Saxsons Group

Radiopharmacist's Notes · KARL100™

One device, two teams, three lanes — where the boundaries actually fall.

KARL100 dispenses in the hot lab AND injects at the bedside. That single device crosses the line between radiopharmacy and clinical administration — which means the site SOP has to be explicit about who owns what. This page splits the responsibility into three lanes (hot-lab side, injection-room side, shared programme) and flags the common failure modes at the boundary.

Three lanes of responsibility

Three columns, three different sources. The middle column (radiopharmacist) is what this page focuses on; the outer two have to be defined for the workflow to close.

This page

Hot-lab side (radiopharmacist owns)

  • Calibration of the Class A dispensing environment
  • Vial-to-mini-injector dose draw — accuracy and sterility
  • Per-batch dispensing record + sign-off
  • Multi-tracer SOPs for the seven supported isotopes (F-18, C-11, Ga-68, Cu-64, Lu-177, Y-90, Ra-223)
  • Mini-injector hand-off to the technologist with documented activity / time

Source: Radiopharmacy SOPs; KARL100 dispenser-side feature set.

Injection-room side (technologist / NM physician)

  • Mini-injector verification on receipt — activity check before injection
  • Patient identification + dose verification at bedside
  • Infusion execution + post-injection survey
  • Injection log entered into the patient record
  • Mini-injector return for survey + decommissioning

Source: Standard nuclear-medicine administration SOPs; KARL100 injection-side feature set.

Shared programme (cross-team)

  • KARL100 service and software-update cadence
  • Annual QC: dispense accuracy + injector activity-meter cross-check
  • AERB licensing under the Atomic Energy (Radiation Protection) Rules 2004
  • Theranostic-centre dosimetry programme (when running Lu-177 / Y-90 / Ra-223)
  • Cross-team training: who can use the device, who can sign off a dose

Source: AERB cyclotron / nuclear-medicine facility documents; site QA programme.

Three things to design out at the boundary

KARL100 is engineered well; the failure modes that hurt are operational. These are the ones to write into the SOP up front, not after an incident:

  1. Hand-off without a written activity / time record is the most common failure mode at the hot-lab → injection-room boundary. KARL100 doesn't enforce the written record; the site SOP has to.
  2. Multi-tracer dispensing on one device means QC has to cover each isotope separately. Lu-177 dispense accuracy doesn't certify Ra-223 dispense accuracy. Cross-isotope QC matrices are required.
  3. Mini-injector decommissioning has to be logged. A "lost mini-injector" is a radiation-safety incident; the SOP has to make sure each device that leaves the hot lab also returns to it.

Sources: Radiopharmacy + nuclear-medicine administration SOP best practice; AERB radiation-safety expectations.

Scope of this page

This is a buyer / SOP-design framework, not a regulatory document. The exact column content reflects how a typical Indian nuclear-medicine department divides radiopharmacy and administration responsibility — your site\'s SOP may differ. The three failure-mode traps are workflow observations, not manufacturer-published claims. Pair this page with the plain-English knowledge hub for the buyer-facing context.

Sources cited on this page

  • the manufacturer. KARL100 — multi-tracer dispenser + injector. temasinergie.com ↗
  • the manufacturer. KARL100 microsite. karl100.com ↗
  • Atomic Energy Regulatory Board (India). Atomic Energy (Radiation Protection) Rules 2004. AERB ↗