Gamma Radiation is a penetrating sterilant. No area of the product, its components, or packaging is left with uncertain sterility after treatment. Even high-density products, such as pre-filled syringes, can be readily processed and used with confidence. Gamma Radiation kills microorganisms by attacking the DNA molecule. Both direct and indirect mechanisms are used in the disrupting of the DNA bond, which results in the prevention of cellular division and, consequently, the propagation of life. Gamma processing is a highly reliable procedure, due primarily to how simple it is. Also, Packaging remains intact with Gamma processing, which can increase cost savings; since there is no requirement for pressure or vacuum, seals are not stressed. In addition, Gamma Radiation eliminates the need for permeable packaging materials.
- Precise dosing
- Uniform dose distribution
- Rapid processing
- Immediate availability of product after processing
- No Residuals, No Radioactivity (Gamma rays, emitted from Cobalt-60, are pure energy, similar in many ways to microwave sand X-rays.)
- Cost effective (Elimination of sterility tests associated with BIs, due to FDA's acceptance of dosimetric release)
Gamma irradiation also provides a number of benefits in both cost and sterility assurance. It can be applied under safe, well-defined, and controlled operating parameters, and is not a heat- or moisturegenerating process. Consequently, there is no heat stress and condensate drainage or outgassing required. Most importantly, there is no residual radioactivity after irradiation. They also have a different lethality mode. A third difference is that the gamma dosage can be measured in each batch using detectors called dosimeters, which enable parametric release.
They both work, it really just depends on which process you favor the most.
"Physics is really nothing more than a search for ultimate simplicity, but so far all we have is a kind of elegant messiness" - Bill Bryson