Bioburden Estimation in Relation to Tissue Product Quality and Radiation Dose Validation

Yusof, Norimah; Shamsudin, Abdul Rani; Mohamad, Hasim; Hassan, Asnah; Yong, Ang Cheng; Rahman, Muhamad Nor Firdaus A

doi:10.1533/9781845690779.5.319

Cited by 7 publications

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“…In tissue banking, the RSD of 25 kGy has been recommended to terminally sterilise tissue allografts. However, the average bioburden of allograft products varies from less than 0.1 (2) up to more than a thousand (3,4). In addition, the species of contaminated organisms may also differ (5)(6)(7)(8)(9)(10).…”

Section: -Sterilisation Of Health Care Products-radiation Partmentioning

confidence: 99%

Validation of 11 kGy as a Radiation Sterilization Dose for Frozen Bone Allografts

Nguyen

Morgan

Forwood

2011

The Journal of Arthroplasty

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A radiation sterilization dose (RSD) of 25 kGy is deleterious to bone allografts. This study aimed to establish a lower RSD for bone allografts using method 1 of International Standard Organisation 11137.2:2006. This provides a database to select an RSD corresponding to an allograft's bioburden, given that the bioburden's gamma resistance is equal to or less than the standard. This can be verified by irradiating 100 allografts at a dose selected to provide a sterility assurance level of 10(-2). The bioburden of our allografts was 0, which prescribed a verification dose of 1.3 kGy. After irradiating 100 allografts, sterility tests returned no positive cultures. We therefore validated an RSD of 11 kGy for allografts with that bioburden. According to the standard, this RSD provides a sterility assurance level of 10(-6) for bone allografts.

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Section: -Sterilisation Of Health Care Products-radiation Partmentioning

confidence: 99%

Validation of 11 kGy as a Radiation Sterilization Dose for Frozen Bone Allografts

Nguyen

Morgan

Forwood

2011

The Journal of Arthroplasty

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Terminal sterilization: Conventional methods versus emerging cold atmospheric pressure plasma technology for non‐viable biological tissues

Marsit

Sidney

Branch

et al. 2016

Plasma Processes & Polymers

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Tissue products are susceptible to microbial contamination from different sources, which may cause disease transmission upon transplantation. Terminal sterilization using gamma radiation, electron‐beam, and ethylene oxide protocols are well‐established and accepted, however, such methods have known disadvantages associated with compromised tissue integrity, functionality, safety, complex logistics, availability, and cost. Non‐thermal (cold) atmospheric pressure plasma (CAP) is an emerging technology that has several biomedical applications including sterilization of tissues, and the potential to surpass current terminal sterilization techniques. This review discusses the limitations of conventional terminal sterilization technologies for biological materials, and highlights the benefits of utilizing CAP.

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Advances of radiation sterilisation in tissue banking

Yusof

2017

Cell Tissue Bank

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Under the auspices of the IAEA tissue banking programme on "Radiation Sterilisation of Tissue Graft" conducted from 1985 to 2004, many scientists and surgeons were involved in various regional research and development (R&D) projects mainly in dealing with radiation dose selection, radiation effects on human tissues and quality system in radiation sterilisation. New findings on radiation effects, tissue processing and preservation were shared during the regional and interregional meetings and workshops. Many tissue banks started to use radiation (25 kGy) to sterilize tissue grafts for tissue safety and efficacy and still continue to use it. The IAEA Code of Practice for Radiation Sterilization of Tissues Allografts developed in 2007 offered simpler methods to conduct radiation dose setting and dose validation experiments for tissue grafts. Advances in dose selection and dose mapping are continued under the quality management system when banks need to be certified to continue their operation. The combination of good tissue processing and preservation as well as good radiation practice will ensure the tissue products are properly sterilised thus safe and of high quality. Experience in meeting challenges in using radiation sterilisation and achievements reported by the tissue bankers are shared here.

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Bioburden Estimation in Relation to Tissue Product Quality and Radiation Dose Validation

Cited by 7 publications

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Validation of 11 kGy as a Radiation Sterilization Dose for Frozen Bone Allografts

Validation of 11 kGy as a Radiation Sterilization Dose for Frozen Bone Allografts

Terminal sterilization: Conventional methods versus emerging cold atmospheric pressure plasma technology for non‐viable biological tissues

Advances of radiation sterilisation in tissue banking

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