Determination of gamma radiation sterilization dose on bioceramic BCP-Sr-Ag as bone graft according to ISO 11137 standards

Q2 Dentistry Journal of Conservative Dentistry Pub Date : 2023-08-03 DOI:10.20473/cdj.v13i1.2023.19-23

D. Wahjuningrum, S. Setyabudi, D. Darwis, Andi Syahrimayani

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Abstract

Background: BCP-Sr-Ag as a bone graft needs to be sterilized. One way of sterilization is to use gamma radiation. Sterilization by gamma radiation requires the correct sterilization dose. Based on ISO 11137 the determination of the sterilization dose through 3 steps: determination bioburden, determination of verification dose, and determination of sterilization dose. Purpose:Determination of gamma radiation sterilization dose on BCP-Sr-Ag bioceramic as bone graft based on ISO 11137 through determination bioburden, determination verification dose, and determination of sterilization dose. Method: A total 30 samples of 3 different batch BCP-Sr-Ag were determined for bioburden using TSA media. A total 100 samples of BCP-Sr-Ag were irradiated with a verification dose using cobalt-60 gamma source. The 100 samples then tested for sterilization using TSA media to determine the sterilization dose. Results: The average bioburden values of batches 1,2, and 3 were 56,8;61,8; and 60,5 CFU. The average value of the whole batch is 59,7 CFU. Based on ISO 11137, the verification dose is 7,4 kGy and the sterilization dose is 20,5 kGy. Conclusion: The average bioburden value of the entire batch was 59,7 CFU. The bioburden value used for verification dose determination is 64,22 CFU so the the gamma radiation sterilization dose is 20,5 kGy.

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根据ISO 11137标准测定BCP-Sr-Ag生物陶瓷骨移植材料的γ辐射灭菌剂量

背景:BCP-Sr-Ag作为骨移植物需要消毒。灭菌的一种方法是使用伽马射线。伽马辐射灭菌需要正确的灭菌剂量。根据ISO 11137，灭菌剂量的测定通过3个步骤:测定生物负荷、测定验证剂量、测定灭菌剂量。目的:根据ISO 11137标准，通过测定生物负荷、测定验证剂量和测定灭菌剂量，测定BCP-Sr-Ag生物陶瓷作为植骨材料的γ辐射灭菌剂量。方法:采用TSA培养基对3批BCP-Sr-Ag样品30份进行生物负荷测定。用钴-60 γ源对100个BCP-Sr-Ag样品进行了验证剂量的辐照。然后使用TSA培养基对100个样品进行灭菌测试，以确定灭菌剂量。结果:第1批、第2批和第3批的平均生物负荷值分别为56、8、61、8;60,5 CFU。整个批次的平均值为59,7 CFU。根据ISO 11137，验证剂量为7.4 kGy，灭菌剂量为20.5 kGy。结论:整批药材的平均生物负荷值为59,7 CFU。用于验证剂量测定的生物负荷值为64,22 CFU，因此伽马辐射灭菌剂量为20,5 kGy。

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来源期刊

Journal of Conservative Dentistry Dentistry-Dentistry (all)

CiteScore

2.10

自引率

0.00%

发文量

114

期刊介绍： The Journal of Conservative Dentistry (ISSN - 0972-0707) is the official journal of the Indian Association of Conservative Dentistry and Endodontics (IACDE). Our journal publishes scientific articles, case reports, short communications, invited reviews and comparative studies evaluating materials and methods in the fields of Conservative Dentistry, Dental Materials and Endodontics. J Conserv Dent has a diverse readership that includes full-time clinicians, full-time academicians, residents, students and scientists. Effective communication with this diverse readership requires careful attention to writing style.