Badan Pengawas Obat dan Makanan Republik Indonesia ...

Aneks 9 – Pembuatan Radiofarmakaterpapar hendaklah lebih rendahdibandingkan dengan area sekitar.Namun demikian, perlu diperhatikanjuga perlindungan produk darikontaminasi lingkungan.30. Radionuklida yang mudah menguapseperti Iodium-131 hendaklahditempatkan dalam lemari asam.Generator radionuklida, sepertigeneratorTeknesium-99mperteknetat, hendaklah ditempatkandalam ruangan yang higienis danterkendali di mana risiko pelepasankontaminasi radioaktif di udararendah.31. Dispensing radiofarmaka untuk dosispasien individual hendaklah dilakukanpada kondisi berisiko mikrobiologirendah, dengan penekanan padakeselamatan radiasi pada saatpengambilan dosis, penerimaanradiofarmaka, pemantauan latar danlain-lain. Perisai, alat ukurradioaktivitas dan lain-lain hendaklahtersedia selama dispensing tersebut.32. Rekonstitusi kit umumnya dilakukandalam prosedur langkah tunggal(single step closed procedure).Tempat kerja yang terkungkungdiperlukan bila pendidihan, pemanasanatau reaksi kimia dilakukan dalamrekonstitusi kit.33. Pusat laboratorium/ pelayanandispensing hendaklah memiliki ruangaseptis (isolator) untuk melakukanelusi generator, rekonstitusi kit dandispensing radiofarmaka; ruangpengukuran radioaktivitas setelahdispensing untuk kegunaan internalatau eksternal (untuk rumah sakitlain); ruang untuk menyimpan bahanradioaktif dan lain-lain.34. Preparasi radiofarmaka yang berasaldari pasien, seperti penandaanradioaktif sel darah, hendaklahdilakukan di dalam ruang aseptisyang terkungkung dan dilengkapidengan filter HEPA. Peralatan yangdigunakan, area kerja dan prosedurAnnex 9 – Manufacture ofRadiopharmaceuticalsbe lower where products are exposedthan in surrounding areas. However, it isstill necessary to protect the productfrom environmental contamination.30. Volatile radionuclides such as Iodine-131 should be placed in fumecupboards. Radionuclide generators,such as Technetium-99m pertechnetategenerator, should be placed in a goodand hygienic room where the risk ofrelease of airborne radioactivecontamination is low.31. Dispensing of radiopharmaceuticals forindividual patient doses should be donein a low risk of microbiologicalconditions, with radiation safety beingemphasized when drawing the doses,receipt of radiopharmaceuticals,background monitoring, etc. Shielding,radioactivity meters etc should be madeavailable during dispensing.32. Reconstitution of kits is normally carriedout in a single step closed procedure. Acontained workstation is needed ifboiling, heating or chemical reaction isinvolved in the kit reconstitution.33. The centralized dispensing laboratoryshould have an aseptic room to handleelution of generators, reconstitution ofkits and dispensing ofradiopharmaceuticals; a room formeasurement of radioactivity dispensedfor internal or external (other hospital)use; a room for storage of radioactivematerials, etc.34. Preparation of radiopharmaceuticals ofpatient origin, such as radiolabelling ofblood cells, should be done in containedworkstations equipped with HEPA filters.The equipment used, the working areaand the operating procedures usedshould ensure safety, hygiene andEdisi 2009 - 55 - 2009 Edition