By Vvon Engineering Team | Published | Updated
Coordinate radiopharmacy workflow, product quality, shielding, measurement, contamination control, ventilation and authorised waste arrangements.
Nuclear medicine RFQ checklist (TXT)
Hot-lab design should support reliable preparation and assay while controlling radiological, microbiological, chemical and ergonomic risks. Layout is one contributor to readiness, alongside supply, staff, product quality and equipment.
Develop workflow, radiation protection and pharmaceutical quality requirements together with the responsible specialists. None should be treated as a constraint added after the other decisions are fixed.
Separate clean materials, preparation, incoming packages and waste flows in a way appropriate to the tasks and facility. Marked surfaces can help, but cannot replace physical separation or controlled environments where those are required.
Map the proposed flows and examine crossings, storage, access and containment with the radiopharmacy and protection teams. A crossing on a diagram is a prompt to assess risk, not automatic proof that a layout is unusable.
Set bench height, access, viewing, shielding and handling equipment for the approved task, operator ergonomics and contamination control. Neither seated work nor an L-block is sufficient or mandatory for every preparation; aseptic product protection and airborne containment may require additional systems.
Select shielding and sufficient handling accessories for the radionuclides, activity, container geometry and workload. Provide compatible cleanable surfaces, waste routes and any authorised sinks or drainage. Shared equipment can be acceptable with suitable availability and decontamination; do not prescribe one shield thickness or a radioactive sink as a universal requirement.
Departments spend a long time selecting a dose calibrator and about five seconds deciding where to put it. The instrument measures the activity in its well plus whatever the room is contributing, and the room contribution changes through the day as the generator is eluted and the stock is drawn down.
Assess changing nearby activity when locating the calibrator, and verify background and shielding with the physics team. A manufacturer-compatible shielding accessory may help, but a 50 mm ring or fixed separation is not a universal remedy. Background and QC checks follow the instrument and approved measurement procedure.
The test set is standard and worth writing into your procedure explicitly.
| Test | Frequency | What it establishes |
|---|---|---|
| Constancy | Every day of use | That the reading has not shifted since yesterday, measured with a long lived reference source in a fixed geometry |
| Accuracy | At the interval set in your procedure | That readings agree with certified reference sources across the range of energies you use |
| Linearity | Periodically, usually by following a decaying source | That the instrument reads correctly from the highest activity you dispense down to the lowest |
| Geometry | Before introducing new containers or relevant measurement conditions, and after changes affecting response | Characterises container/volume effects and needed validated factors; does not prove response is independent of geometry |
| Background | Each session | That the room contribution is known and subtracted rather than assumed |
Keep the reference source, its certificate and its own log together, and treat the certificate as a controlled document. An accuracy check against a source whose certificate cannot be found is not evidence of anything.
Design to prevent contamination and detect it promptly. Encourage reporting and act on results against the authorised levels and investigation procedure rather than treating either contamination or a positive wipe as routine proof of safety.
Provide suitable area and personal monitoring, mapped checks, spill readiness, training and personal dosimetry based on the risk assessment. Define when and how people and items are checked on exit and the actions after abnormal results. Keep food, drink and cosmetics outside radioactive working areas and integrate protection with infection-control procedures.
Decay storage is available only for suitable waste under the authorised procedure. A fixed time or a reading near background does not by itself authorise release. Consider all relevant radionuclides, impurities and non-radiological hazards, maintain container records and prevent new waste from invalidating a planned clearance assessment.
| Waste stream | Planning requirement | Evidence needed |
|---|---|---|
| Sharps and contaminated disposables | Compatible biological and radiological segregation | Documented clearance and approved subsequent disposal route |
| Vials and generator components | Identify radionuclides and agreed return or storage route | Supplier information, inventory and authorised assessment |
| Liquid radioactive waste | Authorised collection, storage or discharge design | Licence conditions and required measurements/records |
| Patient excreta | Clinical and protection assessment for the service | Approved drainage and patient-management arrangements |
| Disused sealed sources | Secure storage and agreed authorised transfer | Source identification, records and recipient acceptance |
Segregate waste using radionuclide, half-life and other hazards so compatible authorised routes remain practical. Mixed long- and short-lived activity can extend storage, but size the facility from the actual inventory, turnover and clearance process rather than assuming every department has the same constraint.
Design ventilation, pressure relationships, extract and discharge from the preparations and containment needs, coordinated with aseptic requirements. A split air conditioner provides cooling rather than a complete ventilation solution. The required room pressure, local enclosure, filtration and discharge location must come from the qualified facility design.
Assess local dust and humidity when setting inspection and maintenance, and monitor relevant airflow or filter indicators. A manufacturer schedule is a starting requirement, not evidence that every filter in Bangladesh blocks sooner. Use the specified condition and replacement criteria.
Where airborne containment or controlled air quality is required, demonstrate the performance of the complete ventilation system. Do not treat an ordinary recirculating cooling unit as proof of containment or pharmaceutical clean-air protection.
Define ventilation-failure alarms, safe suspension of affected work and any essential-power arrangements in the approved design. Loss of extract may undermine containment without necessarily making the room positively pressurised. Resume affected tasks only under the validated recovery procedure.
Assign each required record an owner, retention period, access control and audit trail. Complete records support inspections and continuity, but do not guarantee a shorter inspection or establish that every practice is compliant.
Send Vvon the product and isotope scope, workload and proposed floor plan to discuss shielding, storage and handling equipment. Qualified clinical, radiopharmacy and engineering teams must define the facility requirements; confirm supplied items and specialist design scope in the quotation. Contact +8801805987890 or info@vvon.com.bd.
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