This is a ready-to-use work instruction for building a qualified cold chain shipment. It is the task-level companion to the shipper qualification protocol: the qualification proves a configuration works, and this instruction makes operations reproduce that exact configuration every time. Replace every <<FILL: ...>> placeholder and route it through document control. A filled specimen follows. The pack-out described here must match the validated configuration; if it does not, the qualification does not apply.
Control header
| Field | Entry |
|---|---|
| Document title | Pack-Out and Coolant Conditioning for Shipper <<FILL: config ID>> |
| Document number | <<FILL: WI-ID, e.g. WI-DIST-042>> |
| Version | <<FILL: version>> |
| Effective date | <<FILL: date>> |
| Parent SOP | <<FILL: SOP-ID for cold chain distribution>> |
| Qualification reference | <<FILL: PROT/report ID that qualified this configuration>> |
| Owner | <<FILL: role, e.g. Distribution Operations Lead>> |
Purpose
To pack out shipment product into shipper <<FILL: config ID>> exactly as qualified, so that the product stays within <<FILL: e.g. 2 to 8 degrees C>> for the qualified hold duration. Deviating from the qualified configuration voids the thermal protection the qualification demonstrated.
Materials
| Item | Specification | Check |
|---|---|---|
| Shipper (insulated box) | <<FILL: model / config ID>> | Correct model, undamaged |
| Coolant | <<FILL: type, count, mass>> | Correct type and count |
| Dunnage / product spacer | <<FILL>> | Present as qualified |
| Data logger | <<FILL: model, calibrated>> | Calibration in date |
| Pack-out record / shipping label | <<FILL: form ID>> | Available |
Coolant conditioning (do this first)
Conditioning state drives shipper performance more than any other single factor. Condition coolant exactly to the qualified specification.
| Step | Action | Per-step acceptance |
|---|---|---|
| C1 | Place coolant in the conditioning unit at <<FILL: e.g. 5 degrees C>>. | Unit at set point, mapped worst case known. |
| C2 | Condition for at least <<FILL: e.g. 24 hours>>. | Minimum time met; do not under-condition. |
| C3 | Verify coolant temperature before use with a calibrated probe or per the qualified method. | Reads within <<FILL: conditioning tolerance>>. |
| C4 | Record conditioning unit ID, set point, start time, and verified temperature on the pack-out record. | All fields complete. |
Do not substitute a shortcut (freezer instead of the qualified conditioning temperature) unless that alternative was itself qualified.
Build sequence
| Step | Action | Per-step acceptance |
|---|---|---|
| B1 | Confirm the shipper model and coolant count match the qualification reference. | Match confirmed; if not, stop and escalate. |
| B2 | Place the base coolant layer per the qualified arrangement. | Position and count as qualified. |
| B3 | Insert the payload chamber / dunnage. | Product space formed as qualified. |
| B4 | Load product into the payload space. | Product within qualified min-to-max payload window. |
| B5 | Activate and place the data logger adjacent to the payload at the qualified worst-case location, not loose in void space. | Logger started, placement per qualification, start time recorded. |
| B6 | Place the top coolant layer per the qualified arrangement. | Position and count as qualified. |
| B7 | Close and seal the shipper; apply the correct shipping and any dangerous-goods label. | Sealed; labels correct (see note on dry ice below). |
| B8 | Complete the pack-out record: shipper ID, coolant conditioning data, logger ID and start time, payload, packer name, date and time. | Record complete and signed. |
Dangerous-goods note
If the coolant is dry ice or the shipment uses a liquid-nitrogen dry shipper, dangerous-goods obligations (for example IATA packaging, quantity marking, and labeling for carbon dioxide, solid or for the dry shipper) apply alongside the thermal pack-out. Confirm the shipper is trained and certified for the applicable dangerous-goods requirements before shipping.
Per-step acceptance summary
The pack-out is acceptable when: coolant was conditioned to the qualified specification and verified; the build matched the qualified configuration at every step; the logger was started and placed correctly; and the pack-out record is complete and signed.
Record generated: pack-out record fields
| Field | Format | Required | Who | When |
|---|---|---|---|---|
| Shipment / order ID | text | Yes | Packer | At build |
| Shipper config ID | text | Yes | Packer | At build |
| Coolant conditioning (unit, set point, start, verified temp) | text / C | Yes | Packer | Before build |
| Payload description | text | Yes | Packer | At build |
| Logger ID and start time | text / time | Yes | Packer | At build |
| Packer name and signature | text | Yes | Packer | At build |
| Date and time of pack-out | timestamp | Yes | Packer | At build |
Retain the pack-out record per the records retention schedule, not less than <<FILL: retention period>>.
Filled specimen
| Field | Entry |
|---|---|
| Shipment / order ID | SO-2026-4471 |
| Shipper config ID | CC-96H-2to8-VIP |
| Coolant conditioning | Unit COND-03, set 5.0 C, started 02 Jul 06:10, verified 5.1 C |
| Payload description | 3 cartons finished drug product, max payload |
| Logger ID and start time | LOG-1182, started 03 Jul 08:22 |
| Packer name and signature | J. Rivera, signed |
| Date and time of pack-out | 03 Jul 2026, 08:25 |
In this specimen the packer verified the coolant reached the qualified conditioning temperature before the build, loaded the maximum qualified payload, started and placed the logger at the qualified worst-case location, and completed the record. That is the chain that lets a receiver, days later, trust that the shipment matched the qualified configuration.
Common inspection findings this instruction prevents
- Coolant conditioned by an uncontrolled method, so field performance does not match the qualification.
- Logger dropped loose in the box rather than at the qualified worst-case location, so monitoring underreports the real extreme.
- Payload outside the qualified min-to-max window, so the thermal result is not covered by the qualification.
- Pack-out record missing conditioning data or logger start time, so the shipment cannot be reconstructed.
- A pack-out configuration that quietly drifted from the qualified build with no change control.
How to adapt this instruction
- Set the document number, parent SOP, and qualification reference in the header.
- Enter the exact qualified coolant count, conditioning specification, and build sequence from your qualification report.
- Confirm the dangerous-goods requirements that apply to your coolant and mode.
- Point the pack-out record retention to your real retention schedule.
- Keep this instruction and the qualification reference in lockstep; any change to one triggers review of the other under change control.