Daily SOP · miniGITA Single
Seven steps from strip in the scanner tosigned batch release.
The radio-TLC scanner sits between the labelling vial and the dose calibrator. The purity gate runs here. This page is the seven-step SOP — what happens per release, where the monograph threshold lives, what the AERB inspector reads off the audit trail at the next inspection.
SOP — seven steps
From self-test to batch-record export
- 1
Power-on + self-test
Power the instrument and the QC workstation. The software starts a self-test against the resident reference geometry — detector live time, scan-stage end-stop, communications link. Pass / fail logged automatically. Self-test failure escalates to vendor service before any release work.
- 2
Method selection
Select the per-isotope method from the QC software library — Tc-99m MDP, FDG, Ga-68 DOTATATE, Lu-177 PSMA-617, etc. The method carries the Eur.Ph. / USP <823> threshold, the energy window, the scan length and the integration regions. No operator threshold entry on the release screen.
- 3
Strip preparation
Spot the labelled batch onto the TLC / ITLC strip per the per-product spotting recipe. Develop the strip in the per-product solvent system. Air-dry. The spotted-and-developed strip is what enters the scanner — the labelling chemistry is fixed by the time the strip is prepared.
- 4
Strip scan
Load the strip onto the motorised scan stage at the configured travel length (50 mm / 100 mm). Start the scan. The QC software records the per-pixel count rate in the configured energy window and produces the activity profile across the strip.
- 5
%RCP calculation
The software integrates the activity profile across the configured regions — radiopharmaceutical peak and impurity peaks — and computes %RCP. The number is compared against the monograph threshold carried in the method. The screen returns PASS / FAIL with the integration plot.
- 6
Operator review + signature
The operator reviews the integration plot — peak placement, baseline integrity, integration-region fit. If acceptable, the operator signs the release electronically. If not (peak placement off, baseline drift, low counts), the release is aborted and the batch is held for investigation.
- 7
Batch-record export
The signed release is appended to the batch record — radiopharmaceutical, lot, scan timestamp, %RCP, monograph threshold, PASS / FAIL, operator signature. The record is retained in the 21 CFR Part 11 archive and exported to the daily QA log that the AERB inspector reads.
Per-isotope monograph thresholds
The number the release decision is compared against
| Radiopharmaceutical | %RCP threshold | Reference |
|---|---|---|
| Tc-99m MDP / DMSA / MIBI / ECD / MAG3 | ≥ 95 % | Eur.Ph. monograph per kit; USP <823> |
| [18F]FDG (radiopharmaceutical) | ≥ 95 % | Eur.Ph. monograph 1325; USP <823> |
| [18F]NaF (skeletal imaging) | ≥ 95 % | Eur.Ph. monograph 2100; USP <823> |
| Ga-68 DOTATATE / DOTATOC / PSMA-11 | ≥ 95 % | Eur.Ph. monograph 2482; site SOP |
| Lu-177 DOTATATE / PSMA-617 | ≥ 95 % (NETTER / VISION targets ≥ 99 %) | Eur.Ph. + NETTER-1 / VISION chemistry expectation |
| I-131 (sodium iodide capsule / solution) | ≥ 95 % | Eur.Ph. monograph 0281 / 0282 |
Thresholds carried in the QC-software method library; the operator does not enter the threshold on the release screen. Verify the latest Eur.Ph. / USP <823> monograph values at site IQ / OQ / PQ.
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