E-Beam Monitoring Devices/Supplies
E-Beam vs. Gamma Sterilization
May 23, 2013 2:39 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | Nutek Corp. | Articles | CommentsMany of the sterilization issues concerning gamma and electron beam radiation are the same. This point is supported by the fact that both technologies are governed by the same ISO standards when applied to medical device sterilization—ISO 11137 and ISO 13409. Both technologies have been proven effective at sterilization and are accepted worldwide.
LISTED UNDER: E-Beam Equipment | E-Beam Monitoring Devices/Supplies | Gamma Equipment
Changing from Gamma to E-Beam
May 21, 2013 2:38 pm | by Larry Nichols, COO, and Bob Starrett, CTO, NUTEK Corporation | Nutek Corp. | Blogs | CommentsOrdinarily, changing from a validated gamma sterilization process to E-beam sterilization requires running a dose mapping study and doing a dose verification study similar to a routine quarterly dose audit. The standard radiation validation requirements of ISO 11137 require that data be “available to show that, using the same sterilization dose, microbial inactivation is not affected by differences...
LISTED UNDER: E-Beam Equipment | E-Beam Monitoring Devices/Supplies | Gamma Equipment
