tlp insight issue 5

THE LOGISTICS PORTAL MAGAZINE

TLPINSIGHTIssue 5 - 2014


AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS

TLP Insight: a journal for the life science logistics industry

Only safetythe safe transportation of air cargo

IN-DEPTH INSIGHTON SUSTAINABLEPHARMACEUTICALSPACKAGING

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


MANAGING DIRECTORLee Atkinson

MANAGING EDITORBridget Langston

CONSULTANT EDITORTony Wright

SENIOR DESIGNERJoey Graham [email protected]

EDITORIAL ASSISTANTSNicholas RidgmanJamie Ward

CIRCULATION MANAGERTony Williams

SALESRakesh Makwana, Lee Atkinson, Amy Firth

ADMINISTRATIONKatie Galelli

WEBSITE DESIGNKnut Henriksen

CONTACT USSales:[email protected]

Subscription:[email protected]

TLP INSIGHTIs published 4 times a year March, June, September & December by Intensive Media Ltd. Printed by Premier Print & Direct Mail Group.Send address changes to:145 - 157 St Johns StreetLondonEC1V 4PWUnited Kingdom

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

TLPINSIGHT//MAIN CONTENT

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.

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.

Read the full article on page 24 »

// COMBINING THE BEST ASPECTS OF TEMPERATURE TRACKING

TECHNOLOGIES INTO A SINGLE, UNIQUE DEVICE IMPROVES

PHARMACEUTICAL TEMPERATURE MANAGEMENT CAPABILITIES

Contents continue on page 4 »

Safety First9

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’.

Protecting ambient products at a reasonable price

14

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.

8 Steps to implementing a controlled room temperature strategy

13

TLPINSIGHT www.the-logistics-portal.com4.


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

//FEATUREDCONTENT

//MAINTAINING COLD CHAIN INTEGRITY FOR PHARMACEUTICAL PRODUCTS

FEATURED ARTICLE

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 »

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.

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.

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.

CRT Market Insights15 Sustainability and

pharmaceuticals packaging16

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

32

a high technology smart boxFor highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com

//FEATUREDCONTENTa high technology smart box

For highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com




//TLP INSIGHT FOREWORDWelcome 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


Complete peace of mind for your pharmaceutical and healthcare shipments

[email protected] | www.cargolux.com

Flying with careIt 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.

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+2°C to +8°C +15°C to +25°C




SAFET Y FIRST

Cas

e St

udy

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.

www.the-logistics-portal.com TLPINSIGHT 9.

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

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SAFET Y FIRST

www.CSafeGlobal.com

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 end-

to-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

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8 Steps to Implementing a ControlledRoom temperature Strategy

For More Visit www.ColdChainIQ.com

1. 2.

3.

5.

7.

4.

6.

8.

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:

Know your own products -

required storage and distribution

temperature guidelines, available

stability data etc.

The types of temperature threat

(heat/cold/duration) will determine

the requirements of the protection

equipment required.

Consider the impact of using either

single use or reusable systems. Cost,

return logistics, contamination,

maintenance, disposal are all aspects

that require consideration.

Be prepared to lean on the

expertise of both 3PL and

equipment manufacturer partners.

Both can have valuable experience

and knowledge to offer.

Establish the routes and assess the

temperature threat risk of each.

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.

Be aware of existing and developing

global legislation which could

change the criteria required for

distribution and storage.




Kevin Kohleriter, Director of Marketing for Infitrak

Protecting Ambient Productsat a Reasonable Price

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

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

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

and pasta. They will often have a very long shelf life and are at low

risk or a low purchase price for the consumer.

Because the end-product is typically lower in cost, protecting

these products requires a cost effective means to protect them

from temperature excursions that may spoil them or shorten their

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,

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.

Protecting products that are affected by ambient

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

temperature profile as defined by PDA Technical Report 39. What

are the acceptable environmental conditions the product itself can

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

Three methods for creating an ambient temperature profile (and

how to save money doing it)

There are three methods for creating a ambient temperature profile

that can be used to design thermal packaging:

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”.

The first is for you to provide it (it may be a

company standard or you can use data from a

data logger).

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.

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

available.

1.

2.

3.

For More Visit www.ColdChainIQ.com



CRT Market Insights

Jim Lucie, Senior Manager,

Material Control at AMAG Pharmaceuticals

Michael English, Senior Product Engineer of

Packaging Technologies, Merck

Gary Htchinsom, President, Modality Solutions

“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,”

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.

“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,”

“[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,

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

closer look at that even from a regulatory standpoint.”

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

Jim Bacon, Senior Director, Grifols. Inc




The

packaging

of pharmaceutical

products serves as a

multiple means of providing

protection, identification,

information and convenience from the

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.

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

pharmaceutical packaging demand will increase by more than

6% – to over $57 billion in 2017. Western Europe, the US, and

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

will experience the fastest growth in product demand due to their

rapidly expanding manufacturing capabilities, rising drug exports

and a widespread government programme of national production.

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

pharmaceutical packaging product markets as drug-producing

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

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.

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

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

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

segments based on adaptability to economical unit dose formats.

Reducing the amount of packaging used seems to be the first

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

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

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

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

needed to distribute it, without considering any recycling or heat

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

SUSTAINABIL

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ACKAGING

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A B I L I T Y S E R V I C E S

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


being

damaged

wastes 100%

of the materials

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.

To produce packaging for the pharmaceuticals industry that is

sustainable, the system must not only meet the requirements for

packaging optimisation, but also have a reduced environmental

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

be precisely balanced.

DEVELOPING SUSTAINABLE PACKAGING

Before considering its environmental credentials, packaging

must at first ensure its contents are protected all along the

downstream supply chain. For long distances and transport time

this is particularly complex, as packaging has to resist hazards

such as extreme temperatures, moisture, and light exposure.

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

lightweight, in order to keep shipping costs down.

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

develop sustainable pharmaceuticals packaging?

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

already been started. Sustainability information on products has

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

to increase in the coming years. Corporate social responsibility

and sustainability reporting are based on numbers and figures

extracted from supply chain and manufacturing information.

Additionally, such reporting becomes mandatory in many

countries or multinational companies. Thus, suppliers are being

questioned all along the supply chain with regard to Scope 3

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

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

are implementing product environmental footprint information

to measure and rank products. Sustainability should therefore

not be seen as an end-state but as a continuing process of

improvement.

SCHEMA SCOPE 1-2-3

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

footprint assessment, measuring the total amount of carbon

dioxide and other greenhouse gases emitted over the life cycle

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

interesting but do not help to assess the global environmental

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.

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,

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

path. By showing the connections between the consumption of

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

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

the production process of a product can be mapped and linked

with its most common environmental impacts. LCA is also an

excellent tool to compare different design choices before going

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

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

minimum calorific value to allow optimisation of energy recovery.

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

stage of production, one can identify how to prioritise the

reduction of a product’s environmental impacts and make better

environmental choices without triggering the transfer of pollution

from one stage to another.

EXAMPLES OF SUSTAINABLE PACKAGING

MATERIALS

In recent years the sustainable packaging on offer has expanded

rapidly. Innovative materials are increasingly available, produced

from more sustainable resources, such as plants, or materials

that biodegrade or compost easily and quickly. Characteristics

of sustainable packaging include that it should be well designed,

streamlined, biodegradable and easily recyclable. What follows

is information about the main biopolymers available on the

market that can be used in packaging applications. Their potential

recyclability or environmental impact will fluctuate mainly

according to their purity and the process of production they

undergo.

STARCH

This is a polysaccharide, renewable and widely available raw

material. Corn is the primary source of starch, but it can also

be obtained from various sources such as potato, wheat and

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

shaped as trays or disposable receivers. Starch based plastic

materials are an important part of the market nowadays. Thanks

to a blend of biodegradable starch based polymers (polylactide,

SUSTAINABIL

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ACKAGING

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Main Conference: 23rd-24th April 2014Post-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

Andrey Bulimov QA ManagerNovartis

Inna Nikitina Head of Quality Assurance / National QPRoche Moscow Ltd

Mihail Hazanchuk Quality Control ManagerNovo Nordisk LLC

Sergey Baldin Head of DistributionMicrogen

Andrey Kuharenko Cool Chain Department Vice PresidentNonprofi t Partnership “Development andImplementation of good practice into the Cool Chain”

Gennady Shirshov Director at SPFO Society of Professional Pharmaceutical Organizations

Valentin Tolkunov Supply Chain DeveloperBoehringer Ingelheim

Alexey Voronov RT-Biotechprom

Igor Bakhmetev Manufacturers relationsAlliance Healthcare

Dmitry Koroteev ExpertNonprofi t Partnership “Development and Implementation of good practice into the Cool Chain”

Presentations from leadingRussian and international experts including:

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 fi nancial 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-qualifi ed 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 fi nd 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

For more information please visit www.coolchainrussia.ru

cool-chain-russia-2014-AD.indd 1 19/02/2014 14:42



polyhydroxybutyrate,

polyhydroxyalkanoate,

valeric acid) with aliphatic

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

- Starch-Polyvinyl alcohol blends

- Starch synthetic aliphatic polyester blends

- Starch polybutylene succinate or polybutylene succinate adipate

(PBSA) polyester blends.

CELLULOSE

This is a linear polymer that is abundant in nature. The most

common cellulose based polymer is cellophane. Many of its

derivatives are used in packaging. Among those derivatives,

cellulose acetate is widely used in pharmaceutical packaging and

laboratory products.

XYLAN

These are a group of substances based on hemicellulose, obtained

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

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

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

value by-product with no competition with food. It is commonly

used as a barrier material.

CHITOSAN

This is extracted from the exoskeleton of arthropods such as

crustaceans and insects. It represents the second most abundant

polysaccharide resource after cellulose. Due to its antimicrobial

properties it is widely used in packaging, maintaining a

preservative action while protecting the product from bacterial

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

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

modified atmosphere, the biodegradable laminate used is usually

made of chitosan-cellulose.

SYNTHETIC BASED BIOPOLYMERS

These are produced using industrial processes but based on

natural or modified raw materials and monomers. The high and

rapidly changing cost of biodegradable polymers made from

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

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

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.

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.

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.

For any of the recommendations it is important to:

1. Ensure that the packaging is compliant with legislation.

2. Avoid the transfer of pollution between different systems

(primary, secondary and tertiary packaging) and along the life

cycle of a single packaging.

Recommendations are grouped by:

- Main life cycle stage

o Raw material extraction

o Manufacturing

o Transport

o End-of-life.

- Difficulty of implementation

o * Easy

o ** Reachable

o *** Complex.

RAW MATERIAL EXTRACTION

*Easy

• How to reduce the weight of the case?

• Investigate the basic weight of cardboard to achieve the correct

packaging.

• Would it be possible to remove one packaging element without

disturbing product protection?

• Investigate the possibility of using trays.

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

possible to use any?

• Use packaging with recycled fibres compliant for food contact.

**Reachable

• Has the use of packaging surfaces been optimised?

• Reduce the width of sealing and investigate different

interweaving.

• Can the packaging recyclability be optimised?

• Investigate mono-material packaging elements.



***Complex

• Has the volume of packaging been optimised compared to the

product size?

• Optimise any potential empty space.

• Can the product restitution rate be optimised?

• Investigate different design scenarios to allow complete

product restitution.

• Are there any elements disruptive to packaging recyclability?

• Refer to external recyclability analysis.

MANUFACTURING

*Easy

• Has the weight of packaging been measured among different

suppliers?

• Add ’weight’ criteria when choosing a supplier.

• When choosing a new packaging, has the environmental

performance been compared to the previous option?

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

% of recycled materials).

**Reachable

• Could more sustainable inks/glues be used?

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

• Have transportation distances been optimised?

• Favour a local supplier.

***Complex

• Have product processes been optimised during manufacturing

and packaging?

• Investigate reduction of energy losses on the production lines.

• Has the standardisation of packaging sizes been investigated?

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

diversity of colours.

TRANSPORTATION

*Easy

• Is it possible to reduce the weight of packaging during

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?

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

***Complex

• Is it possible to favour less impacting transportation modes?

• Investigate the use of ship, rail or combined transportation

modes.

• Has the optimisation of transport being investigated?

• Avoid any empty lorries returning to manufacturing site. Work

on optimisation of transportation schemes.

END OF LIFE

*Easy

• Does the patient have enough information to recycle the

packaging correctly?

• Provide clear information on how and what to recycle.

***Complex

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

recycling?

• Investigate the improvement of packaging separability.

CONCLUSION

After implementing sustainability initiatives the last step

would be to communicate them. But in terms of environmental

communication, a high-level vigilance must be applied to the

message that is used. It is important to always communicate

about packaging and product impacts and at the same time have

a communication strategy adapted to the audience (patient,

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

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

panel before external communication.

Finally, packaging is one of the first steps in building a robust,

green pharmaceutical supply chain. Implementation of product

sustainability checklists and use of renewable energy technology

at the warehouse are also avenues being explored for reducing

the supply chain’s environmental footprint.

Danny Hendrikse, VP EMEA Supply Chain Operations, Pfi zer

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

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

Philippe François,VP, Supply Chain EMEA, Baxter Healthcare

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

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

Rod Beard, Principal Pharmacist, Sunderland Royal Hospital, UK

Vision, Strategy & Case Studies From 80+ Leading Players In The Industry:

7 - 10 April, 2014Congress Center Basel, Switzerland

Supply Chain as a Customer Centric Function

7 - 10 April, 20147 - 10 April, 2014Congress Center Basel, Switzerland

Sponsors:

Platinum Partner: Principal Partners:

Lodestone

Event Partners: Principal Sponsors:

Now in its

13th Year

The Leading End-To-End Supply Chain Management Event For The Life Sciences Industry

Wayne Swanton,Vice President, Supply Chain, Actavis

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 unifi ed, consistent and fl exible responses.

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.

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.

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 fi nd and foster talent within your division, and ensure a win-win relationship that lasts?

SEGMENTATION - Profi tability is the driver for segmentation; fi nd 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 – Benefi t 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.

Understand the needs of the customer, how they affect your supply chain and obstacles to unifi ed, consistent

END-TO-END SUPPLY CHAIN ORCHESTRATION

advocate for excellence within your division, and when working with other business units within your company.

about your peers’ experience of resilient and innovative

actual audits and risk mitigation strategies of peers to gain a holistic understanding of regulatory demands

– Understand from front-line experts which ‘emerging markets’ have emerged and how to juggle differing characteristics of hot markets in

business’ greatest asset; how can you fi nd and foster

SUPPLY CHAIN RISK, INTEGRITY & SECURITY

mitigation strategies and robust supply continuity plans

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 benefi t 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 fl at 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 - Pfi zer, 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.

See you in Basel!

Yours Sincerely

Emily Martyr

Event Director

LogiPharma Europe 2014

New Venue

15 % discount for TLP Insight Subscribers, use code WBRTLP15

Secure your place now at www.logipharmaconference.com

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.

9631 AW.indd All Pages 03/03/2014 16:00



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

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

The primary purpose for choosing any

temperature-monitoring device is to

determine whether or not the quality

of a drug product has potentially been

compromised as a result of exposure

to harmful or unwanted temperatures.

Depending on the type of technology

used, some monitors may serve as post-

use analytical tools for determining

weakness in a system, trending analysis,

and performance metrics. The amount

of information varies widely and is

dependent on the application and

technology used.

Electronic Data Logging Monitors

(EDLM)

An electronic data logger monitor

(EDLM) is a small, portable device that

measures, and stores temperature at

pre-determined time intervals by means of

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

external sensor. EDLM’s are similar to, but

more sophisticated than Programmable

Electronic Temperature Indicators.

EDLM’s have programmable alarm

capabilities, contain integrated displays

(LED’s), and create reports and graphs

which may be permanently stored, shared

and analyzed via proprietary hardware,

software, desktop application, or through

hosted databases.

Technology Benefits

EDLM devices are an effective tool for

analyzing sets of data, especially post-

use trending analytics. They are useful

when comparing historic data that can

show trends. One of the most common

uses of EDLM’s is that of temperature

mapping facilities and developing

temperature profiles representative

of various shipping lanes and modes of

transportation. Ambient temperature

profiles are primarily used to develop and

qualify packaging systems by simulating

exposure to expected sample exceeded the

temperature threshold.

Executive Summary



Name Limitation Consequence

Observation Method Typical settings observe temperature readings 4-6 times per

hour (once every 10-15 minutes)

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

(6 readings per hour = 10% of transport time

Alarm Settings High instance of false alarms cause additional data analysis,

non-value added labor costs

Non-value add labot deployed to analyze data and create

exception reorts

Hidden Costs Proprietary additional hardware, software, app or licensing

may be required for downloading data

End users without hardware/software may not be able to

extract data

Volatile Sensors Temperature accuracy varies among manufacturers and over

operating temperature ranges

Requires vigilance at the acquisition stage; and some time

calibration services

Device Costs Typically much more expensive than Chemical or Electronic

indicators

Increased costs are justified by the need for continuous

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).



WWW.THE-LOGISTICS-PORTAL.COM Issue 05 - 2014TLP B E LO W I S A T H E O R E T I C A L W O R S T- C A S E E X A M P L E O F A T E M P E R AT U R E R A M P

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.



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:

Total Value of an Activity Assigned to One Deviation Event

(Fig. 8) Small Firm:

Total Value of an Activity Assigned to One Deviation Event




Hidden Costs of EDLMs

All EDLM devices record temperature and time to provide the user

with insight into environmental or product conditions. The major

differentiation factor of devices in this category becomes the method by

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

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

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

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

the appropriate proprietary equipment and software in order to know

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

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

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

pharmaceutical manufacture.

Opportunities For Continuous Improvement

Smart Managers need smart devices that can provide them with the

critical information they need. Data export needs to be easy and seamless

and statistics need to be prepared automatically so that decisions can

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

and actions taken where needed to implement essential sustainable

improvements. More intelligent devices with multiple alarms set for both

temperature and time single event and cumulative events to include

exceptions such as ToT, allow manufacturers to “pre-program” acceptance

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

speed materials through production safely.

Electronic Data Integrators

Clearly, the industry can benefit from reduced false alarms by

implementing smarter devices a hybrid instrument intelligently

programmed like an Electronic Temperature Indicator (ETI) with the

report/data producing capabilities of an Electronic Data Logging Monitor

(EDLM). By combining the best features and functions of these two

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

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

granularity and data management flexibility. Such a device can be

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

pre-programmed intelligence of the device to integrate functional steps

that are today performed by trained personnel.

Technology Benefits

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

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

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

Silicon Based Temperature Sensor

Silicon-based temperature sensors have been incorporated in various

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

temperature sensors are decidedly more stable over a wider range of

temperatures and for a longer period of time then most standard NTC

sensors used in the industry today.

Five Alarm Settings

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

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

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

Alarms focused on time above or below specific temperature ranges

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

conditions. Also, many firms have developed secondary calculations

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

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

for temperatures that are further away from the target temperatures.

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

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

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

data has been downloaded.

LED Screen

A high visibility LED screen provides non-language specific intelligence

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

alarms improves product flow.

USB Connects Data to Data Bases

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

information. The unique data set generated by the CLm doc device insures

a smooth exchange to multiple vehicles and formats. Firms can import

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

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

This allows the user unprecedented flexibility in retrieving, storing and

analyzing their own temperature data from the device.

Data Selection Method

Data selection for graphing purposes ensures that all relevant data is

captured while minimizing the use of battery power and data storage

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

regulators and QA review. Data selection methods are employed across

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

Definition images for television broad casts have significantly improved

the quality of television graphics while increasing the speed by which

entire movies can be downloaded. To achieve these dramatic quality

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

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

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.

This exception management method used in an CLm doc electronic data

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

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

greater storage capacity, and compensates for the limitations of time

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



to make temperature observations every minute rather than every 15

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

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

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

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

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

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.

Technology Limitations

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

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

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

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

Time-Temperature Integrator Benefits & Limitations).

• 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.

Conclusion




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21ST - 22ND MAY 2014 | MARRIOTT REGENTS PARK | LONDON, UK

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B: Virtual Logics: Managing quality and user acceptance testing

Workshop Leader: Nimer Yusef, Consultant and Founder,

Trial-Brain12.30pm - 4.30pm

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSTuesday 20th May 2014, Marriott Regents Park, London, UK

PHARMA ATTEND FOR:

£999

8.30 REGISTRATION & COFFEE

9.00 Chairman's Opening RemarksAndrea Gruber, Manager Business Process & Standards, IATA

OPENING ADDRESS / KEYNOTE ADDRESS9.30 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, DutchHealth 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, AllerganVimal Unewal, Planning manager, Ferring Pharmaceuticals LtdProf. Dr. Vladimir V. Anisimov, Sr Strategic Biostatistics Director, University ofGlasgowChris Jones, Distribution Manager, R&D Supply Chain, AstraZeneca

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, ProcessesJanice Kite, Traceability Director Healthcare, GS1

12.10 Networking Lunch in the exhibition area

SUPPLY CHAIN EFFICIENCY AND OPPORTUNITIES

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 productdevelopment stages?

• About the NPA • Key challenges in pharmacy supply • EU distribution challenges

Layla Hannbeck, Head of Pharmacy Services, National PharmaceuticalAssociation

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 theseHarvey Rubin, Professor of Medicine, Microbiology and ComputerScience, University of Pennsylvania

4.50 The evolution of patient recruitment for Clinical trials via Communitypharmacy• Ways of completing the recruitment cycle• The pharmacy role and involvement within Clinical trials• The Clinical trials integrated model in collaboration with the community

pharmacyMr. Michele Ingravallo, Director of Business Innovation & Transformation,Alliance Boots

5.30 Chairman's Closing Remarks and Close of Day One


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

OPENING ADDRESS / KEYNOTE ADDRESS9.10 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

MANAGING RISK IN THE SUPPLY CHAIN

9.50 Logistical challenges and strategies for emerging markets: Russia andUkraine

• 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


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 packagingproducts

• 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


3.40 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

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DAY ONE | 21ST MAY 2014

DAY TWO | 22ND MAY 2014

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EUROPE'S LEADING CLINICAL TRIAL LOGISTICS EVENT

KEY SPEAKERS:• Lesley George, Supply Chain Lead, Pfizer• Riekert Bruinink, Member of the GDP drafting Group of the

EMA, Dutch Health Care• Vimal Unewal, Planning Manager, Ferring Pharmaceuticals Ltd• Vanessa Simm, Senior Operations Manager, Allergan• Frauke Bruns, Clinical Trial Supplies Group Leader, Actelion

Pharmaceuticals• Janice Kite, Traceability Director Healthcare, GS1 • Layla Hannbeck, Head of Pharmacy Services, National

Pharmaceutical Association• Andrea Gruber, Manager Business Process & Standards, IATA• Chris Jones, Distribution Manager, R&D Supply Chain, AstraZeneca• Michele Ingravallo, Director of Business Innovation and

Transformation, Alliance BootsAnd many more…

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

A: Tools and Techniques for Optimal Clinical Supply Planning

Workshop Leader: Dr. Vladimir Shnaydman, Founder and President,

ORbee Consulting8.30am - 12.20pm

B: Virtual Logics: Managing quality and user acceptance testing

Workshop Leader: Nimer Yusef, Consultant and Founder,

Trial-Brain12.30pm - 4.30pm

PLUS TWO INTERACTIVE HALF-DAY PRE-CONFERENCE WORKSHOPSTuesday 20th May 2014, Marriott Regents Park, London, UK

PHARMA ATTEND FOR:

£999


9.00 Chairman's Opening RemarksAndrea Gruber, Manager Business Process & Standards, IATA

OPENING ADDRESS / KEYNOTE ADDRESS9.30 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, DutchHealth 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, AllerganVimal Unewal, Planning manager, Ferring Pharmaceuticals LtdProf. Dr. Vladimir V. Anisimov, Sr Strategic Biostatistics Director, University ofGlasgowChris Jones, Distribution Manager, R&D Supply Chain, AstraZeneca

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, ProcessesJanice Kite, Traceability Director Healthcare, GS1


SUPPLY CHAIN EFFICIENCY AND OPPORTUNITIES

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


3.40 NPA: How can big pharma support pharmacy distribution in productdevelopment stages?

• About the NPA • Key challenges in pharmacy supply • EU distribution challenges

Layla Hannbeck, Head of Pharmacy Services, National PharmaceuticalAssociation

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 theseHarvey Rubin, Professor of Medicine, Microbiology and ComputerScience, University of Pennsylvania

4.50 The evolution of patient recruitment for Clinical trials via Communitypharmacy• Ways of completing the recruitment cycle• The pharmacy role and involvement within Clinical trials• The Clinical trials integrated model in collaboration with the community

pharmacyMr. Michele Ingravallo, Director of Business Innovation & Transformation,Alliance Boots

5.30 Chairman's Closing Remarks and Close of Day One


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

OPENING ADDRESS / KEYNOTE ADDRESS9.10 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

MANAGING RISK IN THE SUPPLY CHAIN

9.50 Logistical challenges and strategies for emerging markets: Russia andUkraine

• 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


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 packagingproducts

• 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


3.40 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

Sponsored by

DAY ONE | 21ST MAY 2014

DAY TWO | 22ND MAY 2014

A3Advert 20/02/2014 15:44 Page 1




In 1938 the transport refrigeration business was still in the

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

only practical way for hauliers to keep perishable shipments

from spoiling. Visionary Joe Numero knew there had to be

a better way. Numero commissioned Fred Jones to develop

technology to keep perishable produce from spoiling during

transport. Jones responded about 30 days later after

having developed the first successful mechanical transport

refrigeration unit, giving birth to a whole new industry.

Almost everything about the transport refrigeration industry

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

refrigerated hauliers and refrigeration unit manufacturers,

dealers and service providers are dedicated to moving

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

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

Thermo King, a manufacturer of transport temperature control

systems for a variety of mobile applications and a brand of

Ingersoll Rand, foresees a wide range of important innovations

that will make refrigerated transport even more effective and

efficient in the years to come.

Innovations drive better performance, economy and

reliability

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.

Owners and operators of refrigerated truck and trailer fleets

are not immune from these pressures. In fact, they are often

the first to feel the impact of industry dynamics like fuel price

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

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

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

highly unlikely that the upward trend will change greatly in the

foreseeable future.

Operators recognize that they cannot do much about fuel

prices, so they must focus instead on curbing their fuel

consumption to reduce the impact of rising prices and improve

their bottom-line performance. Much has been done to

improve the fuel efficiency of vehicle engines, but operators

know that innovative technologies and smart operating

practices enable them to achieve best-in-class performance

with their refrigeration equipment.

Delivering Safety, Freshness and Comfort:

The Future of Transport Refrigeration



The Thermo King SLX trailer refrigeration unit has set new

standards for fuel efficiency since its introduction in 2008. The

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

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

SLXe series are more fuel-efficient than other models in its

segment. This improvement was enabled by the introduction

of innovative control technology to maximise performance and

minimise consumption.

Fresh produce requires precise temperature control to reduce

thermal shock, lessen weight loss through evaporation and help

extend shelf life. Operators know that a fast temperature pull-

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

consumption. The Thermo King SLXe Spectrum unit achieves a

much faster pull-down thanks to advanced control technology

and software upgrades. The right temperature is reached

approximately 35 percent faster. Using innovative technology,

the units offer about 7 percent greater refrigeration capacity

and are approximately 8 percent more fuel efficient, while

achieving more accurate temperature control.

The need for quiet transport

With traffic noise being the second biggest environmental

threat to health in the European Union , operating noise is

subject to increasingly stringent regulations across Europe,

especially within urban areas. Transportation companies are

looking for ways to reduce noise levels through innovative

technologies and operating practices.

Thermo King has invested heavily in research and development

to meet and exceed these targets without compromising unit

performance and reliability. The results have been clearly

evident in new ultra low-noise products in the truck and trailer

diesel and cryogenic ranges.

It is now possible for operators to select quiet “Whisper”

variants of refrigeration units in both truck and trailer ranges.

For those requiring almost silent operation, there are units

which are certified to meet and exceed the rigorous standards

set by PIEK, for example the CryoTech range. Transporters

can thus continue to operate round the clock within noise-

restricted urban areas on their critical distribution runs.

In addition, the ability to operate in off-peak hours alleviates

traffic congestion and enables faster delivery cycles. This in

turn means less waste of fresh goods, cutting waste disposal

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

operation also allows for improved local road safety.

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




Innovations address operators’ needs for better

performance

The science of refrigerated transportation has advanced

dramatically over the last seven decades with advancements

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

temperature controls and advanced electronics with remote

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

driven innovations in technology, service and operations that

are just as impactful. Industry leaders like Thermo King are

applying current and emerging technologies and practices to

help their customers meet challenges and achieve higher levels

of performance with lower total cost of ownership.

These are some thoughts on what the future may hold for

the refrigerated transport industry:

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

good reason. Fuel represents the largest component of total

operating costs for most refrigerated fleet operators and

fuel prices represent one of their least controllable expenses.

Refrigeration equipment manufacturers will continue to

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

and to use advanced electronic controls to improve engine

performance and reliability while reducing fuel consumption.

Their focus will be on developing technologies that pay for

themselves many times over the life of the refrigeration system

with better fuel economy and reliability.

• Sustainability will be a watchword for some time to

come. New products have been introduced that use less

fuel and therefore leave a smaller environmental footprint.

For example, Thermo King continues to offer low emission

engines that comply with European Union Directives on

emissions, while also offering better performance, lower cost

of ownership and improved reliability. Operators will willingly

adopt environmentally friendly products and practices if they

make economic sense.

• Highly efficient diesel engines will continue to power most

refrigeration and air-conditioning units on trucks, trailers

and buses for the foreseeable future. But manufacturers are

making advances with other engine concepts and alternative

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

common in the truck and trailer market. All-electric and natural

gas engines are already available for buses. Thermo King

has pioneered the almost silent, zero emissions use of liquid

carbon dioxide in its ground-breaking CryoTech trailer and

truck range.

• The need for safe, comfortable bus and light rail

transportation will continue to grow in the coming years.

The greatest areas for growth will likely be in the developing

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

population is growing and becoming more urban, affluent and

mobile.



• Advances in prognostic capabilities will enable continuous

improvement in refrigeration unit reliability. The use of

predictive software and embedded sensors will detect issues

before they become serious problems and monitor mission-

critical components to maximize their service life and predict

when they might fail so a qualified dealer can intervene.

• Linkage between manufacturers and their dealer networks

will become stronger as both parties work to ensure they

are providing the best possible service to refrigerated fleet

operators.

• Food safety and freshness have become priorities, driven

both by government regulation and consumer pressure.

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.

• Whether they are hauling food, pharmaceuticals, chemicals,

cosmetics or some other temperature-sensitive load,

operators are tapping into advanced tracking capabilities that

use global positioning system data and advanced wireless

communications technologies to provide operators with real-

time and historical information about load temperature and

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

operators’ need for better safety, security and efficiency.

• Operators can monitor temperatures and other variables,

remotely change temperature set-points and control

parameters, download reports, change operating modes and

respond to alarms using any computer, tablet or smart phone

that is connected to their secure network. These capabilities

take pressure off drivers who now can focus totally on the

operation of their vehicles, rather than the operation of the

refrigeration unit.

• The new generation of drivers and other operator

employees – including those born in the information age – has

different expectations than their older colleagues. They expect

to be able to interact with refrigeration systems using smart

devices, which changes the way designers think about user

interfaces.

• Intelligent solutions and advanced analytics give

refrigerated fleet operators the opportunity to squeeze even

more fuel economy from their refrigeration units. For example,

fleet operators and their customers can work together using

advanced analytics to determine the optimal set-point and

control parameters for a particular load. Raising the set-

point by a single degree can yield as much as a 2 percent

improvement in fuel efficiency, according to Thermo King

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

variables gives shippers and operators the information

they need to make data-

supported decisions to

improve efficiency and

reduce fuel costs, without

sacrificing cargo safety

and freshness.

The demand to move food

and other temperature-sensitive goods from their point

of production to their point of consumption will continue to

grow in the years ahead, with no end in sight. A slower than

expected economic recovery, volatile fuel prices and more

stringent environmental and food-safety requirements make

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

owners and operators of refrigerated fleets. Mass transit,

coach and light rail operators face the joint challenges of rising

fuel prices and depressed passenger numbers.

With technology and sound operating practices, the

refrigerated transportation industry stands ready to meet

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

beyond.



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


Almost 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.

Pharmaceutical products require a stable and secure

temperature controlled environment during all stages of

manufacturing and distribution. Controlling the storage and

transportation temperatures is a vital part in quality and

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

Commission Guidelines on Good Distribution Practice (GDP)

of Medicinal Products for Human Use should be consulted

in order to ensure appropriate procedures are followed and

measures taken to maintain product quality throughout the

cold chain and limit risks during transport.

When it comes to transporting pharmaceutical products,

there are typically three temperature regimes to ensure

temperatures are maintained within required parameters:

• -25°C: Typically products transported for clinical trials

should be kept frozen at all times. The cooling compartment

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

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

without deviating from this temperature range.

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

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

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

Each refrigerated transport unit used for the transportation of

pharmaceutical products needs to go through a certification

and qualification process. Qualification is a temperature

validation process that maps the temperature performance

of the unit operating in the temperature ranges listed above.

Temperature sensors are placed in a number of locations

throughout the box to identify if there are any hot or cold spots

that could affect the transportation of the pharmaceutical

products.

Maintaining Cold Chain Integrity for Pharmaceutical Products



It is recommended to conduct the validation at an accredited

laboratory such as the Ingersoll Rand Engineering and

Technology Center (IRETC) in Prague, Czech Republic. Once

the qualification process is completed, the unit can be certified

for pharmaceutical operation.

Other important factors to consider before or during transport

of pharmaceutical products are:

• Load space configuration when the trailer body design is

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

shoots, return air bulkhead design.

• The load space should be kept clean at all times and only

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

• To conform to temperature monitoring and recording

obligations, the units are required to have on-board

temperature recording and monitoring as well as printed

delivery point tickets to prove the temperature integrity of the

load space.

• Because the products have to stay within a particular range,

both temperature and air management must be controlled

within this range with no deviation allowed or any excursions

limited to manufacturer specifications.

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

operate the unit within the GDP requirements.

• Regular maintenance and service records should be kept for

inspection if required by the pharmaceutical companies.

• A calibration check should be completed at least once per

year; individual pharmaceutical companies may request more

checks. A three-point calibration of the sensors is important to

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

space temperature at the set points as listed above.

• To prevent risk of contamination to sensitive shipments

in the compartment, cleaning standards in line with GDP

guidelines should be enforced under the guidance of certified

service personnel.

• Remote monitoring is also recommended and this can be

provided by the means of satellite tracking products such as

the Thermo King TracKing™ system.

Preserving cold chain integrity and maintaining product quality

is an increasing challenge for pharmaceutical companies and

their partners in handling and transporting pharmaceutical

products globally. A stable and secure temperature controlled

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.

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Head of I.T

Head of MRO

Head of HR

CFO

Head of Inflight

Head of Technical

COO

Contact: Cool Chain Logistics Team c/o Adrian Rayner　Tel: +44-(0)1784-422-637

[email protected]　www.jal.co.jp/en/jalcargo/

-SOLUTIONS PHARMA

[RELIABILITY]

Constant Temperature Control Dedicated Logistics Team

COOL CHAIN LOGISTICS

Provide the best solution

for the transportation of

pharmaceuticals.


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

Temperature Mapping Studies

“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: [email protected] www.infitrak.com

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.





















Benefits:

























Benefits:




Dangerous Goods Management is all about

safety and minimizing risk. In air transpor tation,

staying compliant with all of the many rules

and regulations is not an easy task. However,

supported by DGOffi ce.net with its specifi c

modules for air transportation, it becomes a

clean cut operation. From Packing Instructions

to Shipper’s Declaration and ‘NOtifi cation TO

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

Safety fi rstin Dangerous Goods Management

DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790,[email protected], www.dgoffi ce.net

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

run it as you see fi t: within your own network

or on a stand-alone computer.

014016_DGOffice_adv_203x280.indd 2 11-12-12 16:56



//INDEX OF ADVERTISERSIFC

5

7

9

11

12

17

22

30

38

40

IBC

OBC

UPS

Sofrigram

Cargolux

IQPC

Berlinger &Co AG

Biotec

TLP Insight

Logipharm

SMI

Gooey

DGM

Softbox

IATA

FOR ADVERTISING INFORMATION CONTACT:

Sales: [email protected]

Subscription: [email protected]

//EVENTS

BIOLOGISTICS SUMMIT

3RD ANNUAL PHARMACEUTICAL COLD CHAIN INDIA

GLOBAL BIOBANKING 2014

CLINICAL TRIAL LOGISTICS 2014

5TH ANNUAL BIO/PHARMACEUTICAL COLD CHAIN CHINA 2014

June 16- 18, 2014

San Francisco, CA

http://www.pharma-iq.com/

May 22- 23, 2014

Venue To Be Confirmed, Hyderabad, India


21st May to 22nd May 2014, London, United Kingdom

SMi’s Clinical Trial Logistics conference returns in May 2014 for its 8th incarnation.

http://www.smi-online.co.uk/pharmaceuticals/

May 6- 8, 2014

Copthorne Tara, London, United Kingdom


23rd June to 24th June 2014

London, United Kingdom

http://www.smi-online.co.uk/pharmaceuticals/


For more information about this or any other Softbox Packaging System visit www.softboxsystems.comPatent GB2459392 “Transport Container” – International Patents Pending © 2012 Softbox Systems Ltd all rights reserved

EUROPE Softbox Systems Ltd.Units 1-2 RidgewayDrakes DriveLong Crendon Buckinghamshire HP18 9BFUKT: +44 1844 203 560F: +44 1844 203 570E: [email protected]

AMERICASSoftbox Systems Inc.1160 NW Elliot CourtBend, Oregon 97701USAT: +1 541 389 9183F: +1 888 610 0750E: [email protected]

INDIASoftbox Systems India Pvt Ltd.Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206T: +91 2232 222 380F: +91 2143 221 789E: [email protected]

ASIA PACIFICSoftbox Temperature Control Packaging Systems Pte. Ltd.48 Toh Guan Road East#02-115 Enterprise HubSingapore 608586T: +65 6316 9584F: +65 6316 9504E: [email protected]

• 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

Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals

1. Euro & US Pallet Versions2. UV reflective waterproof cover3. Five Euro systems on air pallet 4. Insulated Pallet Base

1

3

2

4

Protecting your pharmaceuticals whatever their destination

www.softboxsystems.com

IATA - DGR54 - Stay Compliant (V7) / The Logistics Portal Jan 2013

full page trim size 210 X 297 mm / safety area 186 X 273 mm

iata.org/dgr

Effective immediately, use the 54th Edition of the DGR Manual or your shipments may be at risk.If you’re not using the 54th Edition of the DGR Manual your dangerous good shipment may not be compliant. Don’t risk having your shipment returned or being fi ned thousands of dollars because of faulty documentation, packing or labeling. Get the 54th edition of the DGR Manual today and be current with the latest regulations for completing the Shipper’s Declaration. Remember, if you use previous editions, you are knowingly putting yourself and your company at serious risk.

Stay Compliant

DDIA00122_DGRad_TheLogisticsPortal_V7.indd 1 2013-01-18 11:31 AM

tlp insight issue 5

Documents