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Validation and Substantiation of 25 kGy as Sterilization Dose for Lyophilized Human Amnion Membrane

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Abstract

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.

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Abbreviations

PMMA:

PolyMethy MethAcrylate

ISO:

International Standard Organisation

SAL:

Sterility Assurance Level

SIP:

Sample item portion

CFU:

Colony Forming Units

API:

Analytical Profile Index

I:

Intercept

S:

Slope

CV:

Coefficient of Variation

SD:

Standard Deviation

References

  • Djefal A, Mahlous M, Nacer Khodja A, Larbi Daho Bachir M (1997) Freeze dried radiosterilized human amniotic membrane in the treatment of burn wound. Alg Rev Nuc Sci 1(1):45–48

    Google Scholar 

  • Hilmy N, Febrida A, Basil A (2000) Validation of radiation sterilisation dose for lyophilized amnion and bone grafts. Cell Tissue Bank 1:143–148

    Article  PubMed  CAS  Google Scholar 

  • Jefferson S, Crawford CG (1967) Development of industrial sterilization of medical products. Proceedings of the symposium on radiosterilization of medical products held by the international atomic energy agency, Budapest, pp 361–365

  • Judlin P, Lejeune V, Quentin R, Abdelmoumene N, Aujard Y, Fréte F, Giglio V, Kacet N, Ledare D, Lucas couturier L, Minguet C, Poulain P, Wollner A (2001) Prévention anténatale du risque infectieux bactérien néonatal précoce. Agence nationale d’accréditation et d’évaluation en santé. Service des recommandations et références professionnelles, France, 38 pp

  • IAEA (2001) Code of practice for the radiation sterilisation of tissue Allograft Requirements for validation and routine control. The IAEA IN /6/052 programme in radiation and tissue Banking

  • ISO 11137 (1995) Sterilization of health care products – Requirement for validation and routine control – Radiation sterilisation. International Standard Organisation, Geneva

    Google Scholar 

  • ISO 11737-1 (1995) Sterilisation of medical devices – Microbiological methods – Estimation of population of microorganisms on products. International Standard Organisation, Geneva

    Google Scholar 

  • ISO/TS 13409 (2002) Sterilization of health care products – Radiation sterilisation – Substantiation of 25 kGy as a sterilization dose for small or infrequent production batches. International Standard Organisation, Geneva

    Google Scholar 

  • Mesli MF, Mokhtari A (2002) Biostatiatique description et analyse des données en médecine et en biologie, 1er édn. Les éditions universitaires le Fennec, Oran, 77 pp

    Google Scholar 

  • Mitiche D, Larbi Dahou BM, Bouatou F, Abchiche MO, Djefal A, Mahlous M (1999) Utilisation des membranes amniotiques chez les brûles – A propos de 25 cas. Annals Burns Fire Disasters XII(1):23–24

    Google Scholar 

  • Tabei M, Sekiguchi M (1995) Evaluation of sterilisation dose for disposable hypodermic needles manufactured under ultra cleaned condition. Radiat Phys Chem 46(4–6):629–632

    Article  CAS  Google Scholar 

  • Zimek Z, Kaluska I (2002) Sterilization dose auditing for various types of medical products. Radiat Phys Chem 63:673–674

    Article  CAS  Google Scholar 

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Acknowledgements

We would like to thank staff of maternity department of the University Hospital Center of Algiers.

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Authors and Affiliations

  1. Radiobiology, Centre de Recherche Nucleaire d’Alger, 2 bd, Frantz Fanon, BP 399, Alger-gare, Alger, 16000, Algeria

    A. Djefal, D. Tahtat, A. Nacer Khodja, S. Saad Bouzid & N. Remane

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  1. A. Djefal
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  2. D. Tahtat
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  3. A. Nacer Khodja
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  4. S. Saad Bouzid
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  5. N. Remane
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Correspondence to A. Djefal.

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Djefal, A., Tahtat, D., Nacer Khodja, A. et al. Validation and Substantiation of 25 kGy as Sterilization Dose for Lyophilized Human Amnion Membrane. Cell Tissue Banking 8, 9–12 (2007). https://doi.org/10.1007/s10561-006-9016-x

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  • DOI: https://doi.org/10.1007/s10561-006-9016-x

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