Pharmaceutical and life science transit packaging has to be demonstrable, not merely adequate. The pack is specified as a bill of components so that what ships is what was approved, and temperature-controlled shipments depend on void volume as much as on the insulation itself.
- Specified as components, not as an outcome
- Void volume, and the most common cold chain failure
- Identification and the integrity of the chain
- Secondary containment
- Returns and sample logistics
- Change control and packaging
- What we need
- A first step for life science businesses
- The short version
- Frequently asked questions
Specified as components, not as an outcome
In most sectors a packaging specification describes a result: protect the product, keep it dry, get it there. Here it has to describe a method - this outer, this insert, this closure, in this order - because the pack is part of a controlled process and has to be reproducible.
A protection standard met by judgement is not controlled, however competent the judgement. That is the single biggest difference from general industrial packaging, and it shapes everything else.
Void volume, and the most common cold chain failure
An insulated shipper performs to its validated specification when it is filled the way it was tested. Half empty, it behaves very differently - the air inside convects, the thermal mass is wrong, and the duration it holds temperature falls sharply.
That makes void fill part of the thermal specification rather than a packing convenience. A shipment that failed on temperature has very often failed because somebody shipped a part-load in a pack validated for a full one.
| Variable | Why it cannot be decided separately |
|---|---|
| Insulation type and thickness | Sets the baseline duration |
| Coolant type and quantity | Interacts with thermal mass |
| Void volume and fill | An under-filled pack behaves differently |
| Route duration | Determines what duration is needed |
| Ambient conditions | Summer and winter are different problems |
| Pack-out method | Validated performance assumes a method |
Cold chain variables that have to be specified together.
Identification and the integrity of the chain
A pack that has to be opened to establish what is inside breaks the chain it exists to protect. Labelling position and documentation placement are part of the specification, and documentation generally belongs on the outside of the primary pack.
Tamper evidence belongs there too rather than being added at despatch - a closure that is evident when disturbed is a specification choice, not a tape choice made at the bench.
Secondary containment
- Liquids need a secondary pack that contains a primary container failure rather than spreading it.
- Absorbent material sized to the volume, not a token amount.
- Sealed secondary containment where the contents require it.
- Compartmented inserts so units cannot contact each other - see Foam Inserts: When a Fitted Pocket Pays for Itself.
- A defined return pack for samples and clinical returns, separate from the outbound specification.
Returns and sample logistics
Return packs are frequently an afterthought and should not be. The contents, the containment requirement and the person packing are all different from the outbound journey, and reusing the outbound pack assumes a competence at the far end that may not exist.
A supplied, specified return pack removes that assumption - see returns management for how returns are handled once they arrive.
Change control and packaging
Because the pack is specified as components, changing any of them is a change to a controlled process. That is a reason to get the specification right rather than a reason never to improve it - but it does mean packaging changes here carry administrative weight that they do not elsewhere.
Practically, it argues for specifying with some headroom and for holding stock of an approved pack rather than re-sourcing frequently. See packaging stockholding.
What we need
The product and its sensitivity, the route and its duration, the temperature requirement if any, whether returns are involved, and any existing validated specification. Where a pack is already validated, the job is usually supply consistency rather than redesign.
See protective packaging for the protective range and packaging supplies for standard lines.
A first step for life science businesses
The two questions worth answering before anything else are whether the pack is genuinely repeatable and whether your cold chain packs are being filled as they were validated.
- Write the pack out as a bill of components. If that document does not exist, the pack is not controlled.
- Check a part-load cold chain shipment. Under-filling a validated pack is the commonest thermal failure.
- Confirm documentation sits outside the primary pack.
- Check your secondary containment against a primary failure, not against normal handling.
- Establish whether a defined return pack exists - see returns management.
The short version
- The pack is specified as components so that what ships is what was approved.
- Void volume is part of the thermal specification, not a packing detail.
- Documentation belongs outside the primary pack, not against the product.
- Secondary containment is designed against a primary container failure.
- Return packs need their own specification rather than reusing the outbound one.
Frequently asked questions
Can you supply temperature-controlled packaging?
We specify and supply insulated liners and the void control that goes with them. The point most often missed is that thermal performance assumes the pack is filled as it was tested - an under-filled insulated box performs very differently.
Why did our cold chain shipment fail on temperature?
Most often because it was a part-load in a pack validated for a full one. Void volume changes convection and thermal mass, and the hold duration falls.
How do you make a pack repeatable?
By specifying it as a bill of components in a defined order rather than as a protection outcome. That is what makes the pack that ships the same as the pack that was approved.
Do you handle clinical returns packaging?
Yes, and it is worth specifying separately from the outbound pack. The contents, the containment requirement and whoever is packing it are all different - see returns management.
Does changing packaging require re-validation?
Where the pack forms part of a controlled process, a change to it is a change to that process. That is an argument for specifying with headroom and holding an approved pack - see packaging stockholding.
How should glassware and vials be packed?
In compartmented inserts or moulded pulp, with nothing loose and no unit able to contact another. Inter-item impact is where glassware fails, and loose fill packed around a group does not prevent it because the units still move within the fill.