Key benefits of partnering with Envirotainer for a New Product Introduction

Christoph Honermann Head of Global Key Accounts, Pharma
christoph.honermann@envirotainer.com

At Envirotainer we have more than 30 years of experience of temperature-controlled air transport. So far, we have helped more than 600 pharmaceutical companies worldwide with both regular shipments and New Product Introductions. In this article, we present what we can do to help you design a successful NPI process and lay the foundation for operational excellence of temperature-controlled shipments. Our experience is that a reliable cold chain is much more than just a container. It is the sum of a combination of products and services that together lead to a successful New Product Introduction.

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Choosing the safest solution for the NPI

A New Product Introduction is a business critical, high-risk event. A safe and reliable logistics solution is crucial to ensure success. Especially temperature-sensitive pharmaceuticals need a protected environment, as even small temperature deviations may lead to degraded products. Envirotainer can offer you the most reliable solution on the market for your product launch – active temperature-controlled containers that can ensure exact temperature ranges to protect your products. Active containers minimize the risks at a product launch when time is critical and the products must be kept intact – also in the case of unforeseen events such as delays or canceled flights that may lead to cargo being stored for a long time in shifting ambient temperatures.

The world’s largest fleet of active containers

Envirotainer is the world leader of active cold chain solutions for air transport. We currently have a fleet of 6,000 temperature-controlled containers that are leased to customers worldwide. Our vast container fleet means that we can support customers all over the globe, also in the case of very large shipments, to build operational excellence in temperature-controlled logistics.

For any type of sensitive pharmaceutical, we can ensure a reliable logistics solution for your NPI. All our containers have FAA (Federal Aviation Administration) and EASA (European Aviation Safety Agency) approval. To reduce the risks in handling of the containers, all containers are certified air cargo ULD (Unit Load Device), which means that they can be directly carried on board and fastened in all common wide-body aircraft types. The containers do not have to be loaded onto a pallet or other type of solution to fit into the aircraft, which saves time and reduces the risks of loading and unloading.

Extensive maintenance and training programs

A correct handling of the containers during transport is necessary to safeguard product integrity and to ensure an unbroken cold chain. To ensure optimal performance of our containers, we have an extensive preventive maintenance program in place. The containers are always monitored by trained personnel after each lease. We have a global network of more than 50 certified service stations that provide ground handling and maintenance. All our service station partners are trained on a regular basis to ensure that the containers are handled correctly. We have implemented CAPA processes to continuously improve our operations and container performance.

All our service station partners are trained on a regular basis to ensure that the containers are handled correctly.

Our QEP (Qualified Envirotainer Provider) program ensures that airlines and forwarders that handle our containers are trained to meet certain obligations defined in current Good Distribution Practices guidance documents. In 2012, QEP won the IQPC Cold Chain Excellence Award for “Innovation in Quality Distribution”. Currently, over 750 stations in 180 airports across the world participate in our QEP program. We also have our Envirotainer Academy that provides basic and advanced training for all personnel handling our containers.

TTP – our qualification services for shipment validation

During our years in the business, we have gathered thorough data on the performance of our containers for intercontinental air freight. The data forms the basis of our shipment validation package – the Technology Transfer Package or TTP. The TTP gives you access to all necessary documentation to qualify our containers for your shipment. This service will both speed up your qualification process and save costs. We also have a laboratory with two climate chambers, where we can simulate shipment routes, temperatures and humidity profiles.

Post-shipment data to support operational excellence

A product launch is a special one-time situation. However, a well-planned NPI process should also lay the foundation for successful future regular deliveries. If you work in an operational excellence team or are an operational excellence manager, or similar, you must be able to evaluate the shipment to see if there is anything that needs to be improved or changed. This means that you will need access to historical data on the shipment. To support you in this process we offer the following services for post-shipment analysis:

1. Active Container Data

Ambient temperature and temperature inside the container are monitored during transport, as well as opening and closing of the container doors. The data is summarized in a two-page report that you will receive within two working days.

2. Transport Evaluation

A quick overview of the shipment with informative graphs and diagrams, which highlight where deviations may have occurred. With this service you will be able to improve communications with external partners and thereby extend your operational excellence strategy to include areas outside of your company.

3. Shipping Summary Reports

The Shipping Summary Report contains an analysis of the shipment and also gives recommendations on how to improve the cold chain.

Other services – cost efficiency, technical support and FDA documents
In addition to our qualification services and post-shipment analysis, we can also support you with other services that can assist you at the New Product Introduction, for example:

  • Pre-packaged documents for FDA
  • Calculation of Total Landed Cost to find the most cost-efficient shipping solution
  • Calculation of carbon dioxide emissions
  • Load optimization to maximize the use of space for each container

 

Total Landed Cost and sustainability

How pharma can save money and be friendlier to the planet

In the pharma industry, approximately 90% of all carbon emissions are generated in the manufacturing phase. The biggest positive impact on carbon emissions the secure cold chain can have is therefore to ensure that every single dose that is manufactured reaches the patient securely and on time.

Good Reads #5: New sulphur cap could be disruptive to ocean freight

Pharma cold chain logistics is very complex with many stakeholders involved. We all work hard to ensure that pharmaceuticals maintain optimal quality all the way to the patients. At Envirotainer we believe that the best way to reach our common goal is to improve collaboration and mutual understanding across the logistics chain, we call it our eco-system thinking. Here, we share articles with our network that we think could benefit us all.

Good Reads #4: Product recalls

Pharma cold chain logistics is very complex with many stakeholders involved. We all work hard to ensure that pharmaceuticals maintain optimal quality all the way to the patients. At Envirotainer we believe that the best way to reach our common goal is to improve collaboration and mutual understanding across the logistics chain, we call it our eco-system thinking. Here, we share articles with our network that we think could benefit us all.

Envirotainer has the following logistics capabilities:

  • More than 5,800 active containers
  • Annual capacity to ship 140,000 pallets
  • A global network of 50 accredited service stations
  • Covers over 200 airports and 2,000 trade lanes
  • Cooperates with more than 100 airlines and more than 40 forwarders over the globe.

Related articles you might find interesting

7 steps for pharma to protect a New Product Introduction from failure

A New Product Introduction, NPI, is a complex and risky process. Even though approval dates are often not known in advance, transport must take place immediately after approval and must follow the specific requirements of the pharmaceutical. Damaged batches or delays could put the whole product launch at risk and could even have devastating consequences for the company and ultimately the patients. Here are seven steps that quality managers could use as a guide to protect the NPI process and to build operational excellence.

Why your New Product Launch is Critical for Success

A New Product Introduction, NPI, is a high-risk operation, being the final stage of years of research and development of a new pharmaceutical.

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