.

  4. Packaging Compatibility: Gamma rays can sterilize devices through their packaging, allowing for terminal sterilization of pre-packaged goods.

Device Types Suitable for Gamma Sterilization Gamma sterilization is particularly effective for:

  • Single-Use Medical Devices: Such as syringes, catheters, and surgical gloves.

  • Heat-Sensitive Devices: Products that cannot withstand high-temperature sterilization methods like autoclaving.

  • Complex Assemblies: Devices with intricate designs or components, such as pacemakers or stents.

  • Pharmaceuticals and Biologicals: Some vaccines and biological preparations when compatible with radiation.

Device Types Not Suitable for Gamma Sterilization Gamma sterilization may not be suitable for:

  • Radiation-Sensitive Materials: Devices made of certain plastics, such as polycarbonate, may degrade or discolor when exposed to gamma rays.

  • Electronics: Sensitive electronic components can be damaged by radiation.

  • Drug-Device Combinations: Some drugs may lose potency or undergo chemical changes when exposed to gamma rays.

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