Media Fill Test for validation of non-radioactive kit for radiopharmaceutical preparations

Introduction: The administration of improperly prepared intravenous fluids might determine healthcare-associated infections. Quality and sterility assurance in radiopharmaceutical manufacturing products must be evaluated by media fill tests that simulate the performance of the aseptic manufacturing procedure. The aim of this study is to show a methodological modification of a specific step of media fill tests, giving an overview of economic and organizational advantages that it might bring. Materials And Methods: Media fill tests were conducted to ensure that they reproduce as strictly as possible the routine aseptic production process with all the critical steps described in the internal Standard Operating Procedures. We introduced an innovative modification in the step 1: instead of using a completely decayed 99Mo/99mTc generator, we used 99Mo/99mTc generator just before its disposal and eluting it with saline solution aspirated in an empty vacuum vial. Results: A total of 47 production runs were performed, and a total of 799 vials were tested for sterility. Thirteen nuclear medicine technicians were assessed. We found contamination in 1% of the total number of vials analyzed). Conclusions: The modification proposed shows several advantages: reduction of the costs of the media fill tests, the possibility to manage these without referring to external services, and decreased injuries for technicians who perform the tests.

Deteksi Karakteristik Peluruhan Radionuklida Medis 99Mo Untuk Memperoleh 99mTc Menggunakan Spektrometer Gamma dengan Sumber Standar Cair Campuran 133Ba dan 152Eu

Technetium-99m (99mTc) is a subsidiary of metastable 99Mo with a half-life of 6 hours. The relatively short half-life, causing 99mTc widely used for diagnostic purposes in nuclear medicine, especially in bone scanning for a faster decay. This research aims to determine the optimal time to product formation of 99mTc until elution profiles have detected 99Mo energy. The instrument used is the 99Mo/99mTc generator with standard sources 133Ba and 152Eu liquid mixture. The results obtained showed that 99mTc radioisotope production is still good until the third day elution 99Mo, whereas in the fourth to ninth day 99Mo energy detected on the decline, so that the activity of the 99mTc resulting product cannot be used for diagnosis.

Comparison of 99mTc Injected Activity with Prescribed Activity in Four Types of Nuclear Medicine Exams

Background: 99mTc is a radioactive isotope that is obtained by eluting a 99Mo/99mTc generator. (PINSTECH, Islamabad) and used for radionuclide scanning. Objectives: The objective of this work is to study the uncertainties in 99mTc activity that exist due to time delay between injection preparation and administration to patients, during the process of gamma camera scanning. Methods: Lead canisters were used for storing elution vials and dose calibrator for measuring 99mTc activity in mCi. The activity of preparing 99mTc injection and its administration to patients were compared with the prescribed values of activity recommended in the Society of Nuclear Medicine procedure guidelines. Results: This study showed that uncertainty in the activity existed in one thyroid patient, 38 bone patients, 5 renal patients and 45 cardiac patients. Conclusion: This uncertainty in activity exists due to time delay between injection preparation and administration to patients, as well as due to residual radionuclide that is not injected into patients and remains in the syringe.

Influence of Contact Time on Loading 99Mo(n,γ) with Alumina Column in 99Mo / 99mTc Generator

<p>Alumina is usually used for ⁹⁹Mo absorbers obtained from ²³⁵U fission product because the use of ²³⁵U is getting limited, and as an alternative ⁹⁹Mo obtained from natural MoO₃ irradiation was used. The problem is that ⁹⁹Mo produced was not carrier-free as ⁹⁹Mo from ²³⁵U fission product because not all MoO₃ is activated to ⁹⁹Mo, then it is necessary to know the effect of contact time when loading ⁹⁹Mo into the alumina column. To find out the effect of contact time, the experiment was carried out using ⁹⁹Mo pH 4, acid alumina column, contact time was varied between 1 to 60 minutes with interval of 15 minutes, and the column was eluted using 2 kinds of eluent namely 0.9% NaCl and MEK. The elution of ⁹⁹Mo/^99mTc generator is performed 3 times, days 1, 2 and 3. The results showed that the performance of alumina in absorbing ⁹⁹Mo influenced by time. The optimal contact time is 15 minutes for 0.9% NaCl solution and 45 minutes for MEK. The amount of ⁹⁹Mo breakthrough (µCi⁹⁹Mo/mCi^99mTc) from the alumina column increases with elution time both using 0.9% NaCl or MEK. The ^99mTc eluate obtained from this study does not meet standard requirements. The use of a tandem column is needed to prevent ⁹⁹Mo breakthrough on the ⁹⁹Mo/^99mTc generator to get the ^99mTc which meet standard requirement.</p>