TRANSPORTATION OF THERMO-SENSITIVE PRODUCTS

THE EUTECTIC PART

The range of our thermal gels allows to keep validated temperature under control. Our refrigerating devices are both efficient and cheap. We use non-toxic thermal gel that is not dangerous not irritating, thus - according to EC directives – does not require labellling. All devices are sealed with a very strong and pierce-resistant multilayer film and closed in a coextruded polypropylene bag, which has a low density that makes it impossible to be deformed and guarantees steady performances in all positions. We are talking about absorbing polymers aggregated in a eutectic mix that can accumulate a very high amount of frigories per unit of weight. This occurs during the passage from liquid/gel to solid state (eutectic change), in which frigories are released during the so called inversed change. Moreover, the cardboard box (PK20) favours a low release of the cold, thus helps to prolong the usage time and avoid the risk of freezing.

The correct  storage and transportation of medicinal products is a key factor to maintain the characteristics of the products unchanged throughout their shelf-life and to guarantee their pharmacological activity. According to Italian Official Pharmacopeia (FU) “A medication is considered stable when during a certain period of time its main properties do not change or change within tolerable limits, it is stored in a suitable packaging and at pre-established temperature, humidity and light exposure conditions”.

TEMPERATURE-SENSITIVE DRUGS

There are always more temperature-sensitive drugs in the market due to the greater availability of biological drugs and the lower time required to verify their stability throughout their shelf life. When evaluating the safety of a pharmaceutical product, the aforementioned condition makes cold chain maintenance during all transport phases a difficult task. The integrity of temperature-sensitive drugs is guaranteed only before minimum variations. The most required temperature ranges for temperature sensitive drugs are +2°C to +8°C, +8°C +25°C and +15°C +25°C.

GUIDELINES ON GOOD DISTRIBUTION PRACTICE FOR MEDICAL PRODUCTS (GDP)

Just like the production of drugs leads to Good Manufacturing Practices (GMP), their wholesale distribution should ensure the implementation of Good Distribution Practices (GDP). Proper GDP implementation guarantees the end user of the quality, efficacy and safety of the drugs.

With the latest update of the European Directive, the new GDP requirements state that medicines must be transported in containers that do not have adverse effects on the quality of the products and that offer adequate protection against external influences, including contamination. Moreover, approved equipment should be used, including Isothermal Cool Kits, for temperature-sensitive medicinal products. The equipment/kits must be validated and adapted to the transport system, to reduce the logistic risks and ensure the safety and integrity of the product. (Directive 2013/C 343/01 updated to November 2013).

COLD CHAIN

The Cold Chain must be maintained through continuous cooling and logistics plans designed to guarantee the stability of the drugs.

The distribution of temperature-sensitive pharmaceutical products generally foresees the transfer of these drugs from the manufacturing sites to an intermediate, national or regional storage point that will then take care of the distribution to pharmacies sometimes via wholesalers network.

The use of isothermal and refrigerated packaging with certified characteristics, customised according to the transport system used, is fundamental to reduce logistic costs and guarantee the safety of the medicinal product.

COLD CHAIN CRITICALITY

The critical issues linked to the cold chain are mainly due to local orography, different steps of the distribution chain (storage site → distributors network → final user) and to the so-called final mile. All these issues can be overcome by using refrigerated isothermal packaging during temperature-controlled transportation in order to have full coverage throughout the transportation phase and, thus, preserve temperature sensitive medicinal products from excursions that may damage the product and make them no longer effective, if not dangerous for the patient’s health.

CERTIFIED QUALITY

Iso ThermoFarma® Kits have been certified for up to 120h in case of temperature controlled shipment of cold chain products (+2°C +8°C) and up to 48h/72h for the shipment of +2°C +8°C or +8°C +25°C products made via express courier (Out Cold Chain) and in different configuration profiles (Winter/Summer). Iso ThermoFarma® Kits have undergone different validation tests also those in compliance with AFNOR NF SN 99700 qualification method and certified by the third entity enabled lstituto Giordano SpA.

Example Test 96h ICC +2°C +8°C Ext T <> +5°C +20°C.

 Example Test 120h ICC +2°C +8°C Ext T <> +5°C +20°C.

Example Test 48h OCC +2°C +8°C Ext T <> +22°C +40°C.

The Mean Kinetic Temperature (MKT) is “a single derived temperature that – if maintained for an established time - causes to a substance or biological product the same thermal effect that would occur if the product faced a sequence of lower or higher temperatures for an equivalent time”*.

This index is achieved - as far as the variation in time of the temperatures is known - through the activation Energy of the event (process, reaction) critical for the quality or stability of the  product/system, and is widely used in the pharmaceutical sector.

The Mean Kinetic Temperature (MKT) can be considered as an isothermal storage temperature that simulates the non-isothermal effects of the changes on the storage temperature. It is not a mere mean value; it also has exponential and logarithmic implications and it is calculated using the so-called Arrhenius equation, expressed as follows:

in which:

• Tk = MKT in K
• ΔH = activation heat/energy (83 KJoule x size^-1)
• R = universal gas constant (8.3144 x 10^-3 KJ x size^-1x K^-1)
• Ti = temperature indicated in K
• n = total number of same-time intervals during which the data was registered

*Source: (US PHARMACOPEIA USP29-NF24)

Ease of management, competitiveness and guaranteed safety.

Compared to other isothermal packaging products made and distributed in Italy or in Europe, Iso ThermoFarma® Kits are the most practical and the best choice also in terms of cost:

- easy to assemble

- optimized management of the inventories due to the weekly delivery service all over Italy

- a highly competitive product-yield-cost ratio and a certified quality to guarantee the stability of the products throughout their period of use.

- ease of disposal: ThermoFarma® packaging in Sintered Expanded Polystyrene, are fully recyclable and easily disposable as they are a single product, compared to coupled packaging, consisting of cardboard and polyurethane or cardboard, aluminum and foam.

ISO THERMOFARMA Kit: Examples of assembly for different configurations

- Weekly shipments all over Italy (full truck)

- Stock always available

- Design and planning of “ad hoc” sizes and configurations

- Climate tests and Reports on request

- Guarantee of Validation Reports made by certified validation bodies such as

  Istituto Giordano SpA

For more information and to request a quote, please contact our sales office :

commerciale@thermofarma.net 

am.lantieri@gmail.com

ThermoFarma®