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Pharmaceutical Logistics: Challenges of Temperature Management

Pharmaceutical logistics represents a major challenge, especially in terms of temperature management throughout various stages of supply chain. It is a risky sector for logistics: the cold chain must never be broken. It needs an infallible and secured storage and transport organization under controlled temperature conditions.

According to “l’Institut International du Froid” (International Institute of Refrigeration), it exists about 50 000 references of medicines across the whole world, and the cold products represent about 500 references. These 500 references represent 10 to 20% of the turnover.

Storage temperatures for drugs are set by the pharmaceutical regulations and the marketing authorization. There are three major categories:

GEODIS_Medicinestemperature

 

Let’s see different challenges related to temperature management:


Regulatory framework

Good Distribution Practices (GDP) relate to frozen products, but also to shipment of ambient products. Logisticians and carriers must insure a proper temperature monitoring while treating health products. Each healthcare logistics actor must be able to prove that he respected the temperature monitoring and maintenance rules. A temperature monitoring must be put in place et controlled on a daily basis.

Each healthcare logistics actor has a major responsibility for being compliant with Good Distribution Practices.


Technical requirements

To keep the right temperature during storage and transportation of health products, there is a need for specific equipment:GEODIS_DataLogger

– Isothermal packaging: crates made of insulating walls and an overpack,

– Icepacks: cold accumulators in the shape of plastic briquettes filled with a special liquid

– Temperature recorders: a temperature monitoring must be performed continuously, thanks to measurement chains (probe, recorder, dataloggers). The devices used to control the temperature must be positioned where temperature variations are most significant.GEODIS_ColdRoom

– Cold Rooms: temperature maintenance equipment, such as cold rooms, are automatically combined with generators, which take over in case of power cut.

– Alarm: an alarm system must also be put in place within the warehouse, in case of exceeding authorized temperatures.

– Refrigerated transport: as for transport, many isothermal solutions are available on the market, to ship pharmaceutical products of high value at the temperature controlled at +2/+8°C: Active packaging supplied by an electric power source; Fully autonomous passive packaging; Semi-active solutions, ie autonomous isothermal packaging that provides constant payload control; etc.

 

At GEODIS, temperature control is insured by:

  • Automated surveillance through temperature recorders and humidity monitoring
  • Radio frequency liaison
  • Centralized server equipped with temperature traceability software
  • System of archiving and conservation of the recorded data
  • Annual calibration of measuring devices
  • Implementation of predefined frequency maps, to define the best locations in the warehouse to place temperature recorders.

 

 

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All of these storage and transport equipment and devices must be qualified and validated. The choice of equipment stays wide and free for logistics actors, only the obligation of result counts: demonstrate that storage and transport conditions for pharmaceuticals have complied with rules, advice, or requirements of the Good Distribution Practices of medicinal products.

 


Financial matters

Dominique SEVENO, a head pharmacist at GEODIS tells us: « Pharmaceutical logistics represents several challenges: financial, regulatory and ecological. The development of the temperature-controlled transport network is an essential prerequisite to face these challenges. In the notice diffused in November 2017 by the Inspection Department, to the head pharmacists, National Agency for the Safety of Medicines and Health Products (ANSM in French) reminds that storage conditions defined in the Summary of Products Characteristics and appearing on the packaging of the medicine, must be respected during transport. To meet these requirements, it is crucial to have a controlled temperature transport network (+2/+8°C, +15/+25°C…), that respects: the transport rules defined in the GDP; the transport delay required for emergencies, while remaining financially accessible to allow the marketing of health products at reasonable costs.”

The prices of healthcare products are quite variable. Some of pharmaceuticals can be very expensive: some biotech products may exceed 1000€, whereas vaccines cost only a few euros. These expensive products thus need packaging, transport and temperature traceability up to their value.

Regarding transport, the transportation of pharmaceutical products, medical devices, and other healthcare products is today more and more demanding and regulated by international and national authorities. Logistics activities linked to the transportation of healthcare products are supervised by the French Public Health Code. The challenge is to find carriers specialized in controlled temperature, capable to provide costs effective services, suchas respect of lead-times and the Good Distribution Practices.


Environmental mpacts

Pharmaceutical logistics is energy-consuming. The constant maintenance of a suitable temperature has an environmental impact. The challenge today is to develop processes that respect the objectives of sustainable development.

Concerning transport, some of healthcare products isothermal cases are not environmentally friendly, because they are not recyclable.

Today, refrigerated trucks with bi or tri-temperatures are being developped. They operate with their own battery. This autonomous system reduces the consumption of diesel and CO2.

 

 

 


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The challenge of pharmaceutical logistics is to respect the integrity of pharmaceutical products and ensure their safety, from production to the final consumer, including storage and transport. The respect of medicines cold chain is a major challenge of Public Health. Temperatures variations can have significant impacts on the healthcare products. Johan GIRARDON, Account Manager for Healthcare Market, tells us: “GEODIS insures the compliance with the GDP within our pharmaceutical depositary site in France, with strict processes and under the responsibility of our site pharmacists. The regular audits of the ANSM (National Agency for the Safety of Medicines and Health Products) support our approach. These procedures, audited and controlled, are provided to all of our transport providers, who distribute to pharmacists, hospitals, wholesalers’ distributors, as well as animal health actors.”

 

 

GEODIS_PharmaceuticalExpert

 

Special thanks to Dominique SEVENO and Johan GIRARDON, for information provided and for their advice.

 

 

 

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  • Terry Chiu says:

    Great job Dominique & Johan. Same here in Hong Kong. Apart from GDP warehouse. We are moving on supplement production line. Can share with you in 2019 Q1