Implementing an End-to-End Temperature-Controlled Alternative


139 DGF Air Load 18 x


Client Basics

Client: Large Biotech Manufacturing
Destination: Ministry of Health in Brasilia, Brazil
Project Scope: $21+ Million USD
Unique Factors: Charter Flight, Envirotainer (e2) Containers

Background

A large European biotech manufacturing client had recently won a contract to ship product to the Ministry of Health in Brasilia, Brazil. The request was very special in nature: to ship 15+ Envirotainer e2 containers on the same flight; the commercial value of the goods totaled more than $21 million USD. Usually, the international transport of biopharmaceutical products is a challenge, but when it comes to moving 15+ cool containers at the same time, it becomes a major one.

Approach

Under unique circumstances, time- and temperature-sensitive products may be sent by charter when regular commercial airlines, including freighters, are not able to meet delivery targets or do not fly the routings clients need. In this instance, the client needed to deliver a large amount of product to its client. Because the available commercial flights lacked the capacity to move 15+ cool containers at a time, LifeConEx proposed a charter flight.

Much more scheduling flexibility is available on charter flights. Charter flights also are almost always direct, meaning the cargo doesn’t have to change planes or wait during layovers. However, some challenges still arise with this method of transport.

Sourcing available cool containers needs to be a coordinated effort and must include storage capacity of the containers at the origin station and destination airport. Because of the magnitude of this kind of operation, actions such as pre-charging the e2 containers had to be done ahead of time to ensure their set temperature was 5°C. This needed to be done before the goods were loaded into the containers within a temperature-controlled warehouse chamber set at 2° to 8°C. All the temperature-sensitive product on the pallets needed to be kept in this 2° to 8°C temperature range.

Another challenge arose while the containers were being charged and the import permits were placed on request: The charter airline operator struggled to get the landing and flight permits because the operator was not a usual one at the origin airport. As is the case with all international shipments, customers shipping to different ministries of health around the world depend on import permits — and these have to match the aircraft available. 

Solution

Through intensive coordination from LifeConEx, all parties involved were aware of their roles and responsibilities, which facilitated collaboration among the client’s logistics and finance departments, the freight forwarder at the origin, Envirotainer, the trucker, airport authorities, ground handlers, loading agents and the destination site. LifeConEx designed a detailed and comprehensible, GDP-compliant SOP that outlined all parties and their duties.

Results

You can have the best of everything — packaging, charter operation, pharmaceutical product competence, complete client support and a very knowledgeable and globally experienced freight forwarder — and still fail.

As regulatory compliance increases, health authorities such as the Brazilian Health Surveillance Agency (ANVISA) are requiring proof of how these transports are executed. These agencies want to see how the process was controlled; stability study data is no longer allowed, only stress study data is accepted. This is where LifeConEx excels. We not only design very detailed processes, we get conformity from all parties and even take special measures to ensure our customers meet their clients’ expectations. In this instance, we deployed one of our managers to be present on the ground in Brasilia to oversee the reception of the containers and their goods.

Because evidence of GDP starts from the moment the product departs the customer’s manufacturing site, every container had an RFID SmartSensor placed on the product pallets. In addition, our team of life sciences specialists collected information 24/7 to ensure all steps outlined on the quality agreement were recorded. This provided our customer the necessary information to provide proof of controlled processes to ANVISA.

Because risks were mitigated based on the regulatory environment, the customer’s shipment was released by customs in Brasilia with no temperature deviations along the 8000km trip — resulting in complete customer satisfaction.