TLPINSIGHT
The Logistics Portal magazine
Issue 1 - 2013
ASSESSING THE OPTIONS
LOOKING AT ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN
Popular Ukraine A BACKGROUND ON CLINICAL LOGISTICS IN THE UKRAINE
IATA
STANDARDS
Transportation of Time and Temperature Sensitive Products
PHARMACEUTICAL LOGISTICS B2B DIRECTORY, WHICH PROVIDES AN INFORMED AND COMPREHENSIVE INFORMATION HUB FOR THE LIFE SCIENCE LOGISTICS INDUSTRY. www.the-logistics-portal.com
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TLPINSIGHT
AIR CARGO - RFID - TEMPERATURE CONTROLLED - CLINICAL - BIO PHARMA - LOGISTICS
1.1.
I am Peace of Mind
Mambio Ravezzi Sales Manager Cargo Italy Of course, Swiss WorldCargo is a hallmark for quality, precision and a dedicated global team. But all you really need to know is this: the moment you hand over your cargo to us, you can stop worrying. This is the true meaning of: We care for your cargo.
SWISSWORLDCARGO.COM
//MAIN CONTENT
TLPINSIGHT
//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING
MANAGING DIRECTOR Lee Atkinson
American airlines look into the Strict Requirements that air cargo handlers
EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward
are placed under. They also tell us how they have implemented a highvisibility, multi-layered tracking program for ExpediteTC, which guarantees all temperature-sensitive shipments. Read the full article on page 17 »
8 IATA Standards: Transportation of Time and Temperature Sensitive Products
Andrea Gruber, Manager Cargo Business, Process & Standards is responsible at IATA for the regulations related to the transport of Live Animals, Perishables and Healthcare Cargo and for delivering the standards and processes for the air cargo supply chain. Dave Brennan, Assistant Director Cargo Safety and Standards, is responsible for coordinating the activities of the Cargo team who are jointly responsible for the IATA standards publications and products that address dangerous goods transported by air. Together they detail the framework in which the Life Science Logistics industry needs to work, and the ways in which IATA are responding to challenges presented by transporting time and temperature sensitive products.
MANAGING EDITOR Bridget Langston SENIOR DESIGNER Joey Graham
CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson ADMINISTRATION Katie Galelli 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
chain logistics for the pharma industry to japan 14 Cool and asia
Adrian Rayner of Japan Airlines talks about Cool Chain Logistics for the pharmaceutical industry to Japan and Asia, and the ever growing customer requirements.
22 Integration of dangerous goods management solutions into existing software environments
Herman Teering, Managing Director of DGM Software Development Group A/S offers dangerous goods logistics solutions that can be added to back office systems and describes the benefits that can be achieved from these as well as the associated pitfalls. » contents continues, PG. 4
Is Published 4 times a year February, May, July, October by Intensive Media Ltd Send address changes to 145 - 157 St Johns Street, London, EC1V 4PW,England The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the publisher and, while every care has been taken in the preparation and design of th is 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
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TLPINSIGHT 3. TLPINSIGHT 02
//CONTENTS 28 Cool Chain and Clinical Trials
Biocair explain the ever-increasing importance of the Cool Chain in Clinical Trials, where different phases often take place on different continents and samples need to be in the right place at the right time and in the right condition.
32 Clinical Logistics in Ukraine
Sergii Pomerantsev, Head of Logistics at Centre of Clinical Research (CCR) and who has managed the clinical supply chain for more than fifty clinical projects in Ukraine and Sergii Myronenko, Quality Assurance Manager at CCR give us practical background information on clinical logistics in Ukraine, an increasingly popular venue for international clinical trials.
38
The Need for Inference: Impacts on Anti-counterfeiting, Serialisation and Product Tracking Peter Norton, Supply Chain Consultant at Intelleflex Corporation and with over ten years experience of working in the pharmaceutical cold chain and logistics industry argues for the need for inference, ‘the method of identifying the contents of a shipping container to confirm its contents without actually opening the container’.
41
RFID and Cold Chain Management
51
China Continues to Attract Biopharma
Alex Guillan, currently CEO of Escort Cold Chain Solutions SA (ECCS) looks forward with optimism to the day when the technology mix used in the Cold Chain can bring assurance of the product to everyone concerned, not least the patient.
Cold Chain IQ Look into growth in temperature controlled pharmaceutical shipments from emerging markets. And how Much of the expected growth is attributed to China’s growing importance in the global pharmaceutical industry.
//MANAGING YOUR RISK IN THE SAFE TRANSPORTATION OF LIFE-SAVING PHARMACEUTICALS ACTIVE VERSUS PASSIVE IN THE DISTRIBUTION SUPPLY CHAIN Kavita Somaroo at DS Smith Plastics Cool Logistics looks at The decision on whether to use an active system or passive packaging to transport temperaturesensitive products. Read the full article on page 45 »
4.
TLPINSIGHT
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Protecting your pharmaceuticals whatever their destination
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Softbox Systems Ltd. Units 1-2 Ridgeway Drakes Drive Long Crendon Buckinghamshire HP18 9BF UK T: +44 1844 203 560 F: +44 1844 203 570 E: info@softboxsystems.com
AMERICAS
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Softbox Systems India Pvt Ltd. Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206 T: +91 2232 222 380 F: +91 2143 221 789 E: info@softboxsystems.com
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Softbox Temperature Control Packaging Systems Pte. Ltd. 48 Toh Guan Road East #02-115 Enterprise Hub Singapore 608586 T: +65 6316 9584 F: +65 6316 9504 E: info@softboxsystems.com
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5.
//TLP INSIGHT FORWARD The first of it’s kind
W
e would like to wish you all a Happy New Year for 2013 and a warm welcome to the first issue of TLP Insight. 2012 has been a tough year in a long line of tough years for everyone in the Life Science Logistics industry, but here at TLP Insight we have remained optimistic from the outset that with a lot of hard work and a desire to bring the very best to mar-
ket we could buck the trend. TLP Insight has grown out of our online presence, The Logistics Portal, a Pharmaceutical Logistics B2B directory, which provides an informed and comprehensive information hub for the Life Science Logistics industry. Our publication is our response to the needs of the industry for a book to compliment the online portal and we are very pleased to have been able to bring it to fruition. We have set out to create a publication that is unique in the Life Science Logistics industry and delivered in a format unlike any other. It is unique in that it is the only book in the industry, the first one, to complete the whole market from technology and software to bulk shipment and air cargo. And unlike any other publication, it will not be split into sections; rather our approach is to present content in a more integrated, holistic format. The aim of this is to encourage the flow of information between all the different parties involved in Life Science Logistics, promote discussion on all topics and nurture a cross-fertilisation of ideas. And in so doing, promote understanding of the different problems and challenges faced by different elements that can ultimately impact on the industry as a whole. In this issue we cover IATA Standards: Transportation of Time and Temperature Sensitive Products; IATA’s Andrea Gruber, Manager Cargo Business, Process and Standards and Dave Brennan, Assistant Director Cargo Safety and Standards provide our main feature which gives an in depth insight into the framework within which our industry needs to work and the ways in which IATA are rising to the challenges presented in the transportation of time and temperature sensitive products. Issues around documenting the authenticity of pharmaceuticals are a very hot topic, with many people working in the industry trying to anticipate changing or new directives from governments. Peter Norton a Supply Chain Consultant from Intelleflex Corporation argues the need for inference in his article The Need for Inference: Impacts on Anti-Counterfeiting, Serialisation and Product Tracking. Alex Guillen the CEO of Escort Cold Chain Solutions SA (ECCS) gives us thought-provoking perspectives on the current state of play of RFID and Cold Chain Management and why he believes that long-awaited progress will be made in this area of our industry. Over the course of the coming year, in what looks to be a full and busy schedule for TLP Insight, we will be focused on covering a variety of topics: from Green Packaging and the various packaging regulations, reusable packaging and labelling associated with it to discussing global regulatory issues within air cargo, within emerging markets and within clinical trial logistics as well as touching further on anticounterfeiting. I would like to thank the contributors and our staff for all their efforts and hope you enjoy the publication. I hope too that you will stay with us as we move from strength to strength. All the best for 2013
Lee Atkinson Managing Director and Founder of Intensive Media Ltd
6.
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Customized temperatures, reaching four corners of the world. We provide the most suitable transit conditions for all perishable cargo to maintain their freshness. Entrust our expertise with your need for ultimate care. For detailed information please contact: specialcargo@thy.com
www.tkcargo.com | +90 0 850 333 0 777
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7.
IATA STANDARDS
Transportation of Time and Temperature Sensitive Products
Air cargo delivering the modern world
and solutions to ensure a safe and harmonised air transport system.
The global economy relies on air transport to deliver high quality
IATA’s vision for cargo is to foster a safe, secure, reliable, efficient
products at competitive prices to consumers worldwide. Interna-
and profitable air cargo supply chain. Specialist drugs, vaccines and
tional trade is now estimated at over USD 15 trillion and about 35%
emergency aid rely on air Cargo to get where they are needed.
of that value is transported by air.
The market for healthcare products continues to grow and shows
With the healthcare market becoming a key engine of the global
strong resilience to global economic downturns. An increasingly
economy, pharmaceutical and biomedical industries are facing new
ageing population requires access to new products and spend-
challenges in adapting to globalization. Air Cargo is an essential link
ing on national healthcare programs is an important part of many
in the consumer supply chain ensuring continual access to quality
government social policies. The emergence and expansion of Brazil,
and choice but it cannot work on its own.
Russia, India, China and South Africa as major consumer markets will shift demand and lead to more balanced trade flows in the air cargo industry. This is already seen in China and to an extent in India. The growing middle classes in emerging economies are discerning high end consumers who will continue to sustain air freight growth in the years to come. Understanding customer needs, anticipating them and adding value in delivery is key to achieving an effective supply chain. In particular the healthcare industry is concerned with ensuring the integrity of sensitive products is maintained when transported by air. IATA in collaboration with supply chain stakeholders and partners has undertaken collaborative actions to address these concerns. Speed to market is essential and the healthcare industry is increasingly dependent upon air cargo. It is vital to address the challenge of keeping products at the correct temperature range to ensure the quality of the product is not affected in transit. Temperature control in transport is therefore an important component of the industry and is continuously rising in line with international trade. The most
8.
The International Air Transport Association (IATA) is the industry’s
important issue for the industry and its logistic providers is to clarify
global trade association and represents some 240 airlines comprising
mutual expectations to minimize risks and challenges for airfreight
84% of global air traffic. Its mission is to represent, lead and serve the
within the cool chain. Temperature deviations and temperature
air transport industry. In Cargo, IATA takes a supply chain approach
excursions throughout the journey requires the establishment of
to all its initiatives, with an aim to benefit all parties (airlines, forward-
a complete logistical process to maintain the shipment integrity.
ers, governments, Customs and shippers). IATA delivers standards
Quality, reliability and performance are crucial, and to achieve this
TLPINSIGHT
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//BIOGRAPHY Andrea Gruber complete supply chain is needed. The shipper is ultimately
Manager Cargo Business, Process & Standards International Air Transport Association
responsible for ensuring the product (and any necessary
Mrs. Gruber joined the International Air Transport Association (IATA) in 2008 as Manager
packaging) is preconditioned to the required temperature,
Business Process & Standards in the Cargo Division and is responsible for delivering the
and will remain within a temperature range for a certain
standards and processes for the air cargo supply chain.
period of time, using the appropriate refrigeration method
Mrs. Gruber is responsible for the IATA regulations related to the transport of Live
dialogue, joint strategy and standardization throughout the
adapted to the shipping circumstances. However the accountability is shared by all of the stakeholders within the healthcare supply chain. Meeting the challenges can only be achieved by cooperation between all stakeholders involved in the supply chain, who recognize the need for guidelines.
Animals, Perishables and Healthcare Cargo. She is secretary to the IATA Live Animals and Perishables Board and the Time and Temperature Task Force. Prior to working with IATA Mrs. Gruber worked at the International Road Transport Union (IRU) as head of a division implementing, at the Customs and business level, tools to assist the application of risk management. Mrs. Gruber studied in Geneva at the University and at the Graduate Institute of International Studies (I.U.H.E.I.) and holds a Master of Sciences in International Relations.
Background To address the challenges in transporting healthcare products, IATA established a dedicated working group, the IATA Time and Temperature Task Force (TTTF) under the supervision of the IATA Live Animals and Perishables Board, a governance body comprised of 12 Airline members, endorsing healthcare standards for the air cargo industry recommended by the Time and Temperature Task Force members. The work undertaken by this healthcare industry subject matter expert Task Force composed of airlines, ground handling agents, freight forwarders, shippers, international or national organizations, airports, and equipment manufacturers led to the inclusion of a specific chapter in the existing IATA Perishable Cargo Regulations (PCR). Today the air cargo
David Brennan
Assistant Director Cargo Safety & Standards International Air Transport Association
David joined IATA in May 2002 as the Manager, Dangerous Goods Technical Services. In April 2004 David was appointed Assistant Director Cargo Safety & Standards. David is responsible for coordinating the activities of the Cargo team who are jointly responsible for the IATA standards publications and products that address dangerous goods transported by air. David is the Secretary of the IATA Dangerous Goods Board and is
industry is using the IATA PCR as the essential reference
also the Panel member nominated by IATA to the International Civil Aviation Organization
guide for all parties involved in the packaging and handling
(ICAO) Dangerous Goods Panel.
and distribution by air of time & temperature sensitive healthcare products. Chapter 17 “Air Transport Logistics for Time and Temperature Sensitive Healthcare Products� in the
Before joining IATA David worked for Australia Post as a consultant on Aviation Security / Dangerous Goods compliance. Prior to that David worked for Ansett Australia for a period of 26 years holding a number of supervisory and management positions
PCR specifically addresses the temperature control management issues identified by the industry and sets out recom-
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TLPINSIGHT
9.
mended standards such as the use of the IATA Time and Temperature
The PCR Chapter 17 requirement mandates the lower half of the
Sensitive label, developed together with the air cargo supply chain,
label to indicate the external transportation temperature range of
and first introduced on July 1st, 2010.
the shipment. The responsibility to apply and complete the label for
Mandatory Shipping Label
time and temperature sensitive healthcare cargo shipments booked as such rests with the shipper (or designated shipper’s agent by
The Time and Temperature Sensitive label came about as a result of
service agreement). Though transportation begins with the shipper,
standardizing the nearly endless parade of labels applied by shippers
IATA, together with its members, is putting an emphasis on the initial
throughout the industry. It is a shipment label, specific to the health-
booking, which is the key step to successful cargo transportation and
care industry, that must be affixed to shipments transported as time
which triggers the appropriate handling and operational processes
and temperature sensitive cargo. Regarded as a recommendation,
associated to healthcare transport. The label only supports the
the air cargo industry recognizes this label as a best practice. There-
booking, thus the transportation temperature range specified on the
fore, effective July 1st, 2012 the IATA Time and Temperature Sensitive
label must match the transportation temperature range stated on
label became mandatory for the transportation of healthcare cargo
the Air Waybill, Service Level Agreement (SLA) or Standard Operating
shipments transported as temperature sensitive cargo. The decision
Procedures (SOP).
To strengthen the overall supply chain a 24-hour contact telephone number of a person knowledgeable about the shipment will have to be provided at the time of booking on the Air Waybill as well as in the SLA or SOP, to allow contacting the appropriate person in the event of a significant delay or disruption to the shipment that may impact on the viability of the contents of the shipment. More information can be accessed on the IATA website using the following link:
+15ºC to +25ºC *(The temperature indicated on the lower half of the label must match the approved transportation temperature range, e.g. +15ºC to +25ºC)
http://www.iata.org/whatwedo/cargo/pharma/Pages/index.aspx
Monitoring devices In addition to the label and new healthcare requirements, IATA is working on a number of other projects to help tackle difficulties in pharmaceutical transportation. IATA by means of an industry work-
to implement this step resulted from a collective recommendation
ing group, the Cargo RFID Working Group (RFIDWG) will be focusing
supported by the Time and Temperature Task Force and Working
on temperature monitoring devices and their use as currently there
Group members and endorsed by the IATA Live Animals and Perisha-
are no clearly defined standards that exist that permit the use of
bles Board.
electrically active devices in cargo shipments.
IATA’s aim is to ensure the integrity of the time and temperature sensitive healthcare cargo shipments and that the air cargo supply chain is prepared to handle the demands of these healthcare shipments. The application of this new requirement will enhance the transport and handling of specific healthcare commodities with the aim to ensure the highest quality through effective cold chain distribution. Therefore, it is imperative that airlines, ground handling agents and other stakeholders in the supply chain – including freight forwarders, terminal operators, ULD manufacturers, packaging and tracking and
The healthcare industry is increasingly using monitoring systems, which may be placed in individual packages, to track temperature or other parameters through the whole distribution chain. These track and trace devices, such as electronic temperature data loggers, are used on or in passive packages but different types of active containers with advanced monitoring and tracing devices are also arriving on the market. These active devices such as Global Positioning System (GPS) systems raise security concerns and also issues with the potential interference with aircraft navigation and electrical systems.
tracing companies – are familiar both with the regulations and the appearance of the label.
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In addition, it is critical to understand that most temperature moni-
Stay Compliant 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 fined 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.
iata.org/dgr www.the-logistics-portal.com
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TLPINSIGHT
11. 11.
toring devices contain lithium batteries (commonly lithium metal batteries), which are dangerous goods. Lithium batteries represent
Training Supply chain excellence is achieved as a result of applying funda-
a significant safety concern. Incorrectly manufactured and/or tested
mental principles that answer customer’s needs. Training therefore
lithium batteries pose a fire risk in transport. All lithium batteries
becomes paramount. Training of staff handling sensitive cargo is
must be transported in accordance with the provisions set out in
crucial to ensure the integrity of the cold chain is maintained. For the
the IATA Dangerous Goods Regulations (DGR) (and ICAO Technical
stakeholders involved in Time and Temperature Management, it is a
Instructions). Guidance material on the transport of lithium batteries
prerequisite for the implementation of the PCR and the air transport
is available at: www.iata.org/lithiumbatteries
logistics of healthcare products. The success of a program like Chap-
In addition active devices must comply with the appropriate air worthiness standards regarding electromagnetic interference of aircraft systems. The responsibility to comply with these requirements is with the shippers of such devices. To determine the requirements shippers are advised to make contact in advance with the applicable airline to determine the suitability of including such active devices in
ter 17 is based on how well it is implemented. It is essential that each member of the supply chain understands what their specific requirements for compliance are, as well as those of others in the supply chain. This allows for greater understanding of the entire supply chain process and smooth integration. As a result, the IATA Training and Development Institute leads training in time and temperature sensitive cargo handling to ensure compliance with the Perishable
shipments.
Cargo Regulation Chapter 17.
IATA is working with the industry and for the industry, and therefore such initiatives are carried out in cooperation with the appropriate cold chain stakeholders in the healthcare industry. This is only the start: there will be continuous development of the standards to
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[RELIABILITY] Provide the best solution for the transportation of pharmaceuticals.
COOL CHAIN LOGISTICS
-SOLUTIONS PHARMA Constant Temperature Control
Dedicated Logistics Team
Contact: Cool Chain Logistics Team c/o Adrian Rayner Tel: +44-(0)1784 - 422- 637 adrian.rayner@jal.com www.jal.co.jp/en/jalcargo/
A SEAMLESS COOL CHAIN
over 200 hours.
Using special coolants so that there is no need for
dry ice, the temperature required is pre-set and a data logger can be
Cool Chain Logistics
attached to monitor the temperature.
COOL CHAIN LOGISTICS FOR THE PHARMA INDUSTRY TO JAPAN AND ASIA
maintain strict temperature control and the popular Envirotainer t2
An introduction to air cargo systems There is a growing demand for transport by air from Europe of temperature sensitive cargo to Japan and various countries in Asia The airlines are called upon to be able to provide various cool
The Envirotainer e1 has been used for pharma on many occasions to
model can be set at a wide range of temperatures. Thermal blankets are used to avoid extremes of temperatures and sudden fluctuations of temperatures.
Ice Battery System
transport products to the European air freight market in order to send temperature sensitive cargo securely and timely to Japan and other Asian destinations by aircraft without risking the quality of the pharmaceuticals. The main commodities transported tend to be in addition to pharmaceuticals, life science samples, bio samples, chemicals, medicals, life saving drugs, clinical trails supplies, diagnostics.
Customer Requirements Certain commodities such as pharma require temperature control and monitoring throughout the transport process. Common temperature ranges requested are -20deg C deep-frozen and 2~8 deg C or avoidance of fluctuations and extreme temperatures whether high or low.
coolant plates placed inside the IBS
Pharma shippers are often looking for written evidence of items such as validation report of cool container condition, check sheet of
Temperature can be set between +5deg C and -20deg C with an
handling, temperature graph of storage room, written information
accuracy of +/- 2deg C. The internal loading space of the box is
to prove standards or explanation of procedures to handle pharma.
41x36x31cms.
These are items that can be prepared by the airlines for air transport
A typical handling procedure would look like this:-
and which provide for individually tailored standard operation pro-
1.
cedures (SOPs), which can be agreed with the shippers.
the cargo holds of aircraft such as thermal blankets, use of Enviro-
2. 3. 4. 5. 6.
tainer e1 and t2, Ice Battery System (IBS) which are used by airlines
7.
Equipment There are various types of cool equipment which can be used inside
The carrier makes the box ready with coolants based on agent’s requirements. Agent pick the box up at Departure Airport. Agent or shipper sets cargo in the box. Agent delivers the box to the airline after Customs clearance. The box is handled by the airline based on the SOP. Agent picks up the box after Customs clearance and deliver it to consignee. Agent return the empty box with coolants to Airport for return.
and forwarders. Airline staff are trained to handle these products and follow carefully made SOPs agreed in advance with the shippers.
An example from LHR (London Heathrow) needed -20deg C. The
The choice of equipment depends upon the degree performance
Unit was prepared and handed over to the designated forwarder in
needed to maintain the quality of the cargo.
Cheshire close to Manchester, the cargo loaded inside the IBS and returned to LHR. As the unit can be kept cool for over 200 hours or
The IBS is able to control temperature with an accuracy of +/-2 deg
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kept frozen for 100 hours this allows for sufficient time that covers
Long Lasting
Over 200 Hours duration of delivery to the origin Europe airport and the flight to
extreme cold too.
Tokyo, the final destination in Japan and time for collection from the
Blankets are available in 2 sizes, LD3 (146x136x145cms) and LD7
airport and delivery to the consignee in Japan.
(292x200x162cms). There are good quality and re-usable blankets but also other disposable sheets are available.
Envirotainer e1 E1 container performance is stable for precise set temperatures
Handling
over many hours and airline staff have training to handle shipments
A seamless cool chain by is provided by the staff of airlines based on
requiring stable temperatures. Internal temperatures can be set
standard operation procedures (SOP).
between 0 dec c and +20deg C with an accuracy of 1deg C. Upon
•
request checks can be made of the temperature inside and outside the units and detailed checks recorded on a check sheet. This unit
Individual SOP for each shipment is prepared, reflecting the customer’s requests.
•
does not require dry ice.
SOPs are based on international guidelines such as IATA PCR Chapter 17 and GDP etc. Staff who are well-trained handle pharmaceutical products.
Envirotainer t2
•
This popular cool container is often to be seen on flights from Euro-
SOP
pean gateways with the latest units from the manufacturer Enviro-
The SOP set up by an airline in agreement with the shipper and cargo
tainer.
forwarder and will include the following type of items to meet the
Temperature can be set from -20 to +20 deg C and is powered by
needs of the shipper and consignee:-
batteries and dry ice.
Training programme
Thermal Blanket Used widely, the Thermal Blanket is able to minimise temperature fluctuations with no extremes of heat or cold. The build up of the blankets and cargo is done under airline staff supervision making certain of secure handling. With shipping temperatures of between 1 and 30 deg C direct sunlight is avoided and
Trained staff in both origin, transit and destination airports.
■ Handling - Confirm the shipment and document is compliant with carrier /country regulations and procedure
■Priority service - Honour the flight schedule , ensure space onboard is available
■Contact list - Communicate delays or problems to the forwarder
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15.
■Check sheet
of the chain are being carefully followed. In cases where any issues or
- Update any temperature log sheets
■Storage area
problems are noted then it provides an opportunity for the process to be re-examined and strengthened in light of that feedback and
- Store the product in conditions that are within a defined temperature range
■On tarmac - Limit the time between the warehouse and aircraft loading/ unloading
■Equipment
agreement between the parties involved to be made.
Conclusion In order to serve the cool transport market by air cargo, airlines offer various categories of service and equipment which are available
- Handle active cooling containers in accordance with the supplier’s instruction
■ Duration - Maintain recommended cargo hold temperature setting
■Loading position - Refrain from loading temperature sensitive freight near the aircraft cargo door, when possible
Customer feedback and satisfaction An increasing number of pharma shippers are requiring temperature
according to the preciseness of temperature control and monitoring of the air transport process required and airlines are able to provide that service to pharma shippers and their forwarders by use of carefully agreed SOPs covering handling, checks and providing special cool equipment. This can encompass the whole air cargo chain from the shippers’ premises, acceptance at the origin airport up to the destination airport by the airline and then delivery to the consignee.
control and monitoring for their transport. Airlines are able to meet
Contacts:
those requirements even including at transit points in Asia when the
JAL Cargo Cool Chain Logistics c/o Adrian Rayner
final destination is beyond the airline hub.
Tel +0044(0)1784 422 283 adrian.rayner@jal.com
Especially appreciated by the customers is the personal check by airline staff and monitoring with the check sheet to ensure all parts
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17.
//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING Pharmaceuticals Require Strict Temperature Controls Pharmaceutical products are considered one of the fastest growing and most valuable cargo commodity categories handled by air
The IATA regulations for the air transport of temperature-sensitive pharmaceuticals were carefully developed using the following information: •
carriers. It is estimated that biotech and pharmaceutical products represent the highest value per air lifted pound of any cargo shipped
from major airlines and freight forwarders •
distribution process travel by air, the significance of maximizing
from key pharmaceutical companies •
references and incompatibility/segregation information •
Pharmaceutical industry confidence in air cargo can be further gained by using state-of-the-art equipment packaging and containers, tracking systems and highly-trained personnel. Processes that
Comprehensive classification of perishable commodities, including temperature/humidity requirements, packaging
shipper confidence in every aspect of the quality and reliability of the shipping process is of utmost importance.
International and local regulations for goods shipped and stored under optimal conditions in on- and off-airport locations
by the airlines. And taking into account that many temperaturesensitive pharmaceutical products will at some point during the
Scientific data from research institutions, and field experience
Airlines contact information, dedicated websites, and specific rules regarding perishable cargo
•
Pharmaceutical product information based on World Health Organization (WHO) guidelines
provide detailed documentation or proof that these sensitive products have been well- maintained throughout the shipping process
Additionally, pharmaceutical and biotech materials are closely
allow pharmaceutical companies the control they need to manage
governed by specific federal requirements that must to be observed,
their products effectively.
including growing requirements for more advanced equipment,
Protecting these valuable assets with proven, precise handling and
permits, and training in order to move medical material and pharma-
strict temperature-control can literally save companies millions of
ceuticals.
dollars in lost inventory. This is also ultimately essential for protect-
With the growth of pharmaceutical manufacturing internationally,
ing patients and end- users of the pharmaceutical products.
it is increasingly common for a drug to start as an active pharma-
Therefore, it is imperative for pharmaceutical companies, freight
ceutical ingredient (API) and go to a finished product in multiple
forwarders and air carriers alike to understand and overcome the
steps across multiple countries. As a result, the requirements have
challenges of cost- effectively delivering high-value, temperature-
increased for packaging, storing, transporting and distributing phar-
sensitive pharmaceuticals across widely varying climates to their
maceutical ingredients and finished products. The shipping process
customers worldwide.
must be as reliable and sophisticated as the manufacturing process for these products.
Requirements-Driven Approach The International Air Transport Association (IATA), which promotes safe, reliable, secure and economical air service practices, has developed additional regulatory requirements for the handling of temperature-sensitive pharmaceutical products. Effective July 1, 2007, the IATA published a separate chapter to its 7th Edition of the Perishable Cargo Regulations, specifically addressing air transport logistics for temperature-sensitive healthcare products, changing its previous passive guidelines to a more strict requirements-driven approach.
18. TLPINSIGHT
Proven Reliability in Handling of Pharmaceutical Shipments Built on the proven service reliability of American Airlines Cargo’s Expeditefs express freight product, American’s ExpediteTC service was developed to deliver a highly-reliable, temperature-controlled service. Successfully tested in 10 U.S. and international cities before its worldwide launch, ExpediteTC offers customers specialized handling, monitoring and tracking of sensitive pharmaceutical shipments. AA Cargo’s ExpediteTC service is available at more than 100 cities throughout its worldwide cargo network.
www.the-logistics-portal.com
AA Cargo provides two solutions - Active and Passive - to serve a
efficient and reliable handling of temperature-controlled ExpediteTC
broad range of temperature-controlled shipping needs. We’ve tested
shipments. These systems enable cargo teams to thoroughly monitor
and retested our procedures for each shipping solution so our cus-
temperature compliance.
tomers can rest assured that their shipment will reach its destination
With this system, AA Cargo is able to provide high-visibility monitor-
with the cold chain intact.
ing and unique tracking of the high-value shipment. Because the pharmaceutical industry is facing more regulation than ever before,
Multi-Layered, High-Visibility System AA Cargo has implemented a high-visibility, multi-layered tracking program for ExpediteTC, which guarantees all temperature-sensitive shipments are closely monitored. ExpediteTC is a program that delivers the specialized air cargo expertise needed by the pharmaceutical industry with all system layers supported by a team of highly trained professionals that have the commitment to deliver ongoing superior service. AA Cargo has also developed innovative internal systems that ensure
AA Cargo has implemented standardized processes and procedures that support customers with their regulatory requirements of tracking shipments to ensure that they have been transported under the correct conditions. Meeting or exceeding their needs, shipments are closely tracked and supervised by knowledgeable service teams. Customer-prescribed Standard Operating Procedures are put in place, which involve highvisibility watch and proactive tracking from end to end. The teams closely monitor the temperature and provide for maintenance services such as re-icing and battery replacement when needed.
www.the-logistics-portal.com
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19.
//MAXIMIZING CONFIDENCE IN TEMPERATURE-CONTROLLED PHARMACEUTICAL SHIPPING Certified Training of Personnel Worldwide Enhances Service Reliability and Accessibility The strength of AA Cargo’s QEP accreditation is bolstered by the extensive hands-on training of more than 2,400 cargo team members globally. Customers are assured that QEP Certified personnel have a thorough understanding of all aspects of Envirotainer control, operation, maintenance and troubleshooting. This includes the complete operation of the control panel all the way to the handling and changing of dry ice, cooling fans and container batteries. Achieving QEP status in multiple key locations and cities worldwide demonstrates AA Cargo’s commitment to providing the highest standard of service and shipment reliability to its temperature-sensitive cargo customers.
Summary American Airlines has made significant capital investments in our cargo facilities to accommodate temperature-senstive shipments in the various cities we serve. Every station is equipped with an environment area for temperature-senstive cargo and several of our key locations (including New York, Chicago, Miami, Dallas and San Juan) will be outfitted with dedicated CRT rooms, specifically designed to accommodate passive packaging. CRT rooms will be added in additional locations worldwide in the near future. AA Cargo has implemented a multi-layered, high-visibility system that combines state-of-the-art Envirotainer containers with accredited, highly-trained cargo personnel in major cities worldwide. All are designed to provide shipper confidence in the end-to-end shipping process for pharmaceutical products. A testament to the success of this multi-layered, high-visibility approach is that customers who started with the air carrier’s pilot program have continued to use AA Cargo for their temperature-controlled shipments.
THE STRENGTH OF AA CARGO’S QEP ACCREDITATION IS BOLSTERED BY THE EXTENSIVE HANDS-ON TRAINING OF MORE THAN 2,400 CARGO TEAM MEMBERS GLOBALLY. CUSTOMERS ARE ASSURED THAT QEP CERTIFIED PERSONNEL HAVE A THOROUGH UNDERSTANDING OF ALL ASPECTS OF ENVIROTAINER CONTROL, OPERATION, MAINTENANCE AND TROUBLESHOOTING.
20. TLPINSIGHT
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DID YOU KNOW? Our Cold Chain Solutions Speak Multiple Languages
So when your temperature-sensitive cargo needs priority boarding in any of the countries we serve, you can rest assured our efficient, state-of-the-art procedures and select interline partners allow us to deliver uninterrupted, temperature-controlled services, even in hard-to-reach locations. Our network alliances build greater partnerships with our customers because strong links are essential in a global cold chain. Come see why no matter where your freight is headed, we speak your language. To learn more about our global cold chain solutions for temperature-sensitive cargo, please visit www.aacargo.com.
AACargo.com AmericanAirlines Cargo and ExpediteTC are marks of American Airlines Inc.
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TLPINSIGHT
21.
INTEGRATION OF DANGEROUS GOODS MANAGEMENT SOLUTIONS INTO EXISTING SOFTWARE ENVIRONMENTS Biography of Heman Teering Managing Director DGM Software Development Group Before coming to DGM in 1997, he was a logistics expert in the Dutch army. He worked for 5 years as a
from the back office system to the danger-
logistics coordinator for Explosives and Fuel distribution and 5 years as expert on International move-
ous goods solution and vice versa.
ment of equipment, ordnance and personnel.
A separate solution could well work in situ-
Herman first joined DGM as a member of the Special Project team at DGM NL. In the years that fol-
ations where a small number of dangerous
lowed he held senior management positions in DGM Systems and DGM Support, the head office of
goods shipments a week are processed, or
the international DGM network.
in situations where IT support is not at hand
Since 2003 he is Managing Director of DGM Software Development Group, an IT company specialized in databases, tools and solutions for all modes of transport, production, storage, handling and waste of Dangerous Goods.
or too expensive to realise one of the other solutions. It could also serve as a basis to realize the connected solution in due time.
The connected solution This setup connects a dangerous goods
As these rules and regulations can differ
as, for instance, goods can be dangerous ac-
between countries, and in some cases even
cording to the Globally Harmonized System
between states or communities, the chal-
of Classification and Labeling of Chemicals
The actual shipments are prepared as usual
lenges for the industry are numerous. On
(GHS), but not dangerous for transport under
in the back office system, but the required
the one hand you would like a minimum
one of the regulations for the Transport of
documentation and/or dangerous goods-
impact on your processes, and on the other
Dangerous goods. Likewise, you can have
related information is processed in the
hand you want to be in compliance with the
goods which are dangerous for one trans-
separate remote dangerous goods logistics
applicable rules and regulations. This means
port modality but not for another. For the
solution.
you must be able to prepare all the required
purposes of this article, the focus will be on
reports and transport documents, have all
the logistics and related transport documen-
article-related documentation – like a mate-
tation.
rial data safety sheet (MSDS)– up to date and
Adding dangerous goods logistics solu-
on hand, and make sure that you have your
tions to existing back office systems like
workplace instructions, product labelling
warehouse management systems (WMS),
and safety measures in place.
customer relation management (CRM) or enterprise resource planning (ERP) solutions
On top of that, you have to be aware of dif-
can create a lot of additional value to these
ferences between the various regulations
systems, but can also cause a lot of prob-
22. TLPINSIGHT
www.the-logistics-portal.com
logistics solution to the back office systems.
The interface connecting the two systems is running in the background and is triggered by user-initiated actions on the back office system. This can be anything from a new order to a simple change in the status of a shipment. The user does not have to take additional actions, other than collecting the processed documents from the printer, the email system or any specified file location.
Safety first in Dangerous Goods Management
Dangerous Goods Management is all about
automated where possible to save you time
safety and minimizing risk. In air transpor tation,
and to reduce error rate to a minimum.
staying compliant with all of the many rules and regulations is not an easy task. However,
DGOffice.net was developed as an on-line
supported by DGOffice.net with its specific
application, meaning you can access it anytime
modules for air transportation, it becomes a
from anywhere in the world. Alternatively,
clean cut operation. From Packing Instructions
run it as you see fit: within your own network
to Shipper’s Declaration and ‘NOtification TO
or on a stand-alone computer.
Caption’: it’s all in the software and highly
DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net
014016_DGOffice_adv_203x280.indd 2
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TLPINSIGHT
23.
11-12-12 16:56
lems – both financial and operational – if the options are not clear and integration is not managed well.
ous goods solution and vice versa. A separate solution could well work in situations where a small number of dangerous
From experience, we have learned that there
goods shipments a week are processed, or
are basically three options to implement
in situations where IT support is not at hand
these solutions, and in this article description
or too expensive to realise one of the other
– as well as positive and negative aspects of
solutions. It could also serve as a basis to
each option – will be given.
realize the connected solution in due time.
The separate Solution
The connected solution
In this setup there is basically no connection
This setup connects a dangerous goods
between the back office system and the dan-
logistics solution to the back office systems.
gerous goods solution. The user processes the orders as usual in the back office system
The actual shipments are prepared as usual
and the switches to the dangerous goods
in the back office system, but the required
solution. This solution can be a software
documentation and/or dangerous goods-
package offered by several suppliers either
related information is processed in the
locally installed on computers, on the com-
separate remote dangerous goods logistics
pany’s intranet, or accessed via the internet.
solution.
Also, the good old ‘copy and paste’ solution is
and the order quantity. Everything else is automatically added from the connected database. The dangerous goods logistics system has a similar setup, but for dangerous goods only. The database is built around unique identifiers. Selecting a specific ID will make all related data available.
Article classification Key in a connected solution is the connection between the article number in the order system and the ID used for the dangerous goods data. This so-called article classification can be done in two ways. The first option is to maintain all information in the order processing system, meaning a complete set of dangerous goods information (including the key) needs to reside in
The interface connecting the two systems is
the system. The dangerous goods key needs
running in the background and is triggered
to be assigned to the article based on the
by user-initiated actions on the back office
characteristics of the article (see MSDS).
system. This can be anything from a new
Also, the chemical and/or technical name (if
The order data is entered in the solution and
order to a simple change in the status of a
required), type of packaging and required
documents are generated accordingly.
shipment. The user does not have to take
quantity need to be defined.
Depending on the solution, there are options
additional actions, other than collecting the
for checking several issues like segregation
processed documents from the printer, the
requirements, mixed packing provisions,
email system or any specified file location.
still used on many occasions whereby a Word or Excel template is completed with information typed in from the regulations.
verification of required information, emergency response information etc. Also depending on the solution, prepared
A remote server solution should be capable of offering the following solutions:
The second option is that the article classification is handled entirely by the dangerous goods logistics solution, whereby the article numbers from the back office system are loaded in the solution and the article classification is completed using the solution itself.
• automatic generation of dangerous goods
Connecting and processing data
declarations for shipments in any mode of
Once the order is ready and shipment
transport
papers need to be made, the back office
• printing the declarations on any printer
system needs to generate a message to the
defined in the user’s network
dangerous goods logistics system. This mes-
• preparation of the declarations in PDF or
sage needs to be drawn up in the specific
be required by some rules or regulations.
XML format (e-freight ready)
format for the chosen solution. If there is no
• adding (version-controlled) documents
The benefit of a separate solution is the
message generator tool available in your
like MSDS or handling instructions to decla-
speed of implementation: for instance, a
back office system, this requires additional
rations based on customer requirements.
solution the can be accessed via the internet
programming.
• instant or batch order processing.
documents are stored within the solution and/or exported in printed and digital format. Options may be available to export the document data for re-use in the back office system, or creation of statistical information to fulfil reporting requirements which may
can be set up in a very short time without
The message contains the shipper and
In general, a typical order processing system
consignee information, the method of
works with articles. These articles have a
transport required, as well as the article in-
also known in advance .
unique identifier, such as the article number.
formation and/or the dangerous goods key.
All other objects specified for a single article
The negative side of a separate solution is
Depending on the way article classification
are linked to the article number on database
the double work in data entry, the different
is handled, additional information might be
level. For example the trade name, pricing,
locations where data is stored, and the issue
needed.
location, stock, and so on. When a customer
of connecting, for example, shipment data
orders a quantity of a specific article, the user
from the back office system to the danger-
will only have to enter the article number
the need of IT staff to interfere as long as access to the internet is possible. The costs are
24. TLPINSIGHT
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In the message, the type of output and where it should be delivered is specified.
For example, the declarations can be sent
Another plus is the time that is saved with
availability and consistency of the danger-
to a local or a remote printer. Messages can
the maintenance of the dangerous goods
ous goods-related data which is needed for
be processed instantly or stored for batch
data as this is handled by the supplier of
the whole system to run on. This requires
processing.
the system, and the automatic production
a thorough planning and inventory of the
Generating results
of documentation based on the input from
minimum needs, the operational require-
the back office system so no need for double
ments, and perhaps additional wishes that
work.
need to be incorporated in the final solution.
In general, the experience is that a con-
Based on that inventory, the dataset needs
nected solution can be realised in a short
to be designed and structures need to be
timeframe. The total time required depends
developed. In this phase the designer should
on the wishes and the availability of IT sup-
be aware that the rules and regulations are
An interesting option is to utilise document
port to the back office system.
dynamic and can change on any particular
management modules if they are available.
Negative points can be the need of IT
moment resulting in additional data or the
Here, additional documentation like MSDSs,
support and/or developers, as the connec-
need for a structure change in the databases.
handling Information or workplace instruc-
tions need to be made with the back office
Also in this phase a decision will need to be
tions, can be connected to your articles and
system. Also the choice of where the actual
made as to who will be responsible for the
printed along with the declarations when
article classification takes place has effect
data. Will it be own staff filling the structures
required. When version control is available,
on the work to be done in the back office
or will it be a third party? In both cases, fixed
you can also make sure your customer will
system.
routines will be required to make sure the
automatically receive the latest version of
Costs can also be unpredictable. However,
data integrity stays intact.
these documents.
the costs for the dangerous goods logis-
The negative side of this setup is budgeting.
Another option is the use of web services
tics solution are mostly transparent. The
As already indicated, regulations and rules
that might be available in the dangerous
changes required in the back office system
change and do not take into consideration
goods logistics system, which can be used to
can cause some serious increase in costs if it
that you are in the middle of designing a so-
retrieve information or checks back into the
is not clear what the needs and wishes are
lution. So during the development, changes
back office system and as such create the
before the work starts.
can be implemented which cause delays and
option to do a storage segregation check
The same is even more important when talk-
increases in costs. Also, changing wishes and
at the moment of receiving goods in the
ing about the third option.
requests for additional functionality during
warehouse, present packing and labeling
The integrated solution
The dangerous goods logistics system will generate the required information or documentation as specified in the message. If the articles are maintained in the solution, it will take all relevant information from there.
information to the packers etc.
the design and development process could
This is more or less the ultimate solution
The major advantage of a connected solu-
whereby all data and processes, as described
tion is the addition of dangerous goods-
in the separate and connected solutions, are
specific information and documentation to
integrated into the back office system.
the back office system without the need to
Some providers of back office systems offer
keep all data in the system. Also, the user
modules or extensions that contain (parts
of the back office system will not notice a
of ) the dangerous goods logistics solution,
difference besides the changes that might
but in most cases the user will have to add
be made in the back office system and of
data and /or functionality to realise the
course the automatic creation of documen-
desired solution.
tation and/or information pages.
The most important issue in this setup is the
drag a project on and on. Hence planning and firm time frames are essential. The big benefit is that the final solution can be as perfect as possible for your situation and can generate tremendous additional value.
Herman Teering Managing Director
DGM Software Development Group A/S www.dgm-sdg.com
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25.
Cool Chain & Clinical Trails transportation of time and temperature sensitive products tered in these climates.
//BIOGRAPHY
The key factors in Cool Chain management of clinical trials are efficiency (speed), value of information and easy to use systems – making the gathering and analysis of data easy and reliable.
Harriet King Marketing Executive, Biocair International. Graduated with a BA(Hons) in Marketing, Advertising and PR; Harriet brings a fresh look to Pharmaceutical Marketing by combining traditional marketing techniques with New Media
Firstly, I will explain the ‘Cool Chain’: A Cool Chain (or Cold Chain) is a supply chain along which a product’s temperature is maintained from the point of manufacture until its end use.
practices. During her education , she worked with
Cool Chain is a core element in the transportation of temperature
a number of PR & Events agencies and spent a
controlled pharmaceutical product. Most Cool Chain products need
year with car giants BMW MINI, before making her
to be stored between +2°C and +8°C for stability and in accordance
debut in Pharmaceutical Marketing with Biocair.
with regulatory body requirements. These temperatures are usually
Email: hjk@biocair.com
the ‘magic numbers’ in the industry. Cool Chain is an expanding part of the industry and will continue to be so given increasing compliance requirements. This coupled with larger numbers of new drugs
I quite often see articles written on Cool Chain and articles writ-
in clinical trials and R&D requiring chilled temperature control in
ten on Clinical Trials, but there aren’t many that integrate the two
storage means a potentially prosperous future for temperature
together. This piece will discuss the current problems that exist in
controlled logistics.
running a clinical trial in an emerging country such as Russia, Brazil
Temperature controlled supply chains are not always ‘cool’. Some
or India – and the Cool Chain issues that will inevitably be encoun-
products have to be kept frozen – this is often achieved by packing it
26. TLPINSIGHT
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with dry ice. Other products must be kept warm – often this means a
terminal cancer or HIV and lack other treatment options (Compas-
room temperature band of something like +15°C to +25°C.
sionate Use Trials).
So, that’s the ‘Cool Chain’ – a chain of transportation ensuring that
Phase II Trials
the product travels at a desired temperature to preserve its qualities. Why is Cool Chain so important in Clinical Trials? To explain this, it is important to understand what a Clinical Trial is, its different stages and how much of the world one Clinical Trial can
In these, the potential drug is tested in around 20 to 300 volunteer patients suffering from whatever condition the drug is to potentially treat. They are designed to show whether the drug is safe in the specific patient population and to look for signs that it might be effective.
cover: Clinical Trials are most commonly performed to analyse new drugs, medical devices, biologics, psychological therapies or other interventions. They are a requirement before the relevant national authority approves marketing of the drug or device. There are several different types of Clinical Trial:
• Prevention Trials – testing new approaches that doctors believe to lower the risk of developing a disease
• Screening Trials – testing the best was to find a condition/disease in it early stages
• Diagnostic Trials - testing better procedures for existing diseases or conditions
• Treatment Trials - testing new medicines or new approaches to surgery/therapy
• Quality of Life - ways to improve comfort and Quality of Life for patients (e.g. incontinence drugs)
• Compassionate Use Trials - treatment option for
Phase III Trials
patients suffering from a disease for which no satisfactory,
If Phase II trials are successful, then the potential drug will undergo
authorised alternative therapy exists
Phase III trials, which are widespread multicenter trials on at least 300 to 3000 patients in clinics to test the efficiency of the product. They
There are four phases to a Clinical Trial involving new drugs, and
are usually randomised and double blind (this is where neither the
each phase of the drug development process is managed as a sepa-
patients or the researcher know who’s being given the active drug).
rate Clinical Trial. These phases are usually known as:
Once Phase III trials are completed, the drug is filed with the relevant
• Phase I Studies • Phase II Trials
country authority for review. In the UK, this is the Medicines and Healthcare products Regulatory Agency (MHRA); in the US, it is the Food and Drug Administration (FDA); in Australia it is the Therapeutic
• Phase III Trials
Goods Administration (TGA) and in Japan, the Ministry of Health
• Phase IV Trials
and Welfare. Some Phase III trials will continue while the regulatory
Phase I Studies
allows patients to continue to receive possibly lifesaving drugs until
This is the first stage of testing in humans. Normally, a small (20-100)
the drug can be obtained by purchase. Because of their size and
group of healthy volunteers will be selected. Phase I Studies most
comparatively long duration, Phase III trials are the most expensive,
often include healthy volunteers, however, there are some circum-
time-consuming and difficult trials to design and run, especially in
stances when real patients are used. Cases where patients who have
therapies for chronic medical conditions.
submission is pending at the appropriate regulatory agency. This
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27.
It is understood that drugs that are intended to be used on humans, must be tested on humans to ensure they are safe for use. It is due to this fact that quite often the samples taken are blood or tissue samples, and need to be sent to the research laboratories quickly, efficiently and undamaged.
Phase IV Trials After the drug is launched, further Phase IV studies are carried out to monitor possible adverse reactions or other responses when large numbers of patients begin using the drug. During the ‘drug pipeline’ or ‘drug discovery process’ drugs may also go through a ‘pre-clinical studies phase’. This stage of the drug development pipeline is a study to test a drug, procedure or other medicinal treatment. They involve in vitro and in vivo experiments using
wide-ranging doses of the study drug to obtain preliminary efficacy, toxicity and pharmacokinetic information. The aim is to collect data in support of safety. Preclinical studies are required before clinical trials start. So, as you can see when coordinating shipments from a Clinical Trial the need for Cool Chain assistance is heightened. It is understood that drugs that are intended to be used on humans, must be tested on humans to ensure they are safe for use. It is due to this fact that quite often the samples taken are blood or tissue samples, and need to be sent to the research laboratories quickly, efficiently and undamaged. It is well known that the different stages of Clinical Trials can take place in many different global locations. This makes the ‘need for speed’ and temperature control even more vital. For example, the drug could be created in a University in Poland, administered to the patient in a hospital or clinic in Africa and the sample be sent to a Research Laboratory in India or China. This is a very long chain of transportation where the drugs and samples will experience a variety of different climates. Appropriate Cool Chain packaging measures must be in place to ensure the shipment arrives at optimum viability.
Emerging Countries We have all read the articles and seen the trend emerging – where countries such as India, China, Russia and more recently many African countries are becoming hotspots for conducting Clinical Trials. Just last month in this publication there was much conversation about Australia and the Caribbean being the ‘Ones to Watch’ in Clinical Studies. The popularity of these countries only amplifies how ‘international’ a Clinical Trial can be. And its this ‘internationality’ that is really beginning to test the Cool Chain. Samples need to be sent quickly, efficiently and carefully to ensure they arrive at their destinations in a usable state, i.e. in perfect condition.
28. TLPINSIGHT
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• Book by 28th March to save £100 • Registration includes a FREE end of Day One Evening Dinner and a FREE Pre-Conference Workshop
SMi presents its 7th Annual Conference on
Clinical Trial Logistics 22ND - 23RD MAY 2013 | COPTHORNE TARA HOTEL | LONDON, UK EUROPE'S LEADING CLINICAL TRIAL LOGISTICS EVENT
KEY SPEAKERS:
• Sandra Hoffman, Project Manager, Boehringer-Ingelheim • Tobias Frey, Global Clinical Label Management Associate, Roche • Mike Isles, Executive Director, EAASM • Tamara Spuergin, Senior Clinical Distribution Manager, Novartis • Vimal Unewal, Planning Manager, Ferring • Biljana Coneska, Chief of the Department for Solid Tumors, University Clinic Macedonia • Harvey Rubin, Director, Institute for Strategic Threat Analysis and Response, University of Pennsylvania • Vladimir Anisimov, Senior Strategic Biostatistics Director, Quintiles • Sharai Chitando, Lead Research Nurse, Guy’s & St Thomas’ NHS Foundation Trust • Tom Cochrane, Head of Security, Napp Pharmaceuticals
KEY REASONS TO ATTEND: PLUS AN INTERACTIVE PRE-CONFERENCE WORKSHOP
Transport Logistic Strategies 13.30 - 17.30 Tuesday 21st May 2013 Copthorne Tara Hotel, London, UK Workshop Leader: Sue Lee, Regional Quality Manager, World Courier
• Explore the latest regulatory challenges currently being faced and consider strategies to comply with GDP and GCP regulations • Learn from industry case studies on logistic developments and warehouse management • Develop your understanding of risk analysis and demand forecasting • Understand the latest in security issues and vendor relationship management • Hear first-hand accounts of conducting clinical trials in emerging markets and running global multi-centre trials • Discuss latest logistical and temperature sensitive distribution issues with key industry professionals
Lead Sponsor
Supported by
Sponsored by
How to book
Visit www.smi-online.co.uk/goto/2013logistics11.asp Alternatively call Fateja Begum on +44 (0)20 7827 6184 Or email her on fbegum@smi-online.co.uk
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29.
Clinical logistics in ukraine
As Ukraine becomes ever more popular as a venue for international clinical trials, industry players need advice on how to operate in this exciting – but still quite specific and challenging – market, particularly in the field of logistics of clinical trial materials. This article gives practical background on the matter.
Ukrainian clinical research market Ukraine has been rapidly emerging as a clinical trial provider since 1996, when the first industry-sponsored trial came to the country. As of November 2012, 917 investigational new drug (IND) trials conducted in Ukraine are registered on www.clinicaltrials.gov 1. The trend has been positive over recent years as well. Thus, the number of regulatory approvals granted for IND trials in Ukraine increased from 142 in 2009 to 201 in 2011 (see Fig 1).
Figure 1: Number of clinical trial regulatory approvals granted in Ukraine in 2008–2011. Source: Ministry of Health of Ukraine
The local market of clinical trials is growing in monetary value as well. The Polish market research company PMR estimates the market at around $208 million in 2011 (a 19% year-on-year increase), with a predicted growth rate of 10–20% over the next three years.
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The unique combination of the following factors contributes to making Ukraine the perfect location for clinical drug development:
5
Study performance •
Lots of treatment-naive patients who are willing to have access to innovative therapies ensure high recruitment rates.
•
There is a Caucasian population of 45 million.
•
It is located in the strategically important region of Eastern
•
•
Low mobility of population contributes to retaining study subjects.
Europe.
•
Data is of a high quality.
Five cities have a population above 1 million.
•
Investigators are motivated and qualified, and see their involvement in clinical trials as an important opportunity to
2
be on the front line of innovations and get integrated into the
Matured clinical research infrastructure •
All top international CROs and Sponsors conduct their studies here.
•
global medical science community. •
recruitment, reasonable startup period), cheaper infrastructure
Global transport companies (TNT, DHL, World Courier) possess
and investigator fees compared to the Eastern European
good infrastructure in Ukraine ensuring fast delivery of clinical study materials from all over the world and throughout the country. •
A number of local depots involved exclusively in clinical trial logistics provide efficient logistical support.
•
A few private laboratories have customized their services to meet most of the industry needs and may be used as study central labs.
3
Well-developed public healthcare system •
The main national healthcare provider is a well-established network of public sector healthcare settings, based on the territorial principle with vertical patient referrals (Soviet heritage!). Such organisation of the healthcare system ensures concentration of patients with certain pathologies in large specialised regional centres, facilitating easy subject recruitment (including orphan indications).
•
The area has the highest number of physicians per 10,000 of population in the Commonwealth of Independent States and Central and Eastern Europe regions (49.3 in 2011)3.
•
Cost efficiency arises from shorter study timelines (fast
countries, EU members and Russia. •
Local CROs have opportunity to hire the brightest people in the local labour market: most local CRAs are certified physicians. This considerably improves quality of clinical oversight.
Criteria for the perfect local depot When planning study logistics in Ukraine one should bear in mind some particularities that make selection of the right local logistics vendor crucial for successful study performance. Firstly, Ukraine has its customs area isolated from both the EU and the Eurasian Economic Community, which gets the customs territories of Russia, Belarus and Kazakhstan united. That is why one cannot ship study materials to investigative sites from the EU or Moscow directly. A locally based depot is needed. This has resulted in the development of a fully matured local clinical logistics market. Up to a dozen local speciality companies currently operate in the field. Some big CROs have their own IMP storage facilities and customs brokers.
The medical education system includes 15 medical universities, and a number of specialised scientific and postgraduate educational institutions.
4
Regulatory policy •
National legislation is being intensively adapted to the EU requirements, pursuing the strategic country’s objective to join the European Union.
•
Regulatory policy is generally favourable to the development of the clinical trial industry, as the government seems to consider clinical trials as an effective tool, both to bring in investment to the public healthcare educate scientific personnel, and to prevent ‘brain drain’.
•
Initial study review by health authorities takes around two months, which is in line with the EU timelines. The absolute majority of clinical trials are approved including paediatric and placebo-controlled studies.
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31.
Secondly, clinical trial logistics involves added complexity in
tolerate delays at customs. This is why the perfect logistics vendor
comparison to the supply of marketed pharmaceutical products, and
should have customs brokers in the staff as well as partner external
there are specific selection criteria for local logistics vendors:
customs brokers as a back-up solution for preventing any potential
• Project-based approach
delays.
Clinical logistics is project-based by its nature. That requires
• IMP handling
involvement of clinical logistics managers (CLMs) at the early stage
All the IPM-handling related procedures need to be described in detail.
in order to forecast logistical needs and risks, calculate budget, set up
Continual environment control, accurate documenting and tracking
timelines and so on, in the course of clinical supply plan development.
of all warehouse operations (receipt, intra-depot transfers and
An experienced CLM with knowledge of the local market is of crucial
dispatch) are essential. Usage of validated warehouse management
importance for the effective and cost-efficient supply chain in the
systems provides a client with precise accountability, tracking and
study.
reporting. Validation of storage premises, used software and shipment methods is a must. The needs of re-labelling/re-packaging arise often in the course of a clinical project. The logistics vendor must be capable of performing these operations in concordance with GMP practices. The process of returning an IMP to a sponsor abroad is long, expensive and complicated, and, consequently, is rarely practised. Investigative sites are not capable of IMPs. In most cases IMPs in Ukraine are destroyed at special destruction sites. The destruction process requires adherence to many regulations and may involve a number
•Regulatory compliance and expertise Clinical logistics activities should be compliant with good manufacturing practice / good distribution practice requirements as well as complementary with good clinical practice standards.
of activities like IMP return from sites, selection and in some cases regulatory approval of adequate destruction methods, video/photo fixation, issuance of destruction certificates and so on. A logistics vendor should select a licensed destruction provider and oversee the
Local regulations prohibit storage of investigational medical products
process efficiently.
(IMPs) with licensed pharmaceuticals. That is why IMP should be stored
• Cold Chain
at dedicated IMP storage facilities only; the Ukrainian legislation does not require having such facilities licensed. A local depot should be skilled in regulatory submissions since import/export licenses need to be obtained at competent authorities. • Experience with import/export operations Customs clearance may be a tough task in Ukraine. Import regulations are frequently changed. Customs authorities have rather formal approach. So sometimes it is quite difficult to meet their requirements and expectations. That may lead to delays, re-evaluation of customs values and other annoying issues. Import/export regulatory paths differ for the marketed products and IMPs as an investigational product have no market licence and are not for sale. So customs brokers experienced specifically in clinical trial materials are needed. Study materials often require urgent delivery. Sponsors do not
32. TLPINSIGHT
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Local depots should have capabilities of storage clinical materials in various conditions:
• • • •
2–8 °C - 20°C -70°C -180°C
It should be kept in mind that storage of cell therapies and transplants require a license in Ukraine. Only validated refrigerators, freezers, shipment methods and temperature monitoring systems should be used. Particular attention should be paid to back-up solutions in the event of refrigerators failure or electricity outage.
•Non-investigational
medical
(NIMPs) and ancillary supplies
products
Apart of IMPs, there is frequent need in ancillary supplies (labkits, administration lines, equipments etc) and NIMPs (eg, co-medication,
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rescue therapy, comparators). These products are commercially available
materials used. Self-reading is the least efficient way of training, so
and the task of the logistics provider is to procure them locally or facilitate
instructor-led trainings and workshops should prevail in a good training
importation. Logistics providers should hold the drug retailer license to
programme. It is not a good sign if a staff turnover is high – a handover
be able to procure pharmaceuticals. Before distribution to clinical sites,
process is always painful and inevitably affects study performance.
NIMPs may require re-labelling adaption following local regulations or sponsor requirements. That is why the depot must have a written re-
Conclusion
labelling procedure compliant with GMP.
Ukraine is an important but still challenging and idiosyncratic market. The logistics of clinical study materials in Ukraine needs involvement of a local
• Quality management
depot. It should be thoroughly selected according to the criteria based on
Quality in clinical trials counts for a lot. ‘Minor’ quality issues may
approach to management of a study supply chain, regulatory expertise,
compromise the integrity of the whole trial with a multimillion-pound
experience with import/export operations, IMP handling procedures,
budget. Quality should be managed by a dedicated Quality Assurance
capabilities of local sourcing of comparators, internal quality assurance
Manager who is independent on the operations. The best practice is
systems, human resources availability and management.
to have back-up quality assurance. The written procedures (standard
The regulations and public institutions are not as advanced and stable
operational procedures – SOPs) covering every single business process
as in Western Europe and the USA. This is why experience and skills of a
are the basic thing to ensure quality. SOPs should outline the way the
local vendor become absolutely crucial. In other words, a good vendor
things are done, ensure uniformity of processes and directly reflect the
will make study progress smooth and will allow you to benefit from all the
level of the logistics provider’s qualification.
advantages of conducting studies in Ukraine.
Besides the logistical processes, the SOPs should also cover other areas like
References
quality assurance, personnel management, vendor selection, information
1. http://www.clinicaltrials.gov/
handling, security, emergency plans etc, as these things may also have
2.http://www.pmrpublications.com/press-releases/303/clinical-market-in-cis-
critical impact on performance and risks. As the matter of fact, a clinical
to-exceed-700m-in-2014
logistics company should ideally have the set of SOPs in concordance with
3. State Statistics Committee of Ukraine; http://www.ukrstat.gov.ua/
ISO standards. Quality has also to be assured by regular self-inspections and independent audits, as well as by tracking, analysis and eliminating of
Authors
root causes of all non-conformances and customer complaints.
Sergii Pomerantsev, Head of Logistics Department at Centre of Clinical
• Human resources
Research (CCR); experience in managing of clinical supply chains for more
A local depot should employ highly qualified personnel who are able to
than 50 clinical projects in Ukraine.
thoroughly follow sometimes rather complicated operational procedures
Email: ccr@ccr.com.ua
and the numerous changeable requirements of various sponsors. A logistics vendor should demonstrate the commitment to its staff continual
Sergii Myronenko, Quality Assurance Manager at Centre of Clinical Research
and extensive education. The quality of training programmes should be
(CCR)
assessed by review of internal educational programmes and training
Email: ccr@ccr.com.ua
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TLPINSIGHT
33.
Biotec Trusted Globally To Deliver
High Quality Clinical Supplies Services Biotec has established itself as a truly international trusted partner delivering clinical supplies services.
Our services include:
Biotec have built a global reputation as a company with the commitment to quality and technical excellence, the accredited expertise and the in-depth experience needed to take your clinical trials from Phase I to Phase IV and onto commercial supply.
Biotec Services International Ltd Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK
RFID and Cold Chain Management manufacturers to
all the way to the patient. Control escaped
finally have seamless
with change of ownership, and due to
monitoring from
the number of players in the supply chain
production to patient,
- distributors, cargo companies, freight
Alex Guillen is currently CEO of Escort Cold Chain Solutions
to be able to monitor
forwarders, pharmacies and physicians - full
SA (ECCS) with HO in Switzerland, and formerly Director of
all the way to, what we
control was difficult. The manufacturer could
Commercial Operations-Public markets for Novartis Vaccines.
call in the industry, “the
make recommendations, audit and qualify
In the last few years ECCS has evolved from the exclusive
last mile”. However,
partners, issue severe warnings, etc. to make
distributor of Escort data loggers for the cold chain market
biotech and pharma
sure the cold chain was strictly controlled,
to an independent solution provider of Radio Frequency
companies with
but full control was, and still is, what could
Identification RFID and real-time monitoring solutions. Today
temperature-sensitive
be described as hard to reach.
ECCS has its own range of temperature monitors and time
products all seemed
temperature indicators (TTI), making particular use of the latest
to agree that while
communication technologies such as tablets, smartphones and
technology was going
transferring and managing data in the cloud.
to take cold chain
Email: aguillen@escortcoldchain.com
management beyond
www.escortcoldchain.com
the enormous amount of manual work needed to program,
We would think new technologies in cold
re-program, download, ship, change, reset,
chain management would have made
restart, re-download, save and retrieve
great progress in terms of automation in
data loggers, they would still not be able to
the last few years, particularly with the
have full retrievable data all the way to the
evolution of temperature sensors using
patient.
RFID communication, but somehow this has not been the case, at least in two of the industries that should benefit the most from it: biotech and pharma. Let us analyse what has happened, why it has happened and why we should believe that things will fortunately change. In the last three years we have heard a lot of buzz in the market that technology will allow temperature-sensitive product
Throughout the supply chain, all the players certainly did and do their best to reinforce “their” chain, and never compromise the efficacy or quality of product, but due to the amount of players, a solution to make one controlled chain instead of several independent ones, seemed always to offer the best way ahead for the future. After all, several players could always hold to one chain, and by having one chain the manufacturer could configure it and analyse it while other parties could control it and react to it - even the pharmacist or the
The interest, of course, by biotech and
physician - all with the same understanding:
pharma companies to evaluate new
if the cold chain was broken the product
technologies was obvious, and many
would not reach the patient. Nevertheless,
pharma companies became active in
despite all the good intentions and strong
investigating new ways to improve their
efforts, cold chain management is still
method of handling the cold chain, but
where it was 10 years ago with few, very few
despite the great efforts there was one
exceptions.
problem: The manufacturer, in most cases, did not always have control of the chain
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35.
Tradition and More Tradition
already started to put new products on the
the cold chain and consequently not
We see that today even in the USA or
market.
allowing intermediate checkpoints along
Europe, and particularly in the UK, stripchart recorders are still widely used to Monitor temperature during transportation for pharmaceuticals. Strip-chart recorders are mechanical loggers that print the temperature history directly onto a strip of paper. They are cheap and they do not require additional equipment or software. Most users know its limitations but also their practicality; there is no need for software to have an idea of the temperature conditions, and the driver can simply sign a piece of
paper upon receipt, confirming that he has seen that the temperature was maintained as it should be.
Technology has had a hard time over the last few decades to replace paper, and cold chain control - not only for pharma, but also for the food industry - was no exception. In fact, the sales in volume for this type of equipment are numbered in millions, despite its large, bulky plastic case and high cost of transport. Nevertheless, alternatives to paper-like ways to read data are coming, and the answer is of course smartphones and tablets, and for this temperature-monitor manufacturers have
36. TLPINSIGHT
The Swiss seem to be pretty innovative
the supply chain.
at this; Elpro was perhaps a pioneer with
RFID data loggers on the other hand are
its innovation. A year ago it launched a
essentially electronic data loggers, with the
quick view solution for quickly obtaining
difference that the data can be downloaded
information fast on paper, namely the
using a wireless link. The main advantages
LIBERO. Berlinger is always developing new
of these kind of devices are the following:
electronic indicators to improve monitoring,
data download does not need manual
particularly in the last mile, and ECCS (Escort
intervention; reading through the box
Cold Chain Solutions SA) developed a USB
is possible so intermediate checkpoints
logger that can be read by an Android
can be implemented without the risk of
tablet and the data sent to a cloud. All this
breaking the cold chain; by mixing the
is happening now quite quickly, but these
identification capability of standard RFID
developments still require some form of
with temperature data logging it is possible
manual intervention, and seamless control
to implement an integrated track and trace
without manual or human intervention is
and cold chain management solution.
what RFID can do. This is the technology that
RFID data loggers are becoming cheaper
not only can provide seamless monitoring
and cheaper with new developments and
all the way to the last mile, but can also
the growth of the market, so that in a few
reduce operational costs.
months they should be well suited for box-
RFID for Cold Chain Management
level monitoring. Still, the cost limits the
While electronic data loggers are similar
usage at item level for most products but, in
to the strip-chart recorders, the difference
these cases, a complete solution for the cold
is that they store the information inside a
chain that also covers the last mile can be
memory that can be downloaded later by
implemented with a mix of technology (e.g.
connecting the device to a PC. They have to
RFID logger at box level plus an RFID passive
be extracted from the isolated box, breaking
label with an integrated TTI at item level
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or 2D barcodes with item level information
exporters and growers who were happy to
the health consequences of broken cold
being stored on the RFID tag using inference
pay a bit more for a technology that gave
chain in the food industry and you will start
to authenticate the product).
them so much information. Stepac has
realising that in fact the food - particularly
Today there are very few players offering
focused development on the food industry
perishables - supply chain also has very
RFID solutions for the cold chain, but
with success, but has also opened a path to
tough regulations, just like pharma and
surprisingly the industry that most rapidly
change with no return to more traditional
biotech do. I heard a few years ago in one
adopted RFID technology for cold chain
systems.
cold chain conference a representative of a
monitoring was fresh produce; growers and exporters of fruits and vegetables. Fruit and vegetable exporters realised that RFID would give them actual data, whereas previously they only used temperature monitors in case there was dispute over the responsibility of breaking the cold chain. Because of this, they, particularly in South America and South Africa as major export markets, just went for it. Exporters could finally reach their wish: “Monitoring food from farm to fork” and not only in terms of temperature, but also the much-needed traceability to give assurance to the consumer that what they had on their plate really came from where they thought it had come. The most recent case of confusion, with terrible health and economic consequences, was when Spain was forced to stop its exports of
As a reader from the pharma industry, you may think that this is new. It is not. The switch started happening over two years ago and today it is almost complete for some countries, while most pharma companies are still in the RFI (request for information) phase. The “D” is still missing. Now the next question is, are these systems good enough for pharma? Just think that while the classic range of control for biotech products like vaccines is 2-8°C, asparagus and cherries must be kept from 1.1°C to 2.2°C. Therefore, excellent accuracy and resolution are fundamental in the conservation of food, just as important as in biotech and pharma. And what about the difference in value, and the “it is not the same thing” argument? Just find out the cost of shipment of cherries and
large biotech company saying that perhaps they should also look at what the food industry is doing on cold chain management to learn from them. She was right to say so, but it is doubtful many companies took this initiative and there are reasons. RFID Technology for Pharma If the technology is there and most pharma and biotech companies know it, what has blocked them from taking a step forward to adopting RFID technology for their cold chain management? Probably it is a combination of three factors. Firstly, the qualification of new products and validation of new processes take a long time and are highly costly in the pharma industry, certainly more than in the food industry. Therefore the traditional pharma
vegetables into the rest of Europe
company changes something in its
because E. coli was suspected to have
operations or process only if is not
come from their cucumbers. Later it
working any more or if there is a
was found that the contamination did
specific project with a clear reason to
not come from Spanish cucumbers,
change (e.g. to reduce cost or improve
but the economic damage to Spanish
the frequency of monitoring). This is
growers and exporters was done.
good until some companies realise
An RFID system manufactured by the company Stepac in Israel was the first to enter this market, as their systems works in such a way that as soon as pallets reach their destination the shipper can see online the condition of their shipment, temperature, humidity and CO2. The switch from electronic data loggers to RFID was followed by a large number of
that the cost of waiting sometimes is higher than the cost of innovating. Secondly, this same resistance to change did not encourage temperature monitor manufacturers to invest in solutions for the pharma or biotech industries. In other words: why invest in innovation for an industry that will hardly change its current solutions anyway? This can be seen by the fact that the number one
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TLPINSIGHT
37.
RFID and Cold Chain Management supplier in temperature monitoring today,
ready.
temperature data logs without modifying
Sensitech, is still the major supplier for the
Two companies that have pushed the
the reader’s firmware). Basically the major
industry, despite the industry seeing that
technology to be suitable for pharma are
advantage of Intelleflex is its long range
some of the new players were being more
Intelleflex and CAEN. Both of their systems
facilitating the installation. Both systems
innovative. Thirdly, in the pharma industry,
have their advantages, and I just would like
can suit specific needs and both deserve
no data to prove that a process is safe means
to set out the major difference so that the
the credit of innovation to be compliant
that it will not be adopted; so since there
reader can understand what to look for.
to the pharma industry. The question is,
was no data that biotech products could be
Intelleflex uses standard UHF frequency and
now that there has been commitment from
affected by radio frequencies then there was
their products are based on both the ISO/IEC
these and other valuable manufacturers to
no way to prove the contrary, and therefore
18000-6:2010 (sometimes called “Class 3”) for
innovate and adapt RFID technology to be
biotech companies did not wish to take a
Battery Assisted Passive (BAP) and EPCglobal
suitable for pharma, will pharma and biotech
chance to be the first ones to do so.
C1G2 standards, while CAEN RFID developed
companies also take the step to appreciate
a technology using standard UHF frequency
and adopt this innovation? Time will
based solely on EPCglobal C1G2 standard.
answer this, but time is not what innovative
To simplify the matter, the major advantage
companies have in excess. It will be up to the
of Intelleflex is its capacity to read the tags
pharma company to reach out and benefit
from up to 100 meters in “Class 3” mode
innovation or remain on more traditional
and thereby through packaging, though at
systems despite its limitations and higher
shorter distances. Intelleflex readers can
operational costs.
also read tags in standard C1G2 mode but
RFID may also not be the best solution
at much shorter distances. The CAEN RFID
for all applications; perhaps in the end it
reader has a shorter range because it uses
will be a combination of RFID and more
standard frequency and could read anything
traditional temperature monitors as well
in an environment, but has the advantage
as 2D barcodes. The key will be to be able
that any UHF reader (including standard
to integrate data from conventional data
PDAs) could read their tags (a standard
loggers, RFID tags and all the information
UHF reader, while it may find/locate the
that is crucial to the management of the cold
tags, they will not be able to read the
chain and shipping of products, so that the
Some biotech companies have been trying to find data and with positive results. A study published in the July/August 2012 edition of the Parenteral Drug Association’s PDA Journal documents research that showed that in vitro test results for more than 100 biopharmaceutical products from eight major drug companies demonstrated no non-thermal effect by radio frequency radiation . This has triggered enthusiasm that something might be about to change. Other biotech companies have been searching for information with frequent RFI on RFID temperature monitoring. And this is good news for the industry, as the technology itself has never been more
38. TLPINSIGHT
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39.
THE NEED FOR INFERENCE IMPACTS ON ANTICOUNTERFEITING, SERIALISATION AND PRODUCT TRACKING Peter Norton Supply Chain Consultant Intelleflex Corporation
transportation of time and temperature sensitive products Face of the Future
be ready − or even have a strategy in place − to jump-start their
Global requirements for documenting the authenticity of
programmes. Governments will likely need to put a stake in the
pharmaceuticals are going to change and change dramatically.
ground. They will need to convert their recommendation into a
The State of California’s e-Pedigree law, now set to go into effect
regulation to prevent yet another delay in what is a much needed
in January of 2015, will impact on every company that sells
initiative. This is due to the annual rise in illegal drugs that are hitting
pharmaceuticals in the state and is, for the moment at least, the de
global markets as a result of supply chain security inefficiencies.
facto standard that pharmaceutical companies and 3PLs are building towards. Many of the people that work in the pharmaceutical
Any of us that have gone through the serialising of a range of
supply chain and logistics field have been anxiously waiting for
products, or managing the conversion of a manufacturing line to
larger governmental agencies (such as the US Food and Drug
print barcodes on moving bottle caps, know that the sheer effort
Administration (FDA) in the United States) to define a regulation or
in doing this without a slowdown in output comes with many
directive that mandates the actual requirements relating to tracking
challenges. However, we should not turn away from the fact that for
drug shipments and anti-counterfeiting measures. Will governments
every day, month and year that there is a delay in implementing a
mandate a 2D barcode at the unit level? Will there be a pedigree
standardised e-Pedigree solution, more and more patients will be
definition? How would inference, the method of identifying the
put at risk due to the quality and security of the distribution source
contents of a shipping container to confirm its contents without
for their medications.
actually opening the container, play into this? The list of questions goes on. So let’s assume that we have a crystal ball and can see
Planning Ahead
beyond 2013 and what may happen before California requirements
Given the alternatives, what’s the best way to prepare for the day
start to become law in 2015.
when serialisation and tracking
Many in the industry feel that, over the next few years, there will be a flood of companies who will be seeking guidance, some form of help, or a delay in implementing the law because they will not
40. TLPINSIGHT
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Face of the Future
programmes. Governments will likely need to put a stake in the
Global requirements for documenting the authenticity of
ground. They will need to convert their recommendation into a
pharmaceuticals are going to change and change dramatically.
regulation to prevent yet another delay in what is a much needed
The State of California’s e-Pedigree law, now set to go into effect
initiative. This is due to the annual rise in illegal drugs that are hitting
in January of 2015, will impact on every company that sells
global markets as a result of supply chain security inefficiencies.
pharmaceuticals in the state and is, for the moment at least, the de facto standard that pharmaceutical companies and 3PLs are building
Any of us that have gone through the serialising of a range of
towards. Many of the people that work in the pharmaceutical
products, or managing the conversion of a manufacturing line to
supply chain and logistics field have been anxiously waiting for
print barcodes on moving bottle caps, know that the sheer effort
larger governmental agencies (such as the US Food and Drug
in doing this without a slowdown in output comes with many
Administration (FDA) in the United States) to define a regulation or
challenges. However, we should not turn away from the fact that for
directive that mandates the actual requirements relating to tracking
every day, month and year that there is a delay in implementing a
drug shipments and anti-counterfeiting measures. Will governments
standardised e-Pedigree solution, more and more patients will be
mandate a 2D barcode at the unit level? Will there be a pedigree
put at risk due to the quality and security of the distribution source
definition? How would inference, the method of identifying the
for their medications.
contents of a shipping container to confirm its contents without actually opening the container, play into this? The list of questions
Planning Ahead
goes on. So let’s assume that we have a crystal ball and can see
Given the alternatives, what’s the best way to prepare for the day
beyond 2013 and what may happen before California requirements
when serialisation and tracking the authenticity of products through
start to become law in 2015.
the supply chain becomes a reality? GS1 compliant 2D barcodes are globally recognisable and are, by
Many in the industry feel that, over the next few years, there will
far, the easiest way to get started on the production line. Many
be a flood of companies who will be seeking guidance, some form
companies have systems that can read and store this data in an
of help, or a delay in implementing the law because they will not
Electronic Product Code Information System (EPCIS) database
be ready − or even have a strategy in place − to jump-start their
that can be synchronised for data integration between system
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TLPINSIGHT
41.
manufacturers. The data from the EPCIS can even be used to
product shipments.
formulate an e-Pedigree and, when linked in with an ERP system,
With serialisation and e-Pedigree, manufacturers, distributors and
can track the individual products from manufacturing to local
couriers will need to focus not only on ensuring quality and efficacy
warehouses to actual shipment, and to the first point of custody
at the item level. but also to ensure security at the total shipment
down the supply chain.
level. Because of this, they’ll need a solution for their supply chain that can track both product IDs and also monitor the status of the
By implementing this approach, the manufacturer is now assured
products as they travel through the supply chain to the end user.
(in principle) that the first leg of the supply chain is secure. You can
The best approach to labeling the individual units, as stated earlier,
provide a security sanity check by comparing the e-Pedigree serial
could well be standard GS1 2D barcodes. But for case and pallet level
numbers against the serial numbers of the received product and the
tagging, 2D or 1D codes as defined by the Health Care Distribution
shipment database, or EPCIS.
Management Association (HDMA) will more than fit the bill, except potentially in the case of Cold Chain shipments.
However, when we look a little deeper into the overall process, once the product reaches the first chain of custody change at the
Even though these standard 2D and 1D shipping container and
warehouse, each one of the individual saleable units would need to
pallet labels will more than suffice for basic drug shipments,
be scanned with a 2D barcode reader to confirm the serial number
and allow for inference, they will only be a “one function, one
(and possibly the product code). This creates an added cost burden
use� solution. In the real world, the need for the recording of the
to the wholesaler, as the wholesaler would need to unpack each
exchange of custody to generate an e-Pedigree will become a reality.
shipping carton to do the scanning which, in the case of cold chain
Therefore, in the case of Cold Chain shipments, if the carton needs to
products, could compromise the entire shipment. This is why there is
be opened to get a reading of the individual product barcodes, the
the need for the acceptance of inference.
entire contents of the container could become compromised.
The Benefits of Inference
Standard RFID tags in some cases are now being used on shipping
Inference was regularly discussed in the days leading up to the
containers and pallets but are generally single-use passive tags.
original California serialisation plans. This is because inference
In the area of temperature monitoring, the commonly used USB
relates to being able to read only the code device on the outer
data loggers or chemical recorders will provide a record of the
shipment package (be it a standard data matrix GS1 2D standard
temperatures and any deviations during the shipping process. The
barcode, standard strip or flat-level GS1 1D container code, or
drawback is that they are typically single use and need to be read
an RFID tag). This in turn, will provide a breakdown of each of
outside of the carton via connections to a computer or a special
the individual item serial numbers contained within the carton
print device and, in the case of the USB tags, this compromises the
it is attached to. Using inference, the time consuming and costly
contents when the carton is opened.
effort of opening each carton to scan individual item codes and serial numbers would be essentially eliminated, reducing cost and
For drug manufacturers developing their strategies for managing
significantly reducing the risk of the compromising of any cold chain
the shipment of cold chain products requiring serialisation and/or
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security tracking, or those who are trying to reduce costs, there is another RFID solution that should be considered. Battery Assisted Passive RFID tags, compared to standard temperature recording data loggers or passive tags, are capable of performing many of the functions that previously required more than one device to handle. Because they can offer sizeable memory, 2 years of battery life and can be read through a pharmaceutical shipping carton, they can be used in transit to show temperature and serial number content. Data can also be entered along the route to record changes in the chain of custody.
When these enhanced features are combined with inference, these newer RFID tags allow any serialised shipment to be read and recorded as part of the chain of custody logging. And, in the case of cold chain products, the current and shipping temperature logs can also be read at the same time – all without even opening the box!
Global manufacturers starting down the serialisation path and developing their e-Pedigree strategy now have a viable and cost effective alternative to the standard printed barcode approach. The ability to cost-effectively capture data in-transit, without opening the container, make Battery Assisted Passive RFID tags an ideal option for cold chain products that need to be consistently monitored on their journey.
Peter Norton is a supply chain consultant with Intelleflex Corporation. He has over ten years of experience working in the pharmaceutical cold chain and logistics industry. Email Peter at pnorton@intelleflex.com.
Š 2012 by Intelleflex Corporation – Used with permission
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Managing Your Risk In The Safe Transportation of Life-Saving Pharmaceuticals
Active Versus Passive in the distribution supply chain
Airfreight is the most expensive mode of transportation and as such, in order for airlines to make money from its cargo, the lanes that are available for shipping are often limited. To combat this, products are often transported via multiple flights that include stopovers: this increases the route’s complexity, duration and touch points where things can go wrong.
The growth in demand for biologics and preventative medicines will only lead to further increase the amount of temperature-sensitive
Furthermore, each country has its own regulations, codes, policies,
products moving though the global supply chains. Today, 25 per
procedures and customs that affect international shipments and
cent of all healthcare products are temperature-sensitive and the
can result in delays. The infrastructure differs greatly from more
requirements for high-value, life saving healthcare products such as
mature markets to those of emerging markets, which of course are
blood plasma, insulin, vaccines and other biological pharmaceuticals
the growth drivers of the future. For example, Frankfurt is Europe’s
are at an all-time high.
busiest cargo hub. It is used to handling temperature-sensitive goods and has a thorough understanding of their requirements,
This means that there is also a rise in the need for the safe and
while a county such as India has a poor modern transport
effective global transportation of these products and as such,
infrastructure which could result in additional overland transport of
industry experts predict that the world cold chain market for
up to 72 hours. In contrast, China has a great transport infrastructure,
healthcare products will grow by 10 per cent year on year.
but delays are possible due to custom regulations. Regulatory requirements are only increasing, particularly in emerging
The challenge for the pharmaceutical industry
markets and then of course there is the pressure of associated cost
Probably one of the most prominent challenges faced by the
implications.
pharmaceutical industry in the safe transportation of temperaturecontrolled pharmaceutical products is to keep the temperature
Assessing the options
of the product within its required band during transit. Indeed, 20
Being able to ensure that a shipment will remain within a
per cent of temperature-sensitive healthcare products have to be
temperature range for an extended period of time largely comes
destroyed as a result of a broken cold chain. Any weak link in the
down to the type of container that is used and the refrigeration
chain can compromise drug or sample integrity, breach security,
method.
delay shipments and ultimately result in financial loss or liability. Factors such as duration of transit, the size of the shipment and Packaging systems, transport companies, freight forwarders and
the ambient temperatures experienced are important in deciding
airlines all need to take the necessary measurements to ensure
what type of system is needed for each route. Options can range
that the product’s temperature stays within its range. This is not an
from small insulated boxes that require dry ice or gel packs, rolling
easy task, especially when multiple handlers are active within the
containers, to 40 foot vehicles, which have their own powered
cold chain or different products with different temperatures are
refrigeration units.
distributed. For high-value products that have strict temperature requirements, Due to the urgency of shipments and the value of the products, most
such as +2°C to +8°C, the two main ways of maintaining the correct
high-value temperature-sensitive products are transported by air.
environment and temperature during transport are active solutions
Shipping across international borders adds complexities above those
or passive temperature-controlled packaging. But which option
of domestic transport due to fragmented supply chains, extreme
provides the best and most cost-effective solution? The decision can
ambient temperatures and the infrastructure of those countries
be reached through assessing the different transport and product
through which the product must pass.
requirements: reviewing the market, quantity, timing, destination and of course cost.
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45.
of maintaining the correct environment and temperature during
systems are generally only cost-effective in large volumes, as partial
transport are active solutions or passive temperature-controlled
loads incur similar costs to full loads. This is because the system still
packaging. But which option provides the best and most cost-
requires the same level of handling and the product transported
effective solution? The decision can be reached through assessing
does not significantly alter the system volume and weight.
the different transport and product requirements: reviewing the market, quantity, timing, destination and of course cost.
Active systems
Passive packaging Whilst ‘less intelligent’ than an active system, passive, by nature means that once the system has been ‘packed up’ it is then not
In a nutshell, active systems are exactly as they say, ‘active’. Similar to
interfered with at any point during its journey.
a refrigerator, generally the containers maintain a thermostatically
Passive temperature-controlled packaging works by combining
controlled environment based on two technologies: compressor
components usually manufactured from a variety of commonly
cooling and electric heating or dry ice refrigeration using a
found insulation materials such as polystyrene, polyurethane
compressor.
or vacuum insulated panels to provide good insulation without significantly increasing temperature.
Small units may use single-use chemical reactions or pressure differences to provide set periods of heating or cooling, while larger
Systems are packed with temperature stabilisers such as ice, gel, cool
units resemble large freezers, fridges or cold rooms and include
packs or other phase-change materials to provide a fixed amount
heating or cooling elements that power air through heat exchangers
of thermal protection for its mapped-out journey. The combination
and circulate it around the product space.
of this blend of componentry acts to keep the temperature of the payload area within a certain temperature range for a specific time
If a product requires heating it is usually done electronically, utilising
up to 120 hours. The use of different component configurations
heavy battery packs or via an external power supply. If cooling
enables the system to cope with a wide range of ambient
is needed, dry ice or conventional refrigeration are the typical
temperatures.
methods, using electrically driven or fuel-powered compressors. The passive packing system requires components to be prepared Because active systems are reliant on external power sources
before being packed around the product. This preparation requires
there are higher cost implications and restrictions on handling
the phase change materials to be preconditioned and maintained
and shipping. To offset the cost, active systems are often leased
at specified temperatures 24 to 48 hours before packing, until the
to customers. They also require attention in the form of human
systems are ready to be assembled.
intervention during transit to either physically replace or recharge the batteries or re-ice after 72 hours.
Units are fitted with control and data logging systems to monitor and verify events such as start and stop operations, cargo and ambient temperature, as well as door openings and alarms for temperature deviations and system failures.
Due to their high cost, active containers are generally leased on a short-term basis to customers, and there are only a certain amount in global circulation. They are positioned at various global ‘stations’ and additional costs might be incurred to deliver the system to the required point of origin. Once at its departure point, an active system often requires limited preparation and can be packed simply following a standard operating procedure (SOP). However, active
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Active systems
Whilst ‘less intelligent’ than an active system, passive, by nature
In a nutshell, active systems are exactly as they say, ‘active’. Similar to
means that once the system has been ‘packed up’ it is then not
a refrigerator, generally the containers maintain a thermostatically
interfered with at any point during its journey.
controlled environment based on two technologies: compressor
Passive temperature-controlled packaging works by combining
cooling and electric heating or dry ice refrigeration using a
components usually manufactured from a variety of commonly
compressor.
found insulation materials such as polystyrene, polyurethane or vacuum insulated panels to provide good insulation without
Small units may use single-use chemical reactions or pressure
significantly increasing temperature.
differences to provide set periods of heating or cooling, while larger units resemble large freezers, fridges or cold rooms and include
Systems are packed with temperature stabilisers such as ice, gel, cool
heating or cooling elements that power air through heat exchangers
packs or other phase-change materials to provide a fixed amount
and circulate it around the product space.
of thermal protection for its mapped-out journey. The combination of this blend of componentry acts to keep the temperature of the
If a product requires heating it is usually done electronically, utilising
payload area within a certain temperature range for a specific time
heavy battery packs or via an external power supply. If cooling
up to 120 hours. The use of different component configurations
is needed, dry ice or conventional refrigeration are the typical
enables the system to cope with a wide range of ambient
methods, using electrically driven or fuel-powered compressors.
temperatures.
Because active systems are reliant on external power sources
The passive packing system requires components to be prepared
there are higher cost implications and restrictions on handling
before being packed around the product. This preparation requires
and shipping. To offset the cost, active systems are often leased
the phase change materials to be preconditioned and maintained
to customers. They also require attention in the form of human
at specified temperatures 24 to 48 hours before packing, until the
intervention during transit to either physically replace or recharge
systems are ready to be assembled.
the batteries or re-ice after 72 hours. Packages can range from single vials to multiple pallets and once Units are fitted with control and data logging systems to monitor
assembled for shipping, they can be sealed and dispatched without
and verify events such as start and stop operations, cargo and
the need for power supply or the requirement for additional
ambient temperature, as well as door openings and alarms for
attention from highly trained personnel, who have needed to be
temperature deviations and system failures.
educated in temperature-sensitive product transportation handling. The only changes to the state of the package are due to physical
Due to their high cost, active containers are generally leased on a
processes caused by the flow of heat through the components, i.e.
short-term basis to customers, and there are only a certain amount
the melting of ice. With this greater flexibility comes the increased
in global circulation. They are positioned at various global ‘stations’
option of transporting a passive shipment via more carriers and
and additional costs might be incurred to deliver the system to
routes.
the required point of origin. Once at its departure point, an active system often requires limited preparation and can be packed simply
Prior to shipment, each passive package goes through a qualification
following a standard operating procedure (SOP). However, active
process where an in-depth understanding of typical and extreme
systems are generally only cost-effective in large volumes, as partial
temperatures a package may encounter is achieved. Compared to
loads incur similar costs to full loads. This is because the system still
active systems, passive packaging has considerably lower capital
requires the same level of handling and the product transported
costs and is available for a range of budgets and performance
does not significantly alter the system volume and weight.
capabilities. They can provide frozen protection below -20°C by using either the dry ice sublimation phase change at -78°C, or the melting
Passive packaging
phase change of tailored materials to keep temperatures above - 40°C. There are also passive systems that can maintain +2°C to
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+25°C and +15°C to +25°C, using both water and specialised phase change materials. However, their main use is for the maintenance of refrigerated products between +2°C and +8°C, while active systems can be tailored to an exact temperature range required, be it greater than -20°C to +20°C.
International transportation When using an active system a logistics service provider and airline carrier are required to have a hands-on monitoring role during transit. Indeed, each cog in the supply chain is responsible for helping to combat extremes of temperature exposure on the route. This demands monitoring of the temperatures upon acceptance, in transit, upon collection and during dwell time, as well as re-icing or replacing batteries, as required.
Air transport can involve the product sat on airport tarmac prior to loading and this is where some of the most common risks occur due to exposure to the ambient temperatures on the day. Active solutions are fitted with control and data logging systems to monitor and verify events such as start and stop operations as well as cargo and ambient temperatures. These register outside temperatures in order to maintain the required conditions inside the container.
By contrast, passive packaging’s basic construction means that it can be shipped without considerable handling restrictions, which in turn offers greater flexibility in terms of having more potential carriers and routes available. However, because of its ‘simplicity’ there is a general misconception that passive packaging does not perform as well as an active solution.
Conclusion Ultimately, active systems can react to changes in the environment, whereas passive packaging resists external temperatures for as long as there is energy available from the coolant within the shipper.
The decision on whether to use an active system or passive packaging to transport temperature-sensitive products is largely determined by the products’ requirements, the owners approach and attitude to risk, as well as the destination and budget. One solution doesn’t necessarily fit all, but the best system for each shipping requirements can be found if you have a comprehensive understanding of the options available.
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“The Life Science and healthcare industry in China holds its own despite the global economic crisis. We are optimistic that this sector will continue to offer promising growth.”
I
ndustry experts predict the biggest growth in
However hurdles for those working in the temperature controlled
temperature controlled pharmaceutical shipments
supply chain still exist, and over one third of professionals 35%
will come from emerging markets. Much of this
who took part in a live polling session at IQPC’s 11th Cool Chain
expected growth is attributed to China’s growing
Logistics Europe in February 2012 think China will not only present
importance in the global pharmaceutical industry.
the greatest business opportunities for cold chain distribution in the BRIC countries, but also the greatest challenges.
As more companies are attracted to the market, by next year China is
A significant number of the survey respondents – over 41% selected
expected to be the third largest pharmaceutical market in the world,
China as the BRIC economy which had the most opportunity for their
with an estimated growth rate of 20% per year through 2010-2015.
business, followed by Brazil and Russia both with 17% and India with
According to Alen Yan, General Manager for World Courier, the costs
14%.
of drug development can be just 10 per cent of the price it would be
A presence in China is a must for most players in the pharmaceutical
in the West.
industry, however “this growth requires a supporting infrastructure
Steve Huang, Managing Director, DHL Global Forwarding China, said:
which allows pharmaceutical companies to transport drugs and
“The Life Science and healthcare industry in China holds its own
related equipment in a safe, timely and cost-effective manner” said
despite the global economic crisis. We are optimistic that this sector
Cold Chain IQ in Cold Chain Management in China. An effective
will continue to offer promising growth.”
risk management strategy to protect the supply chain and skilled
China has proved to be attractive for investors with an influx of companies and global logistics providers in the past few years. Just a few months ago DHL opened its biggest Asian hub in
professionals with local knowledge of the market is also important to maintain business relationships and deal with issues that might arise in real-time.
Shanghai, together with its four express hubs in the Asia-Pacific Shanghai, Hong Kong, Bangkok and Singapore. DHL plans to use the $175 million Shanghai-based hub to better tap into China’s growing demand for logistics services. “Opening the new hub today shows how we are confident in the development in China...and this reinforces our commitment to the logistics business,” said CEO Frank Appel.
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Points in this portal allows you to Search by company name, by country, by category, IATA and ICAO, job function... etc. As proud official partners of CAPA- Centre for Aviation; Gooey has its separate portal on www.centreforaviation.com where in addition to CAPA membership, access to Gooey contact functionality is available as an add-on to their fleet data, news and industry analysis services.
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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