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What’s Inside Page 2 CEO Update Page 3 Q & A with Susan Rocca, Chairman of Envirotainer’s Advisory Board Page 4 The world welcomes Envirotainer’s new RAP e2 container Pages 5 & 6 Improving fleet availability U.S. FAA confirms certification for Envirotainer’s RKN e1 heating and cooling air cargo container Cold Chain Management Dialogue Cold Chain Management Dialogue Newsletter from Envirotainer, leading provider of temperature-controlled solutions in air transportation Issue 20 October 2011 The U.S. Federal Aviation Administration (FAA) has approved the certification of Envirotainer’s RKN e1 electrical heating and compressor cooling air cargo container, providing a welcome boost to the global life science and healthcare industries. Envirotainer, pioneer of the world’s first active temperature-controlled container in 1995, has seen exceptional global demand for the RKN e1 since it was first approved by the European Air Safety Agency (EASA) in June 2005. However, although it is regularly used on U.S. routes by international airlines, the FAA approval required for U.S. flag carriers to fly the container became held up in the E.U.-U.S. aviation safety bilateral agreement. Now, just six months after the European and American authorities concluded their long-awaited bilateral agreement, the FAA has formally approved use of the RKN e1. Niklas Prager, CEO of Envirotainer, said: “The FAA approval of our RKN e1 containers provides more options to the life science and healthcare manufacturers of temperature sensitive products. They can now benefit from an expanded worldwide network through the use of already established codeshare and interline service points provided by airlines and forwarders worldwide. This new development, not possible prior to the FAA approval, increases the global access to the Envirotainer heating and cooling technology which benefits all stakeholders in the healthcare temperature control supply chain.” The RKN e1 has been a great success story for Envirotainer, which has invested very significant amounts of money in its technical and fleet development. Envirotainer has grown its RKN e1 fleet rapidly to meet demand from the life science and healthcare sectors and their airline and logistics partners. It currently has some 725 RKN e1’s in service and a further 75 will be added by the end of 2011, boosted by this latest development and to meet the ever growing demand in all parts of the world. At the turn of the year 2010/2011, following approval by EASA, Envirotainer launched the RAP e2, the next generation of e-technology air cargo containers for highly sensitive healthcare products. As well as embracing the very latest technology advancements, the RAP e2 provides greater volume capacity than the RKN e1 with its ability to accommodate five Euro or four US pallets compared to the RKN e1’s capacity for one Euro or US pallet. Envirotainer has also commenced the FAA certification process for the RAP e2. “This new development increases global access to the Envirotainer heating and cooling technology which benefits all stakeholders in the healthcare temperature control supply chain” Niklas Prager

Cold Chain Management Dialogue - Envirotainer CCMD... · RKN e1 heating and cooling air cargo container Cold ... difference. Whilst Envirotainer ... France-KLM Cargo from Amsterdam

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What’s Inside

Page 2 CEO Update

Page 3 Q & A with Susan Rocca, Chairman of Envirotainer’s Advisory Board

Page 4 The world welcomes Envirotainer’s new RAP e2 container

Pages 5 & 6 Improving fleet availability

U.S. FAA confirms certification for Envirotainer’s RKN e1 heating and cooling air cargo container

ColdChainManagementDialogue

Cold Chain Management Dialogue Newsletter from Envirotainer, leading provider of temperature-controlled solutions in air transportation

Issue 20 October 2011

The U.S. Federal Aviation Administration (FAA) has approved the certification of Envirotainer’s RKN e1 electrical heating and compressor cooling air cargo container, providing a welcome boost to the global life science and healthcare industries.

Envirotainer, pioneer of the world’s first active temperature-controlled container in 1995, has seen exceptional global demand for the RKN e1 since it was first approved by the European Air Safety Agency (EASA) in June 2005. However, although it is regularly used on U.S. routes by international airlines, the FAA approval required for U.S. flag carriers to fly the container became held up in the E.U.-U.S. aviation safety bilateral agreement.

Now, just six months after the European and American authorities concluded their long-awaited bilateral agreement, the FAA has formally approved use of the RKN e1.

Niklas Prager, CEO of Envirotainer, said: “The FAA approval of our RKN e1 containers provides more options to the life science and

healthcare manufacturers of temperature sensitive products. They can now benefit from an expanded worldwide network through the use of already established codeshare and interline service points provided by airlines and forwarders worldwide. This new development, not possible prior to the FAA approval, increases the global access to the Envirotainer heating and cooling technology

which benefits all stakeholders in the healthcare temperature control supply chain.”

The RKN e1 has been a great success story for Envirotainer, which has invested very significant amounts of money in its technical and fleet development. Envirotainer has grown its RKN e1 fleet rapidly to meet demand from the life science and healthcare sectors and their airline and logistics partners. It currently has some 725 RKN e1’s in service and a further 75 will be added by the end of 2011, boosted by this latest development and to meet the ever growing demand in all parts of the world.

At the turn of the year 2010/2011, following approval by EASA, Envirotainer launched the RAP e2, the next generation of e-technology air cargo containers for highly sensitive healthcare products. As well as embracing the very latest technology

advancements, the RAP e2 provides greater volume capacity than the RKN e1 with its ability to accommodate five Euro or four US pallets compared to the RKN e1’s capacity for one Euro or US pallet. Envirotainer has also commenced the FAA certification process for the RAP e2.

“This new development increases global access to the Envirotainer heating and cooling technology which benefits all stakeholders in the healthcare temperature control supply chain” Niklas Prager

Strategy delivers another year of solid growth2011 is proving to be another year of solid growth for Envirotainer.

We are fortunate to be serving industries as strong and robust as life science and healthcare that continue to grow and withstand the impact other sectors are experiencing from the global economic downturn. Having said this, as you know, it is by no means a coincidence that we are in this position.

Several years ago, Envirotainer took the decision to focus its strategic direction on serving the needs of these customers and partners and we continue to see the benefit of that foresight. This year, we are once again seeing our business grow across our full product range and in all geographies.

Our heating and cooling technology – supported by our network – continues to experience very strong demand. We have continued to expand our RKN e1 fleet rapidly in 2011 and we are delighted to have now gained approval from the U.S. Federal Aviation Administration (FAA) for the container so it can now also be carried by U.S. flag carriers.

International carriers have been using the RKN e1 regularly in the United States since its commercial launch and approval by the

European Air Safety Agency (EASA) but as I am sure you recall, the approval process with the FAA became embroiled with the much larger bilateral agreement negotiation between the U.S. and EU. Once these were successfully concluded earlier this year, the RKN e1 approval went through quickly as we had expected with the same specifications that had been approved by EASA.

We want to thank our customers for their understanding and patience as we have observed this process.

Following the successful launch of our latest e-container, the RAP e2, we are also investing heavily in the development of this fleet and our manufacturing plant is currently running at full capacity in support of this. Having already received EASA approval for the RAP e2, we are hopeful of FAA approval within the year. In the meantime, of course,

the RAP e2 is already operational globally, including in the U.S., with our international airline and logistics partners.

In this issue of our newsletter, we also include a Q & A with Susan Rocca, Chairman of the Envirotainer Advisory Board. In such a fast growing business as Envirotainer with so many stakeholders, it is especially important to us to keep our customers close so we understand what their real needs are and we can adapt our offering to meet their rapid pace of development. We want to react quickly to customers’ requirements and the opportunity to engage with them in a formal setting is a valuable way for us to gain feedback on what we are doing and how we can improve.

For Q4 and into 2012, we expect to see continued strong demand for our services. Our priority is a simple one; to provide the highest possible levels of reliability and availability for our customers and to continue to invest in our fleet and capability.

Thank you for continuing to support us.

NIKLAS PRAGER CEO

“Our priority is a simple one; to provide the highest possible levels of reliability and availability for our customers and to continue to invest in our fleet and capability”

We are investing heavily in developing our RAP e2 fleet

The value of customer consultation

Name: Susan RoccaLives in: London and Scotland

Career profile: After graduating in Pure Chemistry with a 1st class honours, I had several analytical laboratory jobs in Biochemistry, power station chemistry and fine chemicals analysis. I moved into Quality Assurance whilst with the Fine Chemicals manufacturer, leading the site to gain ISO 9001 accreditation. I then joined Glaxochem at its Montrose site as a compliance manager. During my time with Glaxo, the firm acquired and merged with other pharma companies to become GSK as it is today. I took on various additional responsibilities, improving quality and regulatory processes for all primary sites in the UK, then as Site Quality Director at Dartford site and also managing quality for all primary UK sites. My final role was to set up a new quality team in logistics, managing processes between manufacturing and commercial companies and sites. This role took me all over the world, with staff on all continents except Antarctica!

Details of your current role: Since leaving GSK in 2010, I have set up a quality

consultancy company, focused on making quality deliver, by working on processes beyond the manufacturing gate.

How long have you been working together with Envirotainer: I have been the Chairman for the Envirotainer Advisory Board for a year and have been working with Envirotainer since the first Advisory Board meeting in 2008.

How do you view Envirotainer as a partner and its role in the cold chain management sector: The service offering that Envirotainer provides to support its technically excellent product makes a difference. Whilst Envirotainer products have been developed for cold chain, there is opportunity to see how the range can be enlarged to include products suitable for transporting controlled room temperature products.

What encouraged you to join and chair the Envirotainer Advisory Board and why is it such a positive initiative: I was keen to take on the role, as I had always had great discussions when I attended the meetings as the GSK nominee. The atmosphere of the meetings is very open to all viewpoints and this helps the level of contribution from all participants.

How often does the Advisory Board meet and how do you go about setting the agenda for these meetings: The Advisory Board meets twice a year - once in Europe and once in the U.S. There is a flow of information from one meeting to the next. Envirotainer looks to present topics on current and potential ideas for future products, where the Advisory Board members’ contribution is most valuable. We also try to ensure we give feedback to the members on any points where the previous discussion points have been used to improve/develop an Envirotainer product or service.

What were the main areas of discussion at the last Advisory Board meeting: There were good discussions around the ‘Save Our Containers’, Business and Service Development and Container Performance Over Time topics. The update on the Envirotainer RAP e2 launch and

latest temperature profiles was well received. A good exchange of information was gathered when asking questions around the members’ experience of regulatory inspections. The meeting also included a member introduction section (there were many new members), and a review of actions at the end of the meeting.

How does participation in the Advisory Board help you in your own business: As a consultant, the networking aspect of the Chairman role is most useful. I also enjoy running the meeting and managing the preparations to ensure all goes smoothly and the members can spend their time in discussions and their own networking conversations.

What are the biggest challenges facing pharmaceutical companies in terms of maintaining the integrity of products through the distribution process: Getting a product/service offering that maintains the product within its registered temperature parameters at the right cost and with good security, especially at the end part of the journey.

Are there any upcoming regulatory changes that will impact the cold chain: There seems to be a constant stream of new requirements from many countries that will lead to improving temperature control during distribution for more classes of pharmaceutical products.

What do you think Envirotainer’s main focus ought to be: Technically reliable, robust products for cold and controlled temperature pharmaceuticals supported with worldwide service across the supply chain.

If you could change one thing about Envirotainer, what would it be: I think Envirotainer could be a bigger company, but keep the same level of ‘personality’ of the small business.

The Envirotainer Advisory Board members provide an invaluable insight into the latest and future cold chain needs of leading companies in the life science and healthcare industry and a clear reference point for how customers see Envirotainer. In this issue, we meet Susan Rocca, Chairman of the Advisory BoardQ&A

Envirotainer’s new RAP e2 container is the latest advance in e-technology air cargo containers for highly sensitive healthcare products and builds on the huge success of the smaller RKN e1 container.Since being approved by the European Air Safety Agency (EASA) and achieving the milestone of its first commercial shipment carried for TEVA Pharmachemie by Air France-KLM Cargo from Amsterdam to New York, the RAP e2 has successfully delivered sensitive cargoes to Europe, North America, Central America, South America, the Middle East and Oceania.

Envirotainer is rapidly investing to expand the fleet of RAP e2 containers during 2011.It has also commenced the approval process with the U.S. Federal Aviation Administration (FAA) for the RAP e2 to be certified for carriage by U.S. flag carrier airlines.

Novartis, one of the world’s largest and most widely respected pharmaceutical companies, has also taken advantage of the RAP e2’s unique transportation capabilities already at an early stage. After conducting thorough tests in Envirotainer’s climate chamber in Lagga, Sweden, Novartis Vaccines & Diagnostics commenced using the RAP e2 for shipments on challenging lanes.

Commenting on its decision to use the RAP e2 and its experience of the container so far, Novartis’ Robert Mueller / Head of Supply Logistic & Warehouse, said: “Following

our approval of most challenging validation and real life test shipment we have been convinced of the robustness of the RAP e2 container. We are looking forward to take the RAP e2 into our portfolio of qualified shipping systems for worldwide distribution to ensure seamless cold chain execution for our products and customer benefit.”

Having pioneered the world’s first ‘active’ temperature-controlled air cargo container in 1995, Envirotainer’s RAP e2 container is the first product in an entirely new generation of containers constructed in an all composite sandwich material. The unique properties

of this material and an optimized design allow for much better insulation - and even higher reliability than traditional aluminum sandwich-based container types.

The RAP e2 showcases the next generation of the well proven e-technology platform for heating and cooling that was established by Envirotainer’s RKN e1 container. This advanced technology paired with the composite material shell and the forkliftable base makes the RAP e2 the leading innovation in container design and performance.

As well as embracing the very latest technology advancements, the RAP e2 provides greater volume capacity than the smaller RKN e1. The Envirotainer RAP e2 is able to accommodate five Euro or four US pallets, whereas the RKN e1 is designed to handle one Euro or US pallet.

Envirotainer’s new composite technology has been developed and manufactured at the company’s high-tech production facility in Sweden.

Envirotainer operates as an open platform service provider. This infrastructure enables the worldwide transportation of temperature-sensitive goods and like all Envirotainer containers the RAP e2 is available for rental through Envirotainer stations and via a network of partners in the airline and forwarding sectors around the globe.

The world of sensitive healthcare products welcomes Envirotainer’s new generation RAP e2 container

The RAP e2 making its first ever commercial flight with Air France-KLM Cargo from Amsterdam to New York with a shipment for TEVA Pharmachemie

In many respects Envirotainer has been a victim of its own success with global demand for its active temperature-controlled air cargo containers sometimes exceeding supply at peak times. It has worked proactively on a series of initiatives aimed at ensuring customers can rent containers when they want to, including a major fleet investment program, container positioning incentives, an improved maintenance and repair scheme and the launch of a highly regarded quality program for its partners.

Wolf-Marten Borgmann, Head of Operations EMEA at Envirotainer, talks to CCMD about the actions Envirotainer has taken and the results so far.

Tell us more about what’s happening?

Envirotainer has worked hard on many levels to increase availability and to increase the numbers of trips at the same time. Since January 2009 the company has added a substantial number of containers (e- and t-technology to the fleet) and will add more from September to December 2011.

We have also improved our own logistics by using all transportations modes to get containers at the right time to the right location. We are currently using trucking, rail, ocean freight and airfreight to position our containers to where customers want them within our network. We also launched a “Save our containers” program with our key partner airlines to avoid damages and this has also helped to increase availability.

On top of this, we are working with all our partner airlines to position containers within our network. A global logistics planning team which is based in Frankfurt, Dallas and Sydney has been set up to coordinate this.

How has the fleet grown in size over the past 3 years?

Since Jan 2009, we have seen a major investment into our t- and e-fleet.

Fleet growth from Jan 2009 to Jun 2011:

RKN t2: 1 %

RAP t2: 9 %

RKN e1: 131 %

RAP e2: Launched at the turn of the year 2010/2011, we are delivering new units to the fleet every week.

How have you worked with customers to improve availability?

We are constantly working with our customers on improving availability and several departments are involved in this.

Our Healthcare Sales team is working with the shippers to get forecasts for expected shipments as early as possible. Forecasting is a very important component for securing availability. It helps us to manage the stock levels at our stations in two ways; to increase the stock level, when shipments are expected but also to decrease the stock level and move units to other locations if no orders are expected.

The Partner Management team is working with airlines on a global level to streamline their processes and procedures to get the orders as early possible, to avoid damages and to speed up the container return process. Placing orders early helps us to secure availability, especially during peak seasons. By having orders in our system,

It’s all about

availability...

“Forecasting is a very important component for securing availability”

we can compare the actual need with the current stock and adjust the stock if needed. Avoiding damages has a huge impact on availability. Units which are returned damaged need to be repaired first and this takes time. If a damaged container is returned to a non-repair station, it needs to be moved to a repair station first before it can be allocated to a new lease.

Is the issue of availability primarily linked to the RKN e1 or to other container types as well?

Due to the major investments in our containers since 2009 and the continuous fleet expansion, we do not see a general availability issue for any container type these days. In general, availability is given for all container types in all regions but due to an unexpected demand increase or a general peak season (e.g. RAP vaccine season in July and August), we can see temporary shortages at certain stations for certain container types.

Even when availability was an issue, did customers remain loyal to Envirotainer?

Even though each customer is expecting 100% order fulfillment all the times, we have not lost any major business due to a temporary container shortage. This is mainly due to the close cooperation between Healthcare Sales, Partner Management and Operations working together with our customers. Finding an acceptable solution for our customers in a shortage situation is always our main goal.

How has the Qualified Envirotainer Provider (QEP) program helped to improve availability?

The QEP program is supporting availability from a mid and long-term perspective. QEP accredited partners have processes and procedures in place to handle our containers in an optimal way. This ensures that all partners along a supply chain know exactly what to do, from the booking stage to the container return stage. By having well defined processes in place, our partners strive for quick container return which is then securing high availability.

What is the current % of bookings that are completed on-time to the customers’ requests?

During the first 6 months in 2011, we had an order fulfillment rate of 99.9% orders as booked. This high level of order fulfillment is valid throughout our network and for all container types.

In terms of availability, what lessons did you learn from the launch of the RKN e1 that you can now apply to the new RAP e2?

The main learning is that working close with our partner airlines helps to secure availability. Also to focus on some key business from our key customers compared to offering a very small fleet to everyone is helping logistics to provide the units when needed.

Are you confident now of being able to offer customers a ‘rent it when you need it’ solution for all container types?

Due to all the investments into our container fleet and the new global logistics planning set up, we are able to offer a ‘rent it when you need it’ solution for the RAP t2, RKN t2 and RKN e1 containers. For the RAP e2, it might take a time to offer this ‘rent it when you need it’ solution, as the fleet is currently too small to offer availability everywhere. But with an ongoing investment in that fleet as well, we will get there within the next 24-36 months.

Is there anything else you wish to mention?

In addition to fleet expansion and better logistics processes, we have invested heavily in IT solutions for the logistics team. We are using barcode technology now to scan our units when they leave/return to our stations and have always ‘real time’ data on hand when it comes to stock levels. This new technology has improved availability considerably. Availability these days is not only the result of better logistics and more units, it is the close cooperation between all Envirotainer departments “to make it happen”.

Envirotainer is working proactively with airline partners to expedite the container return process

“We do not see a general availability issue for any container type these days. We are able to offer a ‘rent it when you need it’ solution for the RAP t2, RKN t2 and RKN e1 containers”

Diary

Envirotainer is a registered trademark owned by Envirotainer AB.www.envirotainer.comEditor in chief: Niklas Prager

Sign up for this newsletter on our web site atwww.envirotainer.com/CCMDTo unsubscribe, simply state your e-mail address on the same web page.

About EnvirotainerEnvirotainer is the world-leader in secure cold chain logistics solutions, primarily within the health care and biotech industries. The company manufactures and leases active temperature-controlled container solutions for air transportation, including validation, support, and service.

For more than 10 years, the company has enabled reliable air transportation of sensitive and perishable products, through an open, global network of airline companies and logistic partners. Envirotainer has offices in 20 countries around the world and is headquartered in Lagga Marma outside of Stockholm, Sweden

Envirotainer is a registered trademark of the company Envirotainer AB.

Envirotainer is participating in a series of leading events in the coming months. To arrange a meeting with a senior member of the Envirotainer team at any of these conferences and exhibitions, please contact [email protected]

New e-containers take centre stage at Air Cargo Europe in MunichEnvirotainer showcased its new RAP e2 electrical heating and compressor cooling air cargo container at the Air Cargo Europe 2011 exhibition and conference in Munich.

Over the course of the week-long event Air Cargo Europe and the integrated transport logistic exhibition attracted 51,310 trade visitors from 137 countries. In the exhibition halls, 1,893 exhibitors represented 59 countries promoting logistics, mobility, IT and supply chain management solutions.

Envirotainer’s prominent exhibition stand attracted strong interest from airline and freight forwarding executives and provided the ideal opportunity to promote its e-container technology. In addition to the RAP e2, Envirotainer exhibited one of its hugely successful RKN e1 temperature-controlled containers and also communicated unique benefits such as its global network, Cold Chain Management services and its QEP/CEP Training and Quality Program.

ESN Pharma-Logistik Meeting/Cool Chain 19 - 20 October 2011, Mannheim, Germany Speaker

INTERPHEX Puerto Rico 2011 20-21 October 2011, San Juan, Puerto Rico Exhibitor

Air Cargo Americas 2011 2-4 November 2011, Miami, USA Exhibitor

IQPC 3rd Annual Clinical Trials Supply & Logistics Summit 7-9 November 2011, San Diego, USA Exhibitor and panelist

4th Annual Conference of the Bio Supply Management Alliance (BSMA) 7-8 November 2011, San Francisco, USA Exhibitor