Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
1883170 | Radiation Physics and Chemistry | 2009 | 4 Pages |
Abstract
The sterilization dose for 106 batches of processed human skin was determined on the basis of the Code of Practice for the Radiation Sterilization of Tissue Allografts: Requirements for Validation and Routine Control (2004) and ISO 11137-2 (2006). They ranged from 17.6 to 33.4Â kGy for bioburdens of >10-162.700Â CFU/100Â cm2. The presence of Gram negative bacteria was checked for each produced batch. From the analysis of the experimental results, it was observed that the bioburden range was very wide and consequently the estimated sterilization doses too. If this is the case, the determination of a tissue-specific dose per production batch is necessary to achieve a specified requirement of SAL. Otherwise if the dose of 25Â kGy is preselected, a standardized method for substantiation of this dose should be done to confirm the radiation sterilization process.
Related Topics
Physical Sciences and Engineering
Physics and Astronomy
Radiation
Authors
E. Kairiyama, C. Horak, M. Spinosa, J. Pachado, O. Schwint,