Per-isotope SOP · MUCHA Nova
Six breakthrough checks the hot lab needs to run —one MCA, one audit trail.
For each isotope and supply chain the hot lab handles, this page lists the breakthrough / nuclide-identity check, the measurement method, the threshold from the relevant monograph, and the failure-mode escalation. The MCA carries the methods; the audit trail captures each check on the per-batch release record.
Tc-99m eluate — Mo-99 breakthrough
When to run
Per generator eluate (typically first elution of the morning + after extended idle).
Method
Direct gamma spectrum on a calibrated aliquot of the eluate. Identify 140 keV Tc-99m photopeak and check for the 740 / 780 keV Mo-99 lines.
Release threshold
< 0.1 % Mo-99 activity per Tc-99m at expiry (Eur.Ph. 0124 / 0283)
Escalation: Mo-99 lines above threshold indicate column breakthrough — escalate to physicist + return to generator vendor under licence terms; the eluate cannot be released into patient kits
Ga-68 eluate — Ge-68 breakthrough
When to run
Periodic (per generator vendor protocol) + end-of-life cycle.
Method
Delayed-spectrum measurement — let Ga-68 decay (10 × t½ ≈ 11 h) then measure the residual spectrum. Any Ge-68 contamination shows up as the persistent 511 keV annihilation line in the post-decay spectrum.
Release threshold
< 0.001 % Ge-68 activity per Ga-68 at expiry (Eur.Ph. 2482)
Escalation: Persistent 511 keV line above threshold indicates Ge-68 breakthrough — escalate to physicist + return to vendor; the generator is at end-of-life
Lu-177 batch — Lu-177m identity
When to run
Per incoming Lu-177 supply (first batch from a lot + per-batch sampling for high-volume programmes).
Method
Direct gamma spectrum on a small aliquot. Identify the 113 / 208 keV Lu-177 doublet AND check for the 228 keV Lu-177m peak. n.c.a. supply should not show 228 keV above the limit of detection.
Release threshold
Lu-177m activity ratio per the supplier certificate of analysis (NETTER / VISION-grade chemistry implies the absence of Lu-177m above LOD)
Escalation: 228 keV peak above LOD on a batch declared as n.c.a. indicates supply provenance issue — escalate to supplier + AERB import paperwork
F-18 batch — cyclotron co-production
When to run
Per cyclotron batch (PET-tracer pharmacies producing in-house F-18).
Method
Direct gamma spectrum. Identify the 511 keV annihilation line and check for unexpected lines from target-material activation by-products (Ga-67, As-72, Sc-44 from FDG-target chemistry depending on target type).
Release threshold
Per Eur.Ph. monograph 1325 and target-material activation profile
Escalation: Unexpected lines above LOD indicate target degradation or wrong target loading — escalate to cyclotron engineer; the batch may need rejection
I-131 batch — short-lived iodine contamination
When to run
Per generator batch + bulk solution batch.
Method
Direct gamma spectrum. Identify the 364 keV I-131 line and check for I-132 (668 keV) / I-133 (530 keV) / I-135 short-lived iodine contamination.
Release threshold
Per Eur.Ph. monograph 0281 / 0282
Escalation: Short-lived iodine lines above threshold indicate generator failure mode — escalate to supplier; in-process activity should decay through before patient administration
Cu-64 investigational
When to run
Per investigator-initiated batch.
Method
Direct gamma spectrum. Identify the 511 keV annihilation + 1346 keV gamma line. Check for Cu-67 / Co-58 / Co-60 cyclotron-by-product contamination from target activation.
Release threshold
Per investigator-protocol acceptance criteria + AERB IIP licence
Escalation: By-product contamination above protocol limit indicates target degradation — escalate to investigator; the batch is held pending decision
Per-isotope thresholds and methods are carried in the QC software library; site IQ / OQ / PQ verifies the latest Eur.Ph. monograph values and locks the method version for routine release.