Seven steps from strip in the scanner to signed batch release.

SOP — seven steps

From self-test to batch-record export

1. 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. 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. 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. 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. 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. 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. 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

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.