TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE
Issue 4 - 2013
Top 25 biotech companies 2013 THE ELECTRONIC AGE
ELECTRONIC MESSAGING DANGEROUS GOODS
false positive Temperature monitoring systems: monitor air or monitor product?
TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS
SWISS 째Celsius Passive For your temperature sensitive supply chain
SWISSWORLDCARGO.COM
//MAIN CONTENT
TLPINSIGHT MANAGING DIRECTOR Lee Atkinson
//TEMPERATURE MONITORING SYSTEMS: MONITOR AIR OR MONITOR PRODUCT? Alistair Bamford, MBA and Colin Ramsay of laboratory equipment specialists, C & M Scientific, talk us through an experiment they undertook, the data outcomes of which assist with how best to integrate monitoring systems and minimise ‘false positive’ alarms in temperature-controlled units. Read the full article on page 8 »
MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright SENIOR DESIGNER Joey Graham EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson, Amy Firth
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Air carrier temperature-controlled programmes & the global trends driving change in the marketplace.
Mark Mohr, Director of Customer Support and Partner Management for CSafe Global, who serves on the International Air Transport Association’s Time and Temperature Task Force, tells us why airlines should no longer be perceived as the ‘Black Hole’ of the temperaturecontrolled supply chain.
ADMINISTRATION Katie Galelli WEBSITE DESIGN Knut Henriksen
CONTACT US Sales: info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk
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Sustainable design of temperature-controlled packaging: single use versus reusable packaging.
TLP INSIGHT Is published 4 times a year February, May, July, December by Intensive Media Ltd Send address changes to: 145 - 157 St Johns Street
Karen Adams, Technical Manager at DS Smith Plastics Cool Logistics, takes a look beyond the obvious at the factors we need to take into consideration when trying to ensure that a temperature-controlled packaging’s design is really valued as sustainable.
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Transportation of pharmaceutical products
Seetha Sasikala, vertical marketing leader for Thermo King and member of The Green Grid, looks at how to ensure the EU’s Good Distribution Practice (GDP) guidelines on a stable and secure temperature controlled environment for the transportation of pharmaceutical products can be met.
Contents continue on page 4 »
London EC1V 4PW United Kingdom The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the Publisher and, whilst every care has been taken in the preparation and design of this book, the Editor nor the Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles. Whilst every care is taken with artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred, The entire content of this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, by any means – electronic, mechanical, photocopying or otherwise – without prior permission of the Publisher. Copyright© 2013 Intensive Media Ltd
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//FEATUREDCONTENT
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Cold Chain IQ’s top content
A leader into our partner Cold Chain IQ’s One Page Guide to global Good Distribution Practice (GDP) Guidelines and Cold Chain IQ’s Ten Commandments for the successful supply of temperature sensitive products. Cold Chain IQ is a division of IQPC.
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Top 25 biotech companies 2013
A leader into the lowdown on the Top 25 biotech companies of 2013 at our partner Pharma IQ’s Innovation Hub: biotech and pharma SME resource hub. Pharma IQ is a division of IQPC.
FEATURED ARTICLE
//ELECTRONIC MESSAGING AND DANGEROUS GOODS Herman Teering, Managing Director of DGM Software Development Group A/S, gives us an insight into electronic messaging and e-Freight solutions and the opportunities in relation to dangerous goods and multi-modal transportation of these goods. Read the full article on page 19 »
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//TLP INSIGHT FOREWORD
S
ome of you might know that I started my international career way back in the very late 60’s. As a youngster starting out in the air cargo business, life was a little simpler then. A shipper delivered his goods, an airway bill was completed and we used the multiple copies of that document to collect revenues, clear customs and deliver. All very simple - but then email had not been invented and
electronic data was a distant vision. Today’s international logistics world is of course vastly different. But how long did it take for that air waybill to become part of the electronic messaging world? Even into the 90’s we were using the same number of copies of that air waybill as had been the case 30 years earlier. Slow progress. Thankfully things have moved on rapidly more recently and the initiatives of IATA with its E-Freight programme have done much to speed up the air cargo process. In his article on Electronic Messaging and Dangerous Goods, Herman Teering of DGM Software Development Group gives us an insight into how all of these initiatives are aimed at replacing the more manual flow with electronic versions that cover the entire end-to-end process. As he points out, this is particularly challenging when there are a variety of different international documents needed as in the case of Dangerous Goods. Herman highlights that using a Standard Messaging system that also allows the shipper (who clearly knows all there is to know about his shipment) to be the start point of the data entry has many advantages including data quality and reduced processing errors. All this undoubtedly adds value to a smoother and more compliant supply chain but Herman also adds caution in how long it will take to get these standards applied globally. Even though we know that product quality and efficacy is fundamental in the world of temperature-sensitive logistics, the search for packaging solutions that are more environmentally sensitive (and cost efficient) seems to be gathering pace. Karen Adams of DS Smith Plastics submits a very interesting article and identifies that meeting standards is a balance between the right design and using the right materials. Karen also raises the issue about whether switching from single use packaging to reusable systems automatically means a more environmentally friendly solution. She rightly highlights that unless this change is part of a process that uses the solution correctly (e.g. at final destination and in the process of return/reuse) then a reusable system could be more expensive for the environment and us. Back to her point about ‘balance’. In terms of creating a sustainable design, I sit firmly in agreement with Karen that to create an efficient solution requires a complete understanding of how that packaging box will be treated within an increasingly complex supply chain. I hereby make my plea for greater use of ‘Transport Qualification’ within the total pharmaceutical logistics process!
Tony Wright CEO Exelsius Cold Chain Management Tony has a thirty-five year history in the distribution; temperature controlled and air cargo logistics sectors. During this time he has been Global Sales and Development Director of British Airways World Cargo and the Senior Vice President of Envirotainer, amongst many other key roles and activities. Lee Atkinson Managing Director - Intensive Media Ltd
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A cost-effective insulated packaging solution
The laws and regulations associated with heat-sensitive products have become stricter over the last few years. At the same time, the arrival of new market players complicates the game. For laboratories, mergers have been the driving strategy for optimising purchasing and finding standard solutions for world logistics circuits. These changes are today leading to more precise specifications and high value-added solutions that respect the cold chain. Sofrigam quickly integrated these new demands, confirming its lead ahead of the competition. Sofrigam generates €23 million in sales, 90%
DESIGN PHASE
Next comes the packaging design phase.
of which is in export, with fifty employees
At the start of the design process, a team of
Vincent Bailleul, Packaging Engineer, works
in France. In the healthcare market, it
specialist cold chain engineers analyses the
in Sofrigam’s R&D department: “We start by
has set itself apart through innovation
customer logistics circuits. Their studies are
drawing the heat-insulated container using
and vision. Through its team of five R&D
based on:
3D software. The manufacturing machines
engineers specialising in high added-value
• Risk analysis relative to temperature
can then use these files. The design office
solutions and their development, Sofrigam
profiles,
makes a single drawing, with no duplicates or
works hard to make heat-sensitive product
• The search for the best working
repetitions, and our production colleagues
transportation safe, secure and easy for its
volume/exterior volume ratio,
use it to parameter the machine. The entire
laboratory partners.
• The implementation of shipping
circuit is computerised from the design to
preparation procedures that are both simple
the manufacture of the finished product.”
POLYURETHANE INSULATION
and strict.
“We design bespoke solutions based on the pharmaceutical products to be transported, by assembling different formats of polyurethane sheeting. This makes it possible to limit empty spaces within the boxes or to adapt to aircraft platforms for ‘long-haul export’ logistics,” notes Laetitia Perche, Sofrigam‘s Marketing Director. Thanks to their thermal performance, polyurethane panels optimise the working volume/ outer volume ratio of insulated containers. “The flexibility of the manufacturing process without physical tools makes it possible to create products that comply with the specific needs of the customers, while guaranteeing the quality and safety of temperature maintenance between 2°C and 8°C. We work using the raw material – insulating polyurethane foam – to give it the required shape,” adds Vincent Bailleul. Sofrigam essentially assists in transporting vaccines, ophthalmic products and chemotherapy solutions. Its main fields of expertise are export and long-lasting protection over 72 hours, adapted to international shipping. The R&D department is specialised in optimising products and researching new, ever-more effective, simple to use, ecological and economical concepts. Over 60 new product concepts are developed every year. SO F RI G AM I N N OVAT I N G F O R LA BO R ATO R I ES Leader in the design of customised polyurethane insulated shipping packaging, Sofrigam is an innovative cold chain partner. With 30 years of experience, the company stands apart because of its ability to anticipate tomorrow’s requirements in healthcare. Sofrigam has developed its shipping solutions to maximise product safety during transport, while minimising the cost and ecological impact. By adopting Sofrigam’s solutions, laboratories can save up to 15% of their cold chain logistics management costs.
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TEMPERATURE MONITORING SYSTEMS: MONITOR AIR OR MONITOR PRODUCT? IN T RODUC T ION
T
he use of a temperature-controlled unit (TCU) to store or incubate material is often supported by the use of independent temperature monitoring systems. Many facilities
operate a system of continuous temperature monitoring. The rationale is often to allow reaction time to any deviations, allowing the product to be relocated before any adverse impact has been created. Most systems allow for dynamic operation, opening up fridges and freezers consequentially leads to a rise in temperature. The temperature increase may be of long or short duration, dependant on many factors such as ambient air temperature, duration of door opening, how wide the door was opened, temperature of materials added, ability of unit to recover, etc. How best to integrate a monitoring system and minimise ‘false positive’ alarms is an issue faced by many. Simple laws on thermal dynamics suggest mass of thermal point being measured will be significant on the time of response obtained. However on researching this fact there appeared to be little published data to support it. At C&M Scientific we undertook a simple experiment in order to establish some core data that might prove the time/temperature influence of sample size.
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MORE THAN JUST A BOX Reduce your total cost of ownership with our Air Cargo Systems Class leading payload capacities, flat packable for storage and return, multi use sustainable solutions and minimal componentry for a quick and easy packout are some of the benefits of Laminar’s new Cargo systems, specifically designed to reduce your total cost of ownership. The graphite enhanced insulation material ensures a superior thermal performance, whilst our unique ‘Lock and Load’™ technology provides a simple visual coolpack check during assembly to guarantee a correct packout at all times. Our cargo systems are more than just a box, they are an evolution in aircraft compatible cold chain packaging.
THE LOGISTICS PORTAL MAGAZINE
METHOD
Materials: The samples used were as follows:
A range of typical laboratory samples were stored in a standard
2 ml plastic cryovials (1.8ml of water)
refrigerator. All samples were allowed to stabilise to a temperature 4 °C.
15 ml plastic falcon tube (10 ml of water)
Once all samples and the chamber air were equilibrated, the power to the
50 ml plastic falcon tube (45ml of water)
fridge was switched off. Throughout the exercise the temperature was
175 T Flask (200 ml of water)
being logged. The aim was to establish the time differential when each
Blood bag (400 ml of water)
sample exceeded the temperature threshold.
Equipment : 5.8 cu ft refrigerator Datalogger with type T thermocouples (Grade A)
Time / °C
Chamber Air
Cryoyials
15ml Tube
50ml Tube
Cell flask 200ml
Blood bag 400ml
6 °C
14:39
14:42
14:53
15:10
15:36
15:29
8 °C
15:02
15:07
15:20
15:38
16:07
16:13
10 °C
15:36
15:36
15:56
16:10
16:43
16:58
The time/temperature points were selected on the basis of C&M Scientific’s client base experience. The data shows that the sample size significantly influences the time/temperature relationship. The following table shows the time differential in minutes between the ‘Chamber Air’ temperature and the time taken for each of the test samples to attain the corresponding temperature. Time differential in ‘minutes’ base point ‘Chamber Air’ temperature. Chamber Air
Cryovials 15ml tube
15ml tube
50ml tube
Cell flask 200ml
Blood bag 400ml
6 °C
+3
+14
+31
+57
+50
8 °C
+5
+18
+36
+65
+71
10 °C
+1
+20
+34
+67
+82
This test picks up that the commonly used cryovial provides little by way of thermal mass. The small volume very quickly equilibrates with air temperature making temperature excursions on small volumes highly probable. We should point out that the testing was on an exposed cryovial and that additional packaging of foil or cardboard would have extended the time to equilibration. The importance of this information is that unless specifically tested the specific time to equilibrate for a given packaging remains unknown. Dynamic operation of entering and leaving cold rooms or freezer rooms is a common occurrence but the more important aspect is: how long does it take for the ambient conditions to return to specification following the dynamic use? The scenario of a busy cold room where product is taken in and out frequently over the shift, should have posed the following questions: • What is the maximum amount of product that can be stored in the room? • At what height can product be stored without adverse impact on airflow? • If the access is left open to an external ambient which is 10-15°C higher, is small product size compromised? And if so, how long does it take to recover? • In the event of room failure how much time is there before the product is compromised? i.e. how quickly does the system need to be backed up or the product moved to another location?
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DISCUSSION Masking the monitoring system probe by immersion in a sample material or increasing the thermal mass of the sensor is commonplace. This strategy is normally employed to ensure that false positives due to dynamic operations are avoided. While empathising with the concept, it would be essential to establish the time/temperature relationship of the weighted probe to the sample types and volumes being stored. The exercise we conducted showed that the time differential between air temperature and product temperature going out of range could be in excess of 1 hour. This means that if the response to air temperature is utilised there is a significant increase in the time window of action prior to samples being influenced by temperature. If the weighted sensor concept is used the window of opportunity to respond will be considerably reduced. It needs to be remembered that the time to ‘warm up’ will be matched or exceeded by the time taken to cool down. The time to return material to the correct temperature is vitally important, so knowing the rate of pull down of the material stored is equally important. Airflow is the essential element to cooling material, the ability to move tempered air in and around the stored material will ensure that cool down and warm up times will be optimised. It is accepted that immediate response to air temperature would result in alarms due to normal dynamic operations (false positives). When introducing systems for the first time this can give rise to a ‘cry wolf” syndrome and serious alarms are ignored. Experience has shown that using a combination of chamber air and a lag time offers the most assured method of minimising out of specification sample material. Regulatory authorities will accept such regimes where the rationale for the time delay has been validated and evidence is present to support the parameters set. PACKAGE MATERIALS The experiment we undertook only considered sample volume and the containers were chiefly constructed of similar lightweight plastics. Glass bottles, cardboard packages, foil packages, fluids, solids, powders, etc. all have different responses to temperature over time.
By recording data profiles over time, concerns of time temperature impact may be reviewed by the application of the Mean Kinetic Temperature (MKT). Many monitoring system vendors now support such calculations within their software packages. MEAN KINETIC TEMPERATURE By recording data profiles over time, concerns of time temperature impact may be reviewed by the application of the Mean Kinetic Temperature (MKT). Many monitoring system vendors now support such calculations within their software packages. The use of MKT is finding acceptance in many industries, as it presents a mathematical model which supports the continued use of product or materials despite data from monitoring systems showing temperature excursions during storage. This methodology is not universally accepted and we would recommend not relying on the use of MKT to correct what might reasonably be seen as a flawed system. CONCLUSION Where homogeneous product is to be stored in a TCU, it is feasible to establish the temperature/time relationship for a product. Allied to thermal mapping it is therefore possible to establish how and where to place monitoring system probe(s). Where non-homogenous product is stored we would suggest monitoring chamber air only. Should false positives present then the judicious use of alarm delay should be applied. Alternately, application of the temperature response of the smallest volume stored could be construed as the worst case and most reactive scenario.
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PROGRAMMES & THE GLOBAL TRENDS DRIVING CHANGE IN THE MARKETPLACE Mark Mohr joined CSafe Global in July 2011 and he currently serves as Director of Customer Support and Partner Management for the organisation. Mark has over 30 years of experience in sales, business development, marketing, process management, as well as extensive experience in the air cargo business. He serves on the International Air Transport Association’s Time and Temperature Task Force, charged with enhancing and expanding airline regulations related to proper handling of temperature-controlled healthcare shipments.
I
f you have been fortunate enough to have attended any
Temperature-controlled shipping programmes typically offer
conferences or tradeshows focusing on healthcare products
the carrier high yields and comparatively stable volumes and
over the last several years, I am sure that you will recall having
there is industry recognition of the value that temperature-
been repeatedly told by the experts that the airlines are generally
managed shipping products bring to air cargo. If you follow the
considered the ‘Black Hole’ of the temperature-controlled supply
air cargo trade news outlets, I am sure that you will have noted
chain.
that there is no shortage of press releases announcing new carrier programmes, accredited stations and a litany of other
Along with a whole host of other high crimes and misdemeanours,
enhancements. And, based on infrastructure spending by the
the perception has been that the carriers operate in a vacuum
freight forwarder community for facilities and soft assets, it is
with little regard for proper process handling or staff and handler
easy to see that it is not just the carriers who have recognised the
training, and more. At one point in history, this perception may
value this important product brings to a company’s portfolio.
have had some merit in certain circles; however, this somewhat debatable observation is quickly falling by the wayside. In today’s
It is important to understand that, while there are potential
world of excess air cargo capacity and shrinking margins, the
similarities, no two carriers’ temperature-managed product
airlines have applied a laser focus towards becoming highly
offerings are the same. Route capabilities, pricing structure,
proficient at moving specialty cargo shipments, in particular,
repositioning abilities and fees, local station proficiencies, and
temperature-controlled shipments.
probably most importantly, the engagement of the carrier’s senior leadership are just a few of the critical components that drive the
Just a few short years ago there were only a handful of air
product and its parameters.
carriers with structured temperature-controlled shipping programmes. This small collection of air cargo innovators changed
It is really important that the users of these valuable services
they way all airlines looked at specialty air cargo products,
understand the carrier’s capabilities and competencies. It is
especially temperature-controlled products and subsequently a
comparatively easy to manage traffic from a hub to a major city.
trail was blazed that others were quick to follow.
But what happens when the shipment needs to go somewhere off the beaten track? Is the infrastructure in place to manage
Fast forward to today and one can easily count more than 30
appropriate storage conditions for a passive box? How about the
airlines that have developed and implemented some level of
capability to replenish dry ice or recharge a ULD? Whilst many of
a specialised temperature-management programme. Not so
these concerns seem daunting, most can be overcome either by
shocking is the fact that there are even more carriers that have
a local accommodation or the selection of a product protection
new product initiatives currently in process.
methodology by the shipper to suit the transit and storage
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TLP
capabilities available in the market. However, there will always
Competitive pressures are forcing a change in mentality
be a number of uncontrollables that technically fall within the air
and have shifted the dynamic between those who choose to
carrier’s realm and can impact how shipments can be managed.
remain stagnant, losing market share and those who embrace
For example, it is rare that a carrier can do anything about the
change and make impressive headway. Niche markets are also
impact of extreme weather or if a customs or regulatory entity
becoming important as competition increases. For example,
places a hold on the shipment, yet it is easy for customers to
specialist opportunities are growing dramatically with a number
blame the carriers rather than conduct a true root-cause analysis
of entities now focusing on clinical trials and other elements of
to understand where the disconnect resides.
the temperature-controlled shipment trade that have received marginal attention in the past. All of these items are creating a
The absolutely crucial aspect is to ensure that there is
completely new period of transition and transformation that can
ongoing communication between all parties involved in the
probably be expected to last for the next 12-18 months.
product movement before the first shipment moves. Proactive communication always trumps trying to figure out what to do
From an airline perspective, key influences in today’s market
when the unexpected transpires.
include increased visibility into the ‘landed cost and ROI’ for the carrier. Fuel burn by cargo position, the marketplace value
There will always be low volume markets where infrastructure
of the position on the aircraft, handling costs, infrastructure
spending is not justified by the return on investment. But, outside
development costs and competitive positioning are just some
of this real-world consideration, carriers are applying significant
of the key elements now being scrutinised more closely than
resources towards their temperature-managed products, their
ever before. Carriers who can balance investment with cost
people and facilities. Ongoing recurring training programmes are
controls while offering customer-centric product flexibility and
now the norm rather than the exception with acronyms like SOP,
out-of-the-box thinking will rule the day. Of course, these types
SLA and GDP now a part of the daily air cargo vernacular.
of transitions are generally good for the customer. Shippers and freight forwarders will be the big winners during this business
There is a little-recognised element that is just starting to
transition as expanded service offerings and continuous quality
impact airline temperature-controlled shipping programmes
improvements are brought forth on a level never experienced
and that is general programme retooling. There are a number of
before.
considerations that are driving current top-to-bottom product reviews at a number of carriers. Some airline programmes have
A potentially wide-reaching industry trend has also appeared
had active programmes for a decade or more and commercial
recently with the airlines becoming actively involved as
product review is a natural progression in a changing business
consultants to the product manufacturers and freight forwarders.
climate. What worked well when there were a small handful of
In the past, airlines have been kept at arms-length from the
service providers does not necessarily translate into today’s
shipper by the omnipresent gatekeeper and their direct customer,
world of enhanced customer options.
the freight forwarder. The thinking on the forwarder’s part has
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been that, if there are not sufficient
across hemispheres to parts of the globe
barriers to keep the airline from reaching
where proper temperature-controlled
out to the shipper, the forwarder will lose
shipping was unheard of just a few years
control of the dialogue and, therefore,
ago.
the customer. However, as more shippers have been forced by regulatory changes
Longer transit times, customs and
and cost constraint considerations to
regulatory clearance delays and the
become aware of how the total transport
need to return equipment to serviceable
cycle of their products are managed,
locations are lengthening lease durations
visibility into the formerly designated
on certain lanes. What is more, the
‘Black Hole’ has become important to the dialogue. The freight forwarders should rest easy as the airlines have no desire to take
current Active ULD leasing model was The key challenge in any carrier or vendor managed fleet is ensuring that the containers are available when and where they are needed
over the functions performed by what
built on having only one option in the marketplace. That in itself has created a culture where the incumbent supplier has been able to leverage their position to force customers to perform services
is essentially the outsourced transportation department for
that are not necessarily in their own best interests in order to
the shippers. Ground transportation, paperwork preparation,
maintain favourable leasing terms. Having customisable pricing
customs documentation and clearance processes are just a few
and lease length options are critical in managing airline costs and
of the forwarder provided services that the air carriers have
by extension the costs experienced by the end user.
no interest in assuming. On the other hand, this increase in visibility has also placed some forwarders with marginal product
A number of airlines are now choosing to maintain longer-term
and service offerings in an awkward position. The end result is
ULD leases and create self-managed fleets to reduce overall
that everyone in the forwarding community is going to have to
leasing costs and increase yield opportunities. In many cases it
up their game in order to remain competitive as well as to gain
is not a big stretch for a carrier to manage a fleet of specialty
market share.
ULDs alongside management of their standard ULD fleet. The key challenge in any carrier or vendor managed fleet is ensuring
Another key factor that will become of increasing importance
that the containers are available when and where they are needed
in this period of transition and transformation will be greater
as well as the number of turns or trips that can be squeezed out
recognition of the FAA’s opinion as to what constitutes proper
of the equipment during the contracted lease cycle. Flexibility
and appropriate safety systems that are mandated to appear
in times like these is critical. And, as seen with the carriers, the
on the current and next generation of active Unit Load Devices
organisation that can take advantage of change opportunities will
(ULD). Discerning the fact that there is only one compressor-
wind up on top.
based active ULD solution approved for use by the FAA should be an indicator as to how the regulatory body is leaning when it
The interested observer can expect significant and beneficial
comes to this issue. Many of the world’s airline regulatory entities
changes to how this important air cargo sector works. While
follow the FAA chapter and verse and this consideration should
evolution can be tough to predict, it is readily apparent that
be of concern to those who rely on non-FAA compliant solutions.
transformation is exactly what is happening. Every industry trade
The wise shipper and forwarder should be aware of this little-
magazine covering the shipper’s domain to the carrier’s realm
known consideration because if it is ignored there is potential
predicts continued double-digit growth in the temperature-
that some regulatory inspired event will change the market
managed shipment sector. As more and more healthcare products
undercurrents and create significant availability issues for active
are developed requiring precise temperature control and as
ULDs in critical markets.
the regulatory environment continues to evolve and expand to markets that may have been ignored in the past, opportunities
An additional component critical to airline temperature-
will only continue to surface for the airlines, the forwarders, their
controlled shipping products and the customers who use them
shippers, and for the suppliers of passive and active temperature-
is that the active ULD leasing model is in flux. The current ULD
controlled transport solutions.
leasing model is also a decade old and it was built around the capabilities of dry ice technology. In today’s world, compressorbased ULDs are the solution of choice for highly sensitive and valuable healthcare products and active ULDs are now travelling
16. TLPINSIGHT
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Biotec Trusted Globally To Deliver
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Our services include:
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Biotec Services International Ltd Biotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK
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Electronic Messaging & Dangerous Goods Herman Teering - Managing Director at DGM Software Development Group
I
n the last few years the logistics world has been overwhelmed
Currently two ways are commonly used to accomplish this
with articles, information and initiatives around the IATA
purpose. The first is the simplest way, which is creating a copy
e-Freight initiative and the call for action from all kinds of
of the actual document by either scanning the document into
organisations and industry associations.
an image file or generating a copy at the moment of printing the document. The created image can be sent via email or other
All parties involved in the logistics chain have been urged to make
means to all parties that need a copy. By using a so called ‘pouch’
changes in their systems and processes to facilitate an overall
all document images belonging to a shipment can be collected and
desire to make e-Freight ‘happen’. The general reasons given as
attached to the Waybill or Air Waybill and printed again from that
to why the parties involved should make these changes are to
pouch when needed. The negative side of this is that the actual
improve speed and reduce costs. The question as to where exactly
content of the documents cannot be used in computer systems
the benefits are for each individual company are more difficult to
without manual input of this data into these systems.
answer as well as trying to get an overview of the financial and time investments involved to earn these benefits. Besides this,
The other way is to generate a message, which contains all the
transportation never takes place by air alone, hence the need
document details in a structured way so it can be reused in other
to involve the other modes of transport in the decision making
computer systems able to understand the structure of that
process is obvious.
message. As these messages only contain the data, their size is smaller than a scanned image and they can be sent to receivers in
This article is meant to give an insight into electronic messaging
more ways than the image files.
and e-Freight solutions and the opportunities in relation to dangerous goods and multi modal transportation of these goods.
A message like this has to be generated according to a fixed structure and this structure should be known to both the system
The purpose of electronic messaging and e-Freight
generating the message as well as the system reading the message. All the systems in between just need to know where
The purpose of electronic messaging and e-Freight is basically
the message needs to be sent. The fixed structure is normally
to replace the current document flow with electronic versions of
described in a document called a standard and in that standard
these documents from the creation point up until the receiving
a couple of important things are determined, for instance the
point in the logistics chain.
message format (like XML), the content of the message and how this content must be listed inside the message.
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THE ISSUES
in the IMDG code unless it complies with all requirements of that regulation. Likewise for a shipment document according to IMDG
Having explained the differences between the two ways of
and offered for shipping by Air.
electronic document creation, I will now take at look at the other topic of this article, which is dangerous goods and, more
This works the same for electronic messaging and e-Freight with
specifically, transporting these goods.
the addition that besides the message standard, the content of the message must contain what is required according the
The transport of dangerous goods is regulated by both
different regulations. That is where trouble starts!
international and national regulations and in the majority of cases the basis for these regulations are the “UN Recommendations on
Knowing that there can be many different regulations for
the Transport of Dangerous Goods”, the so-called ‘Orange Book’.
transporting dangerous goods involved in a shipment from A to B,
The Orange Book serves as a model for the other regulations such
how can you use electronic messaging or e-Freight?
as the ICAO Technical Instructions for Air transport, the IMO IMDG Code for Sea Transport and the different regulations for
Currently in place
road and inland waterways like ADR, TDG, ADG, ADN, CFR 49 etc.
The use of computer systems to retrieve and use information for transport of goods is nothing new. Companies involved in logistics have used this for many years. Just think of Track & Trace options for postal packages, Air Waybills, containers etc. The large integrators such as FedEx, UPS and DHL took the next step by creating tools for their shippers, which could (and still can) be used to generate shipments and upload the data from these tools into their systems. For a shipper it reduces the time needed to book a shipment and also the tool generates the shipping label for him. Most of the time the tool also collects the shipping invoice and other details. The pick-up can be scheduled for a time suitable for the shipper so the benefit to him is obvious. The benefits for the integrator are even more significant as the amount of information available for each shipment gives a wide range of process improvement options. With the data available they can work on pre-clearance, capacity planning, route optimisation, manifesting etc., even before the shipment is picked
All these regulations give detailed instructions to each individual
up from the shipper. The advantage to them is the single standard
party involved in the transport of dangerous goods on how to
of data capture. As the shipment normally stays within the same
classify, handle, segregate, pack, mark, stow and document these
organisation during transport from A to B, there is no need to
goods.
exchange data with other parties involved other than the ones within their own scope, like customs.
Although the basis for the regulations is just one model, each individual regulation diverts from that model to a smaller or larger
Now compare this with a shipment transported from A to B
extent, as the differences in each different mode of transport can
where more parties are involved. For instance a production
be significant. Think not only of the means of transport, the load
plant in Germany shipping a box containing 10 kg of chemicals
capacity, weather and temperature conditions but also the risk
to a customer in the USA. The shipment and accompanying
profiles.
documents are originated from the shipper; handed over to the road transporter; driven to the forwarder (where it might be
This leads for example not only to different packaging materials
consolidated); driven to the airport; handed over to the Ground
and/or different allowable quantities for a substance but also
Handling Company; loaded on Aircraft pallets; loaded in the
the markings and documentation requirements for each mode of
aircraft; on the arrival airport, unloaded from the aircraft; handed
transport may be different.
over to the forwarder; and finally, driven to the consignee.
As result, an ADR declaration for dangerous goods will not be
Besides all the other paperwork there are at least 5 document
accepted as a dangerous goods transport document as described
types needed for the dangerous goods to be transported.
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Safety first in Dangerous Goods Management
Dangerous Goods Management is all about
automated where possible to save you time
safety and minimizing risk. In air transpor tation,
and to reduce error rate to a minimum.
staying compliant with all of the many rules and regulations is not an easy task. However,
DGOffice.net was developed as an on-line
supported by DGOffice.net with its specific
application, meaning you can access it anytime
modules for air transportation, it becomes a
from anywhere in the world. Alternatively,
clean cut operation. From Packing Instructions
run it as you see fit: within your own network
to Shipper’s Declaration and ‘NOtification TO
or on a stand-alone computer.
Caption’: it’s all in the software and highly
DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net
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It starts with the ADR transport document (1) needed to
That standard serves as a basis for specialised software systems
transport the shipment from the shipper to the airport. For
capable of converting the message content to comply with the
acceptance by the Ground Handling Company the Shippers
different dangerous goods transportation regulations involved
Declaration for Dangerous Goods (2) is required. The Ground
in that shipment. Such a system can for instance be used on the
Handling Company has to perform the Acceptance Check and
shipper side to enter all the shipment details and generate the
generate the check list (3). When Accepted, the shipment needs
Road and Air transport documents or the required electronic
to be listed on the Notification to the Captain – NOTOC (4)
equivalents. Based on that information, the system also generates
before it can be loaded on board the aircraft. Finally in the USA
the standard message, which can be used again in the same or
a Bill of Lading (5) complying with the US Hazardous Material
similar system in use at the airport to generate the Checklist and
Regulations is required to transport the shipment from the
Notoc (paper or electronic format). This procedure continues
airport to the consignee.
again on the receiving side.
These 5 documents cover three (four including IATA DGR) different regulations each with their own requirements for documentation and in most cases all information for these documents has to be manually entered into the different systems by different people. The challenge for electronic messaging and e-Freight is to reduce all that paperwork and manual entry to the absolute minimum.
Possible solutions
The challenge for electronic messaging and e-Freight is to reduce all that paperwork and manual entry to the absolute minimum.
As earlier indicated, each regulation has its own specific requirements for the preparation and documentation of
The benefits are obvious. Just one point of entry for the shipment
dangerous goods shipments. Besides which, regulations by
data, namely the shipper. The only party that has all relevant
nature are subject to regular changing and ad-hoc amendments.
details about the shipment and its content. All the other parties in
To develop a messaging standard that covers all possibilities for
the logistics chain have to work on that information as is currently
each existing regulation and also is flexible enough to cover future
the case with the paper versions. They can make additions, such
changes is more or less impossible.
as for instance the forwarder for Air Waybill information, and they can use the content of the electronic message in their own
Instead the solution should be found in a message standard that
systems. No need any more to reproduce data manually or to
incorporates only the basic dangerous goods information and
keep a warehouse full of paper copies of previously processed
detailed packaging and marking information for each shipment.
documents etc. www.the-logistics-portal.com
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Besides this, there is the time saving aspect and the easy
to the regulations. When you maintain your own data, make sure
information and notification option that comes with electronic
to use the latest official published regulations and keep track
data. Last but not least a high reduction in process errors
of amendments of these regulations or use a specialised data
compared with manually entered data systems.
provider and make sure they are able to offer you a Service Level Agreement and Product Liability for the data.
Certainly, there are some areas that need very high attention before using electronic messaging.
The final area is the availability and acceptance of both message standard and software systems. This article begins with the words
The first one is the area of message quality. If the message
‘In the last few years‌’ indicating that it takes time for things
standard is not very clearly defined, there might be
like electronic messaging to be developed. It will take even more
misunderstanding about the content of defined fields in the
years before a standard for electronic messaging will be available
standard and with that, errors in processing the messages. This
or even implemented in all places involved in the logistics world.
can be easily solved by involving specialists in developing the
This means that if you want to start using electronic messaging
standard.
or e-Freight, you need to make sure you are also able to generate paper copies or electronic copies like PDF files to replace these
The second area is the data quality of the message and the
messages in cases where electronic messaging is not possible or
specialised systems handling these messages. Computers
maybe not allowed.
maybe complex but in fact are very simple and rigid machines. If you tell a computer for instance to compare the content of a
As long as you keep the three attention areas in mind, you can
message with the content of the database and respond if there
easily start using electronic messaging or e-Freight for your
is a match, it will do exactly that. So if the message for instance
dangerous goods shipments. Open conversations with your
contains UN 1987, ALCOHOLS, NOS and the database contains
customers, logistic service providers and transporters to find out
UN 1987, ALCOHOLS, N.O.S. the computer will respond that
what the mutual benefits are. From experience I can tell you these
there is no match and reject the shipment while a human would
benefits are substantial and surprisingly easy to achieve.
recognise the missing dots and accept the shipment according
24. TLPINSIGHT
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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
Cold Chain IQ’s One Page Guide to Global GDP Guidelines GDP guidelines in one place!
Download the full Infographic at ColdChainIQ.com
Good Distribu3on Prac3ce (GDP) is the part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condi3on as required by the marke3ng authorisa3on (MA) or product specifica3on. There is no single global GDP standard. Cold Chain IQ has created this easy to-‐ assimilate summary of GDP requirements around the world, enabling you to navigate the landscape. You can keep it as a handy reference, share it around your colleagues or even s3ck it on your wall!
Cold Chain IQ’s Ten Commandments for Successful supply of Temperature Sensi?ve Products Based on in-‐depth interview with Kaoutar Sahli Lenstra, Senior Cold Chain and Special?es Analyst, at Pfizer
1) Thou Shall Not Forget to Priori3se 2) Thou Shall Not Adopt a “One Size Fits All” Approach 3) Thou Shall Not Treat all Partners the Same 4) Thou Shall Not Panic 5) Thou Shall Speak the Same Language Internally
Read Kaoutar’s explana3ons and the rest of her Temperature Sensi3ve Product Commandments at ColdChainIQ .com
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presents the 4th Annual…
“Fantastic value! Loads of good information and great sharing of experiences!” UCB Pharma, Delegate 2013 One Forum. One Community.
One BIG Opportunity
Conference: 22nd-23rd January 2014 | Workshop Day: 21st January 2014 | Frankfurt, Germany
Reducing Waste, Maximising Efficiency and Embedding Flexibility into Your Global Clinical Supply Chain Hear from 25+ senior level industry speakers enabling you to: •
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Implement self configuring IVT systems: hear the latest in advanced forecasting and simulation from UCB Cost effectively access and overcome the challenge of modifying comparator products with case studies from BIAL R&D, Boehringer Ingelheim and TransCelerate Minimise overage and save your company money: Allergan discuss the streamlined supply chain Build the trial with the site and patient in mind with insight from both Pfizer and the NHS Master internal and external communications to gain flexibility in your supply chain, discussion led by Leo Pharma and Novartis Understand and implement the latest EU GDP guidelines at our GDP training day
Brand New for 2014: •
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CRO expert panel: The top CRO’s give insight into their clinical supply priorities Leadership board meetings: 100% interactive afternoon facilitates informal discussion on the hottest topics – tailor your agenda! Blue Sky Graffiti Wall: Brainstorm your challenges throughout the conference and get tailored feedback from a panel of experts
2014 Speakers Include: Kim Tang Hvistendal Director of Clinical Supply, Veloxis Pharmaceutical Sherri Willson Director of Clinical Supply Chain, Pfizer Erik Meyer Associate Director Clinical Trial Supply, Merck Serono Adrian Peskett Clinical Supplies Logistics Director, Pfizer Peter Orosz, Head of Clinical Supply Chain Management Oncology, Boehringer Ingelheim Stuart Pullen Clinical Trial Supply Project Lead, Allergan Samantha Carmichael Lead Pharmacist Clinical Trials, NHS Scotland Jens Mattuschka Director Clinical Logistics Worldwide, Parexel International Anja van Strien Head Clinical Trial Supply, LEO pharma Eef Verhaegen Associate Director Global Clinical Supplies, PPD International
www.clinicalsupplyeurope.com • enquire@iqpc.co.uk • +44 (0) 207 036 1300
28. TLPINSIGHT
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Presents The 13th Annual
27th-29th January, 2014
Luxexpo, LuxembourgKirchberg, Luxembourg www.coolchaineurope.com
Where the logistics industry meets to shape its future What's New Site Tour of LuxairCargo Facilities See first hand how your temperature controlled products are controlled by airlines and ground handlers GDP regulatory input and inspection advice from MHRA, Dutch Healthcare Inspectorate and Austrian Agency for Health
400+ attendees 40+ speakers 181 repeat visitors 5 streams in 2 days 21 countries 1 site visit 39% senior level pharma/bio
audience decision-makers
1 awards ceremony
The new Life Science Global Supply Chain Forum - two days dedicated to Logistics and Supply Chain Directors focusing on Supply Chain Visibility, Data Management and Risk Analysis Ocean freight operational and qualification case studies for CRT and cold chain products - by Sanofi Aventis, Pfizer and Ossur Amazing new case studies on GeoZoning to improve lead times, building a bridge from India and global logistics process optimisation PLUS, brand new and exclusive preevent networking! Connect, plan, network, socialise through Cool Chain's unique online platform.
e venue the prim s i 3 1 0 hain 2 oduct, "Cool C uch a pr s e c u d o o intr Pharma for us t where all e c la p e e it is th blast! W a n e e because b ar it’s k re. So f nd I thin people a ations a t c e p x e high CEO, had very he top" t r e v o ust we are j AG SkyCell
www.COOLCHAINEUROPE.com • enquire@iqpc.co.uk • +44 (0) 207 036 1300
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Block quote can go here to catch more attention
Sustainable Temperature Controlled
Packaging Single Use Versus Reusable Packaging
M
any companies are beginning to make a conscious effort to think about the environmental impact of their temperature-controlled packaging use. But this isn’t just limited to whether the packaging
is single use, returnable or made using recyclable materials, there are many more considerations to be accounted for to ensure that a temperature-controlled packaging’s design is really valued as sustainable. Karen Adams, Technical Manager from DS Smith Plastics Cool Logistics explains.
30. TLPINSIGHT
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Cool Logistics
Intelligent Packaging The Ultimate In Temperature Control
Drugs Patient samples Medical devices Vaccines Clinical trial IMP Diagnostics
Bloodrelatedproducts
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– specialises in
the design, test and qualification of temperature controlled packaging solutions and is dedicated to meeting the complex needs of the global Healthcare Industry. For more information call
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To discuss your temperature controlled packaging needs call +44 (0) 1525 243770 Cool Logistics Celsius House, Stanbridge Road, Leighton Buzzard. LU7 4QQ
www.cool-logistics.com
Cool Logistics is part of DS Smith Plastics
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The challenge of maintaining strict safety standards, while improving a packaging’s environmental credentials within budgetary guidelines means that developing a suitable and sustainable TCP system is now more demanding than ever.
increasing the interest in reusable designs. However, choosing
Environmental awareness
a more sustainable option is not just simply a case of switching
The global cold chain, similar to many worldwide industries
from a single use to a reusable solution; in fact, the science behind
is experiencing major challenges as it’s becoming more
a sustainable packaging’s design is far more complex. Before
commonplace to look at reducing environmental impact, due to
offering a customer the best system for their requirements, TCP
pressures from the Government, regulatory organisations and
manufacturers need to undertake an in-depth analysis of the
corporate social responsibility policies.
route and destination, review the choice of materials, have an understanding of the packaging’s life cycle and adhere to a long
However, temperature-controlled packaging (TCP) manufacturers
list of regulatory compliance.
need to reduce carbon emissions, while having the added demand of maintaining the crucial temperature required, whether it is
Sometimes, sustainable design considerations need to go beyond
a chilled, frozen or ambient temperature environment that is
the basic understanding of what sustainability is perceived to be.
needed to support the effectiveness of temperature-sensitive
This includes looking at what methods would be most effective in
products, including life-saving biologics and vaccines. This stable
eliminating factors or issues that may damage the environment
temperature must be maintained at all times during transit from
(reaching further than assessing the type of materials), as well as
the despatching site to its end destination, or pharmaceutical
evaluating how the packaging is used, in what environment it’s
companies run the risk of losing their high-value cargo. The
applied and if it’s being used effectively. The answer may not be
implications of this would result in millions of pounds worth of
as straightforward as you may think. If a pharmaceutical company
product loss, as well as creating potential health risks.
switches from single use packaging to a reusable system, is it automatically considered more environmentally friendly? Not
Therefore, the challenge of maintaining strict safety standards,
necessarily so. Ultimately, it’s not just about reducing the amount
while improving a packaging’s environmental credentials within
of packaging used or considering a reusable option, because
budgetary guidelines means that developing a suitable and
sometimes, if not used correctly, a reusable system can in fact
sustainable TCP system is now more demanding than ever. In
work out more costly for the environment and the customer.
order to achieve this, TCP manufacturers must develop a balance between creating the right design and using the correct materials.
Evaluating the options Each of our customers has different needs. For some customers
Sustainability and the cold chain Sustainable packaging includes the design and use of a TCP system, which results in improved sustainability over other packaging options. Many TCP designs are single use, but new efforts to choose more sustainable options are
32. TLPINSIGHT
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it might be important to have a biodegradable system, whereas other customers might place an emphasis on the number of trips a system can make before requiring a replacement. The development process for each of these systems would require a completely different design path to be taken and the result might end up being a completely bespoke system for the customer involved.
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Making supply chain integrity TRULY TRANSPARENT
Validating chain of custody and environmental control, from the production line to the patient. The steps you are taking now to protect your pharmaceutical products may not be enough. Regulators increasingly request documented evidence that quality and integrity have been maintained throughout your supply chain. Sensitech can help. We provide a comprehensive, end-to-end solution for monitoring, documenting and validating both temperature control and chain of custody. So you have a single, trusted partner with the expertise and tools to help you ensure the safety and security of your products.
Learn how Sensitech can help you achieve transparency at every step in your supply chain. SENSITECH CAN HELP YOU: • Monitor and document product temperature across your supply chain. • Validate that your products have not been adulterated during transit. • Satisfy regulatory expectations for temperature control and chain of custody.
www.sensitech.com Amsterdam
Bangalore
Boston
Hong Kong
Melbourne
Santiago
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© 2013. Sensitech Inc. All rights reserved.
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As a first step the TCP manufacturer must first consider the journey that the product has to endure on a specific route to ensure that the packaging fulfils the function of protecting
stable and high performing results. However, the design trade off would be with end of life of these components and can be of high cost to the customer. The decision should be taken by the customer as to what their priority is.
its contents. This is particularly challenging during long distances and durations, which potentially subject the packaging
A combination of getting reusable systems to a key location or
to different excursion hazards. For example, it may be stored
patients in these emerging markets tends to cause unexpected
for long periods in a warehouse or refrigeration unit, or left
excursion risks during the cold chain, largely due to poor
on the tarmac where it could be exposed to extreme cold or
transport infrastructure. If a pharmaceutical company uses a
heat, moisture and light penetration. In addition to evaluating
reusable system to ship products to remote global regions they
these risks, the packaging solution must also be robust,
may not get the packaging’s materials back and therefore, by
secure, compact and lightweight to keep shipping costs down.
default, the packaging would become single use.
Once these elements are secure, it is only then that we can begin to look at the more intricate areas of the design. For
Normally the characteristics of a reusable system utilise durable
example insulating material and its mechanical and thermal
premium technology, as well as hardwearing materials such as
properties. Or a unique end of life story for components
plastic cases, metal skinned insulation panels, or rigid plastic
used. For example would you like to water your flowers
refrigerant components. Because of this they generally have
with the coolant used to ship your product after its use? Or
higher cost implications, so while a system that has these added
fertilise your plants with the insulative material used to
security factors ensures that a product will reach a remote
keep your products safe?
destination safe and sound, they also generally make the initial cost of investment higher. So, with no way of getting the reusable
Single use versus reusable
components back, the investment ends there. However, with
The key to finding the most sustainable and best-
the right returnable logistics in place, this additional cost can be
performing solution is to dig deeper than looking at
recouped quickly.
whether the materials used are recyclable, it’s really about evaluating the operational benefits, which
In certain cases, a reusable system can be used numerous times. So to fully benefit, both environmentally and financially, from this type of TCP solution, it really comes down to the type of operation that uses it most effectively.
can determine whether using a particular solution (whether it is single use or reusable) is more efficient and effective in a real world situation. This could basically come down to the physical size of the system itself. Is the system design efficient enough to save volumetric weight? For example if you can deliver the same level of thermal performance in a smaller, functional system can you save the customer freight costs or fit more on a vehicle, thereby reducing the carbon footprint of the
In certain cases, a reusable system can be used numerous
system that way?
times. So to fully benefit, both environmentally and financially, from this type of TCP solution, it really comes down to the
The final destination of a product also needs
type of operation that uses it most effectively. This is another
to be taken into account, as a large number
opportunity for TCP manufacturers to work with the customer
of clinical trials have to be conducted in
by understanding whether they operate a closed loop return
extremely remote areas of the world in
on systems by utilising a 3PL or courier or whether they make
order to gain access to naïve patient groups.
intra company shipments between sites effectively utilising the
The most commonly available insulating
systems at each step so they are never shipping fresh air.
materials seen in the cold chain industry mean that there is a trade off between
It is important to remember that a reusable package would be
sustainable design and practical use.
classed as an asset to the customer, not something which serves
For example a Vacuum Insulation Panel
a single purpose. For a system to be termed as sustainable it is of
(VIP) and an alternative Phase Change
vital importance to be able to track it when it is out in the field,
Material (PCM) would generally give
know when it will be returned and how often it’s used. Whether
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this is through a pen and paper inventory, a more innovative web-enabled database, or using the scanning and tracking software of the courier. Ultimately these ingredients need to come together in order to make a reusable system the most sustainable it can be.
Creating a sustainable design An important factor that temperature-controlled packaging
temperature
manufacturers take into consideration in the sustainable
profile qualified
design of a system is energy efficiency and how the solution is
in the laboratory
created in order to serve its purpose. For example, if a solution
to ensure that it will work
is manufactured locally, but has to import components before it
in a real world situation. To do
is assembled, consideration needs to be given to the transport
this, many temperature-controlled
needed to get the components from their global sites to the local
packaging manufacturers test their products
site, before the solution is even put together for its purpose.
in an environmental chamber. While exposure to unexpected temperatures, such as an unscheduled stop to
Consideration will always be made by the customer as to
remove cargo (which changes the ambient temperature) would
the manufacturing locations of their TCP supplier versus
not be accounted for in a controlled environment chamber (this
the distribution hubs that they have in place. The closer TCP
is why Pharma companies primarily test to ‘worst case’, to prove
manufacturers are to the distribution sites then the lower
a system is capable of maintaining temperature when there are
the potential carbon footprint for transportation. Therefore,
‘unusual’ incidents) the idea is that the more TCP manufacturers
the design itself needs to account for so much more than just the materials themselves, it requires an understanding of how the materials are being
understand the different variables that an ambient profile has, the better they can say that the appropriate system can be used. That itself leads to a more sustainable design.
applied, used and transported. The use of innovative simulation technology, such as multi-physics Before it goes out in the field, the system will have its
(MP) can cut down the time for design in the chamber because the initial development phase is firstly performed virtually on a computer, before any prototype or initial testing is carried out. Technologies such as MP can enable TCP manufacturers to achieve a near accurate result in a shorter space of time and therefore drastically cut the design’s carbon footprint by using less electricity.
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TLPINSIGHT 35.
By taking into account the life cycle of a packaging system and undertaking an in-depth assessment of an organisation’s requirements, it is possible to find a suitable sustainable solution, which ticks all the boxes
Conclusion Evaluating the sustainable credentials of a packaging system, with its ability to protect valuable contents consistently whilst acknowledging a customer’s potentially unique take on the term ‘sustainable’ and also being cost effective can be a challenge. But by taking into account the life cycle of a packaging system and undertaking an in-depth assessment of an organisation’s requirements, it is possible to find a suitable sustainable solution, which ticks all the boxes. Factors to take into consideration when designing a sustainable solution: • Payload to external size ratio • Material properties – are they biodegradable? How strong are they? • End of life properties of components • Inbound and Outbound transportation costs • Local manufacturing • Number of times a system can be re-used.
Author Bio: Karen Adams is Technical Manager at DS Smith Plastics Cool Logistics. Karen is responsible for all aspects of product development, innovation in new product development and qualification. Karen has been with DS Smith Plastics Cool Logistics for five years and has over 10 years experience in both the pharmaceutical and FMCG sectors. Karen is a time-served indentured apprentice and has a bachelor of engineering (BEng) in mechanical engineering design.
PROMOTIONAL FEATURE | GOOEY GLOBAL
E
Speaking on the occasion, Bessem Bikhazi, Managing Director, Gooey UK Ltd; said, "We are re-launching Gooey Data with a clear objective of facilitating database services at one place”. With the philosophy of “Buy, Append or let us arrange data for you”, the new division will be the one stop solution for all data related services that aviation-related companies usually require for their direct networking and other objectives. “Gooey, which is a pioneer company in Air Transport Information management globally has to become a huge success since its inception back in 2010 and is way ahead of its time in its alliances with companies that supports this venture. With our new-style contact databases, we hope to serve the industry in the same dedicated way with an exuded excellence and customized efforts to simplify things for marketers”, adds the director of Data, John Devos.
ntrepreneur Bessem Bikhaziis a man with an ambition to make the everyday life of the aviation businessman that little less stressful.
His well knowledgeable group of industry experts have spent the past few years developing the most powerful communication tool that allows businesses to reach key decision makers with procurement responsibilities faster than ever before.
BRANDS: Airline XL, Airport XL, Cargo XL, Handler XL, Supplier XL and Freight XL is an extension of services by Gooey which provides a host of Direct Key Contacts of CEOs, VPs and 20 other Department heads from 192 global locations. A subscription based model (fixed fee) wherein the data and information services can be availed as per chosen package offered by Gooey including free and frequent updates. Gooey has an extensive reach practically in all aviation verticals encapsulating over 55,000 business details followed by names, job title, email addresses and direct-dial of those key contacts. Points in this portal allows you to Search by company name, by country, by category, IATA and ICAO, job function... etc.
To Request a Brochure, contactCharlotte Willis: info@gooey.uk.com
“WE ARE PUSHING AT AN OPEN DOOR WITH THIS ONE AND WE’LL BE GLOBAL VERY SOON.” m Bikhazi, MD: “we are pushing at an open door with this one”
Gooey was founded in 2010 with a unique concept of Aviation Information and Database marketing and has not looked back since. Gooey has lead its way to providing unmatched services in the global market roping in strong partnership and subscribers everywhere. Services of Gooey includes gaining direct access to key contacts on a platform similar to a Spreadsheet but smarter! With numerous clients from airlines, airports, airport authorities, handling agents, industry suppliers, organisations and association and conference/tradeshow organisers. Industry players are very much in favour of this venture, remarks Bessem. “ we are pushing at an open door with this one and we’ll be global very soon.”
‘’Our mission is to help aviation professionals help themselves by simplifying processes while reducing costs and improving
Head of Business Development
Executive VP/ Deputy CEO Chairman/ CEO
Quality & Risk Assessment
Head of Strategy & Planning
Head of I.T Head of Technical
Head of MRO Head of Networking & Routes
Head of HR
Head of Supply Chain
Head of Flight Operations
Head of Sales/ Communication
COO CFO
Head of Inflight
Head of Commercial Services
Head of Ground Operations Head of Safety/Security
direct networkinG: Gain access to world airlines, airports & handlers direct key contacts! Gooey has spent the last few years developing the most powerful communication tool that allows aviation professionals to reach key decision makers faster than ever before.
claim your free trial: info@gooey.uk.com www.gooey.uk.com | www.gooey-global.com
TLP
THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 04 - 2013
40. TLPINSIGHT
www.the-logistics-portal.com
TRANSPORTATION OF PHARMACEUTICAL PRODUCTS Seetha Sasikala, vertical marketing leader for Thermo King
A stable and secure temperature controlled environment is crucial when transporting pharmaceutical products and ensuring their efficacy. In order to maintain product quality and reduce supply chain risks, the European Union (EU) Commission Guidelines on Good Distribution Practice (GDP) of medicinal products for human use should be followed.
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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 04 - 2013
Careful attention to a stable and secure temperature-controlled environment is very important to ensure product efficacy during pharmaceutical cargo operations. There are typically three temperature regimes for pharmaceutical
hot or cold spots that could affect the transportation of the
products to ensure temperatures are maintained within required
products. It is ideal if this validation process can be completed
parameters:
at an accredited lab such as the Ingersoll Rand Engineering and Technology Center (IRETC) in Prague, Czech Republic.
-25ºC: Typically products transported for clinical trial and other purposes should be kept frozen at all times and thus the cooling
Ingersoll Rand Engineering and Technology Center (IRETC)
compartment should not be allowed to rise any higher than
situated in Prague is dedicated to research and development
-20ºC. The recommended storage handling temperature regime
activities within the mechanical and industrial engineering
for medicinal shipments such as blood plasma is -30ºC. Other
sector. IRETC is an ISO 9001: 2000; ISO 14001 and ISO 18000
products within this temperature regime may be carried at -25ºC.
certified institute and is authorised for ATP certification. IRETC also offers engineering expertise to Thermo King and third party
+4ºC or +6ºC: Medicinal products carried in this temperature
companies. Specifically for pharmaceutical transport, IRETC
range, such as vaccines and antibodies, should be maintained
offers certification and qualification services.
between +2ºC and +8ºC and not deviate outside of this range. At IRETC, a range of functional and performance tests can +20°C: Products carried in this specified temperature regime
be conducted in a controlled environment to certify that the
such as active pharmaceutical ingredients (APIs) or small
refrigeration equipment used for pharmaceutical transportation
molecules, should be maintained between +15ºC and +25ºC and
can perform to required specifications. This includes:
not deviate outside of this range. • Thermal mapping of trailers and trucks from -32°C to +60°C Each transport unit, such as a refrigerated trailer unit that is
• Vibration tests to replicate over-the-road conditions for loads
entering into service for the pharmaceutical industry, needs to
up to 10 000 kg
go through a certification and qualification process. Qualification
• Calorimeter tests of unit cooling and heating capacities at
is a temperature validation process that maps the temperature
simulated extreme ambient conditions
performance of the unit operating in the temperature ranges
• Thermography to visualise temperature spread within loaded
listed above. Temperature sensors are positioned in a number
vehicles.
of locations throughout the box to identify if there are any
42. TLPINSIGHT
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THE LOGISTICS PORTAL MAGAZINE Issue 04 - 2013 WWW.THE-LOGISTICS-PORTAL.COM
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On completion of the qualification process, the unit can be
• To prevent risk of contamination to sensitive shipments in the
certified for pharmaceutical operation.
compartment, cleaning standards in line with GDP guidelines should be enforced under the guidance of certified service
Below are some important considerations to review when
personnel.
beginning or during on-going operations: • The load space should be kept clean at all times and only • Because the products have to stay within a particular range,
cleaning agents that will not affect the cargo should be used.
both temperature and air management must be controlled within this range with no deviation allowed or any excursions limited to
• To conform to temperature monitoring and recording
manufacturer specifications.
obligations, the units are required to have on-board temperature recording and monitoring as well as printed delivery point tickets
• There are load space configuration details to be considered
to prove the temperature integrity of the load space.
when the trailer body design is carried out, such as whether to include dividing doors, air shoots, return air bulkhead design.
• Remote monitoring is also recommended and this can be provided by the means of satellite tracking products such as the
• Drivers are required to be trained to show that they can
Thermo King TracKing™ system.
operate the unit within the GDP requirements. Careful attention to a stable and secure temperature-controlled • Regular maintenance and service records should be kept for
environment is very important to ensure product efficacy during
inspection if required by the pharmaceutical companies.
pharmaceutical cargo operations. Plan ahead now to make sure that requirements are met and systems are in place to maintain
• A calibration check should be completed at least once per year;
product quality and optimise supply chain integrity.
individual pharmaceutical companies may request more checks. A three-point calibration of the sensors is important to ensure that when the unit is operating it can maintain the load space temperature at the set points as listed above.
www.the-logistics-portal.com
TLPINSIGHT 43.
//INDEX OF ADVERTISERS IFC
Swiss World Cargo
5
Turkish Airlines
7
Sofrigram
9
Laminar Medica
13
Cold Chain IQ
17
Csafe
18
Biotec
21
DGM SDG A/S
22
TLP Insight
25
IATA
27
IQPC
28
Cold Chain IQ
31
Cool Logistics
33
Sensitech
37
Jal Cargo
38-39
Gooey
44
The Logistics Portal
IBC
Air Canada Cargo
OBC
Softbox
THE LOGISTICS PORTAL MAGAZINE Issue 04 - 2013 WWW.THE-LOGISTICS-PORTAL.COM
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FOR ADVERTISING INFORMATION CONTACT: Sales: Info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk
www.the-logistics-portal.com
TLPINSIGHT 45.
//EVENTS OUTSOURCING IN CLINICAL TRIALS WEST COAST 28-29 January 2014 - San Francisco, CA Paul Adams E-mail: PaulAdams@arena-international.com Telephone: +44 207 936 6948
4TH ANNUAL COLD CHAIN MENA December 8-11, 2013 - Amwaj Rotana, Dubai, United Arab Emirates Contact us on +971 4 364 2975 email : enquiry@iqpc.ae now! © IQPC
COOL CHAIN EUROPE 2014 January 27-29, 2014 - Luxexpo, Luxembourg-Kirchberg, Luxembourg 0800 652 2363 or +44 (0) 20 7368 9300 email enquire@iqpc.co.uk
CLINICAL TRIAL SUPPLY January 21-23, 2014 - Hilton Frankfurt Airport hotel, Frankfurt am Main, Germany Contact us on 0800 652 2363 or +44 (0) 20 7368 9300 email enquire@iqpc.co.uk +44 (0) 20 7368 9300
5TH ANNUAL BIO/PHARMACEUTICAL COLD CHAIN CHINA 2014 March 5-7, 2014 - Renaissance Beijing Capital Hotel, Beijing, China, Asia Contact us on +65 6722 9388 email enquiry@iqpc.com.sg
Our care is an extensiOn Of yOurs.
At Air Canada Cargo, we understand the vital importance of healthcare shipments. Our AC Absolute˚ and AC Pharmacair solutions are designed to give pharmaceutical products the extra care and attention they need. Whether your shipments require an active temperature control unit like Envirotainer™ or not, we ensure that their integrity is maintained as they travel to reach the people you’ve developed them for.
Visit us at aircanadacargo.com
AC Expedair | AC Live | AC Secure | AC DGR | AC General Cargo | AC Compassion | AC Cool Chain | AC Post
Protecting your pharmaceuticals whatever their destination
Reduce costs and maintain “Label Claim” temperature for shipping pharmaceuticals • Cost effective protection of ambient products • Innovative design uses only 6 components • Insulated pallet shields product from hot tarmac • Supplied with UV reflective waterproof cover • Moulded insulation panels for “Glide Fit” assembly • No coolant required – pack and ship in minutes • Flat packs to reduce delivery, storage & return costs • Manufactured from 100% recyclable materials
2
1
4
www.softboxsystems.com EUROPE
Softbox Systems Ltd. Units 1-2 Ridgeway Drakes Drive Long Crendon Buckinghamshire HP18 9BF UK T: +44 1844 203 560 F: +44 1844 203 570 E: info@softboxsystems.com
AMERICAS
Softbox Systems Inc. 1160 NW Elliot Court Bend, Oregon 97701 USA T: +1 541 389 9183 F: +1 888 610 0750 E: info@softboxsystems.us
3
INDIA
Softbox Systems India Pvt Ltd. Survey No. 146-148, Village Ajivali, Kon, Old Pune Highway NH-4, Taluka Panvel, District Raigad, Maharashtra 410206 T: +91 2232 222 380 F: +91 2143 221 789 E: info@softboxsystems.com
1. Euro & US Pallet Versions 2. UV reflective waterproof cover 3. Five Euro systems on air pallet 4. Insulated Pallet Base
ASIA PACIFIC
Softbox Temperature Control Packaging Systems Pte. Ltd. 48 Toh Guan Road East #02-115 Enterprise Hub Singapore 608586 T: +65 6316 9584 F: +65 6316 9504 E: info@softboxsystems.com
For more information about this or any other Softbox Packaging System visit www.softboxsystems.com Patent GB2459392 “Transport Container” – International Patents Pending
© 2012 Softbox Systems Ltd all rights reserved