In pharmaceutical distribution the cold chain runs on the same physics as food but speaks a different language. What matters here is that the holding time is validated and repeats on every trip.
What the guide asks for on the transport side
In its shipping chapter, the Turkish Medicines Agency's Good Distribution Practice guide states several points plainly:
- It is the wholesaler's responsibility to protect products against breakage, deterioration and theft, and to ensure temperature conditions stay within acceptable limits during carriage.
- A risk assessment of delivery routes must be carried out to determine where temperature controls are needed.
- Equipment used for temperature monitoring inside vehicles or containers during shipment must be maintained and calibrated at regular intervals, at least once a year.
- For temperature-sensitive products, qualified equipment must be used: thermal packaging, temperature-controlled containers or temperature-controlled vehicles.
- Temperature mapping must be performed under representative conditions, taking seasonal variation into account.
What stands out in those clauses is that the container is treated as the equal of the vehicle: the guide names temperature-controlled containers and vehicles in the same sentence.
Separate rules for ice packs
The guide does not forbid the use of ice packs in insulated boxes; it regulates them. What it asks: the packs must be positioned so the product is not in direct contact with them; staff must be trained in the use of insulated boxes across seasons and in the reuse of packs; a control system must exist so that packs which are not fully frozen are not used by mistake; and there must be adequate physical separation between frozen and chilled packs.
That last point is the one most often missed on the ground: if packs at +5 °C and at -21 °C sit in the same store, mixing them quietly ruins a shipment.
Transfer points and waiting
The guide defines a transfer point as a temporary storage location where products may be held for a maximum of 72 hours provided the necessary measures on storage conditions are taken, and requires temperature monitoring, cleanliness and security there. Where products requiring special storage conditions pass through, the conditions defined in the supplier's shipping validations must be followed - polystyrene boxes, ice packs and datalogger placement are given as examples.
In practice that means the arrangement inside the box is not arbitrary; it is part of the validation study. The same box with a different internal layout is a different system.
What is examined on the equipment side
| Topic | What is required | Where it is met |
|---|---|---|
| Temperature-controlled container | Use of qualified equipment | An insulated container with a plate regime chosen for the range |
| Temperature monitoring | Records throughout the shipment, calibration at least yearly | A logger placed inside the box |
| Temperature mapping | Representative conditions, seasonal variation | A study run in summer and winter conditions |
| Pack management | Control of fully frozen packs, physical separation | Separate slots on the freezing rack, labelling |
| Product-to-pack contact | No direct contact | Intermediate shelf and plate rails |
| Procedure | Written, consistent with the validation | The organisation's own quality system |
Why insulated containers come up at all
The route profile in pharmaceutical distribution resembles the food one: a vehicle leaves the warehouse and calls at dozens of pharmacies a day, the door opens at every stop, each drop takes minutes. A system holding the cold in the body air starts over at every stop; a closed container is opened only at the drop it belongs to.
The second reason is the record: when the logger sits inside the box, the record tells the story of one shipment. A vehicle record is an average across the whole round and shows nothing about what a single box experienced.
Which equipment on the Isotec side
The GEBHARDT Isotec TBX comes in nine sizes from 410 to 1500 litres, with 500-700 kg payload and regimes of 0…+2 °C and -21…-25 °C. The holding time GEBHARDT states with eutectic plates or dry ice runs up to 24 hours. Inside the box, an intermediate shelf and plate rails keep the goods away from the plate, and a rail arrangement under the lid holds the plate in place.
For the 2-8 °C range the plate regime is chosen for that range; a deep-freeze plate is wrong for the job and risks freezing the product. Send Aris Makina your product group, target range, route duration and seasonal conditions and we will set the size and plate regime with you; the technical data needed for a thermal analysis we obtain from GEBHARDT and pass on.
Preparing for the validation study
A shipping validation is usually built in these steps: define the worst case (longest route, hottest day, most door openings), fix the internal layout, place loggers at more than one point, repeat under summer and winter conditions, and turn the result into a written procedure. The equipment is an input to that study, not its output - buying the box does not mean the validation has been passed.
