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Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden

Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization do...

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Autores principales: Marsit, Nagi, Dwejen, Samira, Saad, Ibrahim, Abdalla, Sedigh, Shaab, Arej, Salem, Salma, Khanfas, Enas, Hasan, Anas, Mansur, Mohamed, Abdul Sammad, Mohamed
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Netherlands 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221624/
https://www.ncbi.nlm.nih.gov/pubmed/24676699
http://dx.doi.org/10.1007/s10561-014-9433-1
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author Marsit, Nagi
Dwejen, Samira
Saad, Ibrahim
Abdalla, Sedigh
Shaab, Arej
Salem, Salma
Khanfas, Enas
Hasan, Anas
Mansur, Mohamed
Abdul Sammad, Mohamed
author_facet Marsit, Nagi
Dwejen, Samira
Saad, Ibrahim
Abdalla, Sedigh
Shaab, Arej
Salem, Salma
Khanfas, Enas
Hasan, Anas
Mansur, Mohamed
Abdul Sammad, Mohamed
author_sort Marsit, Nagi
collection PubMed
description Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10(−1), and sample item portion = 1, was carried out using Method VD(max)(25) of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products—radiation—part 2: establishing the sterilization dose, Method VDmax—substantiation of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid sterilization dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor’s type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %).
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spelling pubmed-42216242014-11-11 Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden Marsit, Nagi Dwejen, Samira Saad, Ibrahim Abdalla, Sedigh Shaab, Arej Salem, Salma Khanfas, Enas Hasan, Anas Mansur, Mohamed Abdul Sammad, Mohamed Cell Tissue Bank Original Paper Preparation of amniotic membrane (AM) by air drying method followed by radiation sterilization is simple and valuable approach; sterility and quality of the final AM product are depending on the quality management system at the tissue bank. Validation and substantiation of radiation sterilization dose (RSD) for tissue allografts is an essential step for the development and validation of the standard operating procedures (SOP). Application of SOP is perfectly relying on trained staff. Skills differences among personnel involved in AM preparation could have an effect on microbiological quality of the finished product and subsequently on the RSD required. AM were processed by four different couples of the tissue bank technicians. The AM grafts were randomly selected and subjected to bioburden test to validate and substantiate the 25 kGy RSD. Bioburden test for AM grafts were also useful to evaluate the skill of the tissue bank technicians and thus, to validate the current SOP for air dried AM. Moreover, the effect of placental source on bioburden counts on AM grafts was assessed. Substantiation of the 25 kGy RSD at a sterility assurance level of 10(−1), and sample item portion = 1, was carried out using Method VD(max)(25) of the International Organization for Standardization, document no. 11137-2 (ISO in Sterilization of healthcare products—radiation—part 2: establishing the sterilization dose, Method VDmax—substantiation of 25 kGy or 15 kGy as the sterilization dose, International Standard Organization, 2006). The results showed that there were no significant differences in the bioburdens of the four batches (α = 1 %), this means no significant differences in the skill of the four couples of the tissue bank technicians in terms of their ability to process AM according to the air dried AM SOP. The 25 kGy RSD was validated and substantiated as a valid sterilization dose for the AM prepared with the current established SOP at the Biotechnology Research Center experimental tissue bank. The donor’s type of delivery, normal or caesarean, showed no significant effect on the levels of microbial counts on the tested AMs (α = 1 %). Springer Netherlands 2014-03-28 2014 /pmc/articles/PMC4221624/ /pubmed/24676699 http://dx.doi.org/10.1007/s10561-014-9433-1 Text en © The Author(s) 2014 https://creativecommons.org/licenses/by/4.0/ Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.
spellingShingle Original Paper
Marsit, Nagi
Dwejen, Samira
Saad, Ibrahim
Abdalla, Sedigh
Shaab, Arej
Salem, Salma
Khanfas, Enas
Hasan, Anas
Mansur, Mohamed
Abdul Sammad, Mohamed
Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title_full Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title_fullStr Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title_full_unstemmed Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title_short Substantiation of 25 kGy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
title_sort substantiation of 25 kgy radiation sterilization dose for banked air dried amniotic membrane and evaluation of personnel skill in influencing finished product bioburden
topic Original Paper
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4221624/
https://www.ncbi.nlm.nih.gov/pubmed/24676699
http://dx.doi.org/10.1007/s10561-014-9433-1
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