QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
QA issues in radioisotope production for nuclear medicine
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LFMCong<br />
82701<br />
<strong>QA</strong> challenges with radioactivity<br />
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Radiation levels limit direct handl<strong>in</strong>g by staff<br />
Most process<strong>in</strong>g must be done remotely <strong>in</strong> a hot cell<br />
Clean<strong>in</strong>g, contam<strong>in</strong>ation control, sterility difficult to ma<strong>in</strong>ta<strong>in</strong><br />
s<strong>in</strong>ce direct manned access to hot cell <strong>in</strong>teriors very restricted<br />
New glassware and reagents always used. [high radiation levels<br />
and harsh chemistry from concentrated acids can limit bacterial<br />
growth]<br />
Production of very small number of units and very small volumes<br />
(<strong>in</strong> my group 2-4 batches/month each ~10mL of 0.1N HCl)<br />
QC <strong>in</strong> this situation means every batch must be analyzed rather<br />
than selected units<br />
For short lived <strong>radioisotope</strong>s (eg. O-15, half life=2m<strong>in</strong>) it is not<br />
possible to complete all assays (chemical purity,sterility,<br />
pyrogenicity) prerelease or even be<strong>for</strong>e human use<br />
Process validation data and post release assay is done <strong>in</strong> this<br />
case<br />
Brookhaven Science Associates<br />
U.S. Department of Energy
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