E-Beam | X-Ray Sterilization

Keeping things clean, safe, and sterile is one of the most crucial parts of drug manufacturing.

MediZap’s Electron-Beam processing, or electron irradiation, is the most advanced sterilization technology on the market. This technique uses beta radiation - a form of high energy electrons - to penetrate and disrupt microorganism’s RNA/DNA chains (their genetic material and means of survival). Electron Beam | X-Ray provides the highest level of sterility assurance at 10⁻⁶. When these chains are disrupted, it means that the microorganism can no longer survive, and eliminates any risk of their contamination.

The X-Ray irradiation process utilizes photon radiation for terminal sterilization of drug products. X-Ray irradiation is safe, reliable and highly effective at treating a wide variety of drug products with varying densities. The combination of shorter exposure time and improved Dose Uniformity Ratios (DUR) make X-Ray irradiation a viable processing option for a variety of drug products. Similar to electron beam, X- Ray processing is powered by electricity.

Sterility testing quarantine is not required after processing using established and recognized dosimetric release procedures. MediZap is unique by fast-tracking your turnaround time from Gamma's standard 5 - 8 business days to only 2 business days with MediZap Electron Beam | X-Ray processing. The FDA recognizes ISO guidelines for sterilization process validation. E-Beam | X-Ray terminal sterilization is the future of compounded pharmaceutical sterility assurance.

Examples of the types of drug product primary packaging to be processed by E-Beam irradiation include: blister packs, small volume vials (2ml-10ml), prefilled syringes, and ophthalmic droppers.

Type of drug product primary packaging to be processed by X-Ray irradiation include: bulk drug raw materials, mini IV bags, and large volume vials (30ml+).

E-Beam | X-Ray sterilization provides various advantages, including convenience, efficiency, and 10⁻⁶ sterility assurance. Not only does E-Beam | X-Ray benefit over other methods, but this form of sterilization also offers the lowest minimum run quantities and the least potential deleterious effects of any sterilization methodology in the industry.

Learn more about our E-Beam | X-Ray sterilization services today.