Radiopharmacy software.

1The product is losing activity while you work.

Radiopharmaceutical manufacturing has a constraint that ordinary planning systems do not model: the product loses usable activity while it is made, tested, released, transported and prepared for administration. A synthesis delay, a repeat test or a courier change alters which doses remain feasible.

Seal makes time, activity and destination part of the batch state. Demand, radionuclide source, synthesis, rapid QC, disposition, dose preparation, labels, shipment and later-arriving evidence remain one traceable operation.

The operation also crosses manufacturing, laboratory, pharmacy, logistics and clinical boundaries, so each fact needs one authority. Hospital or scheduling systems can own the clinical request and patient context. Seal can own accepted manufacturing demand, batch and dose identity, GMP execution, samples, calculations, release, labels, custody and reconciliation. Cyclotron, synthesis, dispensing, dose-calibrator and analytical systems stay authoritative for control and acquisition, and radiation-safety systems can keep licensed-material inventories. Interfaces carry controlled identifiers, activity with reference time, status and permitted patient context, and a retried message must not create a second dose or shipment.

1.1Why teams choose Seal for radiopharmaceutical manufacturing

When release evidence is spread across controllers, instruments, spreadsheets and phone calls, the question “which doses can still be delivered?” is answered by whoever is holding the whiteboard. Seal puts the release clock, the evidence and the affected dose population on one record, and holds the decay calculations as versioned configuration. Each delay or result recalculates what remains feasible, and each exception carries its time and activity context from the moment it occurs.

2Treat the batch as a time budget.

The question is not only whether the process is complete, but whether the batch can still meet ordered activity at the reference time, finish its release work, reach each destination and remain usable at administration. Seal calculates the timeline from the product, radionuclide, reference time, ordered doses, preparation, QC duration, release review, transport and administration windows. Every delay consumes the same budget.

Decay correction is controlled calculation, not a display convenience. The half-life or approved decay constant, measured activity, measurement time, target time, units and rounding determine the result, and Seal versions the calculation and retains every input and output used for planning, release, dispensing and labelling. A manual adjustment preserves the original measurement, rationale and review. Unit conversion and timezone behaviour are tested so values do not shift across sites or daylight-saving boundaries.

Measurements at end of bombardment, end of synthesis, QC sampling, bulk vial, dispensed dose and dispatch coexist without overwriting one another, each with its reference time and physical source.

3Demand begins with the patient or destination.

Many operations manufacture against same-day orders: product, activity, calibration time, administration time, site, route, container and delivery requirements. Seal turns accepted orders into a production and dispensing plan, aggregating the required batch activity with process loss, QC samples, retains, decay and contingency represented explicitly. Protected identifiers stay visible only to authorised roles.

A cancelled dose, revised administration time or destination delay updates the plan and downstream labels without overwriting the original instruction. Production sees the current executable demand; QA sees the full decision history. Planning across runs and sites uses the real constraints (target or generator availability, synthesis module and hot-cell state, QC instruments, staff qualification, release duration and courier routes), and a shortage is never resolved by silently changing a dose or its patient association.

4Genealogy starts with the radionuclide.

The source may be produced on site, received from a supplier or eluted from a generator. Its identity, production run or lot, activity, reference time and status begin the product genealogy, and Seal links it to the synthesis and every vial or dose derived from it. Precursors, reagents, cassettes, cartridges, filters and containers keep their own lot, expiry and use history, so a supplier finding or target issue traces forward to every dispatched dose, and a complaint traces back to the full source population.

Before the run, Seal verifies the product, synthesis unit, program version, cassette configuration, precursor and reagent lots, calibration and maintenance, line clearance and operator qualification. A wrong or expired component blocks the normal path; an authorised replacement records both configurations. Process control stays in the synthesis module. Seal receives its accountable events, critical values and alarms, missing controller data remains pending, and after an interface outage the expected run and time range are reconciled rather than copied from a printout without provenance.

5Rapid QC and release keep pending distinct from passed.

Identity, radiochemical purity, radionuclidic identity, activity, pH, residual solvents, endotoxin, filter integrity and sterility have different durations and data sources. Seal creates the required panel from the effective specification, and results appear against the release clock as they are approved. A failing, invalid or delayed result triggers the defined exception path and recalculates the feasible dose population. Rapid review is not reduced review: suitability failures, repeats, OOS results and changed calculations remain visible.

Short-lived products may have release models in which long-duration evidence, such as sterility, completes after distribution, subject to the applicable product, procedure, regulation and quality oversight. FDA set specific current good manufacturing practice requirements for PET drugs in 21 CFR part 212 and publishes a PET drug CGMP small-entity compliance guide. Seal represents each requirement with its actual state: approved, pending under an authorised release condition, failed, invalid or not applicable.

The disposition record shows the evidence available at decision time, the approved basis for any pending obligation, the signatures and the affected dose population. An open obligation has a due state and escalation. When the later result arrives, it attaches to the historical disposition and the distributed population, and a concerning result opens the defined notification and investigation workflow without rewriting the release history.

6Dispense, label and dispatch from current data.

Each dispense records its source container, activity, measurement and reference time, calculated volume, order, container, preparer, verifier and status. Seal can receive dose-calibrator readings directly, barcode checks confirm the intended order and presentation, and a released bulk vial does not by itself make every later dispense acceptable. Split, remade, cancelled, returned or unused doses remain explicit states in batch and activity reconciliation rather than disappearing through a quantity correction.

Labels render from the approved product, batch, measurement, order and timing records, with template and printer versions controlled and scanning confirming the label against the physical container. If timing or activity changes, the source data changes first and the next approved label reflects it. A reprint requires a reason, and withdrawn labels stay in reconciliation so they are not reused.

Each shipment links doses to pack-out, courier, route, destination and handoffs. A route delay recalculates activity and feasibility for the specific dose, and the approved rule determines whether to continue, redirect, return or remake it. Courier tracking informs the operation, but a delivery scan is not qualified receipt by the destination.

7Equipment, radiation safety and deviations keep pace.

Seal gates execution on the configured state of cyclotrons, synthesis modules, hot cells, dose calibrators, radio-HPLC and other assets. Pre-use checks are executable work on the asset, and an out-of-tolerance calibration identifies every sample, release calculation and dose measured in the affected interval.

Radiation surveys, contamination checks, waste segregation, decay-in-storage and licensed-material records may remain governed by the radiation-safety programme. Seal links the required state to the activity that needs it without copying sensitive records broadly, and waste events keep their source batch, activity, reference time and disposal evidence. GMP activity reconciliation and radiation-safety accounting then agree on the same physical events, and a discrepancy opens a bounded investigation instead of being corrected separately in two systems.

A deviation opened after the shift is too slow when the batch may be unusable within hours. Seal creates the event from the active batch, test, alarm or delayed shipment with its time and activity context attached, and the defined response can hold the affected population, require immediate quality assessment or notify a destination. Impact is assessed against the affected batches and doses: a ten-minute delay can be negligible for one radionuclide and decisive for another. The approved continuity design covers interface, instrument, printer and application outages, with safe hold points and reconciliation that cannot create duplicate doses.

8Prove one order-to-administration day.

Rehearse one complete day: accept orders, plan activity, produce or receive the radionuclide, verify the synthesis setup, execute the batch, capture rapid QC, make the release decision, dispense and label doses, dispatch, acknowledge receipt, reconcile residuals and waste, and attach later evidence.

Exercise a late order, a synthesis alarm, a failed suitability check, a missing controller interval, a delayed courier, a cancelled patient, a reprint, an unavailable dose calibrator, a hospital-interface retry and an adverse post-release result. The system is ready when the clock, the product, the evidence and the affected population stay aligned through each exception.