Affiliation:
1. Department of Periodontics, Faculty of Dentistry, Universitas Padjadjaran, Bandung, Indonesia
2. Research Center for Radiation Process Technology—National Research and Innovation Agency (NRIA), Indonesia
Abstract
Abstract
Objective Membrane sterility is very necessary considering its function as an implant material. Therefore, this research aims to determine the dose of gamma-ray irradiation for the sterilization of polyvinyl alcohol (PVA)–collagen–chitosan composite membranes used as regenerative surgery materials.
Materials and Methods A total of 100 pieces of the composite membranes were prepared in a size of 2.0 × 1.5 cm by mixing 7.5% PVA, 3% collagen, and 2% chitosan using the film casting method in three batches. Furthermore, the bioburden test was performed to determine the initial microbial count in the sample by following ISO 11737-1. The results were used to ascertain the dose of gamma-ray irradiation on the sample according to ISO 11137-2. The dose verification test was then performed at the sterility assurance level 10−6.
Results The average result of the bioburden test from three batches was 6.6 colony forming unit; hence, the verification dose was 4.8 kGy. In the verification dose test, since there was only one contaminated sample, the sterility dose test was continued.
Conclusion The sterile gamma-ray irradiation dose for PVA–collagen–chitosan composite membrane was 17.1 kGy.