Saxsons Group

Radiopharmacist's Notes · WGHS™

What the equipment records, and what you still have to verify.

WGHS generates a per-cycle audit log automatically. That log is the cleanest possible starting point for an AERB inspection — but it is a starting point, not the whole story. This page draws the line between what the equipment records on its own and what the radiopharmacy programme still has to verify, document and review around it.

Two layers of the audit trail

The first column is automatic. The second column is the radiopharmacy\'s ongoing work. Both columns are required for the trail to clear an inspection.

Automatic

WGHS records automatically

  • Time + activity reading when off-gas first entered the system
  • Confirmation that the host hot cell was isolated
  • Storage tank assignment and time of transfer
  • Decay-monitoring readings over the storage window
  • Time + reading when the gas met the release threshold
  • Time of safe atmospheric release

Source: WGHS product page — "checks and records data for each waste cycle"

Radiopharmacy still verifies + documents

  • Periodic calibration of the WGHS radioactivity sensors against a reference source
  • Storage-tank integrity (leak test, pressure-hold test) on the SOP-defined cadence
  • Operator authorisation log — who responded to each isolation event
  • Release-threshold values themselves (engineered and reviewed by RSO)
  • Annual review of the cycle log against AERB inspection expectations

Source: AERB cyclotron-facility licensing path; site SOPs.

Four rules of thumb at AERB inspection time

  1. The cycle log should be exportable for the inspection window — not buried in a vendor format that needs the manufacturer teleassistance to read.
  2. Sensor calibration certificates should map onto the cycle-log timeline. The inspector will check that the readings were taken with a calibrated instrument.
  3. Storage-tank integrity records should be inside the period the cycle log covers — gaps are findings.
  4. The release-threshold value should be in the site's radiation safety SOP, not just in the equipment's default configuration.

Sources: AERB Regulatory Requirements & Guidelines for Medical Cyclotron Facility (2017); site SOPs.

Scope of this page

The WGHS public product page confirms "checks and records data for each waste cycle" but does not publish the per-field detail of what the log captures. The first column on this page reflects the data the cycle log can reasonably be expected to contain in a decay-then-release workflow — confirm the exact log fields via the brochure or via Saxsons before validating against your site SOP. The AERB licensing path is the Indian regulator\'s framework; specific inspection findings depend on the inspector.

Sources cited on this page

  • the manufacturer. WGHS — Waste Gas Handling System. temasinergie.com ↗
  • Atomic Energy Regulatory Board (India). Regulatory Requirements and Guidelines for Medical Cyclotron Facility. AERB, 2017. AERB PDF ↗

Knowledge Hub →

WGHS in plain English

Decay-then-release safety cycle and the AERB licensing context.

Sibling →

FLEX cyclotron GMP stack

The full Annex 3 + Annex 1 + Annex 11 + AERB requirement set the off-gas log sits inside.