Abstract
There is a growing demand in Turkey for human tissue to use in surgery and wound healing. However, our country does not have facilities for local production of tissue grafts and generally depends on imported products. Under a multi-year project initiated in 1997, the International Atomic Energy Agency has provided main equipment for tissue processing and experts on Tissue Banking as well as training on tissue processing methods.
In this presentation, information on various stages of the project implementation is given. Details of lay out for the process laboratories and equipment are given. Donor selection and testing criteria, processing procedures for bone and amnion, setting up product design, implementation of quality system and radiation sterilisation are described briefly. Quality procedures included preparation of quality manual, record forms, document control, non-conformance and corrective actions, training records, equipment maintenance and calibration are all in line with GMP/GLP Standards. Clinical applications of tissue grafts and medico-legal position of organ and tissue donation in Turkey are also discussed briefly.
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References
Phillips GO, Multi-Media Distance Learning Package on Tissue Banking, Module 0: Historical Background
Sterilization of Medical Devices-Microbiological Methods-Part 1: Estimation of Microorganisms on Products, ISO 11737-1
Sterilization of Health Care Products-Radiation Sterilisation-Substantiation of 25 kGy as a Sterilisation Dose for Small or Infrequent Production Batches, AAMI/ISO TIR No. 13409
Sterilization of Medical Devices-Validation and Routine Control of Sterilization by Irradiation, TS-EN 552, ICS-11.080 (Turkish)
Guide of GMP for the Production of Sterile Products and their Control by the Ministry of Health, 1986.
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Yilmaz Erkol, A., Haznedaroglu, H., Özkara, T. et al. Initiation of Bone and Amnion Banking in Turkey. Cell Tissue Banking 4, 169–172 (2003). https://doi.org/10.1023/B:CATB.0000007019.77379.64
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DOI: https://doi.org/10.1023/B:CATB.0000007019.77379.64