As a medical device manufacturer, understanding the best method of sterilization for the finished product can be a difficult consideration. By working with a top medical device sterilization process company with experience in medical equipment, it will be easier to review your options and choose the most effective process.
When trying to determine the correct method for medical device sterilization, it will be important to know the following issues about the device. With this information, the company can work with you to evaluate the methods and choose the most cost-effective and best match for your needs.
Materials in the Device
One of the critical and limiting factors in any medical device sterilization will be the type of material used in the device. For example, if the device contains electronic components or even some types of plastics or resins, high heat, pressure, and moisture should not be used as a sterilization method.
Other methods that use gas, such as EO (ethylene oxide), gamma or electron beam sterilization will be more effective and eliminate the concern of the medical device sterilization damaging the device.
Packaged or Unpackaged
It may be essential to have some medical devices sterilized while in their packaging. Other devices may be sterilized and then packaged, which will also require different methods and options.
Validation and Testing Requirements
Not all facilities are designed to meet all global requirements for medical device sterilization. There are other facilities that are designed to meet or exceed regulatory standards that are accepted globally or within the specific countries where your products are marketed and sold.
Another consideration that is more logistics based than process based is the location of the facility in relation to your manufacturing and distribution services. It is possible to find a company that matches your needs, but you will need to have a clear understanding of standards and requirements before you start your search.