The Top 10 Facts About E-beam Sterilization of DEA-regulated Substances

The top 10 facts about e-beam sterilization of DEA regulated substances at E-BEAM Services, Inc.

  • E-BEAM Services is licensed by the DEA and the Ohio Board of Pharmacy to process class III non-narcotic drugs.
  • E-BEAM Services sterilizes in accordance with International Standards (ISO9001-2008, ISO13485, ISO11137) for the operation of our equipment, dosimetry systems, and product qualification.
  • Class III drugs are defined as drugs with a moderate to low potential for physical and psychological dependence (such as testosterone).
  • For E-BEAM Services to sterilize your controlled substance, you also will need to be licensed by the DEA and the Ohio Board of Pharmacy.
  • Our Ohio facility has two separate e-beam accelerators, which provide built-in backup capacity.
  • E-beam sterilization has a higher dose rate than gamma, meaning a faster processing time and less degradation to the products.
  • We can process the products in their final packaging, which means a time savings for us and a cost savings for you!
  • If your product has never been validated for sterilization before, we will validate it by performing a material test, dose map, and dose audit.
  • We have the ability to process and ship your products within the same day.
  • We have a DEA-approved secured storage room on site, and when removed from the room, your controlled substances are monitored by at least two E-BEAM personnel at all times.

Still have questions or want to start the validation process? Give us a call at 513-933-0031!