Storage temperature does not equal transport temperature
Since the EU Guideline on Good Distribution Practice – known as the GDP Guideline – was introduced there has been a lot of debate between pharmaceutical wholesalers and producers in Germany; the reason being the very strict rules adopted by the authorities for the temperature specifications for distributing medicinal products for human use.
According to GDP specifications medicinal products for human use must be transported “in an acceptable range”; temperature here is governed by the storage temperature indicated on the packaging. Drug manufacturers and wholesalers feel that this wording does not sufficiently consider the various transport process steps (loading, unloading, etc.). Even using commercially viable, certified standard transport systems, they say, it will be impossible to safeguard the defined storage temperatures at all times without any interruptions. This is why industry representatives demand acceptance criteria for brief interruptions (up to 12 hours) for local transport. Stress tests have shown, they add, that short-term interruptions and/or exceedance of the storage temperature indicated on the packaging will not negatively impact the quality of medicinal products in the European climate zone I/II. They feel it is therefore not necessary to adopt particular specifications for transport within the EU. Highly sensitive medicinal products are of course exempted from this.
Packaging solutions for medicinal products in need of cooling
In Germany there are over 2,000 medicinal products in need of cooling or cold chain transport. These include not only specific vaccines, asthma sprays or biological preparations used to treat rheumatic or oncological diseases, but also insulins. They may only exceed a temperature of +8 °C for a short period of time. The mandatory storage range for such highly temperature-sensitive active agents is from +2 °C to +8 °C. Temperatures must never fall below 0 °C. At sub-zero temperatures these substances may freeze and change their structure, which can entail intolerances or side-effects in patients. Ointments, lotions or drops must also be protected from overheating.
Be it one-way or recyclable, folding or robust – The packaging industry has numerous solutions for the suitable transporting and storing of pharmaceutical products for both wholesale and retail customers in store. Cool boxes in polyurethane foam, polypropylene or extruded polystyrene with an aluminium foil coating boast outstanding insulation properties against extreme temperatures while ensuring the required impact resistance at the same time.
Bags with several layers of insulating foil are also perfectly suited for transporting private end users’ drugs from the pharmacy. Standard cardboard boxes can be equipped with insulating inlays and cooling elements so that the temperature range of 2-8°C can even be ensured for 24 hours with an ambient temperature of 20-25°C.
Special insulating foils consisting of two layers of aluminium-coated bubble foil reflect UV and heat radiation. This means they are ideally suited for pallet transport but also lend themselves to insulation inside: in combination with dry ice they also allow frozen goods to be transported.
The solution for long-haul transport by plane or vessel is extremely rugged PVC overseas containers. Pallets are protected against extreme temperatures by thermal covers. As an alternative, the industry offers insulating transport cartons. These consist of a ring and an inverted tray of rugged corrugated board laminated with an insulating foil. This is a practical solution as it renders additional stretch-film wrapping superfluous.
In the pharmaceutical industry the use of temperature loggers is mandatory for nearly all shipments of temperature-sensitive goods. Loggers record and control temperature. State-of-the-art devices are equipped with USB interfaces that save the reports in pdf format or even print out the temperature curves while measuring.
Mean Kinetic Temperature (MKT)
The mean kinetic temperature is the kinetic mean (average) of all temperatures that the medicinal product was exposed to during storage and transport in the supply chain. Source: Position paper BAH, BPI, vfa, Pro Generika and PHAGRO, November 2015.
Those preferring natural solutions can also deploy wool for protecting highly sensitive pharmaceutical products. Developed in the United Kingdom, the insulating “LifeGuardian" pack consists of 100% wool and guarantees safe transport and storage of drugs at 2 °C - 8 °C for up to 150 hours.