Per-isotope SOP · MUCHA Nova
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.
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
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
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
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
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
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.