TLP INSIGHT issue 5

THE LOGISTICS PORTAL MAGAZINE

TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE

Issue 5 - 2014

S O S U S TA I N A B L E

IN-DEPTH INSIGHT ON SUSTAINABLE PHARMACEUTICALS PACKAGING

Only safety

the safe transportation of air cargo

TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS

//MAIN CONTENT // COMBINING THE BEST ASPECTS OF TEMPERATURE TRACKING TECHNOLOGIES INTO A SINGLE, UNIQUE DEVICE IMPROVES PHARMACEUTICAL TEMPERATURE MANAGEMENT CAPABILITIES Patrick McGrath, General Manager of Berlinger USA presents a White Paper, which discusses an advance in technology created to merge the most effective features of existing devices to achieve the additional goals of lowering operational costs, improving profitability, and reducing risk.

Read the full article on page 24 »

TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE

MANAGING DIRECTOR Lee Atkinson MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright SENIOR DESIGNER Joey Graham info@designedbyjoey.co.uk

EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson, Amy Firth

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ADMINISTRATION Katie Galelli

Safety First

Tony Wright, CEO of Exelsius Cold Chain Management Consultancy talks to us about something we often take for granted when we are flying, the transportation of the air cargo underneath our seats, and how CSafe Global is leading the way in meeting FAA and EASA approval.

WEBSITE DESIGN Knut Henriksen

CONTACT US Sales: info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk

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TLP INSIGHT

8 Steps to implementing a controlled room temperature strategy

Is published 4 times a year March, June, September & December by Intensive Media Ltd. Printed by Premier Print & Direct Mail Group.

Send address changes to:

Cold Chain IQ asks Peter Lockett, Director of TP3 global for advice to companies who are analysing and deciding how to implement a Controlled Room Temperature for their products.

145 - 157 St Johns Street London EC1V 4PW United Kingdom

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Protecting ambient products at a reasonable price

Cold Chain IQ presents us with an article by Kevin Kohleriter, Director of Marketing for Infitrak.

He talks to us about ambient products, which unlike chilled or frozen products that require cooler environments, need a ‘room temperature’.

The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the Publisher and, whilst every care has been taken in the preparation and design of this book, the Editor nor the Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles.

Whilst every care is taken with artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred, The entire content of this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, by any means – electronic, mechanical, photocopying or otherwise – without prior permission of the Publisher.

Copyright© 2013 Intensive Media Ltd

Contents continue on page 4 »

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

//FEATUREDCONTENT

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CRT Market Insights

Cold Chain IQ presents us with insightful comment from industry experts on the current state of play and future trends and developments in Control Room Temperature.

32

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Sustainability and pharmaceuticals packaging

Pierre Boccon-Gibod from SGS talks of the increasing pressure on all of us to take sustainable packaging at all levels, more seriously. He provides us with a comprehensive article that is both informative and helpful on a practical level for those making decisions on sustainable packaging.

Delivering safety, freshness and comfort: the future of transport refrigeration

Karin De Bondt, Regional Director for UK and Ireland, West and South Europe for Thermo King, foresees a wide range of important innovations that will make refrigerated transport even more effective and efficient in the years to come.

FEATURED ARTICLE

//MAINTAINING COLD CHAIN INTEGRITY FOR PHARMACEUTICAL PRODUCTS Karin De Bondt, Regional Director for UK and Ireland, West and South Europe for Thermo King, looks at the factors to consider when maintaining the quality and integrity of pharmaceutical products during transport, a critical need for both manufacturers and for public health and patient safety.

Read the full article on page 36 Âť

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STP is a division of Sofrigam www.sustainablethermalpackaging.com

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

//TLP INSIGHT FOREWORD Welcome to Issue 5 of TLP Insight and, I am very pleased to say, the first of our second year of publication.

At the outset, in Issue 1, we said that we wanted to create a publication unique in the Life Science Logistics industry, where we covered the whole market, from technology and software to bulk shipment and air cargo. Looking back over our first year, we can see we are fulfilling this vision, and hope to continue to fulfil it throughout the coming years.

In this issue we carry an in-depth article on sustainable pharmaceuticals packaging. This is something that occupies a lot of thought in the industry and Pierre Boccon-Gibod from SGS talks of the increasing pressure on all of us to take sustainable packaging, at all levels, more seriously. Additionally, he gives us practical advice to help us when making these all-important decisions.

Tony Wright, our Consulting Editor, is currently on vacation, and so has provided us with, instead of his usual insightful foreword, an article on the safe transportation of air cargo. This is probably not something you wish to think about when flying at 30,000 feet, and it is extremely reassuring to know that companies like CSafe put a great deal of energy and investment into products which ensure the safety of both passengers and planes.

Among the events we are telling you about in this issue is the must-go Logipharma 2014, taking place between 7th and 10th April 2014 in Switzerland: ‘Supply chain as a customer centric function’. This will be the 13th annual Logipharma, which provides a platform for learning, debate, discussion and networking in the industry.

Finally, I would like to thank all of our advertisers, contributors and staff members who have made such an excellent success of our first year and given us a strong foundation to build on. We look forward to working with you in the future.

All the best for 2014.

Lee Atkinson Managing Director and Founder of Intensive Media Ltd

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Complete peace of mind for your pharmaceutical and healthcare shipments

Flying with care It is essential that the quality and integrity of your high value and temperature sensitive pharmaceutical and healthcare products is protected throughout the entire transportation cycle.

Backed by our fleet of advanced Boeing 747-8 and 747-400 freighter aircraft and a brand-new purposebuilt 3,000 m2 warehouse facility with temperature- and humidity-controlled environments at our Luxembourg hub, we offer you speedy, reliable and tailored solutions to meet your sophisticated needs.

On and off ground, your pharmaceutical products are in the best hands with our dedicated team of highly trained and experienced professionals. And, as you would expect from true pioneers, we are the first GDP certified airline in the world.

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+2째C to +8째C

+15째C to +25째C

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SAFET Y FIRST

Safety First Remember the predictions of how email, video conferencing and the other now commonplace means of communication, would erode the need for so much air travel? I also remember how airlines created various loyalty programs targeted at maintaining their share of the business traveler market as promises of reduced travel for employees was just on the horizon. OK, so how well did you do in reducing your travel?

If you’re like me, you will know the value of face-to-face communication and how it can be the real difference between securing that deal and letting your competitor get the win. For most of us in the business world, air travel remains a fundamental part of our lives and so I pay my fare and get that next red-eye to wherever. But in doing so, there is one thing that I have always just taken for granted – that whoever I am flying with will always put my personal safety above anything else.

And that’s not just about the flight safety announcement and whether I am seated near an exit. As someone involved in the global logistics and air cargo sector, I am keenly interested in what’s in that cargo hold under my feet. Even more so now since, like many others, I have heard and seen the tragic crashes of air cargo aircraft that seem to have been caused by fires from overheating cargos. Whilst more aircraft manufacturers incorporate extensive fire safety systems into the airplanes, dealing with a fire at 40,000 feet remains an undeniable challenge.

In the daily international distribution of those valuable life-science healthcare products that need temperature control, air cargo is an essential part of the supply chain process. And so with it has been the development of specialized containers that can maintain internal temperatures whatever the outside environment might be – either the heat of a Memphis ramp area in July or a Moscow airport in January. These containers inevitably use sophisticated technologies and have self-contained power sources to ensure end-to-end temperature assurance. And that means electrical compressors, cooling fans and a whole lot of other onboard electronic systems, all of which generate heat.

So who regulates the manufacturers of these containers and checks that they are safe to be onboard that passenger plane I might be sitting on? Who makes sure that if, heaven forbid, there was a fire in flight, that the container with all its equipment won’t make things worse?

Thankfully, there are saviors at hand.

Since 1958, the Federal Aviation Administration (FAA) has been at the forefront of flight safety and is globally recognized as probably the world’s leading authority on the subject.

Together, with other organizations around the globe, most notably the European Aviation Safety Agency (formed 10 years ago), they have the responsibility of approving a wide range of cargo equipment - and that includes the active electrical containers that many of us in the pharma logistics sector know well.

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Case Study

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Case Study

SAFET Y FIRST

To gain the ‘seal’ of approval from the FAA in terms of certification is an exacting task for any equipment manufacturer, involving a very lengthy process of safety and performance submission testing and data, and supplier and manufacturer inspection. The testing and the process are costly and takes much time, but isn’t that worth ensuring things are safe? (It’s certainly what makes me feel comfortable).

To be sure of being able to fly these electrical containers on the world’s leading USA and European airlines, and therefore creating an uninterrupted global distribution network for life science companies, requires the approval of both the FAA and EASA. Right now, only one supplier – CSafe Global -has the approval of both authorities for an RKN electrical container and this is because of its highly sophisticated smoke detection system. The design incorporated into this aircraft unit load device (ULD) means that it immediately shuts down the external fans on the container should it detect any form of smoke from a potential fire within the aircraft cargo hold. The FAA saw this as an essential component of ensuring that the smoke detection system of the aircraft was not impacted nor that there was any effect on the all important fire suppression system used onboard aircraft.

The immediate significance of this is that no US registered air carrier is permitted by the FAA to fly an ‘unapproved’ container. Additionally, and since many of the world’s other airline regulatory authorities use the FAA guidance as the framework to regulate their national carriers, there has been an immediate withdrawal by two international carriers from using the electrical container from their European based supplier, since that container does not have FAA approval.

Why could this be important to a life science manufacturer? Manufacturers spend a lot of time and money on risk mitigation to ensure that there is contingency planning in raw material supply, manufacturing and distribution. This includes items such as ensuring there are multiple sources for key raw materials, having the capability to produce key products at multiple plants and having several transportation lane options qualified.

Many will know this is part of Good Distribution Practice (GDP) - identifying where potential risks in the supply chain might occur and having a contingency plan in place. It’s a subject we teach in-depth at our training courses and it’s clear that shippers needing the security of endto-end temperature management should be applying the same methodology. Using the FAA and EASA approved alternative solution from CSafe might just be the contingency you need.

For more information on the CSafe air cargo container please visit our website www.CSafeGlobal.com

www.CSafeGlobal.com

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8 Steps to Implementing a Controlled

Room temperature Strategy Right now lots of companies are analysing and deciding how to implement a CRT (Controlled Room Temperature) or ambient strategy for their products. But many companies are asking; where do I start? Cold Chain IQ asked Peter Lockett, Director of TP3 Global Ltd for his advice:

1.

Know your own products required storage and distribution

2.

Establish the routes and assess the temperature threat risk of each.

temperature guidelines, available stability data etc.

3.

The types of temperature threat (heat/cold/duration) will determine

4.

the requirements of the protection equipment required.

5.

Consider the impact of using either single use or reusable systems. Cost, return logistics, contamination,

6.

One type of protection may not suit all routes and seasons - be prepared to test and adopt a number of protection equipment types to suit different product groups and temperature threats.

Consider protection equipment availability – global locations, stock, capability etc.

maintenance, disposal are all aspects that require consideration.

7.

Be prepared to lean on the expertise of both 3PL and equipment manufacturer partners.

Both can have valuable experience

8.

Be aware of existing and developing global legislation which could change the criteria required for distribution and storage.

and knowledge to offer.

For More Visit www.ColdChainIQ.com www.the-logistics-portal.com

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

Kevin Kohleriter, Director of Marketing for Infitrak

Protecting Ambient Products at a Reasonable Price Ambient, or in some cases called ‘room temperature’, is a term used within the pharmaceutical, food and drink manufacturing industry related to either product types or storage. Unlike chilled products that require a chilled environment, or like frozen foods that require a frozen environment, ambient products require the surrounding environment to be at “room temperature”.

Ambient products are what form a good portion of a drug store or

temperature profile as defined by PDA Technical Report 39. What

supermarket and can include (but are not limited to) soft drinks,

are the acceptable environmental conditions the product itself can

aspirin, cold remedies, tea and coffee, cereals, canned meat, rice,

be exposed to and how does it affect the products efficacy.

and pasta. They will often have a very long shelf life and are at low risk or a low purchase price for the consumer.

Three methods for creating an ambient temperature profile (and how to save money doing it)

Because the end-product is typically lower in cost, protecting these products requires a cost effective means to protect them

There are three methods for creating a ambient temperature profile

from temperature excursions that may spoil them or shorten their

that can be used to design thermal packaging:

shelf life. This requires a balance of packaging cost and product protection.

What influences ambient temperatures?

Ambient temperature is determined by a number of factors,

1.

The first is for you to provide it (it may be a company standard or you can use data from a data logger).

including:

the weather outside

the quality of insulation in the room or transport vehicle

what or who is inside the room

the use of heating and cooling systems

For example, a data center with a lot of servers will be warm due to the heat generated by the computer systems. Body heat caused by people or even animals will also have an ffect. Ambient temperatures can also be affected by humidity.

2.

The second is by using predetermined profile developed by a trusted 3rd party, who has mapped out 24, 48, and 72 hour profiles based on ISTA standards and tested them for the critical variables.

3.

The third method, and likely the most effective, is to get the profiles from a company, like Infitrak, who has been performing studies long enough to have temperature profiles already

Protecting products that are affected by ambient

available.

temperatures Similar to frozen or refrigerated products, when qualifying your protective packaging, you need to first identify and document the requirements, including identifying product stability data, mode of transportation, and temperature sensitivity.

After you have your requirements, package design and testing can begin. Start with an understanding your product’s ambient

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CRT Market Insights “[The Industry] seems to be more focused now on the CRT portion of shipments as drugs come off 2ºC - 8ºC and they try to get a wider range for shipping and storage,

“A lot more questions over the control of these products are coming up for transit and there are several attempts to maintain this tight range especially for clinical items. I think manufacturers are better able to demonstrate robustness of these products for ambient shipping and should do that,”

which just makes it easier for the supply chain itself, from a drug standpoint, but it seems like there’s a new focus on control room temp from the shippers, and a little bit

Michael English, Senior Product Engineer of Packaging Technologies, Merck

closer look at that even from a regulatory standpoint.”

Jim Lucie, Senior Manager, Material Control at AMAG Pharmaceuticals

In and article for Parmafile on providing controlled room temperature logistics using specialst packaging Nathan Barnard, Cool Chain Manager at Biocair said: At Biocair, we see requirements for Controlled Room Temperature packaging and logistics vary over the year.

Requirements increase during the winter as colder temperatures give more concern over cold temperature risks. Similarly, some hot emerging market destinations justify a CRT logistics solution in the summer, especially if there are potential delays in an uncontrolled Customs warehouse.

In conclusion, specialist logistics solutions for Controlled Room Temperature shipping are available. For some products and research samples, a CRT option must always be selected as a specific temperature band such as +15°C to +25°C is required. With many other products and samples, the risk of degradation is limited and an assessment can be made as to what level of logistics solution is required. By using support from their specialist logistics provider, smart decisions based on a risk assessment of the route can be used to ensure the solutions chosen are appropriate and efficient.

Nathan Barnard, Cool Chain manager, Biocair

“I think that’s going to be a huge market. I don’t think the volume is necessarily increasing, but the stance that the regulators are taking and even internal quality people at each individual pharmaceutical company are really starting to ask some questions about at least our product at controlled room temperature and how do we maintain that temperature and show those controls in our distribution channels as well,”

Gary Htchinsom, President, Modality Solutions

The ease of storage by the end user (patient/hospital/pharmacy) has driven development of these products, and getting them through the supply chain is the new challenge as these tight temperature parameters require sophisticated solutions protecting against the extremes. Increased use of phase change materials in passive solutions and further development of heating/cooling active solutions creates both challenges and opportunities for solution providers to meet these changing needs and controls / requirements from regulators.

As the industry (manufacturer/provider/regulator) matures, the need for temperature controlled distribution is bright.

Manufacturers will seek out those providers that can create end-to-end solutions ensuring integrity of product and meeting the changing regulations.

Cold Chain IQ and industry groups create the collaborative platforms for all participants to map out guidelines that can or could become global standards in the future. As well, the need for real time data not only for temperature, but also shock, humidity, light, etc and security concerns is leading to integrated approaches to measuring and maintaining integrity of shipments.

Jim Bacon, Senior Director, Grifols. Inc

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

Many sectors of the airfreight industry are suffering. The weaknesses in Europe’s economy have led to a decline in volume.

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sectors upgrade and diversify in the area of generic ethical drugs.

As an example, in the household sector, packaging represents about 8% of the carbon content of the annual consumption

of a French resident. This varies from 3% to 33% depending on the type of packaging. For the pharmaceuticals sector the number of products sold has been stable over the last 3 years and the weight of packaging put on the market has only

The packaging of pharmaceutical

products serves as a

slightly changed during the same period. Thus, packaging has not been the centre of interest for weight or volume reduction as 70,000 tons of pharmaceuticals packaging is still thrown away each year in France.

multiple means of providing protection, identification,

In terms of products, the fastest growth is expected for pre-

information and convenience from the

fillable syringes, followed by vials and ampoules. In spite of

production phase to the use or administration phase. The type of material used depends upon its function and plays a very significant role in the maintenance of quality standards.

increasing competition from alternative materials and containers, plastic bottles will remain globally, the most widely used package for oral drugs. On the other hand, world consumption of glass pharmaceutical bottles is expected to decrease gradually over the long term. Strip packs and paperboard boxes will be the largest

According to recent studies, within the next 4 years, the world

segments based on adaptability to economical unit dose formats.

pharmaceutical packaging demand will increase by more than 6% – to over $57 billion in 2017. Western Europe, the US, and

Reducing the amount of packaging used seems to be the first

Japan will account for nearly 60% of this amount. India and China

necessary step, but under-packaging is usually far worse,

will experience the fastest growth in product demand due to their

environmentally speaking, than over-packaging. Indeed, a product

rapidly expanding manufacturing capabilities, rising drug exports

over-packaged by 5% means that 5% of the materials needed

and a widespread government programme of national production.

to produce the packaging are wasted, and extra energy will be

Brazil, Mexico, and Turkey will also progress into fast-growing

needed to distribute it, without considering any recycling or heat

pharmaceutical packaging product markets as drug-producing

recovery. However, under-packaging that results in the product

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interesting but do not help to assess the global environmental being damaged wastes 100% of the materials

burden caused by a single product over its whole life. How do you consider the impact on water, on land use or on non-renewable resource use? It is necessary to go one step further and use the Life Cycle Assessment method or LCA.

used to produce both the packaging and its contents, and all of the energy used to distribute it. Therefore packaging optimisation rather than reduction is an important part of a sustainable initiative.

SCHEMA LCA/ PRODUCTION PATH OF PACKAGING The LCA method is a multi-step, multi-criteria sustainability assessment method. It considers the whole life cycle of a product, from the design, the extraction and processing of raw materials, through manufacturing and distribution, to final use and recycling,

To produce packaging for the pharmaceuticals industry that is

or disposal, commonly mentioned as the ‘Cradle-to-grave’

sustainable, the system must not only meet the requirements for

path. By showing the connections between the consumption of

packaging optimisation, but also have a reduced environmental

resources, energy use, waste, and climate change, LCA allow a

impact. To do this, materials, shape and technical aspects have to

more global understanding of a product’s impact. Through LCA,

be precisely balanced.

the production process of a product can be mapped and linked with its most common environmental impacts. LCA is also an

DEVELOPING SUSTAINABLE PACKAGING

excellent tool to compare different design choices before going

Before considering its environmental credentials, packaging

to production. For example, it allows the design and simulation

must at first ensure its contents are protected all along the

of different material choices, end-of-life scenarios, including

downstream supply chain. For long distances and transport time

minimum calorific value to allow optimisation of energy recovery.

this is particularly complex, as packaging has to resist hazards such as extreme temperatures, moisture, and light exposure.

By looking at the whole supply chain or zooming-in on a particular

Additionally, it must be robust and secure, but also compact and

stage of production, one can identify how to prioritise the

lightweight, in order to keep shipping costs down.

reduction of a product’s environmental impacts and make better environmental choices without triggering the transfer of pollution

Considering all these aspects, when and how should one start to

from one stage to another.

develop sustainable pharmaceuticals packaging?

For the question When? ‘Today’ is a good answer if it has not

EXAMPLES OF SUSTAINABLE PACKAGING MATERIALS

already been started. Sustainability information on products has

In recent years the sustainable packaging on offer has expanded

never been more often asked for than in 2013, and it’s expected

rapidly. Innovative materials are increasingly available, produced

to increase in the coming years. Corporate social responsibility

from more sustainable resources, such as plants, or materials

and sustainability reporting are based on numbers and figures

that biodegrade or compost easily and quickly. Characteristics

extracted from supply chain and manufacturing information.

of sustainable packaging include that it should be well designed,

Additionally, such reporting becomes mandatory in many

streamlined, biodegradable and easily recyclable. What follows

countries or multinational companies. Thus, suppliers are being

is information about the main biopolymers available on the

questioned all along the supply chain with regard to Scope 3

market that can be used in packaging applications. Their potential

reporting. Also more and more national or multi-country pilot

recyclability or environmental impact will fluctuate mainly

schemes, such as the CFP Japan or the EU PEF/OEF scheme,

according to their purity and the process of production they

are implementing product environmental footprint information

undergo.

to measure and rank products. Sustainability should therefore not be seen as an end-state but as a continuing process of

STARCH

improvement.

This is a polysaccharide, renewable and widely available raw material. Corn is the primary source of starch, but it can also

SCHEMA SCOPE 1-2-3

be obtained from various sources such as potato, wheat and

For the question How? one method frequently used is the carbon

rice. Once extracted it can be processed into thin layers and

footprint assessment, measuring the total amount of carbon

shaped as trays or disposable receivers. Starch based plastic

dioxide and other greenhouse gases emitted over the life cycle

materials are an important part of the market nowadays. Thanks

of the product. Clearly, concepts like the carbon footprint are

to a blend of biodegradable starch based polymers (polylactide,

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Main Conference: 23rd-24th April 2014 Post-Conference Workshop: 25th April 2014 Moscow, Russia

Ensuring Quality, Complying with Local and Global Regulations and Implementing Practical Solutions to Drive an Innovative Temperature Control Strategy

5 Reasons Why You Cannot Miss This Event:

Find out about the latest regulatory changes in the industry relating to the Federal Law No. 61 “On Circulation of Pharmaceutical Products”

Learn about the best tactics to manage Cool Chain risks and minimise financial losses: Inna Nikitina show you how.

Keep up to date with the latest trends in the European Cool Chain Market, to stay one step ahead of your competition

Learn about the latest GDP standard implementation in Europe and the enforcement practice in Russia: hear directly from Novo Nordisk end users

Discover effective methods for training highly-qualified staff to ensure proper management of the key stages of the cool chain

Find out about the latest methods for ensuring safety in cool chain logistics

Take advantage of:

Our high quality interactive events including roundtables, panel discussions, seminars

The chance to establish new business relationships with experts and industry leaders and to ask them questions you have long wanted to find answers to

The knowledge of our expert speakers as they reveal the most cutting edge research insights and how they can be applied to your own work

The relaxed informal atmosphere in which to make new contacts.

Great to keep up to date with changes in legislation, get practical insights and experience from managers on the coal face, keep in touch with industry colleagues and further develop friendships and business. MD, TP3

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Presentations from leading Russian and international experts including: Andrey Bulimov QA Manager Novartis Inna Nikitina Head of Quality Assurance / National QP Roche Moscow Ltd Mihail Hazanchuk Quality Control Manager Novo Nordisk LLC Sergey Baldin Head of Distribution Microgen Andrey Kuharenko Cool Chain Department Vice President Nonprofit Partnership “Development and Implementation of good practice into the Cool Chain” Gennady Shirshov Director at SPFO Society of Professional Pharmaceutical Organizations Valentin Tolkunov Supply Chain Developer Boehringer Ingelheim Alexey Voronov RT-Biotechprom Igor Bakhmetev Manufacturers relations Alliance Healthcare Dmitry Koroteev Expert Nonprofit Partnership “Development and Implementation of good practice into the Cool Chain”

For more information please visit www.coolchainrussia.ru

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moment. Synthetic petroleum-derived compounds can also be a starting point for biodegradable polymers. These polymers have technical properties resembling those of polyethylene (LDPE).

Although these polymers are produced from synthetic starting materials, they are made fully biodegradable and compostable. polyhydroxybutyrate, polyhydroxyalkanoate, valeric acid) with aliphatic

They represent a dynamic field of development and will allow extended packaging application in the near future, on their own or mixed with natural biopolymers.

polyesters or polyvinyl alcohol, their properties have been increased, and have a significant use in various industrial applications. Four types of starch based polymers are commonly available: - Thermoplastic starch products

WHERE TO START? In order to implement a sustainable packaging initiative it is important to consider multiple areas of improvement. Several recommendations have been listed below, adapted for the pharmaceuticals sector and based on LCA methodology.

- Starch-Polyvinyl alcohol blends - Starch synthetic aliphatic polyester blends

For any of the recommendations it is important to:

- Starch polybutylene succinate or polybutylene succinate adipate

1. Ensure that the packaging is compliant with legislation.

(PBSA) polyester blends.

2. Avoid the transfer of pollution between different systems (primary, secondary and tertiary packaging) and along the life

CELLULOSE

cycle of a single packaging.

This is a linear polymer that is abundant in nature. The most common cellulose based polymer is cellophane. Many of its

Recommendations are grouped by:

derivatives are used in packaging. Among those derivatives,

- Main life cycle stage

cellulose acetate is widely used in pharmaceutical packaging and

o Raw material extraction

laboratory products.

o Manufacturing

o Transport

XYLAN

o End-of-life.

These are a group of substances based on hemicellulose, obtained

- Difficulty of implementation

as residue from agricultural industries. Also occurring in nature, it

o * Easy

is the most common form of carbohydrate found in the plant cell

o ** Reachable

wall and some algae. It is biodegradable and a compostable low-

o *** Complex.

value by-product with no competition with food. It is commonly used as a barrier material.

RAW MATERIAL EXTRACTION *Easy

CHITOSAN

• How to reduce the weight of the case?

This is extracted from the exoskeleton of arthropods such as

• Investigate the basic weight of cardboard to achieve the correct

crustaceans and insects. It represents the second most abundant

packaging.

polysaccharide resource after cellulose. Due to its antimicrobial

• Would it be possible to remove one packaging element without

properties it is widely used in packaging, maintaining a

disturbing product protection?

preservative action while protecting the product from bacterial

• Investigate the possibility of using trays.

growth. It has also the distinctive property of being able to absorb

• Is there any recycled material in the packaging? Would it be

heavy metal ions. In the packaging of fresh products under a

possible to use any?

modified atmosphere, the biodegradable laminate used is usually

• Use packaging with recycled fibres compliant for food contact.

made of chitosan-cellulose. **Reachable

SYNTHETIC BASED BIOPOLYMERS

• Has the use of packaging surfaces been optimised?

These are produced using industrial processes but based on

• Reduce the width of sealing and investigate different

natural or modified raw materials and monomers. The high and

interweaving.

rapidly changing cost of biodegradable polymers made from

• Can the packaging recyclability be optimised?

synthetic substances (e.g. aliphatic-aromatic copolyesters) has

• Investigate mono-material packaging elements.

made it difficult for them to reach a large-scale market for the

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***Complex

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• Investigate the re-use of isothermal boxes and pallets.

• Has the volume of packaging been optimised compared to the product size?

***Complex

• Optimise any potential empty space.

• Is it possible to favour less impacting transportation modes?

• Can the product restitution rate be optimised?

• Investigate the use of ship, rail or combined transportation

• Investigate different design scenarios to allow complete

modes.

product restitution.

• Has the optimisation of transport being investigated?

• Are there any elements disruptive to packaging recyclability?

• Avoid any empty lorries returning to manufacturing site. Work

• Refer to external recyclability analysis.

on optimisation of transportation schemes.

MANUFACTURING

END OF LIFE

*Easy

*Easy

• Has the weight of packaging been measured among different

• Does the patient have enough information to recycle the

suppliers?

packaging correctly?

• Add ’weight’ criteria when choosing a supplier.

• Provide clear information on how and what to recycle.

• When choosing a new packaging, has the environmental performance been compared to the previous option?

***Complex

• Add environmental criteria when choosing a new packaging (e.g.

• Is it possible to take apart the packaging elements to ease

% of recycled materials).

recycling?

• Investigate the improvement of packaging separability.

**Reachable • Could more sustainable inks/glues be used?

CONCLUSION

• Reduce the use of ink/glue and favour water based substances.

After implementing sustainability initiatives the last step

• Have transportation distances been optimised?

would be to communicate them. But in terms of environmental

• Favour a local supplier.

communication, a high-level vigilance must be applied to the message that is used. It is important to always communicate

***Complex

about packaging and product impacts and at the same time have

• Have product processes been optimised during manufacturing

a communication strategy adapted to the audience (patient,

and packaging?

retailer, public agency, etc). In compliance with ISO 14040 series

• Investigate reduction of energy losses on the production lines.

LCA results must undergo a critical review by a third-party expert

• Has the standardisation of packaging sizes been investigated?

panel before external communication.

• Limit the use of too many different packaging sizes or wide diversity of colours.

Finally, packaging is one of the first steps in building a robust, green pharmaceutical supply chain. Implementation of product

TRANSPORTATION

sustainability checklists and use of renewable energy technology

*Easy

at the warehouse are also avenues being explored for reducing

• Is it possible to reduce the weight of packaging during

the supply chain’s environmental footprint.

transportation?

• Reduce the weight of boxes and dividers. Favour lightweight pallets.

• Has a transportation supplier with an environmental involvement been chosen?

• Consider adding environmental criteria when choosing the supplier (e.g. ISO14001 or EMAS certification, Footprint reduction programme). **Reachable • Has the packaging grouping been adapted to the size of the product being transported?

• Investigate the reduction of empty spaces.

• Is it possible to re-use tertiary packaging?

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TLPINSIGHT 21.

The Leading End-To-End Supply Chain Management Event For The Life Sciences Industry Focusing On The hallenges That Most Affect You & Your Business DEFINING THE CUSTOMER & THEIR NEEDS Understand the needs of the customer, how they affect your supply chain and obstacles to unified, consistent and flexible responses.

7 - 10 April, 2014 Congress Center Basel, Switzerland

Supply Chain as a Customer Centric Function Vision, Strategy & Case Studies From 80+ Leading Players In The Industry:

END-TO-END SUPPLY CHAIN ORCHESTRATION – Plan your strategy for orchestrating an end-to-end supply chain that achieves the status of a customer centric function.

SUPPLY CHAIN LEADERSHIP – Become the advocate for excellence within your division, and when working with other business units within your company.

MARKET DRIVERS & PRODUCT LAUNCHES – Understand the shifting dynamics around product launches and other market drivers that impact your supply chain.

NETWORK & DISTRIBUTION DESIGN – Hear about your peers’ experience of resilient and innovative network and distribution designs.

Alessandro de Luca, SVP, Head of Global Supply Network Operations, Merck

Philippe François, VP, Supply Chain EMEA, Baxter Healthcare

GDP DIRECTIVE IMPLICATIONS – Learn from actual audits and risk mitigation strategies of peers to gain a holistic understanding of regulatory demands facing pharma supply chains.

EMERGING MARKETS – Understand from front-line experts which ‘emerging markets’ have emerged and how to juggle differing characteristics of hot markets in a global supply chain.

Daniel Kolacko, Vice President, Global Planning, Global Supply Chain, Bristol-Myers Squibb

Wayne Swanton, Vice President, Supply Chain, Actavis

Stephan Gotthardt, Vice President, Corporate Supply Chain Management, Boehringer Ingelheim

Salvatore Paparelli, Regional Logistics Officer & Head of Sales Operations Europe, Sony Electronics

Danny Hendrikse, VP EMEA Supply Chain Operations, Pfizer

Event Partners:

Platinum Partner:

Rod Beard, Principal Pharmacist, Sunderland Royal Hospital, UK

PLANNING & OPTIMISATION – Refresh your approach to planning and optimising supply chain processes by hearing from innovative topic experts.

TALENT MANAGEMENT – People can be a business’ greatest asset; how can you find and foster talent within your division, and ensure a win-win relationship that lasts?

SEGMENTATION - Profitability is the driver for segmentation; find how to identify differing product characteristics & customer requirements in order to segment your supply chain.

SUPPLY CHAIN RISK, INTEGRITY & SECURITY – Understand how to establish and maintain risk mitigation strategies and robust supply continuity plans that ultimately protect product reliability.

MASTER DATA MANAGEMENT – Benefit from tailored workshops delivered by subject thought leaders & experts, designed to facilitate Q&A opportunities around topics relevant to you.

PERFECTING TEMPERATURE CONTROLLED DISTRIBUTION – Hear both tactical and strategic recommendations for maintaining the integrity of temperature sensitive products.

Principal Partners:

Principal Sponsors:

Lodestone Sponsors:

Dear Colleague Welcome to the 13th annual LogiPharma – the unique industry event providing a platform for learning, debate, discussion and networking.

On behalf of our Advisory Board, I am delighted to invite you to join this four day meeting and benefit from unrivalled networking opportunities with over 350 senior supply chain professionals. These thought leaders and decision makers attend each year from all over the world to discuss supply chain issues affecting the Pharma, Generics, Biotech, Clinical trials and Animal Health segments.

Every year LogiPharma is relied upon by the industry to enable discussions around best practice, innovative strategies and spotting emerging challenges & opportunities early on. Never has this been more necessitated than in today’s climate. Businesses are working to grow margins under the pressure of a flat economy, eliminating risk in all areas has never been more pressing and understanding and acquiescing to the latest in regulatory guidelines is of paramount importance to any business that wants to maintain a competitive edge.

The LogiPharma 2014 event will bring together a panel of industry leading, senior decision makers to address these topics. At no other conference will such a speaker line up of supply chain VPs be gathered together, representing top 100 Pharma companies - Pfizer, Roche, Novaris, Merck Serono, Mylan, Bayer, UCB, Teva and Astellas to name a few – giving practical advice on solutions for driving progress across the end-to-end supply chain.

We look forward to you joining this industry gathering, where you can meet new business contacts and your peers can help address your business queries. Take a look at the exciting event features and new additions outlined in this preview prospectus, and what LogiPharma can do for your business in 2014.

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15 % discou n TLP In t for Subsc sight ribers, use co WBRT de LP15

See you in Basel!

Yours Sincerely

Secure your place now at www.logipharmaconference.com Emily Martyr Event Director LogiPharma Europe 2014

Newe Venu Join LogiPharma 2014 in Basel!

LogiPharma 2014 has changed venue to create an even more business friendly conference & exhibition; with all the sessions in one, purpose-built congress hall, you will be able to join more sessions, network more easily with colleagues, and meet more partners and suppliers in a light and airy exhibition. Moreover, Basel is a global hub for pharma professionals, offering you the chance to make the most of your trip to the event. Don’t miss this unique opportunity to be part of a truly international pharma supply chain community.

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Combining the Best Aspects of Temperature Tracking Technologies into a Single, Unique Device Improves Pharmaceutical Temperature Management Capabilities Patrick McGrath General Manager - Berlinger USA

- Meets regulatory expectations - Performs as a validation device for commercial and clinical trial materials - Provides greater data management flexibility - Provides high-value labor savings - Lowers risk Executive Summary The processes for maintaining product quality during manufacturing, transporting, storing and distributing pharmaceutical and biological products requires documented evidence of temperature history and management of exceptions in the temperature environment. Processes and procedures are painstakingly developed to avoid temperature exceptions, but circumstances change and temperature deviations still occur. These exceptions are commonly observed at a rate of 10- 20% as captured by current limits of temperature tracking technology. Nearly all recorded temperature exceptions receive approval by the manufacturer’s Quality Team once the data is reviewed internally against the drug’s temperature stability profile. These “allowable excursions,” or so-called “false alarms” provide an opportunity to improve operational efficiencies, speed products to market, and effectively reduce risk, without compromising drug quality or patient safety. By developing improved temperature monitoring technology designed for validating pharmaceutical shipments, manufacturers can integrate the users’ need for specific information while eliminating non-value added processes and labor from their operation.

What follows is a discussion - an advance in technology created to merge the most effective features of existing devices to achieve the additional goals of lowering operational costs, improving profitability, and reducing risk.

Current Temperature Tracking Process

Electronic Data Logging Monitors

Technology Benefits

The primary purpose for choosing any

(EDLM)

EDLM devices are an effective tool for

temperature-monitoring device is to

An electronic data logger monitor

analyzing sets of data, especially post-

determine whether or not the quality

(EDLM) is a small, portable device that

use trending analytics. They are useful

of a drug product has potentially been

measures, and stores temperature at

when comparing historic data that can

compromised as a result of exposure

pre-determined time intervals by means of

show trends. One of the most common

to harmful or unwanted temperatures.

a built-in sensor, or in some instances, an

uses of EDLM’s is that of temperature

Depending on the type of technology

external sensor. EDLM’s are similar to, but

mapping facilities and developing

used, some monitors may serve as post-

more sophisticated than Programmable

temperature profiles representative

use analytical tools for determining

Electronic Temperature Indicators.

of various shipping lanes and modes of

weakness in a system, trending analysis,

EDLM’s have programmable alarm

transportation. Ambient temperature

and performance metrics. The amount

capabilities, contain integrated displays

profiles are primarily used to develop and

of information varies widely and is

(LED’s), and create reports and graphs

qualify packaging systems by simulating

dependent on the application and

which may be permanently stored, shared

exposure to expected sample exceeded the

technology used.

and analyzed via proprietary hardware,

temperature threshold.

software, desktop application, or through hosted databases.

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Name Observation Method

Alarm Settings

Hidden Costs

Volatile Sensors

Device Costs

Limitation

TLP

Consequence

Typical settings observe temperature readings 4-6 times per

90% of the time products are in transit they are not monitored

hour (once every 10-15 minutes)

(6 readings per hour = 10% of transport time

High instance of false alarms cause additional data analysis,

Non-value add labot deployed to analyze data and create

non-value added labor costs

exception reorts

Proprietary additional hardware, software, app or licensing

End users without hardware/software may not be able to

may be required for downloading data

extract data

Temperature accuracy varies among manufacturers and over

Requires vigilance at the acquisition stage; and some time

operating temperature ranges

calibration services

Typically much more expensive than Chemical or Electronic

Increased costs are justified by the need for continuous

indicators

improvement

Historical and Regulatory Background The United States Pharmacopeia Convention (USP), whose General Guidance Chapter <1079> Good Storage and Shipping Practices, states that the document is intended to “facilitate the movement of drug products through the supply chain in a manner that is controlled, measured, and analyzed for continuous improvement...” and strongly recommends the “use of continuous verification by calibrated monitoring equipment in systems (packaging) used for drug product transport.”

While primary responsibility for the life-cycle management of the drug product ultimately resides with the manufacturer or (license applicant), the USP also emphasizes the need for complete supply chain integrity, from manufacturer to the patient with a focus on a robust Quality Management Program. “All involved should ensure the product to its point of use, creating a contiguous supply network that is collaborative and emphasizes preventive measures to protect drug product quality.” Within the United Kingdom “a Qualified Person must certify that acceptable limits of temperature have been experienced during shipment prior to product release.”

Health Canada Guide 0069 also states, “temperature excursions outside of their respective labeled storage conditions, for brief periods, may be acceptable provided stability data and scientific/technical justification exist demonstrating that product quality is not affected.”

Other countries such as Mexico, Saudi Arabia and Brazil have all made such monitoring a requirement for the acceptance of shipments into their respective countries.

Limited Temperature Observations A major limitation of EDLM’s is the programmed time interval between temperature observations. This time interval – or the device’s ability to capture data - is dependent on the size of the memory and duration of the observation time. Nearly all EDLM’s used within the pharmaceutical industry today contain a 2K memory chip capable of storing 1,920 data points. Larger memory chips are available, but costly and not widely used. To overcome the limits of memory, the industry yields to longer time intervals between temperature observations. Typically, EDLM’s used in the pharmaceutical industry are pre-programmed to record data at intervals of 15 minutes.

Increasing temperature observations to 5 or 10 minutes is generally thought to be impractical and unnecessary, impractical because it uses up precious memory and decreases the duration of a devices’ operating time, unnecessary because it creates too much extraneous data. However, there is a third reason: often the time interval is dictated by the device’s Tau Rating which is the ability to detect, adapt and respond to environmental changes in temperature. These limitations often set the precedent for measuring intervals, not user dictated requirements or parameters, and the reason most EDLM’s are programmed to measure at intervals of 15 minutes (logging data only 4 times per hour of operation). In doing so the resolution of information gathered can be vastly diminished and critical information missed as the amount of data is decreased by a factor of 15 over a device measuring at one-minute intervals.

It is important to note that lengthening time intervals between readings creates observational gaps that can negatively impact the accuracy of the overall system being monitored. This is especially critical on peak measurement observations and alarm times, creating an incomplete data set that can hide temperature deviations as illustrated below. (Fig. 2).

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM 05 - 2014 BELOW ISIssue A THEORETICAL WORST-CASE EXAMPLE OF A TEMPERATURE RAMP

1. Two devices are used to measure and log temperatures within a system; one taking a measurement every minute, the other, every 15 minutes.

2. Ramp and data logging starts at 20°C at 6:00 3. A peak temperature of 42°C is achieved at 6:22 4. With a 15 minute measuring interval, the peak temperature is not recognized nor recorded and the accuracy of the system is off by 7°C over the device measuring at 1 minute intervals.

5. If an alarm was set for temperatures above 35°C then the device measuring every 15 minutes would not see those temperatures when the product would see 15 minutes of temperatures above 35°C. Increased measurement intervals provide for a more accurate account of temperature exposure.

Alarm Settings: “Create Allowable Excursions” vs. “Intelligently Inform” Traditional EDLM’s with limited information retention capabilities and limited alarm settings can and often do, create alarms that the industry reconciles as “allowable excursions.” This is often the case when a data logger can only support two temperature alarms (e.g.

2°C and 8°C) with no allowances for “time out of refrigeration” (ToR) or “time out of temperature” (ToT), which realistically and without exception, occurs. The stability of a drug product takes into consideration ToR. In today’s environment, known ToR allowances beyond label claim storage conditions (e.g. 2° and 8°C) are addressed manually after alarms are triggered. Such alarms are examined and a determination is made as to whether they are acceptable aberrations.

Consequently, material flow is slowed or stopped, inhibiting time to market. A preponderance of these false alarms are declared “non-critical” or pose little to no additional risk to the product. This results in costly non-essential and non-value-added processes and procedures, as skilled labor is deployed to manage such excursions.

A firm operating in a cGMP environment is obligated to demonstrate continuous improvement, following a Plan, Do, Check & Act methodology.6 (Fig. 3) In order to reduce deviations in temperature controlled shipping, the observation tools used must be designed to send alerts only when a real deviation has occurred. To do this, the device must be intelligent, flexible, and expandable, and logically programmed with alarm modes that help a firm match the reporting to its drug stability profile. By changing the methodology for measuring temperature in transit, firms can significantly cut their excursion rate (estimates range to a 50% or greater reduction). (Fig. 5) This flow chart (Fig. 4) is a generic version of the steps that can be required within any firm that experiences a temperature deviation during product transport.

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The charts below demonstrate a method for calculating the potential savings associated with documenting “allowable excursion” investigations. The assumption is that skilled labor assigned to tasks costs the firm ($100k annual = $65k salary + $35k benefits)

(Fig. 6) Calculating Administrative Costs of Allowable Excursions

(Fig. 7) Large Firm:

(Fig. 8) Small Firm:

Total Value of an Activity Assigned to One Deviation Event

Total Value of an Activity Assigned to One Deviation Event

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Hidden Costs of EDLMs All EDLM devices record temperature and time to provide the user

Five Alarm Settings

with insight into environmental or product conditions. The major

Utilizing a wide range of alarm settings, firms can incorporate both known

differentiation factor of devices in this category becomes the method by

drug stability profiles and corporate Time out of Refrigeration (ToR) or

which the information is extracted from the device. This is done primarily

Time out of Temperature (ToT) calculations into the alarm functions.

through a connector cable and a cradle (holding device for the EDLM).

Alarms focused on time above or below specific temperature ranges

Other methods include RFID, USB or Near Field Technology (NFT). The

can allow a firm to leverage their product intelligence to avoid alarm

objection to these extraction methods is that users must be equipped with

conditions. Also, many firms have developed secondary calculations

the appropriate proprietary equipment and software in order to know

(or internal scoring methods) that speed the analysis of temperature

if products are OK for use. Typically, these extra cables and software

excursion data. For example, a firm may assign a higher degree of volatility

cost $100 - $250/user location. This becomes especially cumbersome

for temperatures that are further away from the target temperatures.

when the receiving facilities are numerous or outside the control of the

In such a scenario, the temperature itself can be multiplied against the

pharmaceutical manufacture.

time exposed to that temperature to generate a score. If the total score is above a predefined range, then the alarm would trigger. Currently, these

Opportunities For Continuous Improvement

complex formulas are calculated manually, off-line, after the temperature

Smart Managers need smart devices that can provide them with the

data has been downloaded.

critical information they need. Data export needs to be easy and seamless and statistics need to be prepared automatically so that decisions can

LED Screen

be made faster. Key performance indicators need to be defined quickly

A high visibility LED screen provides non-language specific intelligence

and actions taken where needed to implement essential sustainable

about trip temperatures. This feature, when combined with the intelligent

improvements. More intelligent devices with multiple alarms set for both

alarms improves product flow.

temperature and time single event and cumulative events to include exceptions such as ToT, allow manufacturers to “pre-program” acceptance

USB Connects Data to Data Bases

levels, avoid the time and expense of managing alarm exceptions and

Integrating the data file through a USB port speeds the flow of

speed materials through production safely.

information. The unique data set generated by the CLm doc device insures a smooth exchange to multiple vehicles and formats. Firms can import

Electronic Data Integrators

data in a pdf, Excel files, ERP data bases or streamed into a cloud network

Clearly, the industry can benefit from reduced false alarms by

without the need for any hardware, software, or desktop applications.

implementing smarter devices a hybrid instrument intelligently

This allows the user unprecedented flexibility in retrieving, storing and

programmed like an Electronic Temperature Indicator (ETI) with the

analyzing their own temperature data from the device.

report/data producing capabilities of an Electronic Data Logging Monitor (EDLM). By combining the best features and functions of these two

Data Selection Method

devices, the user can realize the efficiency of a Go/No Go device with

Data selection for graphing purposes ensures that all relevant data is

the record retention and data tracking of an EDLM but with greater

captured while minimizing the use of battery power and data storage

granularity and data management flexibility. Such a device can be

space. This information will remain as part of the permanent record for

categorized as an Electronic Data Integrator (EDI) because it uses the

regulators and QA review. Data selection methods are employed across

pre-programmed intelligence of the device to integrate functional steps

the continuum of electronic products in use today. For example, High

that are today performed by trained personnel.

Definition images for television broad casts have significantly improved the quality of television graphics while increasing the speed by which

Technology Benefits

entire movies can be downloaded. To achieve these dramatic quality

Berlinger AG produces the Q-tag® CLm doc Electronic Data Integrator.

improvements, only the pixels that change between frames are exchanged.

This device has a few unique features/ technology advances that adapt to

The stable images in a picture remain unchanged until there is movement

the user’s needs rather than the user having to adapt to the technology.

that warrants additional data. The result is a higher resolution image and the ability to download all the data for an entire movie in seconds.

Silicon Based Temperature Sensor Silicon-based temperature sensors have been incorporated in various

This exception management method used in an CLm doc electronic data

electronic devices for more than twen- ty years. Silicon-based

integrator, acts as a motion detector for temperature. Consequently,

temperature sensors are decidedly more stable over a wider range of

data are more concise, relevant and exception oriented. It allows for

temperatures and for a longer period of time then most stan- dard NTC

greater storage capacity, and compensates for the limitations of time

sensors used in the industry today.

intervals employed by EDLM’s. By storing data when temperatures move at pre-defined limits (e.g. every 0.5 c movement), the CLm doc is able

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to make temperature observations every minute rather than every 15

Technology Limitations

minutes, while recording all of the changes in temperature. The Clm doc

The limitation of the device is that a user must define alarm settings

data selection method records the dates, time and temperature when the

(either time and temperature related or math calculations; or both) in

temperature moves up or down 0.5°C. The user has the ability to widen

order to employ the device and achieve the desired benefit of reducing

this setting up to 2.0°C and will typically employ this reduced sensitivity

the quantity and cost associated with false temperature alarms. (See Fig. 6

for temperatures in the “OK range” (e.g. between 10°C – 25°C for CRT

Time-Temperature Integrator Benefits & Limitations).

products). Based on the information in Figure 4 above we have already seen that readings every minute can be more precise than readings every 15 minutes. The MKT calculation remains the same, but the memory and battery are saved, allowing for a greater length of observation time.

Conclusion • The process for maintaining product quality during manufacturing, transporting, storing and distributing pharmaceutical and biological products is heavily scrutinized by global regulatory authorities. Regulatory trends require documented evidence of temperature history and management of exceptions in the temperature environment.

• Temperature exceptions or “allowable excursions” in the pharmaceutical supply chain are commonly observed at a rate of 10-20% as captured by current limits of temperature tracking technology. These so-called “false alarms” must be investigated and cause a delay to market.

• An overwhelming majority of allowable excursions are ultimately approved.

• Improved temperature tracking technology provides operational efficiencies and reduces risk, without compromising drug quality or patient safety.

• Electronic Data Integrators combine the best features and benefits of current technologies with more intelligent means for capturing and recording temperature data.

• Non-value added labor is removed from temperature sensitive data analysis and redeployed where it can add value to the organization.

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KEY SPEAKERS:

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NEW EXPANDED EVENT FOR 2014:

• More panel discussions, more case studies and more speakers than ever before • Find out the latest information on GDP regulations and their application to clinical trials • Enhanced networking for delegates through the use of roundtables • Focus sessions on GDP regulations and trials in emerging markets • Refreshed programme focusing on the latest issues from across the globe PHARMA ATTEND FOR:

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPS

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A: Tools and Techniques for Optimal Clinical Supply Planning

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Workshop Leader: Dr. Vladimir Shnaydman, Founder and President, ORbee Consulting 8.30am - 12.20pm

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www.clinical-trial-logistics.com Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711

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DAY ONE | 21ST MAY 2014 8.30

REGISTRATION & COFFEE

9.00

Chairman's Opening Remarks Andrea Gruber, Manager Business Process & Standards, IATA

9.30

SUPPLY CHAIN EFFICIENCY AND OPPORTUNITIES

OPENING ADDRESS / KEYNOTE ADDRESS Dispelling the myths on GDP compliance in clinical trials • Legal requirements or best practices: A look at variations between EU member states • What is legally required • What is likely to be enforced Riekert Bruinink, Member of the GDP drafting Group of the EMA, Dutch Health Care Inspectorate

10.10

Morning refreshments and networking in the exhibition area

10.40

PANEL: Clinical trial supply chain challenges and comparisons • What measures do you have to consider with a clinical trial chain compared to a commercial chain?

• How and when should your CTL comply with GDP regulations?

• Managing temperature controlled products in emerging markets Moderator: Bob Hayes, Director, Cold Chain Consultants Panellists: Vanessa Simm, Senior Operations Manager, Allergan Vimal Unewal, Planning manager, Ferring Pharmaceuticals Ltd Prof. Dr. Vladimir V. Anisimov, Sr Strategic Biostatistics Director, University of Glasgow Chris Jones, Distribution Manager, R&D Supply Chain, AstraZeneca

1.50

Managing supply chain efficiency • Replenishment by buffer system model, consumption driven • Impact on end-to-end supply chain (Patient – CRO – Manufacturer – Vendors(suppliers)) • Impact on stock levels Vimal Unewal, Planning Manager, Ferring Pharmaceuticals Ltd

2.30

How can you optimise pharmaceutical road transit • Current supply chain challenges • Where are the delays occurring?

• What can you do to reduce cost and optimise deliveries Peter J Cullum, Head of International Affairs, Road Haulage Association

3.10

Afternoon refreshments in the exhibition area

3.40

NPA: How can big pharma support pharmacy distribution in product development stages?

• About the NPA • Key challenges in pharmacy supply • EU distribution challenges Layla Hannbeck, Head of Pharmacy Services, National Pharmaceutical Association

4.20

KEYNOTE SESSION: Overcoming key inefficiencies in your supply chain • How can efficient management ensure cost savings in CTS chains?

• Effectively monitor delays in trial shipping • Identifying your weak spots and how to overcome these Harvey Rubin, Professor of Medicine, Microbiology and Computer Science, University of Pennsylvania

11.30

GS1 Standards: Enabling supply efficiency • Who we are and what we do • The case for global supply chain standards • Enabling regulatory compliance, e.g. EU Falsified Medicines Directive • Improving Patient Safety and Supply Chain Security through Traceability: Products, People, Processes Janice Kite, Traceability Director Healthcare, GS1

4.50

The evolution of patient recruitment for Clinical trials via Community pharmacy • Ways of completing the recruitment cycle • The pharmacy role and involvement within Clinical trials • The Clinical trials integrated model in collaboration with the community pharmacy Mr. Michele Ingravallo, Director of Business Innovation & Transformation, Alliance Boots

12.10

Networking Lunch in the exhibition area

5.30

Chairman's Closing Remarks and Close of Day One

DAY TWO | 22ND MAY 2014 8.30

REGISTRATION & COFFEE

9.00

Chairman's Opening Remarks Andrea Gruber, Manager Business Process & Standards, IATA

9.10

OPENING ADDRESS / KEYNOTE ADDRESS Managing the challenges of clinical supplies in third party blinded studies • Review of different scenarios that may be encountered • What are the options when defining your blinding strategy?

• What can go wrong? Identifying risks and mitigations Lesly George, Supply Chain Lead, Pfizer

1.50

Clinical supply modelling and forecasting • Clinical supply forecasting tools vs. spreadsheets - advantages and disadvantages • Which aspects of clinical supply should be addressed? What factors/drivers should be included?

• Clinical supply risk - what level of risk should be accepted? Is zero risk tolerance policy viable?

Vladimir Shnaydman, President, ORBee Consulting

2.30

PANEL: Discussing efficient methods used when labelling and packaging products • What’s the right solution for global labelling inefficiency?

• Managing time and temperature sensitive labelling Peter J Cullum, Head of International Affairs, Road Haulage Association Martin Dearden, Corporate Microbiologist, UCB

3.10

Afternoon refreshments in the exhibition area

3.40

INTERACTIVE ROUND TABLE: Crisis management: What to do when the worst has come to pass • Best practices when dealing with crises • How can you ensure trial validity • What you can do to get back on track Bob Hayes, Director, Cold Chain Consultants

4.20

Avoiding counterfeit medicines entering trials • Falsified Medicines Directive and its impact on logistics •Opportunities and threats • How to protect your supply chain Mike Isles, Executive Director, European Alliance for Access to Safe Medicines

5.10

Chairman’s Closing Remarks and Close of Day Two

MANAGING RISK IN THE SUPPLY CHAIN 9.50

Logistical challenges and strategies for emerging markets: Russia and Ukraine • Case studies in emerging markets for clinical trials • How to accelerate clinical trials • Supply chain optimization Angus McLeod, Sr. Manager, CTS, Catalent

10.30

Morning coffee and refreshments in the exhibition area

11.00

CASE STUDY: Overcoming challenges in the clinical supply chain • Identifying a smart approach to ambient temperature controlled shipments • At which development stage does a switch from cost of goods to transfer prices make commercial sense • How can we implement the IVRS in a smart way, with regards to costs, for reconciliation Frauke Bruns, Clinical Trial Supplies Group Leader, Actelion Pharmaceuticals

11.40

CASE STUDY: Clinical Trial Supply Chain & Risk • Not Measuring the Risk • Tools to measure Risk • Which Risk Level is acceptable Nimer Yusef, Consultant and Founder, Trial-Brain

12.20

Networking Lunch in the exhibition area

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

Delivering Safety, Freshness and Comfort: The Future of Transport Refrigeration I

n 1938 the transport refrigeration business was still in the

Innovations drive better performance, economy and

proverbial ice age, a time when using ice and salt was the

reliability

only practical way for hauliers to keep perishable shipments

Slow global economy, highly volatile fuel prices, increasingly

from spoiling. Visionary Joe Numero knew there had to be

stringent environmental regulations and a worldwide focus on

a better way. Numero commissioned Fred Jones to develop

food safety and load security are putting enormous pressure

technology to keep perishable produce from spoiling during

on every link in the cold chain, from producer to consumer.

transport. Jones responded about 30 days later after having developed the first successful mechanical transport

Owners and operators of refrigerated truck and trailer fleets

refrigeration unit, giving birth to a whole new industry.

are not immune from these pressures. In fact, they are often the first to feel the impact of industry dynamics like fuel price

Almost everything about the transport refrigeration industry

volatility. It is almost impossible to predict the price at the

has changed since then - except its mission. Now, as then,

pump week-to-week. Back in 2008 crude oil dipped as low as

refrigerated hauliers and refrigeration unit manufacturers,

$40 a barrel. Today, it is almost three times higher. It seems

dealers and service providers are dedicated to moving

highly unlikely that the upward trend will change greatly in the

temperature-sensitive shipments by truck, trailer, ship or rail

foreseeable future.

from Point A to Point B safely, reliably and economically.

Operators recognize that they cannot do much about fuel Thermo King, a manufacturer of transport temperature control

prices, so they must focus instead on curbing their fuel

systems for a variety of mobile applications and a brand of

consumption to reduce the impact of rising prices and improve

Ingersoll Rand, foresees a wide range of important innovations

their bottom-line performance. Much has been done to

that will make refrigerated transport even more effective and

improve the fuel efficiency of vehicle engines, but operators

efficient in the years to come.

know that innovative technologies and smart operating practices enable them to achieve best-in-class performance with their refrigeration equipment.

32. TLPINSIGHT

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THE LOGISTICS PORTAL MAGAZINE Issue 05 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

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Slow global economy, highly volatile fuel prices, increasingly stringent environmental regulations and a worldwide focus on food safety and load security are putting enormous pressure on every link in the cold chain, from producer to consumer

The Thermo King SLX trailer refrigeration unit has set new

subject to increasingly stringent regulations across Europe,

standards for fuel efficiency since its introduction in 2008. The

especially within urban areas. Transportation companies are

new SLXe series, launched in 2012, raised the bar even higher.

looking for ways to reduce noise levels through innovative

Head-to-head testing by Thermo King demonstrates that the

technologies and operating practices.

SLXe series are more fuel-efficient than other models in its segment. This improvement was enabled by the introduction

Thermo King has invested heavily in research and development

of innovative control technology to maximise performance and

to meet and exceed these targets without compromising unit

minimise consumption.

performance and reliability. The results have been clearly evident in new ultra low-noise products in the truck and trailer

Fresh produce requires precise temperature control to reduce

diesel and cryogenic ranges.

thermal shock, lessen weight loss through evaporation and help extend shelf life. Operators know that a fast temperature pull-

It is now possible for operators to select quiet â&#x20AC;&#x153;Whisperâ&#x20AC;?

down saves valuable pre-cooling time and can help reduce fuel

variants of refrigeration units in both truck and trailer ranges.

consumption. The Thermo King SLXe Spectrum unit achieves a

For those requiring almost silent operation, there are units

much faster pull-down thanks to advanced control technology

which are certified to meet and exceed the rigorous standards

and software upgrades. The right temperature is reached

set by PIEK, for example the CryoTech range. Transporters

approximately 35 percent faster. Using innovative technology,

can thus continue to operate round the clock within noise-

the units offer about 7 percent greater refrigeration capacity

restricted urban areas on their critical distribution runs.

and are approximately 8 percent more fuel efficient, while achieving more accurate temperature control.

In addition, the ability to operate in off-peak hours alleviates traffic congestion and enables faster delivery cycles. This in

The need for quiet transport

turn means less waste of fresh goods, cutting waste disposal

With traffic noise being the second biggest environmental

and thus reducing carbon dioxide (CO2) emissions. Off-peak

threat to health in the European Union , operating noise is

operation also allows for improved local road safety.

www.the-logistics-portal.com

TLPINSIGHT 33.

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014

Innovations address operators’ needs for better

• Sustainability will be a watchword for some time to

performance

come. New products have been introduced that use less fuel and therefore leave a smaller environmental footprint.

The science of refrigerated transportation has advanced

For example, Thermo King continues to offer low emission

dramatically over the last seven decades with advancements

engines that comply with European Union Directives on

such as nose-mounted units, diesel-powered units, start–stop

emissions, while also offering better performance, lower cost

temperature controls and advanced electronics with remote

of ownership and improved reliability. Operators will willingly

monitoring. The next years will no doubt bring about customer-

adopt environmentally friendly products and practices if they

driven innovations in technology, service and operations that

make economic sense.

are just as impactful. Industry leaders like Thermo King are applying current and emerging technologies and practices to

• Highly efficient diesel engines will continue to power most

help their customers meet challenges and achieve higher levels

refrigeration and air-conditioning units on trucks, trailers

of performance with lower total cost of ownership.

and buses for the foreseeable future. But manufacturers are making advances with other engine concepts and alternative

These are some thoughts on what the future may hold for

fuels. For example, fuel-saving hybrid-electric engines are

the refrigerated transport industry:

common in the truck and trailer market. All-electric and natural gas engines are already available for buses. Thermo King

• Fuel economy will be a big driver of innovation - and with

has pioneered the almost silent, zero emissions use of liquid

good reason. Fuel represents the largest component of total

carbon dioxide in its ground-breaking CryoTech trailer and

operating costs for most refrigerated fleet operators and

truck range.

fuel prices represent one of their least controllable expenses.

Refrigeration equipment manufacturers will continue to

• The need for safe, comfortable bus and light rail

look for ways to design and build more fuel-efficient systems

transportation will continue to grow in the coming years.

and to use advanced electronic controls to improve engine

The greatest areas for growth will likely be in the developing

performance and reliability while reducing fuel consumption.

countries of Asia-Pacific, India and Latin America, where the

Their focus will be on developing technologies that pay for

population is growing and becoming more urban, affluent and

themselves many times over the life of the refrigeration system

mobile.

with better fuel economy and reliability.

34. TLPINSIGHT

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THE LOGISTICS PORTAL MAGAZINE Issue 05 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

• Advances in prognostic capabilities will enable continuous

to be able to interact with refrigeration systems using smart

improvement in refrigeration unit reliability. The use of

devices, which changes the way designers think about user

predictive software and embedded sensors will detect issues

interfaces.

TLP

before they become serious problems and monitor missioncritical components to maximize their service life and predict

• Intelligent solutions and advanced analytics give

when they might fail so a qualified dealer can intervene.

refrigerated fleet operators the opportunity to squeeze even more fuel economy from their refrigeration units. For example,

• Linkage between manufacturers and their dealer networks

fleet operators and their customers can work together using

will become stronger as both parties work to ensure they

advanced analytics to determine the optimal set-point and

are providing the best possible service to refrigerated fleet

control parameters for a particular load. Raising the set-

operators.

point by a single degree can yield as much as a 2 percent improvement in fuel efficiency, according to Thermo King

• Food safety and freshness have become priorities, driven

analysis. The ability to do “what-if” modelling using multiple

both by government regulation and consumer pressure.

variables gives shippers and operators the information

Current and pending regulations in Europe, the United States and elsewhere place new expectations on food producers, processors and transporters, including the requirement to trace shipments across all links of the supply chain. To help meet these requirements, advanced refrigeration systems include the capability to track, record and transmit data that can help fleet operators establish the location of a particular load at a particular time, as well as document conditions inside the refrigerated container, truck or trailer.

• Demand for safer food supplies will continue to grow in the developing regions such as Asia, India and Latin America, creating new opportunities for the refrigerated transport industry. Globalization of the food supply will lead to the increasing use of intermodal transport for temperature-sensitive loads.

they need to make datasupported decisions to

• Whether they are hauling food, pharmaceuticals, chemicals,

improve efficiency and

cosmetics or some other temperature-sensitive load,

reduce fuel costs, without

operators are tapping into advanced tracking capabilities that

sacrificing cargo safety

use global positioning system data and advanced wireless

and freshness.

communications technologies to provide operators with realtime and historical information about load temperature and

The demand to move food

asset location – for one trailer or an entire fleet – answering

and other temperature-sensitive goods from their point

operators’ need for better safety, security and efficiency.

of production to their point of consumption will continue to grow in the years ahead, with no end in sight. A slower than

• Operators can monitor temperatures and other variables,

expected economic recovery, volatile fuel prices and more

remotely change temperature set-points and control

stringent environmental and food-safety requirements make

parameters, download reports, change operating modes and

this a challenging time for everyone in the cold chain, including

respond to alarms using any computer, tablet or smart phone

owners and operators of refrigerated fleets. Mass transit,

that is connected to their secure network. These capabilities

coach and light rail operators face the joint challenges of rising

take pressure off drivers who now can focus totally on the

fuel prices and depressed passenger numbers.

operation of their vehicles, rather than the operation of the refrigeration unit.

With technology and sound operating practices, the refrigerated transportation industry stands ready to meet

• The new generation of drivers and other operator

the needs of its customers and society for the next years, and

employees – including those born in the information age – has

beyond.

different expectations than their older colleagues. They expect www.the-logistics-portal.com

TLPINSIGHT 35.

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THE LOGISTICS LOGISTICS PORTAL THE PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 04 05 - 2013 2014

Maintaining Cold Chain Integrity for Pharmaceutical Products A

lmost 30% of scrapped sales at pharmaceutical companies can be attributed to logistics issues. Maintaining the quality and integrity of pharmaceutical products during transport is critical for its manufacturers and for public health and patient safety.

should not be allowed to rise any higher than -20°C. The recommended storage handling temperature regime for medicinal shipments such as blood and plasma is -30°C. Other products within this temperature regime may be carried at -25°C. • +4°C or +6°C: Medicinal products such as vaccines and

Pharmaceutical products require a stable and secure

antibodies should be maintained between +2°C and +8°C

temperature controlled environment during all stages of

without deviating from this temperature range.

manufacturing and distribution. Controlling the storage and transportation temperatures is a vital part in quality and

• +20°C: Products such as active pharmaceutical ingredients

risk management of the product. The European Union (EU)

(APIs) or small molecules should be kept between +15°C and

Commission Guidelines on Good Distribution Practice (GDP)

+25°C and not deviate outside of this range.

of Medicinal Products for Human Use should be consulted in order to ensure appropriate procedures are followed and

Each refrigerated transport unit used for the transportation of

measures taken to maintain product quality throughout the

pharmaceutical products needs to go through a certification

cold chain and limit risks during transport.

and qualification process. Qualification is a temperature validation process that maps the temperature performance

When it comes to transporting pharmaceutical products,

of the unit operating in the temperature ranges listed above.

there are typically three temperature regimes to ensure

Temperature sensors are placed in a number of locations

temperatures are maintained within required parameters:

throughout the box to identify if there are any hot or cold spots that could affect the transportation of the pharmaceutical

• -25°C: Typically products transported for clinical trials should be kept frozen at all times. The cooling compartment

36. TLPINSIGHT

www.the-logistics-portal.com

products.

THE LOGISTICS PORTAL MAGAZINE Issue 05 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

It is recommended to conduct the validation at an accredited

• Drivers are required to be trained to show that they can

laboratory such as the Ingersoll Rand Engineering and

operate the unit within the GDP requirements.

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Technology Center (IRETC) in Prague, Czech Republic. Once the qualification process is completed, the unit can be certified

• Regular maintenance and service records should be kept for

for pharmaceutical operation.

inspection if required by the pharmaceutical companies.

Other important factors to consider before or during transport

• A calibration check should be completed at least once per

of pharmaceutical products are:

year; individual pharmaceutical companies may request more checks. A three-point calibration of the sensors is important to

• Load space configuration when the trailer body design is

ensure that when the unit is operating it can maintain the load

carried out, such as whether to include dividing doors, air

space temperature at the set points as listed above.

shoots, return air bulkhead design.

• To prevent risk of contamination to sensitive shipments • The load space should be kept clean at all times and only

in the compartment, cleaning standards in line with GDP

cleaning agents that will not affect the cargo should be used.

guidelines should be enforced under the guidance of certified service personnel.

• To conform to temperature monitoring and recording obligations, the units are required to have on-board

• Remote monitoring is also recommended and this can be

temperature recording and monitoring as well as printed

provided by the means of satellite tracking products such as

delivery point tickets to prove the temperature integrity of the

the Thermo King TracKing™ system.

load space.

Preserving cold chain integrity and maintaining product quality • Because the products have to stay within a particular range,

is an increasing challenge for pharmaceutical companies and

both temperature and air management must be controlled

their partners in handling and transporting pharmaceutical

within this range with no deviation allowed or any excursions

products globally. A stable and secure temperature controlled

limited to manufacturer specifications.

environment is very important to ensuring product efficacy during pharmaceutical transport.

Ingersoll Rand Engineering and Technology Center (IRETC) The Ingersoll Rand Engineering and Technology Center (IRETC) situated in Prague is dedicated to research and development activities within the mechanical and industrial engineering sector. IRETC is an ISO 9001: 2000; ISO 14001 and ISO 18000 certified institute and is authorised for ATP certification. IRETC also offers engineering expertise to Thermo King and third party companies.

Specifically for pharmaceutical transport, IRETC offers certification and qualification services.

At IRETC, a range of functional and performance tests can be conducted in a controlled environment to certify that the refrigeration equipment used for pharmaceutical transportation can perform to required specifications. This includes: • Thermal mapping of trailers and trucks from -32°C to +60°C • Vibration tests to replicate over-the-road conditions for loads up to 10 000 kg • Calorimeter tests of unit cooling and heating capacities at simulated extreme ambient conditions • Thermography to visualise temperature spread within loaded vehicles On completion of the qualification process, the unit can be certified for pharmaceutical operation.

• • • •

Thermal mapping of trailers and trucks from -32°C to +60°C Vibration tests to replicate over-the-road conditions for loads up to 10 000 kg Calorimeter tests of unit cooling and heating capacities at simulated extreme ambient conditions Thermography to visualise temperature spread within loaded vehicles

On completion of the qualification process, the unit can be certified for pharmaceutical operation.

www.the-logistics-portal.com

TLPINSIGHT 37.

PROMOTIONAL FEATURE | GOOEY GLOBAL

E

Speaking on the occasion, Bessem Bikhazi, Managing Director, Gooey UK Ltd; said, "We are re-launching Gooey Data with a clear objective of facilitating database services at one place”. With the philosophy of “Buy, Append or let us arrange data for you”, the new division will be the one stop solution for all data related services that aviation-related companies usually require for their direct networking and other objectives. “Gooey, which is a pioneer company in Air Transport Information management globally has to become a huge success since its inception back in 2010 and is way ahead of its time in its alliances with companies that supports this venture. With our new-style contact databases, we hope to serve the industry in the same dedicated way with an exuded excellence and customized efforts to simplify things for marketers”, adds the director of Data, John Devos.

ntrepreneur Bessem Bikhaziis a man with an ambition to make the everyday life of the aviation businessman that little less stressful.

His well knowledgeable group of industry experts have spent the past few years developing the most powerful communication tool that allows businesses to reach key decision makers with procurement responsibilities faster than ever before.

BRANDS: Airline XL, Airport XL, Cargo XL, Handler XL, Supplier XL and Freight XL is an extension of services by Gooey which provides a host of Direct Key Contacts of CEOs, VPs and 20 other Department heads from 192 global locations.

A subscription based model (fixed fee) wherein the data and information services can be availed as per chosen package offered by Gooey including free and frequent updates.

Gooey has an extensive reach practically in all aviation verticals encapsulating over 55,000 business details followed by names, job title, email addresses and direct-dial of those key contacts.

Points in this portal allows you to Search by company name, by country, by category, IATA and ICAO, job function... etc.

To Request a Brochure, contactCharlotte Willis: info@gooey.uk.com

“WE ARE PUSHING AT AN OPEN DOOR WITH THIS ONE AND WE’LL BE GLOBAL VERY SOON.” m Bikhazi, MD: “we are pushing at an open door with this one”

Gooey was founded in 2010 with a unique concept of Aviation Information and Database marketing and has not looked back since. Gooey has lead its way to providing unmatched services in the global market roping in strong partnership and subscribers everywhere. Services of Gooey includes gaining direct access to key contacts on a platform similar to a Spreadsheet but smarter! With numerous clients from airlines, airports, airport authorities, handling agents, industry suppliers, organisations and association and conference/tradeshow organisers.

Industry players are very much in favour of this venture, remarks Bessem. “ we are pushing at an open door with this one and we’ll be global very soon.”

‘’Our mission is to help aviation professionals help themselves by simplifying processes while reducing costs and improving

THE LOGISTICS PORTAL MAGAZINE

Head of Business Development

Executive VP/ Deputy CEO Chairman/ CEO

Quality & Risk Assessment

Head of Strategy & Planning

Head of I.T Head of Technical

Head of MRO Head of Networking & Routes

Head of HR

Head of Supply Chain

Head of Flight Operations

Head of Sales/ Communication

COO CFO

Head of Inflight

Head of Commercial Services

Head of Ground Operations Head of Safety/Security

direct networkinG: Gain access to world airlines, airports & handlers direct key contacts!

Gooey has spent the last few years developing the most powerful communication tool that allows aviation professionals to reach key decision makers faster than ever before.

claim your free trial: info@gooey.uk.com www.gooey.uk.com | www.gooey-global.com

[RELIABILITY] Provide the best solution for the transportation of pharmaceuticals.

COOL CHAIN LOGISTICS

-SOLUTIONS PHARMA Constant Temperature Control

Dedicated Logistics Team

Contact: Cool Chain Logistics Team c/o Adrian Rayner Tel: +44-(0)1784 - 422- 637 adrian.rayner@jal.com www.jal.co.jp/en/jalcargo/

THE LOGISTICS PORTAL MAGAZINE

Temperature Mapping Studies

Infitrak Temperature Mapping Studies – an evidence-based approach to understanding the temperature and/or humidity distribution of your storage environments while demonstrating compliance.

“Drug products must be transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions; potentially impacting the safety, quality and effectiveness of the drug product”. Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069) – January 28, 2011. Statements with similar meaning can be found in FDA, EU and WHO regulations and guidance.

How does your company demonstrate compliance?

The Supply Chain Challenge The shipment and storage of pharmaceuticals is highly regulated throughout North America and most of the world under such guidelines as GUI-0069 in Canada, and 21 CFR Part 11 in the United States. As well, guidelines such as USP <1079>, provide additional direction to companies to ensure good storage and shipping practices.

Whether you are a manufacturer, third party logistics firm, distributor or wholesaler, compliance with these regulations is essential to your business.

Infitrak Temperature Mapping Overview The objective of a Temperature Mapping Study is to document temperatures within defined areas where temperature sensitive products are stored or shipped. This can range in size from a small refrigerator to transport trailers and large warehouses. Using our proven analytical process, the Infitrak team works with your staff to not only conduct a temperature study, but also to empower your staff with the know-how to improve your processes and environments.

T: 905 470 1318

TF: 1 866 421 8367

E: sales@infitrak.com

www.infitrak.com

Temperature Mapping Studies

The Infitrak temperature mapping process follows a comprehensive and proven methodology, including: • Mapping protocols adapted to the unique needs of your environment, and its conditions. Before a study begins, protocols are reviewed and pre-approved by your staff • Calibrated and independent N.I.S.T. traceable temperature data loggers (no hardwiring) • Documentation of environmental conditions that identify the temperatures recorded over the life of the Study, and the thermal variations within the studied areas at any given time • Calculation of mean kinetic temperature (MKT) within each unique area being studied • Multi-seasonal comparisons that can include winter, summer, spring and fall • Pre-qualification studies that can pave the way for new or expanded storage areas • Identification of locations within the studied area that demonstrate high and low temperatures (hot and cold spots) as compared to the desired temperature range for the area • Location of temperature collection points for on-going monitoring • Follow-up with your staff to address any adverse situations identified as part of the study Expertise and Knowledge Transfer With more than 15 years of experience in pharmaceutical and supply chain analysis, Infitrak offers a comprehensive range of Cold Chain services that do not end with temperature mapping. We specialize in the identification, design and implementation of solutions for all Cold Chain related issues. Our end goal is to empower our clients with the knowledge and skills required for continual improvement, self sufficiency and the internal management practices necessary for SOPS and regulatory compliance.

Benefits: • Infitrak’s expertise and proven track record of success • Time-tested methodologies that meet regulatory requirements • Cost-effective routes to compliance • Knowledge transfer to ensure your team is empowered with a complete understanding of the work being completed and the appropriate responses to audit and regulatory questions • Post-study products and services to assist you in responding to any identified deficiencies For further guidance on cold chain management and good distribution practices, please contact the Infitrak team.

T: 905 470 1318

42. TLPINSIGHT

TF: 1 866 421 8367

E: sales@infitrak.com

www.the-logistics-portal.com

www.infitrak.com

THE LOGISTICS PORTAL MAGAZINE Issue 05 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

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Safety first in Dangerous Goods Management

Dangerous Goods Management is all about

automated where possible to save you time

safety and minimizing risk. In air transpor tation,

and to reduce error rate to a minimum.

staying compliant with all of the many rules and regulations is not an easy task. However,

DGOffice.net was developed as an on-line

supported by DGOffice.net with its specific

application, meaning you can access it anytime

modules for air transportation, it becomes a

from anywhere in the world. Alternatively,

clean cut operation. From Packing Instructions

run it as you see fit: within your own network

to Shipper’s Declaration and ‘NOtification TO

or on a stand-alone computer.

Caption’: it’s all in the software and highly

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net

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TLPINSIGHT 43.

11-12-12 16:56

//INDEX OF ADVERTISERS IFC

UPS

5

Sofrigram

7

Cargolux

9

IQPC

11

Berlinger &Co AG

12

Biotec

17

TLP Insight

22

Logipharm

30

SMI

38

Gooey

40

DGM

IBC

Softbox

OBC

IATA

THE LOGISTICS PORTAL MAGAZINE Issue 05 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

TLP

FOR ADVERTISING INFORMATION CONTACT: Sales: Info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk

www.the-logistics-portal.com

TLPINSIGHT 45.

//EVENTS BIOLOGISTICS SUMMIT June 16- 18, 2014 San Francisco, CA http://www.pharma-iq.com/

3RD ANNUAL PHARMACEUTICAL COLD CHAIN INDIA May 22- 23, 2014 Venue To Be Confirmed, Hyderabad, India http://www.pharma-iq.com/

GLOBAL BIOBANKING 2014 May 6- 8, 2014 Copthorne Tara, London, United Kingdom http://www.pharma-iq.com/

CLINICAL TRIAL LOGISTICS 2014 21st May to 22nd May 2014, London, United Kingdom SMiâ&#x20AC;&#x2122;s Clinical Trial Logistics conference returns in May 2014 for its 8th incarnation. http://www.smi-online.co.uk/pharmaceuticals/

5TH ANNUAL BIO/PHARMACEUTICAL COLD CHAIN CHINA 2014 23rd June to 24th June 2014 London, United Kingdom http://www.smi-online.co.uk/pharmaceuticals/

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Protecting your pharmaceuticals whatever their destination

Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals • Cost effective protection of ambient products • Innovative design uses only 6 components • Insulated pallet shields product from hot tarmac • Supplied with UV reflective waterproof cover • Moulded insulation panels for “Glide Fit” assembly • No coolant required – pack and ship in minutes • Flat packs to reduce delivery, storage & return costs • Manufactured from 100% recyclable materials

2

1

4

www.softboxsystems.com EUROPE

Softbox Systems Ltd. Units 1-2 Ridgeway Drakes Drive Long Crendon Buckinghamshire HP18 9BF UK T: +44 1844 203 560 F: +44 1844 203 570 E: info@softboxsystems.com

AMERICAS

Softbox Systems Inc. 1160 NW Elliot Court Bend, Oregon 97701 USA T: +1 541 389 9183 F: +1 888 610 0750 E: info@softboxsystems.us

3

INDIA

Softbox Systems India Pvt Ltd. Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206 T: +91 2232 222 380 F: +91 2143 221 789 E: info@softboxsystems.com

1. Euro & US Pallet Versions 2. UV reflective waterproof cover 3. Five Euro systems on air pallet 4. Insulated Pallet Base

ASIA PACIFIC

Softbox Temperature Control Packaging Systems Pte. Ltd. 48 Toh Guan Road East #02-115 Enterprise Hub Singapore 608586 T: +65 6316 9584 F: +65 6316 9504 E: info@softboxsystems.com

For more information about this or any other Softbox Packaging System visit www.softboxsystems.com Patent GB2459392 “Transport Container” – International Patents Pending

© 2012 Softbox Systems Ltd all rights reserved

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