Ionizing radiation is the second most prevalent method in the industrial sterilization market, accounting for nearly 45%. While E-Beam and Gamma have been the traditional choices, X-Ray is a more recent addition.
Similarities
All three technologies ensure sterility and adhere to the ISO 11137 standard. The same dosimetry system can be utilized, and practically, 25 kGy delivered by an Electron Beam accelerator or an X-Ray machine is equivalent to 25 kGy delivered by Gamma radiation.
Differences
E-Beam Radiation: This method involves machine-generated high-energy electrons. Due to the mass of electrons, penetration is limited by energy. This makes E-Beam technology highly effective for low- to medium-density products and more suitable for box processing rather than whole pallets.
Additionally, E-Beam is ideal for sensitive products as the dose can be delivered much faster than Gamma or X-Ray, in seconds or minutes rather than hours. Consequently, the detrimental effects are minimized as the reaction time is significantly shorter.
Industrial X-Rays: These are produced using an Electron Beam accelerator coupled with a metal target. When electrons strike the metal target, X-Rays are generated. X-Rays consist of photons (with different energies than gamma), making them suitable for medium to high-density drug products.
Gamma Radiation: This method involves photons generated by the decay of a radioactive nucleus (cobalt-60), with the dose rate governed by the decay. Photons, having no mass, can penetrate deeper into matter, but their energy spectrum cannot be altered. Thus, medium to high-density products are ideal for Gamma processing.
The dose rate for X-Ray and E-Beam is higher than Gamma since they are machine-powered, but X-Ray is slower compared to E-Beam. For instance, delivering the standard sterilization dose of 25 kGy takes about 2.5 hours or more with Gamma radiation, less than an hour to multiple hours with X-Rays, and seconds to minutes with E-Beam technology.
The duration of irradiation and temperature changes during sterilization make E-Beam and X-Ray the optimal choices to minimize deleterious effects on drug products.
MediZap offers both E-Beam, preferred for mostly all drug applications and X-Ray if the penetration requires this specific technology application.