The next USP chapter in this series, <1229.10>, discusses radiation sterilization. This process “utilizes the lethal effect of various forms of radiation as a means of microbial destruction.” There are two primary types of radiation: ionizing (gamma, x-ray or beam) and nonionizing (microwave, infrared, x-ray, ultraviolet light).
Because of how radiation works, there is potential for a substantial effect on any materials exposed to this cycle. Advantages of using radiation, according to USP, “include simplicity, absence of mechanical complexity, reproducability, and overall efficiency.” The radiation dose is measured in kGy (kilogray), which has a direct correlation to the lethal effect on the microorganisms.
This chapter also delves into the following:
- Gamma sterilization
- X-ray sterilization
- E-beam sterilization
- Validation of radiation sterilization
- Dose setting
- Material compatibility
- Dose verification
- Validation activities
- Routine process control
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