Summary

Device manufacturers originally moved away from in-house sterilization because they wanted to avoid the potential liabilities associated with handling radioactive isotopes and deadly chemicals. No similar risks exist with electron beam; and, as reliability and integrity issues are properly addressed by high quality electron beam system suppliers, look for electron beam sterilization to move back into the production lines.

Supply management goals utilizing in-line sterilization can provide ample justification for the system capital expenditures when the total processing costs are considered. The higher the product value, the easier the task of moving to electron beam as just-in-time manufacturing objectives are set.

The reliability of the high energy components has stabilized and matured thanks to the success of the oncology therapy systems with their production needs of several hundred systems per year. Just as the oncology therapy market has successfully switched from isotopes to electrons, medical device manufacturing is likely to follow for the same reasons.