Radiopharmaceuticals🇺🇸United States·

Decay-corrected batch records, conditional release, hot-cell ready.

Built for 21 CFR 212 (PET), 21 CFR 210/211, USP <823>, and NRC / state radioactive materials licensing.

Start free for Radiopharma

← Different industry

Built around your regulators

The codes you're accountable to — at the data layer.

21 CFR 212

cGMP for PET drug products

21 CFR 210/211

cGMP for finished pharmaceuticals (therapy radiopharma)

21 CFR Part 11

Electronic records & signatures

USP <823>

Radiopharmaceuticals for PET — compounding, investigational, research

USP <797>

Pharmaceutical compounding — sterile preparations

10 CFR 35

NRC medical use of byproduct material

49 CFR 173

DOT shipping of Class 7 radioactive material (Type A)

How V5 maps to your floor

Five steps from receive to release — with the regulator on the hook at the end.

Tap to expand · download as PNG · paste into an audit prep deck.

A day in the life

From login to release — no end-of-shift paperwork.

What the auditor receives

The record assembles itself as the operator works — no end-of-shift paperwork project.

21 CFR 212 / NRC — RADIOPHARMACEUTICAL DECAY-AWARE FLOW (Conditional Release + Decay)

🇺🇸United States

KDE CAPTURED

› isotope
› A₀ (MBq)
› calib time
› manifest

ISOTOPE RECEIVE

KDE CAPTURED

› A(t)=A₀·e⁻ᵏᵗ
› λ / T½
› target dose
› calc by

DECAY CALC

KDE CAPTURED

› hot-cell run
› yield
› QC sample
› operator

SYNTHESIS

KDE CAPTURED

› dose (MBq)
› calib at
› patient ref
› operator

UNIT DOSE

KDE CAPTURED

› radiochem purity
› endotoxin
› QP sig
› conditional

QC RELEASE

KDE CAPTURED

› A at calib
› transport idx
› carrier
› ETA

SHIP + CALIB

PHYSICAL EVENT INFORMATION EVENT

KDE = the minimum data fields required to trace the lot through this step. Captured automatically as the operator works.

21 CFR 212 / NRCCOMPLIANT· CONDITIONAL RELEASE· DECAY-CORRECTED

TRACE IT. TRUST IT.

T-zero·step 01
Calibrate to T0
Activity calibrated to the reference time — every later step decays from this anchor with A(t)=A0·e^(−λt).
T+15·step 02
Synthesis
Cyclotron / synthesiser captures yield + activity. Operator has decay-corrected display, never raw counts.
T+45·step 03
QC + sterility
Conditional release: shipment goes out before sterility result, then retroactive sign-off when sterility completes.
21 CFR 212.70(d)
T+60·step 04
Unit-dose dispense
Each patient dose dispensed at calibration time. Activity at administration is the dispense activity decayed forward.
T+24h·step 05
Retroactive sterility sig
When the sterility test reads negative, the conditional release is finalised. Record locks. If positive → recall protocol fires.

Speaking your language

The terms your auditor uses

V5's UI uses these names for radiopharma workspaces — no cross-industry jargon to translate.

PET: Positron Emission Tomography — imaging using positron-emitting radiopharmaceuticals (e.g. 18F-FDG).
Half-life: Time for activity to decay to 50%. Drives the entire production + dispense schedule.
Conditional release: Shipping the lot before sterility completes (212.70(d)) — sterility result attaches retroactively.
T0 / calibration time: Reference time the activity is reported at — every dose is decayed from this anchor.
Becquerel / Curie: Units of activity. 1 Ci = 3.7×10¹⁰ Bq.
Hot cell: Shielded enclosure where radiopharmaceutical compounding happens.

What keeps you up at night

Sound familiar? We built this for you.

Decay correction lives in spreadsheets — every batch a manual re-calc, every transcription a deviation waiting to happen.

PET conditional release per 212.70(d) is paper-based; sterility close-out lags the dose by hours and never ties cleanly back to the batch.

Patient unit-dose dispense records (activity at injection time, syringe ID, calibration time) are reconstructed after the fact.

Survey, wipe-test, TLD, and decay-in-storage waste logs sit in three different binders and four different systems.

NRC / state license inspections turn into a week of re-assembly because no system carries the license number through to the records.

Self-Building Compliance Records

The record assembles itself as the work happens.

No paperwork project at end of shift. No reconstruction at audit time. The evidence IS the workflow.

Built-in isotope master

Pb-212, Ac-225, Lu-177, F-18, Tc-99m, Ga-68, I-131 and more — half-lives, decay modes, default shelf-lives all wired in. Decay correction A(t)=A₀·e^(−λt) at every read, no spreadsheets.

Calibration-time batch record

Every work order carries a calibration datetime. The BMR records activity AT calibration; every later read auto-decays from there.

Conditional release with forced close-out

Per 212.70(d) — release the dose for patient use before sterility testing completes, with a system-enforced retroactive sterility sign-off that ties back to the original batch and operator.

Patient unit-dose dispense

One synthesis, many patient doses. Each dose has its own calibration time, syringe ID, and decay-corrected activity at injection — captured live, signed by the dispenser.

Two-signature batch release

Same 211.186 / 211.188 discipline as conventional pharma — preparer + independent reviewer e-sigs, immutable batch record, snapshot-from-MMR construction.

Ready to see it on your batches?