Knowledge / Testing and the packing process
Preparing and Packing Pharmaceutical Thermal Packaging
For tested thermal packaging to perform as intended in shipping, the same components, preparation and packout must be used. Good packing instructions show item numbers, quantities and positions. They also define the checks required before closing and what happens if work is interrupted.
Practical guidance
Avoid mixed-up coolant packs, incomplete loading and excessive waiting times at the packing station.
Loading paper thermal packaging. The packing instructions define sequence, positions and separating layers.
In this guide
- Assign the correct components to the order
- Prepare cooling elements according to the packing instructions
- Verify preparation time with fully loaded equipment
- Limit the time between preparation and packing
- Load the packaging in the prescribed sequence
- Check before closing
- Document packing completion, handover and deviations
- Trial the instructions before routine shipping
Assign the correct components to the order
Check the order’s temperature range and product quantity. Select the approved packaging version and prepare the specified components. Compare item numbers and markings; a similar size or colour is insufficient.
Separate different temperature variants, and prepared packs from those not yet ready for use. Separate, labelled storage positions prevent staff from having to guess an element’s state at the packing station.
Example identification fields: system identifier, temperature range, seasonal or all-season configuration, and packing-instruction revision. For coolant packs, add the item identifier and preparation status. Use the actual approved documents; matching shape or colour does not establish the correct variant.
Prepare cooling elements according to the packing instructions
The packing instructions specify temperature, duration and any subsequent equilibration time. Follow the permitted stacking and equipment loading as well. A tightly packed stack can take longer than individually spaced elements.
Where frozen gel packs are specified, freeze them flat so they fit the intended packout. Identify their release status and the permitted time until packing. Additional tempering based on intuition does not replace the defined preparation.
If the goods become too cold after packing, the cold shock troubleshooting guide helps identify the cause and next check.
Source: THERMOCON: Gel packs.
Verify preparation time with fully loaded equipment
The equipment display measures at its sensor. It does not show whether the core of every pack has reached the required state. Airflow, stack height, initial temperature, door openings and additional warm elements influence cooling.
Verify preparation with the loading that actually occurs in shipping operations. Measurements at unfavourable positions can identify the minimum duration and arrangement required. A pack prepared individually in the laboratory does not validate preparation in a full freezer.
At your site, establish which elements take longest to reach the required state with the intended equipment loading.
Limit the time between preparation and packing
After removal from the equipment, the state of the packs continues to change. Define how long they may be staged at the expected room temperatures and what to do once this time expires.
Example at the packing station: only the parts belonging to the order are staged. The instructions show identification, quantity, position and separating material. If packing is interrupted, the defined time limits apply. A pack left out is checked before its next use and prepared again if necessary.
Also trial a high-volume shipping day: are there enough prepared sets of packs? Do queues form? Do packed shippers wait too long? These observations show whether more preparation capacity or a different process is needed.
Load the packaging in the prescribed sequence
- Check that the shipper and reusable parts are in the prescribed condition.
- Insert cooling elements by item, quantity and position.
- Install all separating layers and spacers.
- Compare product quantity and arrangement with the permitted payload.
- Position and activate loggers or sensors as specified.
The EU GDP Guidelines specify arranging coolant packs without direct contact with medicinal products. Staff must be trained in packing and reuse.
For PCM packs, the solid or liquid state influences their effect. The article on preparing and using PCM explains the physical reasons.
Check before closing
Turn the current packing instructions into a short workstation check. Record the result and resolve open points under the defined procedure. Use the risk of error to decide where a second person or technical check is needed.
| Check | Compare against the instruction | Result or deviation |
|---|---|---|
| Order and packaging | System identifier, temperature variant and packing-instruction revision. | __________ |
| Coolant packs | Item identifier, number, position and documented preparation status. | __________ |
| Goods | Product quantity, arrangement and permitted initial state. | __________ |
| Separators and restraint | All specified parts present and correctly positioned. | __________ |
| Temperature monitoring | Logger activated; assignment and position match the instruction. | __________ |
| Closure and identification | Specified closure, shipment identification and completion of packing. | __________ |
This template does not replace product-specific packing instructions or dispatch approval. Record packing completion and handover dates and times, plus deviations and the decision made under your procedure.
A photograph can document arrangement and completeness. It does not show the state inside the pack core. This is assured through verified preparation. The article on qualification explains how the test configuration and work instructions relate.
Document packing completion, handover and deviations
Record the required details of preparation, version used, packing completion and handover. If collection is delayed, check the permitted waiting time and designated storage location for the packed shipper.
If an incorrect pack was used or a spacer omitted, handle the error through the defined procedure. If the same error recurs, change material staging, instructions or training to address its cause.
Trial the instructions before routine shipping
Have a trained person follow the packing instructions without additional verbal guidance. Record missing item details, unclear images, time spent searching and waiting times. Correct these points and check the process again before releasing it for routine shipping.
Sources
- THERMOCON: Gel packs. Product and handling information for THERMOCON gel packs.
- EU GDP Guidelines 2013/C 343/01, Chapter 9. Chapter 9: transport, packaging and special storage conditions for medicinal products for human use.
Editorially updated on 5 November 2026.
Discuss your packout with THERMOCON
Describe the packout, the equipment used to prepare the coolant packs and the step that does not work reliably in daily use. Existing packing instructions, photographs and temperature histories help the technical discussion.