TLP INSIGHT issue 3

TLPINSIGHT ENVIRONMENTAL CREDENTIALS SUSTAINABILITY AND PHARMACEUTICAL PACKAGING

the wireless objective interview with iata’s cargo wireless technology advisory group

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

THE LOGISTICS PORTAL MAGAZINE

Issue 3 - 2013

swiss 째Celsius Active For your temperature controlled supply chain

swissworldcargo.com

//MAIN CONTENT

TLPINSIGHT MANAGING DIRECTOR Lee Atkinson

//INTERVIEW WITH IATA’S CARGO WIRELESS TECHNOLOGY ADVISORY GROUP

MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright SENIOR DESIGNER Joey Graham

An industry must-read, TLP brings you updates and insights on IATA Cargo’s latest initiatives, from the group known previously as ‘Cargo RFID Working Group’. The change in name is the group’s response to the increasing number of applications of other wireless technologies in the cargo operations, such as GPS and GPRS. Read the full article on page 8 »

EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson ADMINISTRATION Katie Galelli

12 Carlos Castro on Cold Chain Supply

Carlos is the Cold Chain / Transportation Project Manager for Bayer Healthcare at Berkeley and provides expertise in temperature-controlled logistics, transportation, packaging and supply chain. He has more than 12 years of combined experience in the US, Europe and Latin America.

He shares with us here his forecast for industry developments in a time of change driven by the growth in emerging markets.

18 Sustainability and Pharmaceuticals packaging

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

24 Supply Chains Still the Biggest Issue When Sourcing for Trials

The results of research by Pharma IQ give us an insight into why the process of sourcing comparators is fraught with difficulty. They look at current issues and future plans.practical level for those making decisions on sustainable packaging.

WEBSITE DESIGN Knut Henriksen PRINTED BY CBF Cheltenham Business Forms Ltd www.cbfnet.co.uk CONTACT US Sales: info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk TLP INSIGHT Is published 4 times a year March, June, September & December by Intensive Media Ltd Send address changes to: 145 - 157 St Johns Street London EC1V 4PW United 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.

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Contents continue on page 4 »

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 03 - 2013

//CONTENTS

30 Prepare, Prepare, Prepare in Clinical Supply Lindsay Pinnick, Clinical Supply Manager at UCB, speaks to Pharma IQ about how to deal with the difficult issues surrounding international supply at a time when budgets are getting smaller and smaller.

40 Risk in the Latin American Temperature Controlled Pharma Supply Chain Humberto Laserna, Quality Coordinator at Pfizer Peru, joins Cold Chain IQ to tackle the challenges of designing and implementing a quality strategy for the cold chain in Latin America.

//RISK MITIGATION: THE INVISIBLE COMPONENT OF COLD CHAIN MANAGEMENT Smart cold chain management addresses the underlying structure and stability of their monitoring programmes by looking beyond the visible components to risk mitigation. In this White Paper, Sensitech looks at the kind of questions we need to ask ourselves in relation to this, in our quest for quality management in the cold chain.

Read the full article on page 34 Âť

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//TLP INSIGHT FOREWARD September sees the implementation of the revised EU Guidelines on Good Distribution Practices of Medicinal Products and attention has inevitably been focused upon the readiness of the supply chain process to these improved guidelines. How effective has the preparation been? How aware are wholesalers and brokers of their redefined responsibilities? How much training has taken place so that all of those responsible for Good Distribution Practice (GDP) can meet the new requirements? The following months may tell!

Of course, GDP is not new. It has been a feature of the growing international trade in temperature-sensitive pharmaceutical and healthcare products for some considerable time and those serious about the logistics process have played a significant role in the growing awareness of GDP. In this edition we include articles that focus upon two important aspects of Good Distribution Practices.

Firstly, in his article on Sustainability and Pharmaceuticals Packaging, Pierre Boccon-Gibod from SGS talks of the increasing pressure on all of us to take sustainable packaging at all levels, more seriously. He makes the interesting comment that whilst we might think more about reducing the amount of packaging for a pharmaceutical product as a way of reducing waste; under-packaging (or perhaps inadequate packaging) has potentially a far more detrimental effect through product damage and the sometimes resultant total waste of the packaging and its contents.

A recent report published by the BBC told of the GBP 300m of prescribed drugs that are thrown away each year due to overprescription. Even though unused drugs may be returned to the dispensary, pharmacists simply don’t know if they have been stored correctly and therefore cannot risk any re-issue. Packaging is very much a part of that wastage.

Pierre Boccon-Gibod makes the case that ‘now’ is the right time to start developing sustainable pharmaceutical packaging and that to do this effectively requires the use of Life Cycle Assessment methodology. This allows us to consider not just one aspect of packaging sustainability but the entire product-to-patient process and he offers a number of initiatives that are achievable.

As the pharmaceutical logistics industry looks for more cost effective supply chain models, making use of technology, particularly in data management, has become vital. Though the airline cargo sector has been slow to adopt the kind of technology that has been in use for many years by their passenger handling colleagues, there are signs of positive change.

The International Air Transportation Association (IATA), in representing over 90% of the world airlines, has the considerable task of trying to establish a set of RFID industry standards in a market where an increasing number of wireless applications are being developed.

In our interview with IATA, it is clear that their newly formed ‘Cargo Wireless Technology Advisory Group’ will be looking not only at the increasing (and sometimes legally-required) use of temperature and humidity monitoring devices, but other aspects of ensuring how RFID can be safely used on aircraft and in the air cargo process. Interestingly, they see their role as more looking at this from the user perspective rather than anything to do with technology development.

It is heartening to hear that this group includes a good cross-section of industry stakeholders. Without this, we may not see the kind of much-needed harmonisation of technology standards that are so vital to an efficient and cost-effective pharmaceutical logistics process.

Tony Wright CEO Exelsius Cold Chain Management

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USE OF RFID IN AIR CARGO T

To give you an update, we are in the process of changing the

pilot testing projects on cargo side have been carried out by only a

name of the ‘Cargo RFID Working Group’ to ‘Cargo Wireless

few airlines. To me the impact has been minimal compared with the

Technology Advisory Group’ mainly because of the increasing number

application of RFID for baggage handling purposes on the airport/

of applications of other wireless technologies in the cargo operations,

passenger side.

such as GPS and GPRS. 1. How do you feel RFID has impacted the industry over the last 5 years?

2. How do you see the CRFIDWG helping the industry in terms of providing clear regulations and standards for approval for active RFID devices on board an aircraft?

The IATA Cargo Services Conference Recommended Practice 1640

The Cargo Wireless Technology Advisory Group (former Cargo RFID

(Use of Radio Frequency Technology for the Automatic Identification

Working Group) has been established to provide recommendations

of Unit Load Devices) was introduced in 1991 and its most recent

to the Cargo Business Processes Panel (CBPP) on the common

amendment was done in 1996, and since then it has not been

industry standards and best practices for the application of wireless

updated. Does it mean that the RP 1640 was stable enough without

technologies in cargo operations for the purposes of ensuring

the need to review and update? Knowing that most of the references

compatibility and interoperability.

contained in the current RP 1640 have already been out of date for

The group has just completed the review of CSC RP 1640 for the

quite some years, the answer is apparently no. There could be two

automatic identification of ULDs and passive RFID technology has

main reasons for the lack of review:

been recommended to meet specific business requirements as well

• RFID technology was not that mature until recently, so the costs of

as to align it with the RFID technology chosen by the passenger side

infrastructure as well as the RFID tags were relatively expensive

for baggage handling purposes. In other words, the group has not yet

• Very few airlines were implementing it (e.g. one of the largest cargo

officially started work on the application of any active devices.

airlines is still scanning bar-coded ULD ID Code markings).

Assigned by the parent body, the CBPP, the next task of the group Having said that, applications of RFID and other wireless

will be to focus on ‘Time & temperature monitoring devices’, which

technologies are now appearing at the top of the cargo agenda and

will definitely cover the applications of active devices on board an

the main drivers are believed to be the following:

aircraft. One of the deliverables of the next task will be to provide

• RFID has become a relatively mature technology and the price of

recommendations on how to ensure regulatory compliance by

RFID tags has been decreasing

clarifying the following:

• The growing air cargo market is generating higher competitive

• Who are the relevant regulators?

pressures, which require new cost-benefit-sharing models and

• What are the applicable regulations?

efficient logistics procedures to survive in such an environment

• What are the compliance specifications?

• The complexity of the air cargo supply chain demands the improved

• What are the acceptable means of compliance?

flow of real-time information as air cargo shipments are in general,

• Who should comply?

time and quality sensitive.

• Who should apply for approval?

• What are the standard approval procedures?

Wireless technologies contribute considerably towards addressing

• Who should approve?

these upcoming challenges. Various applications in air cargo operations have been developed, such as:

The recommendations provided by the group will then need to

• automatic identification and logistics management of ULDs

be approved by the CBPP and eventually by the Cargo Services

• time/temperature/humidity monitoring

Conference, if the recommendations are considered significant

• valuable cargo tracking

enough to become a new CSC RP similar to RP 1640.

• piece level tracking • unauthorized door opening and vibration monitoring for security control.

Representatives from the major aircraft manufacturers are members of the group and it is believed that the IATA recommended practice on the application of wireless technologies on board an aircraft

In short, over the last 5 years only a few local solutions and small

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will help aircraft manufacturers certify and install buyer furnished

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THE LOGISTICS PORTAL MAGAZINE www.the-logistics-portal.com Issue 02 - 2013

wireless devices and/or required radio frequency network on board

the intention of the group. We as participants in the air cargo supply

the aircraft at the aircraft design and production stage. This will

chain should consider ourselves potential users of various wireless

prevent inefficient multiplicity, which makes interoperability an

technologies and we basically want to be informed users who are

impossible task for the industry.

familiar with both our business requirements and the available options in order to make the appropriate decisions.

It would be absolutely necessary for IATA to actively participate in rule making groups of regulators such as EASA and FAA to represent

In order to make sure that the group has the required expertise to

the industry’s interest.

support its progress, the following measures have been implemented: • The membership of the group consists of not only airlines/freight

3. Will the CRFIDWG help the industry in terms of compatibility and interoperability?

forwarders/ground service providers but also wireless devices manufacturers, aircraft manufacturers, IT service providers, who would definitely bring in additional technical support to the group

Yes, definitely, the ultimate objective of the group is to ensure, as

• Representatives from relevant international standard organizations

much as possible compatibility between devices/equipment and

such as ISO/IEC, GS1, ATA are always invited to participate in the

systems from different manufacturers/service providers as well as

regular meetings of the group

interoperability across the air cargo supply chain participants.

• IATA Secretary maintains regular liaison with relevant IATA industry groups (e.g. ULD Panel, Time & Temperature Task Force, Cargo

The tasks of the group are to be identified by the CBPP based on

XML Task Force) as well as other IATA RFID projects (e.g. passenger

the needs and wants of the industry, and these should represent the

baggage handling, aircraft part tracking & tracing, ground support

trends in air cargo operations. Therefore, an industry recommended

equipment identification) to ensure synergy and alignment.

practice on a specific application would definitely be beneficial to whoever would like to deploy such technology for guidance and references.

5. How do you see the CRFIDWG in 5 - 10 years in terms of involvement in the industry?

As mentioned in my answer to the previous question, the group itself

The technical readiness of the various industry members differs

is an industry advisory group consisting of industry stakeholders

dramatically, as do their perceived needs. Some are simply concerned

with well-established regular coordination and communication

with asset tracking, others believe ‘time and temperature’ monitoring

networks both inside and outside IATA as well as with invited industry

are immediate needs, and still others wish to provide full monitoring

observers; the involvement in the industry is a MUST. Without

of location, environmental conditions, intrusion alarms, and chain of

involving the industry stakeholders I don’t see how we could ensure

custody. Some members wish to drill down to ‘piece level tracking’

compatibility and interoperability across the air cargo supply chain.

while others are satisfied with asset tracking, and still others look to identify assets as they are being loaded through aircraft

IATA is in the process of creating the ‘Wireless Technology in Air

doors. Finally, some members want their required information

Cargo Industry Think Tank’, consisting of airlines, state of the art

instantaneously while others perceive real time as relative, finding

technology providers, international standard organizations, startups,

it completely acceptable for updates to be given later. Faced with

venture capitalists, leading research specialists from top universities,

these diverse challenges, the group will consider an approach that

etc. The Think Tank aims to take a strategic and comprehensive view

meet the most basic needs while permitting the expansion of the

on how the latest wireless technologies can be used in various areas

same infrastructure to the widest possible applications of wireless

of the air cargo environment. Again, the Cargo Wireless Technology

technology. Here our cooperation with international standard

Advisory Group will focus on identifying business requirements

organizations such as the ISO and JTC 1 communities becomes

and recommending the minimum required, commonly acceptable,

crucial, staying abreast of ISO developments, whilst not getting too

technical and operational specifications to achieve the business

far ahead of standards development.

requirements. It could be envisaged that the Think Tank provides the vision and industry position, and the Advisory Group will make it

In short, it is believed that IATA should play a greater leading role

happen.

in establishing the industry standards and procedures for the application of RFID and other wireless technologies throughout

In short, I would expect to see IATA playing a more active role in

the air cargo supply chain to maximize efficiency as well as ensure

establishing industry standards and recommended practices in the

compatibility and interoperability.

application of wireless technologies through engaging with the industry.

4. What do you see that needs to happen to improve expertise in RFID technology deployment?

Developing new technologies should neither be the objective nor

For more information contact: Zhi Yong Liao - liaozy@iata.org

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SPOTLIGHT Due to the increase in the need for security, the customs clearance process in many countries has become longer and the few countries with shorter clearance times are today the exception.

Cold Chain Industry Forecast Carlos Castro on cold chain supply.

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 03 - 2013

The growth in emerging markets has been faster than the logistics expansion efforts to support this growth, so the logistics industry has seen many changes. One of those changes is in the available carriers

obtain a fast, efficient and resilient supply chain.

They have understood that they are not just

to support the emerging markets. The long-haul routes, historically

an extension of the airlines cargo sales. The traditional model

dominated by American and European airlines, are now a competition

where freight forwarders sold cargo space at standard rates on a

ground where Latin American, Asian and Middle Eastern carriers

commission basis is no longer applicable, and the freight forwarders

have shown a deeper knowledge of their regional markets and have

must create value to their customers by actively optimizing costs

not only gained market share by expanding their networks to include

and reducing risks. This integration of the freight forwarders has

hubs in the European and US cities but also responded to the cold

increased information sharing among carriers, containers suppliers,

chain needs by investing in their fleet, facilities and trained personnel.

and other participants.

Carriers are also increasing the amount of narrow-body aircrafts in

Regulations, standards and other industry good practices in

their fleets, especially in regional markets to take advantage of the

temperature-controlled distribution as well as supply chain integrity

more fuel-efficient smaller aircrafts and the flexibility to respond to

(security) have grown exponentially, which confirms the demand

changes (i.e. expansion and contraction) in passenger demand. All

expansion in emerging markets and the need to communicate among

these changes in the carriers’ network have increased the level of

the logistics participants. Regulatory bodies in emerging markets

complexity in managing cold chain logistics for emerging markets

have actively created or updated the regulations, which may not have

because the logistics process by nature includes a high number of

a global alignment yet. Many industry organizations have also created

participants and interfaces.

standards and pushed them to their members with limited success in the adoption of these new standards. Due to the increase in the need

The freight forwarders and logistics providers (3PL) have also

for security, the customs clearance process in many countries has

stepped up to the challenges and understand that they must

become longer and the few countries with shorter clearance times

orchestrate the supply chain complexity and its participants to

are today the exception.

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A increased demand for information sharing (temperature records,

the supply chain. One example where value can be added is ensuring

tracking, etc) and linking temperature records to each logistics

the best volume and weight balance in the vessel by aggregating

step to help the supply chain participants monitor the process have

demand of light and dense products. Another example will be

resonated with the suppliers of these tracking devices and they have

providing storage and conditioning for containers to free up space

responded with cloud-based systems, but the adoption has been slow.

and resources at the pharma companies.

In the near future I expect to see the following developments: 1) More collaboration among freight forwarders, carriers and container suppliers to optimize cargo (cube and weight) by designing containers with the right balance weight and volume for the vessel selected (aircraft, truck, etc.). This effort will be supported by the stability data for distribution that pharma and biotech companies are creating. They are aware that missing or delayed stability data for distribution will create over-designed containers and transportation.

I foresee a bigger need for a narrow-body shipping container that will support distribution in regional markets.

3) An alignment of the current regulations and industry standards. I also expect more information sharing so each supply chain participant understands how all the parts fit together. Training and logistics audits will become more popular to ensure these standards are being used correctly. I see an opportunity for freight forwarders to take the lead in providing the training and audit services.

4) More cloud-based systems to integrate freight forwarder, temperature and manufacturer data and make it available not only to the consignee, but also the carriers, health authorities and customs.

The need for cloud-based platforms to share information is valid for global and domestic distribution because information flow will help optimize the supply chain costs and risks and will benefit the participants by highlighting the processes that can be improved to 2) The increased integration among the participants and optimization may decrease the revenue for some participants (e.g. Freight Forwarders, carriers, etc), so these participants must actively work to offset the revenue decrease by creating services that add value to

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Sustainability & Pharmaceutical Packaging Pierre Boccon-Gibod Global Sustainability Services

M

any sectors of the airfreight industry are suffering. The

the other hand, world consumption of glass pharmaceutical bottles

weaknesses in Europe’s economy have led to a decline in

is expected to decrease gradually over the long term. Strip packs and

volume.

paperboard boxes will be the largest segments based on adaptability to economical unit dose formats.

Introduction: The packaging of pharmaceuticals products serves as a multiple

Reducing the amount of packaging used seems to be the first

means of providing protection, identification, information and

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

convenience from the production phase to the use or administration

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

phase. The type of material used depends upon its function and plays

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

a very significant role in the maintenance of quality standards.

produce the packaging are wasted, and extra energy will be needed to distribute it, without considering any recycling or heat recovery.

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

However, under-packaging that results in the product being damaged

pharmaceutical packaging demand will increase by more than

wastes 100% of the materials used to produce both the packaging

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

and its contents, and all of the energy used to distribute it. Therefore

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

packaging optimisation rather than reduction is an important part of a

will experience the fastest growth in product demand due to their

sustainable initiative.

rapidly expanding manufacturing capabilities, rising drug exports and a widespread government programme of national production.

To produce packaging for the pharmaceuticals industry that is

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

sustainable, the system must not only meet the requirements for

pharmaceutical packaging product markets as drug-producing sectors

packaging optimisation, but also have a reduced environmental

upgrade and diversify in the area of generic ethical drugs.

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

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

Developing a sustainable packaging

resident. This varies from 3% to 33% depending on the type of

Before considering its environmental credentials, packaging must

packaging. For the pharmaceuticals sector the number of products

at first ensure its contents are protected all along the downstream

sold has been stable over the last 3 years and the weight of packaging

supply chain. For long distances and transport time this is particularly

put on the market has only slightly changed during the same period.

complex, as packaging has to resist hazards such as extreme

Thus, packaging has not been the centre of interest for weight or

temperatures, moisture, and light exposure. Additionally, it must be

volume reduction as 70 000 tons of pharmaceuticals packaging is still

robust and secure, but also compact and lightweight, in order to keep

thrown away each year in France.

shipping costs down.

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

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

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

develop sustainable pharmaceuticals packaging?

competition from alternative materials and containers, plastic bottles will remain globally, the most widely used package for oral drugs. On

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

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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

showing the connections between

environmental footprint information to measure and rank products.

the consumption of resources,

Sustainability should therefore not be seen as an end-state but as a

energy use, waste, and climate change,

continuing process of improvement.

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

Schema Scope 1-2-3

production process of a product can be

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

mapped and linked with its most common

footprint assessment, measuring the total amount of carbon dioxide

environmental impacts. LCA is also an excellent

and other greenhouse gases emitted over the life cycle of the

tool to compare different design choices before going to production.

product. Clearly, concepts like the carbon footprint are interesting

For example, it allows the design and simulation of different material

but do not help to assess the global environmental burden caused

choices, end-of-life scenarios, including minimum calorific value to

by a single product over its whole life. How do you consider the

allow optimisation of energy recovery.

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

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

method or LCA.

stage of production, one can identify how to prioritise the reduction of a product’s environmental impacts and make better environmental

Schema LCA/ production path of packaging

choices without triggering the transfer of pollution from one stage to

The LCA method is a multi-step, multi-criteria sustainability

another.

assessment method. It considers the whole life cycle of a product, from the design, the extraction and processing of raw materials,

Examples of sustainable Packaging materials

through manufacturing and distribution, to final use and recycling,

In recent years the sustainable packaging on offer has expanded

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

rapidly. Innovative materials are increasingly available, produced

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TLPINSIGHT 19.

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 from more sustainable resources, such as plants,

atmosphere, the biodegradable laminate used is usually made of chitosan-cellulose.

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

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

information about the main biopolymers available on the market that

for them to reach a large-scale market for the moment. Synthetic

can be used in packaging applications. Their potential recyclability or

petroleum-derived compounds can also be a starting point for

environmental impact will fluctuate mainly according to their purity

biodegradable polymers. These polymers have technical properties

and the process of production they undergo.

resembling those of polyethylene (LDPE). Although these polymers are produced from synthetic starting materials, they are made fully

Starch

biodegradable and compostable. They represent a dynamic field of

It is a polysaccharide, renewable and widely available raw material.

development and will allow extended packaging application in the

This is a polysaccharide, renewable and widely available raw material.

near future, on their own or mixed with natural biopolymers.

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

Where to start ?

can be processed into thin layers and shaped as trays or disposable

In order to implement a sustainable packaging initiative it is

receivers. Starch based plastic materials are an important part of the

important to consider multiple areas of improvement. Several

market nowadays. Thanks to a blend of biodegradable starch based

recommendations have been listed below, adapted for the

polymers (polylactide, polyhydroxybutyrate, polyhydroxyalkanoate,

pharmaceuticals sector and based on LCA methodology.

valeric acid) with aliphatic polyesters or polyvinyl alcohol, their properties have been increased, and have a significant use in various

For any of the recommendation it is important to:

industrial applications. Four types of starch based polymers are

1 Ensure that the packaging is compliant with legislation.

commonly available:

2 Avoid the transfer of pollution between different systems (primary,

- Thermoplastic starch products.

secondary and tertiary packaging) and along the life cycle of a single

- Starch-Polyvinyl alcohol blends.

packaging.

- Starch synthetic aliphatic polyester blends.

- Starch polybutylene succinate or polybutylene succinate adipate

Recommendations are grouped by:

(PBSA) polyester blends.

- Main life cycle step

o Raw material extraction

Cellulose

o Manufacturing

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

o Transport

cellulose based polymer is cellophane. Many of its derivatives are

o End-of-life

used in packaging. Among those derivatives, cellulose acetate is

- Difficulty of implementation

widely used in pharmaceutical packaging and laboratory products

o * Easy

o ** Reachable

o *** Complex

Xylan These are a group of substances based on hemicellulose, obtained as residue from agricultural industries. Also occurring in nature, it is

1 - Raw material extraction

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

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

• How to reduce the weight of the case?

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

a Investigate the basis weight of cupboard to reach correct

barrier material.

*Easy

packaging. • Would it be possible to remove one packaging element without

Chitosan

disturbing product protection?

This is extracted from the exoskeleton of arthropods such as

aInvestigate the necessity to use trays.

crustaceans and insects. It represents the second most abundant

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

polysaccharide resource after cellulose. Due to its antimicrobial

possible to use any?

properties it is widely used in packaging, maintaining a preservative

a Use packaging with recycled fibres compliant for food contact.

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 02 - 2013

a Reduce the weight of boxes and dividers. Favour light weight **Reachable

pallets.

• Has the use of packaging surfaces been optimized?

•Has a transportation supplier with an environmental involvement

a Reduce the width of sealing and investigate different interweaving.

• Can the packaging recyclability be optimized?

been chosen? a Consider adding environmental criteria when choosing the

a Investigate mono-material packaging elements.

supplier (e.g. ISO14001 or EMAS certification, Footprint reduction programme).

***Complex

• Is packaging volume optimized compared to the product size?

a Optimize any potential empty space.

• Is the packaging grouping adapted to the size of the product being

• Can the product restitution rate be optimized? a Investigate different design scenarii to allow complete product restitution.

**Reachable transported?

a Investigate the reduction of empty spaces.

• Is it possible to re-use tertiary packaging?

• Is there any disruptive element for packaging recyclability?

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

a Refer to external recyclability analysis.

***Complex

2 - Manufacturing

• Is it possible to favour less impacting transportation modes?

a Investigate the use of ship, rail or combined transportation modes.

*Easy

• Have weights of packaging been measured among different suppliers?

• Has the optimization of transport being investigated? a Avoid any empty lorry returning to manufacturing site. Work on

a Add“weight” criteria when choosing a supplier.

optimization of transportation schemes.

• When choosing a new packaging, has the environmental performance been compared to the previous option? a Add an environmental criteria when choosing a new packaging (e.g. % of recycled materials)

4 – End of life

*Easy

• Does the patient have enough information to recycle correctly the packaging?

**Reachable

a Provide clear information on how and what to recycle.

• Could more sustainable inks/glues be used? a Reduce the use of ink/glue and favour water based substances.

***Complex

• Have transportation distance been optimized?

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

a Favour a local supplier.

recycling? a Investigate the improvement of packaging separability.

***Complex

• Have product processes been optimized during manufacturing and packaging?

Conclusion After implementing sustainability initiatives the last step would be to

a Investigate reduction of energy losses on the production lines.

communicate them. But in terms of environmental communication,

• Has the standardization of packaging sizes been investigated?

a high-level vigilance must be applied to the message that is used. It

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

is important to always communicate about packaging and product

diversity of colours.

impacts and at the same time have a communication strategy adapted to the audience (patient, retailer, public agency, etc). In compliance 3 - Transportation *Easy

with ISO 14040 series LCA results must undergo a critical review by a third-party expert panel before external communication.

• Is it possible to reduce the weight of packaging during transportation?

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.

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Supply Chains Still the Biggest Issue When Sourcing Comparators for Trials A graphical representation of the thermal simulation provides a simple method to appraise the performance of the shipping system.

With healthcare’s growing emphasis on the comparative effectiveness of new drugs in relation to what is already available, recent times have brought forth an expectation for developers to prove additional benefits at the clinical trial stage. But with more and more studies being conducted on a global scale, the process of sourcing comparators is fraught with difficulty.

According to a poll conducted by Pharma IQ, ahead of next year’s Clinical Trial Supply Europe event in Switzerland, complex supply chains are still the biggest challenge for drug developers trying to source comparators for clinical trials. Generally speaking, there are two main issues

holding back the supply of comparator drugs – security and time delays.

COMPARATOR SUPPLY CONCERNS Based on responses from key members of the clinical supply field, the Pharma IQ research indicates that cost remains the main difficulty for 22.2 percent when sourcing comparators. And while finding the right partner is seen as the key concern by 27.8 per cent, the majority of respondents, more than 61 per cent, cited supply chain complexities as their biggest challenge.

SUPPLY CHAIN SECURITY It is widely accepted that the two main difficulties hindering supply of trial comparators are supply chain security and the delays that often arise when restocking comparator supplies throughout the study. The issue of security threats are regretfully something with which drug companies have had to increasingly be wary of in recent decades.

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Estimates suggest that, in the EU alone, more than €10 billion (£8.7 billion) is lost annually due to spurious pharmaceuticals that continue to flood the market. Local governments have worked tirelessly with manufacturers to roll out anti-counterfeiting measures, such as trace-andtrack systems and serialization. But the problem of fake comparators slipping through the net still poses a major challenge when sourcing for clinical trials in Europe.

PROBLEMATIC LEAD TIMES Aside from security, the other main issue affecting the procurement of drug trial comparator products is delays to resupply at various stages of the study process. Problems in this area can prove extremely costly for drug producers in the long run and top the agenda for many firms as a result.

The challenge of minimizing lead time is not helped by the fact that pharma companies nowadays depend more and more on numerous third parties in meeting their comparator needs.

According to the Pharma IQ survey, 68.4 per cent already work with – or expect to work with - more than one comparator sourcing vendor.

CONTROLLING TRIAL COSTS As part of its latest survey, conducted ahead of the 2012 Clinical Trial Supply Europe event, Pharma IQ also polled key community members on the areas in which they see the most potential for cost savings to be made. More than 55 per cent of respondents cited pooled supply as an area with significant cost-cutting potential.

The second most popular option after pooled supply was just-in-time labeling, named by 50 per cent of companies as a promising method of reducing costs, while a third of delegates said continuous supply of comparators would be a good way for them to make savings. Eliminating booklets was chosen by 22.2 per cent and almost 39 per cent were exploring the use of interactive voice response systems (IVRS) for more efficient clinical trial management.

By delivering automated logistics management, drug supply savings and real-time project information, IVRS can provide a sophisticated method of optimizing and managing the clinical trial supply chain. For at least the past decade, IVRS has been employed in combination with direct advertising to speed up recruitment of participants. Systems of this kind use the telephone as a means of data input, with pre-recorded prompts giving the user a multiple-choice method of providing vital information. Use of IVRS is now a tried-and-tested tool in efficient clinical trial management, but it also presents a number of distinct challenges.

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DIFFICULTIES WITH IVRS Pharma IQ polled key members of the clinical trial supply community on the biggest challenges facing them in terms of using IVRS to boost the efficiency of clinical trial management. Interestingly, a third of the survey’s respondents said establishing potential efficiency savings, compared with their current methods, presented the most difficulty.

Perhaps unsurprisingly, cost emerged as another key concern among firms employing IVRS in clinical trials. Almost 28 per cent singled out the task of managing the financial impact of investments in voice response systems as their main difficulty. An equal proportion of 27.8 per cent said user friendliness was their biggest concern, while choosing the right software and point of contact were found to be the IVRS challenges preoccupying the fewest clinical trial supply professionals.

FUTURE PLANS Finally, the Pharma IQ survey enquired as to the main goals of the companies running clinical trials in the year ahead. Emerging markets were found to be one major area of interest, with 22.2 per cent of respondents saying their main goal in 2012 would be to move into Asia. Similarly, almost 17 per cent were reviewing the possibility of moving trials to Russia.

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THE LOGISTICS PORTAL MAGAZINE

PROMOTIONAL FEATURE | GOOEY GLOBAL

WWW.THE-LOGISTICS-PORTAL.COM Issue 03 - 2013

E

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

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

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

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

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

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

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

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

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

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

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

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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 03 - 2013

Prepare, Prepare, Prepare in Clinical Supply Clinical trial supply is a complicated enough business, but working internationally can really complicate matters. Lindsay Pinnick, Clinical Supply Manager at UCB, speaks to Pharma IQ about how to deal with the difficult issues which surround international supply.

An Interview with Lindsay Pinnick

Today we are joined by Lindsay Pinnick, Clinical Supply Project Manager at UCB. Lindsay, what are the main challenges in clinical trial supply and how does working internationally complicate these?

Lindsay Pinnick: So basically I think that some of our main challenges today in supplying clinical trials is to be able to supply based on smaller and reducing budgets but also excelling timelines. Everyone’s budgets are getting smaller and smaller but you really have to figure out a way to optimise your process and meet the timelines even faster than normal to make sure your product makes its way through the study and that we can try and get it to market. And then working internationally only complicates things because really when you are trying to work faster and hit these milestones you need answers quicker. And when people are spread across different time zones it makes it very difficult to get answers in a timely manner. For example

In most cases what I’ve seen is it takes months to be able to get

my company is based out of Belgium and I’m only one of two CT

material into these countries due to the timelines for documentation,

people in the US so if I have an urgent issue or an urgent answer that

specifically around import licence being approved by the Ministry of

I’m requesting from my quality group for instance and it’s after 11am

Health and in all of these countries you actually need approval every

my time, I’m definitely not going to get an answer at least until the

time you ship. So to be able to overcome these you really need to be

next day. So it makes it even more difficult to be able to supply our

able to plan your supplies very much in advance and ensure that not

trials in a timely manner.

only are you planning ahead but that your documentation is correct the first time. And if it’s correct the first time then you don’t have all

Clarke: You have to deal with regulation in many different countries.

these back and forth things because even if you submit one time with

What are the countries that offer particular challenges with regards

one piece of small information that is incorrect and it gets submitted

to good distribution practice and what can be done to overcome

to their MoH, you can put yourself at least a month behind in being

them?

able to get a new shipment into these countries.

Lindsey: I work with a lot of different countries that we could talk

Clarke: At the upcoming Clinical Trial Supply event in Boston I see

about here but I think the most difficult country that I’ve had lately

you will be talking about the BRICS nations. How has the clinical trial

happened to be in South America and the particular challenges with

market grown in these areas and with changes to regulation do you

them are mostly due to importation.

see this growth continuing?

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THE LOGISTICS PORTAL MAGAZINE Issue 03 - 2013 WWW.THE-LOGISTICS-PORTAL.COM

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HOW HAS THE CLINICAL TRIAL MARKET GROWN IN THESE AREAS AND WITH CHANGES TO REGULATION DO YOU SEE THIS GROWTH CONTINUING?

Pinnick: Yes, I definitely see this growth continuing. The CT

when we’re outsourcing a lot of our items to our CROs is

market has grown substantially in the BRICS nations in the

prepare, prepare, prepare. I think as a company we need to

past five years and it’s basically what we call the untouched

have our processes and our standards and our documentation

populations for clinical trials, people who are really willing to

in place to be able to easily show the CRO how our things

participate in the clinical trials there because of their poor

are done internally and how we would like to see things done

economy situation or maybe this is the only access that they

on their side. It makes the whole process more smooth and

have to these kinds of products. And since we’re now just

understandable for everyone involved. I also think that there’s

starting to have clinical trials there, of course the regulation

another kind of shift in mindset where people are going to have

is just now starting to really turn up in these countries and

to allow an outside organisation to really take over processes

it’s really evolving even daily. If you think about it, the EU and

that maybe always have been internal. And so maybe it’s not so

the US and our first world countries have had years and years

much of a physical preparation of documentation and things like

to develop these processes and regulations but it’s really the

that for this piece but more of a mental preparation, thinking

beginning for these BRICS countries and so I think that we will

things through, what do you exactly want to go to the CRO,

see a lot of change in the coming years. And I think that the best

what you don’t want to go and really ensuring that those lines

way to handle it is ensure that you are keeping up with your

are drawn and there are no grey areas.

changing regulations and that you have a way to implement the new regulations and processes as soon as they occur.

Clarke: What have been the biggest changes in the regulatory landscape recently and how do you think that clinical supply will

Clarke: There has been a shift in the industry to working closer

change in the next five years?

with CROs. How can companies better prepare for this shift?

Pinnick: I think the biggest changes will mostly come from Pinnick: I think that one of the key things that we’re seeing

32. TLPINSIGHT

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our BRICS nations actually in the regulatory realm. Most of

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the regulations are new restrictions, there’s a lot of IP to be owned

monitoring, packing shipments, things like that from a distribution

in the country, cost to import, really new, constantly changing

standpoint. So just this one little piece of regulatory could really

documentation which makes it difficult when we don’t really have

change how we’re going to do things in the next five years.

enough time to keep up with the changes let alone change our documentation, and even be paying more costs to import. I think that

Clarke: Thank you very much, Lindsay, for sharing your insights and

the next five years will definitely continue to be the evolution from

your time with us today. We look forward to hearing more from you at

these nations in regulations and definitely some standards being set

the Clinical Trial Supply USA event.

and maybe it will be easier to maintain. However, I think that one of Pinnick: It’s no problem. Thank you for having me.

Our main challenges on the horizon for regulatory will be the EU’s new recommendation for all ambient material to be monitored on the way to investigators’ sites.

Clarke: If you would like to find out more about this topic and the Clinical Trial Supply conference in Boston this September 10th and 11th, visit us at www.ClinicalSupplyUSA.com

our main challenges on the horizon for regulatory will be the EU’s new recommendation for all ambient material to be monitored on the way to investigators’ sites. And so this is actually trying to be added to an EU regulation that will take place in 2016 and if that occurs the US will follow suite and then I’m sure the rest of the world will follow suite soon after. Not only will it be an extremely large expense to the pharma companies who haven’t really dealt with this in the past but it will also lengthen our timelines and we’ll need more resources for

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R i s K M i t i G At i o n

The Invisible Component of Cold Chain Management Overview The practice of cold chain management continues to evolve rapidly. New developments in hardware, software and global connectivity provide an unprecedented window into cold chain performance.

This has led to dramatic improvements in handling, storage and distribution, and the promise of greater cooperation among supply chain partners.

This has also convinced cold chain managers that their monitoring program must be greater than the sum of its parts. Robust, responsive and accurate dataloggers are essential, as is powerful software and reliable, secure web hosting. However, smart cold chain management looks beyond the visible components of monitoring programs to address their underlying structure and stability. One of these critical but less visible components is risk mitigation.

Defining Risk Mitigation Risk mitigation of cold chain management is defined by three key, auditable elements: • IT security and redundancy • Supply chain risk management • Disaster recovery planning If these three components are properly structured, the long-term viability and efficacy of a cold chain program is substantially strengthened, as is the confidence of the cold chain management team.

In addition, knowledgeable managers also look to the stability, industry knowledge and thought leadership of their solution provider as another way to assess the strength and competitiveness of their program.

A part of UTC Climate, Controls & Security

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A Company Commitment Quality Management System (QMS) Sensitech’s QMS represents a companywide commitment to Quality that enhances every activity the company undertakes. As a supplier of “critical components,” the company tests its hardware and software products against rigorous standards, including the National Institute of Standards and Technology (NIST), ISO 9001:2008, and applicable elements of common Good Manufacturing Practices (cGMP). Sensitech adheres to validation protocols and enforces quality control at every level. The underlying QMS is grounded in a well-documented and audited program of continuous process improvement and incorporates standards in Relentless Root Cause Analysis (RRCA) and Corrective Action / Preventative Action (CAPA). Finally, Sensitech’s manufacturing principals are grounded in six sigma and lean manufacturing programs.

Element 1 IT Security and Redundancy Sensitech is a subsidiary of Carrier Transicold, which is part of UTC Climate, Controls & Security, a $17 billion unit of United Technologies Corporation. The internal IT resources available to Sensitech, and the standards for redundancy and security it must meet under UTC quality guidelines, embody world-class practices.

Designed with redundant architecture, Sensitech’s ColdStream® solution is used by customers to collect data, monitor shipments, and provide notification and alarms. The ColdStream smart client installed on customers’ desktops works in online or offline modes, reducing impact on the real-time acceptance of product and ensuring data integrity in the event of intermittent internet connectivity at a remote receiving site. Network infrastructure and servers are fully redundant to insure minimal impact to customers in the event of a server or network issue.

Customer-specific ColdStream databases are hosted on dedicated application servers, in a hardened data center, located in an offsite, independent facility that provides power sources, redundant points of connectivity to the Internet, and security mechanisms against fire, physical threats and natural disasters. All ColdStream databases are monitored and supported 24x7 with a fully replicated mirrored site in a separate geographic region of the United States. Data is synchronized between the two sites, regularly audited, and compliant with Statement on Standards for Attestation Engagements (SSAE) 16.

The ColdStream application and data hosting components are built to satisfy the requirements of FDA 21 CFR Part 11, including audit trail and traceability for all electronic records, multi-layered permissioning, and backward compatibility for previously acquired data files.

Customer data is backed-up according to information technology best practices. Before the data is stored in an offsite data vault, the back-up process includes encryption and compression; these formats remain throughout the length of storage. Backed-up data is tested and verified to be recoverable annually.

Sensitech’s ColdStream environment and Quality Management System (QMS) have successfully passed all customer audits, now numbering more than 100 over the past decade, to the satisfaction of our cGMP customer base. Sensitech securely hosts cold chain and logistics data for over 200 companies around the globe.

Key Questions 1 Is data integrity ensured?

2 Is data warehousing adequate and compliant with 21 CFR Part 11?

3 Can these cold chain protocols be audited?

Risk Mitigation The Invisible Component of Cold Chain Management

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Element 2 Supply Chain Risk Management Many of Sensitech’s customers consider temperature dataloggers and their related systems to be “critical components” of a Quality Management System. Therefore, a disruption in the supply of monitors can lead directly to disruption of the shipment of a customer’s product.

Sensitech has three primary means of mitigating this risk: • Adequate safety stock • Dual-sourcing strategy for critical components • Multiple manufacturing sites Sensitech employs high standards to meet its goal of adequate safety stock, factoring in the variability of demand at the component, work-in-process, and finished goods levels. The use of a pull-based replenishment system supports global flexibility and drives a high-velocity supply chain. Sensitech maintains at least three month’s finished goods inventory in various global locations, at manufacturing sites and in-transit. Safety stocks are verified through scheduled reporting and site visits.

The company’s dual-sourcing strategy incorporates alternate component qualifications, as well as testing and validation of goods produced with these alternate components. Sensitech’s quality procedures ensure continuous testing from the component specification to the finished goods level with quarterly reported statistics. Additionally, unit-level calibration is linked to the unique serial number at the device level and documented in certificates of validation provided with each order.

Finally, Sensitech’s products can be manufactured in Asia, Eastern Europe and the United States. Each manufacturing facility has the assets and infrastructure to meet all Sensitech volume requirements. Sensitech’s primary manufacturers also have remotely located sister companies that support the manufacturer’s disaster recovery program and provide added assurance to Sensitech.

Questions to AsK 1 Does my cold chain provider keep adequate safety stock?

2 Does my provider have a credible plan for the dual-sourcing of critical components?

3 Does my provider have the reach and supply chain muscle to carry out its plans?

4 Do I feel comfortable that the risk of product disruption is minimized?

Element 3 Disaster Recovery Planning Under the guidance of United Technologies Corporation, Sensitech adheres to a Business Continuity and Disaster Recovery protocol designed to either maintain or resume mission-critical functions in the event of a disaster. The Sensitech plan specifies annual readiness evaluations, and the ability to deploy multiple monitor programming sites and fulfillment operations around the globe. Sensitech’s practices mandate the monitoring of adequate safety stock, coverage by appropriate levels of general liability insurance to protect Sensitech assets and infrastructure, and immediate notification to customers in the event disaster recovery is invoked.

At all times Sensitech has access to the corporate resources of Carrier, UTC Climate, Controls & Security, and UTC. Questions to AsK 1 Does my cold chain provider have a Business Continuity / Disaster Recovery Plan?

2 Is it adequate to meet the needs of my cold chain in the event of a disaster?

3 Are notification practices adequate?

4 Are my cold chain provider’s insurance levels adequate to protect its assets and infrastructure?

Risk Mitigation The Invisible Component of Cold Chain Management

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Stability and Thought Leadership Founded in 1990, Sensitech is a global leader in cold chain monitoring. First certified under ISO in 1999, Sensitech has an unbroken history of recertification in its primary facilities, and currently is certified to ISO 9001:2008 standards.

All of Sensitech’s outsourced manufacturing sites are certified to ISO 9001:2008 and ISO 13485 standards for Founded in 1990, Sensitech is a global leader in cold chain monitoring. First certified under ISO in 1999, Sensitech medical device manufacturing. has an unbroken history of recertification in its primary facilities, and currently is certified to ISO 9001:2008 standards.

The rst companyoutsourced to offer global, single-use,sites electronic monitoring has provided almost All offiSensitech’s manufacturing are certifi ed to ISOprograms, 9001:2008Sensitech and ISO 13485 standards for a quarter of innovation and thought leadership in driving Good Cold Chain Management Practices (GCCMP) medicalcentury device manufacturing. for the pharmaceutical, food, and industrial chemical industries.

The first company to offer global, single-use, electronic monitoring programs, Sensitech has provided almost a This includes active membership the Parenteral DruginAssociation (PDA), in a number of subgroups, quarter century of innovation andinthought leadership driving Good Coldparticipation Chain Management Practices (GCCMP) and contributions to Technical Reports.

Sensitech hasindustries. also participated as a member of the technical steering for the pharmaceutical, food, and industrial chemical committee of the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit This includes(ISTA) activeThermal membership in the Drug Association (PDA), participation in Chain a number of subgroups, Association Council, the Parenteral Association Francaise du Froid (AFF) French Cold Council, and is on and contributions to Technical Reports.

Sensitech has also participated as a member of the technical steering the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live committee the PDA’s Pharmaceutical Cold Chain Interest Group (PCCIG), the International Safe Transit to U.S. Animal and of Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices Association (ISTA)(USP) Thermal Council,and the Storage Association Francaise du Froid (AFF) FrenchofCold Council, and<1079> is on Pharmacopeia’s Packaging Expert Committee for the re-write USPChain General Chapter the International Air Transport Association’s (IATA) Time and Temperature Task Force (TTTF) a subgroup of its Live Good Storage and Distribution Practices for Drug Products.

Animal and Perishable Board (LAPB). Additionally, Sensitech has contributed documentation of best practices to U.S. Sensitech’s efforts overPackaging the past decade have Expert helped Committee to clarify standards for lithium battery compliance, and Pharmacopeia’s (USP) and Storage for the re-write of USP General Chapter <1079> for electromagnetic interferencePractices (EMI) compliance and documentation. In support of this effort, Sensitech was Good Storage and Distribution for Drug Products. awarded the Cool Chain Europe 2010 Best Quality, Qualification or Risk Management Project by Pharma IQ. Sensitech’s efforts over the past decade have helped to clarify standards for lithium battery compliance, and Beyond regulations,interference Sensitech continues to provide thedocumentation. cold chain industry with electronic dataloggers, for electromagnetic (EMI) compliance and In support of this effort, Sensitechsoftware, was and globalthe cold chain programs serveQualifi over 12,000 customers around the world.by Pharma IQ. awarded Cool Chain Europe that 2010presently Best Quality, cation or Risk Management Project

Stability and Thought Leadership

Beyond regulations, Sensitech continues to provide the cold chain industry with electronic dataloggers, software, and global cold chain programs that presently serve over 12,000 customers around the world.

Sensitech Inc.

Putting it All Together

Sensitech Inc. Sensitech is proud of its commitment to a disciplined Quality Management System, rigorous Security and

Redundancy comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning Putting it practices, All Together and thought-leadership throughout the global cold chain monitoring industry. Taken together, these practices Sensitech is proud with of itsacommitment a disciplined System, Security and of provide customers level of Risk to Mitigation that isQuality uniqueManagement in the industry, and anrigorous essential component Redundancy practices, comprehensive Supply Chain Risk Management, powerful Disaster Recovery Planning every Sensitech customer offering. and thought-leadership throughout the global cold chain monitoring industry. Taken together, these practices provide customers with a level of Risk Mitigation that is unique in the industry, and an essential component of every Sensitech customer offering.

A part of UTC Climate, Controls & Security

2/13 1000

© 2013 Sensitech Inc. All rights reserved.

Amsterdam Boston Hong Kong Melbourne Mumbai Santiago A part of UTC Climate, Controls & Security 2/13 1000 Sensitech EMEA • Lireweg 42-52 • P.O. Box 59 • 2150 AB Nieuw-Vennep • The Netherlands • Tel: +31 (0)252 211 108 • Fax: +31 (0)252 231 032 © 2013 Sensitech Inc. All rights reserved. www.sensitech.com • info@sensitech.eu Amsterdam

Boston

Hong Kong

Melbourne

Mumbai

Santiago

Sensitech EMEA • Lireweg 42-52 • P.O. Box 59 • 2150 AB Nieuw-Vennep • The Netherlands • Tel: +31 (0)252 211 108 • Fax: +31 (0)252 231 032 www.the-logistics-portal.com www.sensitech.com • info@sensitech.eu

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Risk in the Latin American Temperature Controlled Pharma Supply Chain Humberto Laserna

Humberto Laserna, Quality Coordinator at Pfizer Peru, joins Cold Chain IQ to tackle the challenges of designing and implementing a quality strategy for the cold chain in Latin America. To listen to the interview in full go to Defining and Implementing a Quality Strategy for Cold Chain Supply in Latin America:

to understand what you have in the country. You don’t have a lot of

Cold Chain IQ: What are the challenges for access in Peru?

Cold Chain IQ: In your opinion what is the single largest trend with

international providers and that can be different if you need to work with validated packages. You have to implement that locally and I suppose that is more of a challenge for us in Peru to understand whatever you have and whether you need to evaluate, what can do the job best.

respect to cold chain logistics and technology in your region?

H Laserna: The challenges for access in Peru are you need to understand the different situations that you are going to have. You

H Laserna: In my opinion, the latest trend in cold chain is maybe,

need to implement a risk assessment, because in Peru you have

in the next 2-3 years to have a lot more regulation, because at the

different cultures, not everybody speaks Spanish. You have other

moment in Latin America you don’t have a lot of regulations. Some

languages that are similar to Quechua and Aymara, and that’s very

countries are similar to Brazil where you have more restrictions, but

common outside of Lima.

this is not very common in a lot of countries in Latin America.

You have a lot of problems, you have tropical jungles, you don’t

Cold Chain IQ: Humberto, what would you say are the top three risks

have a lot of roads and you need to understand that. And you have

for the temperature controlled pharmaceutical supply chain in Latin

to work with what you are provided with in that moment. You need

America?

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H Laserna: In my opinion the principle risk is that you have a lot of

Cold Chain IQ: Are you seeing the supply chain stakeholders

stakeholders; in a big chain you can have big risks. The other risk

working closer together to ensure quality within the cold chain?

that you have is that not everybody has a good training plan, and we talk about this with distributors, providers and with logistics

H Laserna: Yes. You have some stakeholders that you can work

operators. And the last risk that I can say is that we don’t have a lot

with, you can have other stakeholders, you couldn’t work with, for

of facilities, you can have a cold room, but maybe it’s not that cold or

example the customs. It’s very complicated to work with them.

it’s not qualified and the person does not have a good maintenance plan and that can be a risk.

Cold Chain IQ: With regard to the pharmaceutical cold chain, what do you see globally as the one thing that could happen to improve

Cold Chain IQ: What actions have your company either taken to

the cold chain?

overcome these challenges?

H Laserna: For a final message about the cold chain, it’s not H Laserna: In my opinion the company has a good strategy, you

complicated to implement a cold chain system, it’s not easy but

have to implement quality systems around the principles in cold

it’s not complicated, you have to work with a good plan, with good

chain, and the next step is how to package and validate and the third

people and you will need a good risk assessment.

step is training.

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biopharmaceutical logistics in central america

Are you planning on expanding your supply chain into Central America? Did you know over 50% of our “Temperature Controlled Biopharmaceutical Logistics in Central America” survey participants are planning to increase their supply chain activities in the region and all within the next 3 years.

Central America is going through a new era of growth, offering new cold chain opportunities. In this handy infographic we examine recent trends the biggest risks to the Central American temperature controlled pharmaceutical supply chain. about the survey respondents

56%

18%

18%

9%

operators in central america

Which countries do you have facilities / deposits / sites in?

ht eig r Fr de L/ ar 3P rw nt Fo me ge na Ma r ta lie Da upp S

ing ag r ck ide Pa rov P r ma ure ar ct Ph fa Bio anu m

Mexico 38% Costa Rica 20% El Salvador 33% Guatemala 33% Honduras 33% Nicaragua 33% Panama 27% Puerto Rico 40%

do you currently operate in central america?

40%

88%

What types of products do you ship via the cold chain?

Bio Specimens Pharmaceutical

vaccines Clinical supplies/IMPs

other is your company considering expanding your supply chain into central america?

64% 46% 46% 36% 27% Yes 55%

said Nicaragua is the country where they were experiencing the greatest challenges in road and infrastructure

of participants distribute products into Mexico

EL SALVADOR 40%

nicaragua 20%

What country are you experiencing the greatest challenges With security during transit?

mexico 20% honduras 20%

no 9% Don’t know 36%

if yes, What time frame?

14%

72% 14%

Under 6 months Within a year

biggest risks in the central american temperature controlled pharmaceutical supply chain

last mile transportation and 37% consider infrastructure to be the biggest risk in the Central American Temperature Controlled Pharmaceutical Supply Chain

1-3 years

3-5 years

More than 5 years

What do you feel are the barriers to you making changes Within your company to the temperature controlled supply chain?

Knowledge/ budget training 20%

60%

time

20%

maturity of technologies

10%

production constraints

10%

37% 18% 18% 9% 9% 9% y rit cu se ing ain as ch re ly nc pp s i Su ue iss al l tim de op mo he on g t ati tin ort lec sp Se an tr e ur ct us ru io st ar ra in v inf ith le w ab ds ail oa es Av nd r ntri a ou c

om try ry fr n to e ou la nc o c gu lia y t es Re mp tr iat co un fil r s co af ’ fo tion ith ies lu on ies g w pan t so uti tr tin m es ib un ra co b tr co bo ter and dis ous lla sis se tic ri Co nd ‘ erti mes he va a xp do t e r n fo ithi w e

n ur tio ct le ta ru mi or st st sp ra La rand inf t n a

Interested in finding out more about cold chain logistics in Central America? go to www.coldchainiq.com 42. TLPINSIGHT www.the-logistics-portal.com

The information in this infographic is intended for research and subject to change. IQPC herein take no responsibility for information that may be inaccurate. Statistics from the survey – conducted in June 2012.

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//INDEX OF ADVERTISERS IFC

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UPS

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Biotec

23

Cool Logistics

28

Gooey

31

Softbox

38-39

EVA International

43

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IBC

Air Canada

OBC

American Airlines Cargo

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