The lifespan of such medicines reduces significantly if the storage temperature drops or is exceeded even only briefly. In the worst case scenario, the pharmaceutical is rendered ineffective – this is particularly dramatic if the medicines are for treating life-threatening illnesses, which is frequently the case with refrigerated pharmaceuticals.
The high standards applied to organisational processes and security, as well as the observation of these standards across the Celesio Group ensure that our deliveries are of an impeccable quality within our cold chain logistics. We want to be a role model for Germany in exampling how a medicine makes its long journey from the manufacturer to the patient.
Konrad Betzler, Head of Quality Governance Group Operations, says: Modern, biopharmaceuticals help to treat illnesses today which, just a few decades ago, spelled certain death for the patient. However, these pharmaceuticals are sensitive to temperature and it is often impossible to see the damage caused by heat or cold.
The journey begins with the manufacturer of the medicine. Pharmaceuticals requiring cool storage are packed in cool boxes here or loaded onto refrigerated vehicles which maintain the temperature between two and eight degrees Celsius. They are then delivered to one of GEHE's 19 wholesale branches. To ensure that the cold chain is not broken, it is vital that goods are accepted and stored quickly. We also verify the transport temperature, either by reading out the temperature recorder in the refrigerated vehicles or by checking the data logger supplied with the cool boxes. If we note a deviation from the temperature range, the goods are withdrawn immediately from circulation.
Pharmacists and patients can have complete confidence in us: we guarantee quality.Konrad Betzler, Head of Quality Governance Group Operations
If everything is in order, the medicine is kept in cold stores. To ensure that the medicines are stored quickly and then later removed just as quickly, the cool storage units must be integrated seamlessly into the goods flow. We often use single opening drawers and transparent glass fronts just like you find in the supermarket. This allows us to remove the goods quickly and efficiently while minimising cold loss.
As a basic technical requirement, a cool storage unit must have two separate refrigeration units to ensure sufficient cooling should one unit fail. The refrigeration unit's ability to maintain consistent, steady temperatures between two and eight degrees Celsius in the storage area must also be verified by taking regular, independent measurements.
The connection of an emergency power unit, which is tested regularly for efficiency usually on a monthly basis, is also mandatory, as is round-the-clock temperature monitoring. Any temperature deviations raise the alarm and initiate emergency plans. In the event that temperature deviations or other technical malfunctions occur, emergency plans are in place to be able to evacuate the warehouse contents at night or at the weekend either to other storage rooms or into refrigerated vehicles.
Once a pharmacist has ordered the medicine, we get busy with the travel preparations. After the medicine has been removed from the cold store, it is transferred directly to an insulated transport box, a reusable container with a Neopor® lining. This high-tech material has an insulation value that is 20 per cent higher than normal polystyrene.
Extra frozen cold packs are then added. Exactly how many is determined by the outside temperature. During the transition periods between seasons, the number of cold packs used can vary over the course of a single day. So that the right number of cold packs is always included, electronic displays are available on site to provide the employees in the warehouse with the latest information.
Even at an outside temperature of 40 degrees Celsius, our cool boxes ensure secure transportation of up to 24 hours.Robert Krause, GEHE branch manager in Stuttgart
Even freezing and defrosting cold packs is a science in itself. Specific provisions apply here which define how long and at what temperature the units can be cooled and how far in advance they need to be defrosted before being used. All these aspects had to be proven for the boxes through extensive tests confirmed by the TÜV (German Technical Inspection Association).
The cool boxes can then be transported and delivered together with the goods that are less sensitive to temperature. At this stage, it is important that the pharmacist is immediately able to recognise the refrigerated goods as such once they arrive. GEHE leaves nothing to chance here. The typical blue GEHE boxes have a red standard lid that is labelled with "Refrigerated pharmaceuticals". Since the pharmaceuticals remain chilled in the cool box for ten hours even at an outside temperature of 40 degrees Celsius, it is usually possible to make deliveries at night. Overnight deliveries are frequently the largest orders of the day since they enable the pharmacist to stock up early in the morning when there are not many patients in the pharmacy.
The medicine requiring refrigeration has now reached its destination in perfect condition. And GEHE has once again contributed to a secure pharmaceutical supply in Germany.
Facts and figures of the cold chain:
- The GEHE branches delivered 70,000 different pharmaceuticals in 2014.
- Of these, around 3,000 were refrigerated goods.
- Refrigerated goods are products which need to be stored and transported between two and eight degrees Celsius.
- This equates to 2.7% of all delivered packages.
- Refrigerated products, however, represent 23% of the goods value and are therefore on average eleven times more expensive than other pharmaceuticals.
- This temperature range also has to be maintained during dispatch.
- Biological and genetically engineered high-tech pharmaceuticals, such as vaccinations, blood products, insulin, cancer drugs and immunotherapeutic agents must be refrigerated.
- The key element in GEHE's DIN ISO 9001-certified cold chain logistics is its insulated cool box.
- Even at an outside temperature of 40 degrees Celsius, the cool box keeps pharmaceuticals chilled for ten hours.
- So that pharmacists are able to recognise immediately that the goods are refrigerated pharmaceuticals, the typical cyan-blue GEHE cool boxes have red standard lids labelled with "Refrigerated pharmaceuticals".