[en] A facility for the production of ⁹⁹Mo-^99mTc generators (GPL) in clean room system was provided by the IAEA under Technical Cooperation Project. Regular production of Pakgen ^99mTc generators has been started from January 2003. The GPL is provided with A, C and D categories of clean room specifications and various materials used for generator preparation are transferred through airlocks while dress change rooms are provided for personnel. More than 1800 Pakgen ^99mTc generators with calibrated activities (five days reference date) ranging from 300 to 600 mCi of ⁹⁹Mo have been supplied to various nuclear medical centres in Pakistan. Before preparation, the generator bodies and various sections of GPL have been cleaned and disinfected. During the preparation, required calculated activity of ⁹⁹Mo has been loaded on the columns of pre assembled generators by prewash, loading and postwash steps and quality of the generator has been checked by elution efficiency and molybdenum breakthrough of eluate obtained after an hour from postwash step by comparing the measured activity with the theoretical activities. All these calculations have been carried out using computer programme MOGEN-I developed in Visual Basic 6 software; this software is suitable for recording and acquitting commercial data, monitoring production and quality control. Mathematical equations for theoretical calculation of generator parameters using ⁹⁹Mo-^99mTc-⁹⁹Tc decay schemes have been used in this software; otherwise these calculations are laborious and time consuming. During the elution, theoretical prediction of the performance of a ⁹⁹Mo-^99mTc generator, in terms of the activity of ⁹⁹Mo, ^99mTc on the column, activity of ^99mTc in the generator eluate, the generator elution efficiency and the total mass of technetium (^99mTc + ⁹⁹Tc ) present in a given eluate, have been carried using another software MOGEN-II. The input variables are ⁹⁹Mo activity, generator elution efficiency, number of elutions, the growth time between elutions, the decay time between elution and the use of ^99mTc. The output of the program for each elution gives the activities of ⁹⁹Mo and ^99mTc, atom numbers of ⁹⁹Mo, ^99mTc and ⁹⁹Tc and the ⁹⁹Tc/^99mTc atom ratio for the generator immediately before elution, for fresh eluate, for decayed eluate and for the generator after elution. This software will be useful for judging the quality of Pakgen ^99mTc generators for a week or so. Pakgen ^99mTc generator provides, by elution, ^99mTc-sodium pertechnetate in sterile, isotonic solution ready for intravenous or oral administration or for aseptic preparation of ^99mTc labelled radiopharmaceuticals. All Pakgen ^99mTc generators are test eluted before shipment. Quality tests performed are elution efficiency, molybdenum breakthrough, radiochemical purity, chemical purity, radionuclidic purity, sterility and apyrogenicity. The eluate fulfils the quality control criteria prescribed by International Atomic Energy Agency and various Pharmacopoeias like United States, British and European for sodium pertechnetate ^99mTc injection. In hospitals, the Pakgen ^99mTc generators showed optimum performance in terms of elution yields, molybdenum breakthrough, labelling yields and quality of gamma scans

[en] A facility for the production of ⁹⁹Mo-^99mTc generators, along with a clean room system was established at PINSTECH by the IAEA under a technical cooperation project (PAK/4/04) with finance of US $200 000. This generator production facility comprises three clean rooms: (i) preparatory room (grade D), (ii) generator loading room (grade C), and (iii) quality control room (grade B). The materials used for generator preparation are transferred through airlocks while dress change rooms are provided for personnel entry. Two hot cells equipped with in-cell equipment are installed in a generator production room. The prepared generators are transferred via conveyor belt to the quality control room for measuring elution efficiency and ⁹⁹Mo breakthrough. Regular production of Pakgen ^99mTc generators started in January 2003. More than 1900 Pakgen ^99mTc generators with calibrated activities (five days reference date) ranging from 300 to 600 mCi of ⁹⁹Mo have been supplied to various nuclear medical centres in Pakistan. Before preparation, the generator bodies and the various sections of the Generator Production Laboratory are cleaned and disinfected. During preparation, the required calculated activity of ⁹⁹Mo is loaded on the columns of preassembled generators by pre-wash, loading and post-wash steps and the quality of the generator is checked by elution efficiency and molybdenum breakthrough of eluate obtained after one hour of the post-wash step. All these calculations are carried out using the MOGEN-I computer program developed in Visual Basic 6 software. This software is suitable for recording and acquitting commercial data and monitoring production and quality control. All Pakgen ^99mTc generators are test eluted before shipment. Quality tests performed include: elution efficiency, molybdenum breakthrough, radiochemical purity, chemical purity, radionuclidic purity, sterility and apyrogenicity. The eluate fulfils the quality control criteria prescribed by the IAEA and the European Pharmacopoeia. In hospitals, the Pakgen ^99mTc generators showed optimum performance in terms of elution yields, molybdenum breakthrough, labelling yields and quality of gamma scans. (author)

[en] Reactor produced beta emitting radionuclides such as ¹³¹I, ¹⁷⁷Lu, ¹⁶⁶Ho and ¹⁵³Sm are emerging as important tools for the treatment of various diseases, including cancer. Among these, ¹⁷⁷Lu is considered to be important for therapy, since it decays with a half-life of 6.71 d by the emission of beta particles (E_β of 498 keV (78.6%), 384 keV (9.1%) and 176 keV (12.2%)) to stable ¹⁷⁷Hf. It also emits gamma rays with energies of 208 keV (11%) and 113 keV (6.4%), which are suitable for imaging. Recently, the somatostatin analogue DOTA-Tyr³-octreotate (DOTATATE) has been identified as a very successful peptide in targeting tumours and, when radiolabelled with a therapeutic isotope, in helping reduce tumour size in patients with metastatic neuroendocrine tumours. The report describes studies of the optimization of the production of ¹⁷⁷Lu, ¹⁶⁶Ho and ¹⁵³Sm radionuclides in PARR-1 (Pakistan Atomic Research Reactor-1), using their naturally occurring and enriched metal oxide targets. High production yields were obtained for all three radionuclides. In studies of the labelling of DOTATATE with ¹³¹I, ¹⁷⁷Lu, ¹⁶⁶Ho and ¹⁵³Sm, different experimental variables were used to determine the optimal preparation conditions. The ¹³¹I-DOTATATE, ¹⁷⁷Lu-DOTATATE, ¹⁶⁶Ho-DOTATATE and ¹⁵³Sm- DOTATATE prepared were of optimal purity. Thin layer chromatography was used to measure the quality of these labelled peptides. The stability of the four complexes was studied in an acetate/ascorbate buffer and in saline at 4, 12, 24 and 36 h intervals. Quality control of the complexes was performed using the radio TLC technique. The results showed that these complexes were stable in both the acetate/ascorbate buffer and in saline for the 36 h period. Results of animal studies using rats indicated that the critical organ for the labelled peptides was the pancreas and the excretion route was via the kidney. Internalization studies of the ¹⁷⁷Lu-DOTATATE carried out with AR42J cells showed greater than 7% internalization into AR42J cells after 80 min. (author)