TLP Insight Issue 4 digital

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.

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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

www.the-logistics-portal.com

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

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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.

www.the-logistics-portal.com

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

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.

20. TLPINSIGHT

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

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

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: •

•

•

•

•

•

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

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

Cool Logistics

– 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

+44 (0) 1525 243770

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

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

Shanghai

© 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

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

40. TLPINSIGHT

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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.

TLP

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.

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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

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

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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