%0 Journal Article
%T Study to Define Frequency in Routine Analytical Controls in the Radiolabelling Process
%A F. Ria
%A G. Albini
%A S. Battista
%A V. Salvatore
%A R. Messere
%A A. Bergantin
%A I. Redaelli
%A P. Bonfanti
%A A. S. Martinotti
%A P. Gandolfo
%A S. Papa
%J Open Access Library Journal
%V 4
%N 6
%P 1-9
%@ 2333-9721
%D 2017
%I Open Access Library
%R 10.4236/oalib.1103602
%X <div style="text-align:justify;">
	<span style="line-height:1.5;">In
the radiolabelling process, the frequency of routine analytical testing must be
defined with a risk assessment based on different factors (Pharmeuropa Vol. 26
No. 2, 5.19). Aim of this study is to define the criteria based on the risk
assessment required for setting the frequency of analytical controls. 331 preparations
of three different radiopharmaceuticals labeled with </span><sup>99m</sup><span style="line-height:1.5;">Tc were
examined analyzing temporal trends o</span><span style="line-height:1.5;">f radiochemical purity values, potential
correlation between radiochemical purity values and total radioactivity content
of bulk as well as potential correlation between radiochemical purity values
and radioactivity concentration of bulk. The analysis shows no direct
correlation between percentage of radiochemical purity and total radioactivity
content of preparation and between radiochemical purity values and
radioactivity concentration in final bulk solution. Moreover, the routine
analytical controls executed for one year on each preparation made it possible
to determine how the analytical values do not have inter-operator dependency
and there is no evidence of specific temporal trends over time. The study is
aimed to assess any eventual criticality related with radiochemical purity
tests, determine the possibility of a parametric release and the optimal
frequency of tests, without reducing the level of safety of the preparations.
This will produce a substantial reduction of costs and of radiation exposure to
ionizing radiation of the staff dedicated to Quality Control procedures.</span>
</div>
%K Analytical Controls
%K Radiolabelling Process
%K Frequency
%K Risk Assessment
%U http://www.oalib.com/paper/5285226