Limulus Test for Pyrogens and Radiometric Sterility Tests on Radiopharmaceuticals. Part of a Coordinated Programme. Final Report for the Period 1 September 1972--30 April 1976

摘要

Sterility testing of radiopharmaceuticals prepared at BARC were carried out using the radiometric technique (Radiometric detection of the metabolic product exp 14 Co sub 2 ). Batches of different radiopharmaceuticals were tested for pyrogen using the limulus lysate method and the results were compared with the rabbit method. The results of sterility test on 202 batches of 19 different radiopharmaceuticals show that the radiometric method can be used for sterility testing of radiopharmaceuticals labelled with exp 35 S, exp 51 Cr, exp 57 Co, exp 59 Fe, exp 82 Br, exp 86 Rb, sup(99m)Tc, sup(113m)In, exp 125 I and exp 169 Yb. The radiometric test proves to be more rapid than the conventional one for the sterility testing of such radiopharmaceuticals. Detection time is between 6 and 21 hours. In the case of exp 131 I-labelled radiopharmaceuticals and in the case of chlormerodrin-Hg-203, it was found an interference due to volatile species (sup(131m)Xe in the case of exp 131 I and some volatile mercury form in the case of chlormerodrin). In these cases it would be possible to carry out the radiometric sterility test after separation of the microorganisms from the radioactive material (by filtration). The limulus lysate method can be employed for control of various pyrogen-prone raw materials and radiopharmaceuticals. Such method is the only method at present available for detecting the low level pyrogen contamination in intrathecal injections. The limulus test is more rapid than the rabbit test. (Atomindex citation 08:332009)