Validation and Substantiation of 25 kGy as Sterilization Dose for Lyophilized Human Amnion Membrane
| Autor: | N. Remane, A. Djefal, Djamel Tahtat, S. Saad Bouzid, A. Nacer Khodja |
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| Rok vydání: | 2006 |
| Předmět: |
medicine.medical_specialty
Biomedical Engineering Biology Biomaterials Bioburden Freeze-drying Pregnancy Fetal membrane medicine Humans Sterility test Amnion Transplantation Chromatography Bacteria Sterilization Dose-Response Relationship Radiation Cell Biology Sterilization (microbiology) Surgery Freeze Drying Membrane medicine.anatomical_structure Gamma Rays embryonic structures Female Gamma irradiation |
| Zdroj: | Cell and Tissue Banking. 8:9-12 |
| ISSN: | 1573-6814 1389-9333 |
| Popis: | The validation and substantiation of sterilization dose for lyophilized human amnion membrane by gamma irradiation delivered by Co60 source were investigated. The validation experiments were conducted according to ISO 13409 method B. A total of 120 human amnion membranes were collected. Of these, 10 membranes were used for estimation of bioburden and 20 membranes were used for the individual sterility test at verification dose. The average bioburden per product unit with sample item portion (SIP = 1) for lyophilized human amnion membrane was 572 cfu. The verification dose experiments were done at dose of 8.1 kGy and the results of sterility tests showed that human amnion membrane got one positive. Consequently, the sterilization dose of 25 kGy was confirmed and substantiated. |
| Databáze: | OpenAIRE |
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