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Understanding Sterilization Methods for Medical Packaging Applications

Posted by Jimmy Shah on October 22, 2019

shutterstock_345750104In today’s world, patient safety is the primary concern throughout all stages of the medical packaging supply chain. The use of pre-sterilized devices or kits designed for one-time use is an effective way to ensure the cleanliness of the medical device being used.  Plastics is an ideal material for single-use packaging because of their versatility, light weight nature, sustainability, and ability to withstand the harsh sterilization techniques required to destroy dangerous bacteria and pathogens.

Effective decontamination through the use of sophisticated sterilization techniques is a key step in preventing the introduction or transmission of potentially dangerous pathogenic organisms and diseases to the medical device and, in turn, to the patient. Through sophisticated sterilization, all living organisms, including resistant forms such as bacterial or fungal spores, are removed or destructed helping to reduce the risk of healthcare-associated infections and the spread of disease. There are a variety of sterilization techniques commonly used in the medical industry for single-use disposable medical devices.

Continue reading for a brief recap of the most common sterilization techniques used in the medical packaging industry:

  1. Autoclave/Steam Sterilization: Autoclave, or steam, sterilization process works by forcing saturated steam into a pressure chamber. High heat resistant plastic must be used with this process.

  2. Ethylene Oxide Sterilization (EtO): A gaseous sterilization method using EtO gas.  EtO is a low temperature sterilization method and, as a result, most plastic materials are compatible with this method.

  3. shutterstock_588023315Radiation Sterilization: This sterilization method can be performed using two types of radiation - ionizing and non-ionizing radiation. Ionizing radiation utilizes Gamma or X-rays, whereas non-ionizing uses longer wavelength and lower energy.  

  4. Gamma Sterilization: An ionizing sterilization technique that involves exposing materials to gamma rays, most commonly Cobalt-60. More than 40% of all single-use medical devices are sterilized using gamma irradiation technique.

  5. Electron Beam (Ebeam) Sterilization: This process utilizes an electron beam to sterilize the product through a uniform dose of radiation. Materials that can be gamma sterilized can also be Ebeam sterilized.

  6. Dry Heat Sterilization: Heat sterilization method conducted at 160°C-170°C for a minimum of two hours. Because of the high heat exposure, this method typically requires packaging to be made from a specialty engineered plastic with a high heat tolerance.

  7. Plasma Sterilization: Product is exposed to Plasma, an ionized gas with special properties, where sterilization occurs as a result of a chemical reaction. This method is typically used for applications that cannot withstand high temperatures.


For a more detailed description on the various sterilization techniques commonly used in the medical packaging industry, download your free whitepaper today!

WHITEPAPER: Understanding Sterilization Techniques for  Medical Packaging Applications

Topics: Medical Packaging, Medical Device Packaging, ISO 9001:2015

Written by Jimmy Shah

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