How are Medical Devices Sterilized?
When it comes to the sterilization of medical devices, electron beam irradiation is a widely used, successful sterilizing modality that has been used for decades to service the medical industry. The most common use of electron beam irradiation in this market is for single-use disposable medical devices. Its safe, effective, and efficient technology offers many advantages over other alternative sterilization modalities such as gamma irradiation and ethylene oxide gas, including less material degradation. Essentially, the high energy electrons inactivate any microorganisms within the packaging, rendering the product sterile.
In recent years, various difficulties and inefficiencies with these gamma irradiation and ethylene oxide gas methods have propelled the use of electron beam sterilization, making it one of the fastest growing sterilization techniques in the medical device industry today.
What Medical Products Can Undergo E-Beam Sterilization?
With fast turn-around times, electron beam irradiation is exceptionally convenient for sterilizing medical devices. The products can be exposed to the beam even after final packaging due to the high energy electrons having the ability to penetrate the package—this allows the package to remain intact and doesn’t need to be opened or otherwise distrubed. Further, electron beam technology does not employ any harmful chemicals or radioactive materials. This elimination of unnecessary waste is why many people choose e-beam sterilization for its environmentally friendly nature.
While low- to medium-density disposable medical devices and pharmaceuticals are great candidates for sterilization by electron beam irradiation, if the packaging is engineered correctly, high density materials will also find success in using electron beam technology. Common applicators and devices that are easily processed through e-beam sterilization include:
- Spinal Implants
- Drug Delivery Patches
- Hip & Knee Implants
- Blood Collection Kits
- Drug containers
- Pipette tips
Experienced Medical Device Sterilization Professionals
With a registered quality system, material compatibility testing, and dose selection assistance, Iotron Industries offers top-of-the-line quality professionals for all cases of medical device sterility assurance.
We contacted Iotron as an option for sterilizing our start-up company’s new medical device. Their electron beam technology was the right fit for our style of product. They were very helpful and informative in walking us through the technology, process steps for validation, and assisting us with the 3rd party accredited testing laboratory for certification. They made it easy and were the best economic option for us. I highly recommend giving Iotron the opportunity to serve your business needs. It’s always great to work with nice people! – Greg Ottinger
For more information on how Iotron Industries can assist with your medical sterilization needs, request a quote from our team and we’ll get back to you with more information.