Pharmaceutical cold chain3 / 9

Using the ICH Q1B confirmatory dose, its packaging stages and a one-day worked example: where light exposure builds up and what the outer carton does.

Assess a refrigerator against product instructions and measurement records, not its category. Verify temperature distribution, alarms and excursion response.

Read WHO's 1967 Gambia example with cold-chain difficulty and health outcome as separate evidence.

Red cells are stored at +2 to +6 °C, platelets at +20 to +24 °C on an agitator, fresh frozen plasma below -18 °C. Putting all three in one box puts all three at risk.

Primary receptacle, leakproof secondary with absorbent, outer packaging; 95 kPa, a 1.2 m drop and the UN3373 mark. Where road rules under ADR P650 and air rules under IATA PI 650 part ways.

Dry ice cools, but it also produces gas and burns. In a closed vehicle the real risk is not the product but the person carrying the box.

Do not apply minus 70 degrees to every product; current instructions, equipment range, and route validation all matter.

In a 17-minute simulated flight in Malaysia, with the same load and the same ice packs, an EPS foam box held 4.70 °C while an aluminium box reached 11.46 °C. The box material matters as much as the flight time.

Compare peak stock and quarantine needs with qualified layout, then verify usable capacity from temperature records.

Define the boundary and reporting unit first, then collect transport, energy, packaging, and loss data for the same period.

Measure per-shipment quantities by material and weighing method, while tracking product protection.

Link each reagent's label and SDS instructions to its receipt record. Contact the supplier after delay, damage or unclear conditions.

Combine product value with documented labour and replacement costs in one incident file.

Match identity, expression time, container instructions and handoff records to current guidance.

Make the transplant coordinator’s plan traceable with route, container ID, seal and timestamps.

Match unit ID, component workflow, container layout and receipt time to blood-centre procedure.