Exploring Medical Packaging Sterilization Approaches

MedTech Outlook | Tuesday, March 30, 2021

Sterilization techniques must be compatible with the medical device and its packaging: common sense, but increasingly challenging to implement.

FREMONT, CA: Patient safety is the primary concern at all stages of the medical packaging supply chain in today's world. Using pre-sterilized devices or one-time-use kits effectively ensures the cleanliness of the used medical device. Plastics are an ideal material for single-use packaging due to their versatility, lightweight, sustainability, and resistance to the harsh sterilization techniques required to eliminate dangerous bacteria and pathogens.

Effective decontamination via sophisticated sterilization techniques is critical for preventing the introduction or transmission of potentially dangerous pathogenic organisms and diseases to the medical device and, consequently, to the patient. All living organisms, including resistant forms such as bacterial or fungal spores, are removed or destroyed during sophisticated sterilization, reducing the risk of healthcare-associated infections and disease spread. Sterilization techniques for single-use disposable medical devices are numerous. The following are the most frequently used sterilization techniques in the medical packaging industry

Autoclave or steam sterilization is accomplished by forcing saturated steam into a pressure chamber. This process requires the use of highly heat-resistant plastic. Ethylene oxide sterilization (EtO) is a  gaseous sterilization method utilizing EtO gas. Because EtO is a low-temperature sterilization method, it is compatible with most plastic materials. Radiation sterilization is the method of sterilization that can be used with either ionizing or non-ionizing radiation. Gamma or X-rays are used in ionizing radiation, whereas non-ionizing radiation uses a longer wavelength and lower energy. Gamma sterilization is the method of ionizing sterilization that involves exposing materials to gamma rays, most commonly Cobalt-60. Gamma irradiation is used to sterilize more than 40 percent of all single-use medical devices. Electron Beam (Ebeam) sterilization is the process of sterilizing the product using an electron beam to deliver a uniform radiation dose. Ebeam sterilization can be used on materials that can be gamma sterilized. Dry heat sterilization is a method of heat sterilization that requires a minimum of two hours at 160°C-170°C. Due to the prolonged exposure to heat, this method typically involves packaging made of specially engineered plastic with high heat tolerance. Plasma sterilization is the method where a product is exposed to plasma, an ionized gas with unique properties, where it undergoes a chemical reaction that sterilizes it. Typically, this method is used for applications that cannot withstand elevated temperatures.