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Journal : The Journal of Pure and Applied Chemistry Research

Effect of Radioactivity of Technetium-99m on the Autosterilization Process of non-sterile Tetrofosmin Kits

The Journal of Pure and Applied Chemistry Research Vol 6, No 1 (2017): Edition of January - April 2017
Publisher : Chemistry Department, The University of Brawijaya

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Abstract

Technetium-99m labeled radiopharmaceutical is commonly used in nuclear medicines as a diagnostic agent, by mixing the sterile kit with Tc-99m. Manufacturing of kits requires an aseptic facility which need to be well designed and maintained according to cGMP, since mostly kits can not be terminally sterilized. Radiopharmaceuticals as pharmaceuticals  containing radionuclide is assumed to have an autosterilization property, but correlation between radioactivity and capability of killing microorganisms has to be studied so far.  The aim of this study is to investigate the effect of radioactivity on the autosterilization process of radiopharmaceuticals.  The study was carried out by adding Tc-99m of various radioactivity into non-sterile tetrofosmin kits, then the samples were tested for sterility. Sterile tetrofosmin kit and non-sterile kit with no Tc-99m added will be used as a negative control and positive control respectively. The sterility was tested using standard direct inoculation method, by inoculating samples in culture media for both bacteria and fungi and observing qualitatively within 14 days. The results showed that the samples with radioactivity of 1, 3 and 5 mCi changed the clarity of the media to turbid,  conformed with the performance of positive controls but samples with radioactivity of 10 mCi and 20 mCi did not change the clarity of the media, conformed with the performance of negative control, indicating neither growth of bacteria nor fungi.  It is concluded that Tc-99m behaves as an autosterilizing agent at certain radioactivity. Therefore the preparation of Tc-99m radiopharmaceutical can be considered as terminal sterilization rather than aseptic preparation.

Co-Authors ABDUL GAFUR Adang Hardi Gunawan Afif, Muhammad Nur Agung Cahyono Agung Putra Wijaya, Agung Putra Agus Sugiarto Andini, Yuri Tri Aprilina, Ulfah Arnelis Djalil Asih Purnami Widiastuti Asri, Peggy Nurida Bidari, Masgusti Dinda Caswita Caswita Cecep Taufik Rustendi Dharma Himawan, Muhammad Agung Dian Mulawarmanti, Dian Diba, Shofura Farah Dwi Kurniawati, Dwi Dwi Laila Sulistiowati, Dwi Laila Elin Erlina Sasanti Eni Indriani Eni Kartika, Eni Enny Lestari Eva Meizara Puspita Dewi, Eva Meizara Fajarin, Rindang Febby Eka Putri Febrian Budi Pratama FELLY YULIAN FF, FELLY Fitri Rahmawati Fitriyani ZS, Syawalia Florensia Evindonta Bangun, Florensia Evindonta Gita Novian Hermana Gunawan, A. H. Guslihan Dasa Tjipta, Guslihan Dasa Hamzah Afandi Hanafiah A. Haninda Bharata Hariyati Purwaningsih Hasaruddin Hafid, Hasaruddin Indah Damayanti, Indah Iswanti, Nina Iwan Nurwantoro, Iwan Jayadinata, Asep Kurnia Juhamzah, Sulfiani Karim, Nina Karina Katibi, Ahmad Yakub Khairi, Husain Kholid, Rifki Rachman Kusuma, Ariya Eka Laksmi A. Lenap, Indria Puspitasari Lucia Maria Santoso, Lucia Maria M Coesamin M. Coesamin Mahfudho, Zahidatun Maskuroch Adesty Muhammad Safrudin Yafie Muhammad Yusuf Mulia, Septi Dianna Bunga Mustika, Lia Nanda, Evi Tirto Nasrun Nasrun Ningrum, Nia Widya Novianti, Elvita Lia Nurhanurawati Nurhanurawati Nurlaili Nurlaili Nurul Rohmah Nurvita Nurvita Nur’ainingsih, Dyah Parindra Kusriantoko Pentatito Gunowibowo Pratiwi, Ganjar Febriyani Pratiwi, Rafi Puji Rahayu Purnama Dewi Putri, Apriliani Qorri Ayuni Rani, wayan Widya Regina Lichteria Panjaitan, Regina Lichteria ria septiana Ridfah, Ahmad Ridfah, Ahmad Rini Asnawati Rini Rita T Marpaung Riyanto Riyanto Rizal Ramadhan Rizki Agustianto Robith Hudaya ROCHMAN R, ROCHMAN Rosalia Deviana Cahyaningrum Rusdi Setiono Sangaji, Darma Sapitri, Nonik Mega Sarlina Sarlina, Sarlina Silvana, Silvana Siti Laelatul Chasanah, Siti Laelatul Slamet Suprayogi Soraya, Rahayu Sri Hastuti Noer Sri Hastuti Noer Sri Setiyowati Sri Setyowati Sriyono Sriyono Sugeng Sutiarso Sukmawati, Fitriani Supriatmo Supriatmo, Supriatmo Syakir Mahid Tina Yunarti Titi Murniati Utami, Fithrina Yudha Utari Rezki Veronika Yulianti Wayan Rumite Wijayanti, Chusna Yuliana Yuliana Yulisa Yulisa Yuniarti, Tina Yunilda Yunilda YUSLI MARIADI Zuma Herdiyanti