Sterilization Validation of a Medical Device
Medical devices that must be sterilized before use, appropriate sterilization cycle parameters must be determined through a sterilization validation process. Medical device sterilization validations are one of the prime aspects of medical device testing as an improper sterilization method could lead to severe patient consequences or even patient death.
All products have unique designs, material compatibility, and packaging configurations, sterilization conditions that are sufficient and appropriate for one device may prove inadequate for another. Thus, it is necessary all sterilization processes must be validated based on the device. Choosing a method for sterilizing depends on the type of material from which it is made up, the number of potential microorganisms involved, the classification of the device, and the availability of each sterilization method.
(Related – What is Process Validation )
There are many different sterilization methods but the most commonly used are steam sterilization, heat sterilization, Irradiation sterilization and Ethylene Oxide Sterilization techniques.
Proper sterilization methods will destroy or remove all forms of microbes such as pyrogen, bacteria and other disease-causing microorganisms from Medical devices during the sterilization process.
The aim of sterilization validation involves inoculation of a device or product with bacterial spores prior to performing a sterilization cycle. The device or product is finally tested for sterility to determine whether the required Sterility Assurance Level (SAL) is achieved.