tlp insight spring summer 2015

THE LOGISTICS PORTAL MAGAZINE

WWW.THE-LOGISTICS-PORTAL.COM S/S 2015TLP

TLPINSIGHTSpring/Summer 2015


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

TLP Insight: a journal for the life science logistics industry

COLD CHAIN MANAGEMENT How to best approach CRT shipments

Plus The challenges of warehousing for clinical supplies companies

And A sustainable solution for temperature controlled urban distribution



Protecting product qualityAT EVERY STEP

Medicinal products demand special protection at every step in the supply chain—from the production line to the patient.

Sensitech can help. We combine industry-leading environmental monitoring and control with end-to-end logistics security. The result is a comprehensive solution for ensuring product quality and integrity across your entire supply chain.

One trusted partner for end-to-end temperature control and supply chain integrity

Learn how Sensitech can help protect your products— and the patients who rely on them.

SENSITECH CAN HELP YOU:

• Document specific Controlled Room Temperature (CRT) throughout your supply chain.

• Validate that your products have not been adulterated during transit.

• Satisfy regulatory expectations for chain of custody documentation.

www.sensitech.com

Amsterdam Bangalore Boston Hong Kong Melbourne Santiago Shanghai

© 2015. Sensitech Inc. All rights reserved.



MANAGING DIRECTORLee Atkinson

MANAGING EDITORBridget Langston

CONSULTANT EDITORTony Wright

SENIOR DESIGNERAdam Tannous [email protected]

EDITORIAL ASSISTANTSNicholas RidgmanJamie Ward

CIRCULATION MANAGERTony Williams

SALESRakesh Makwana, Lee Atkinson, Amy Firth

ADMINISTRATIONKatie Galelli

WEBSITE DESIGNKnut Henriksen

CONTACT USSales:[email protected]

Subscription:[email protected]

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

The opinions and views expressed by the authors in this book are not necessarily those of the Editor or the Publisher and, whilst every care has been taken in the preparation and design of this book, the Editor nor the Publisher are not responsible for such opinions and views, or for any inaccuracies in the articles.Whilst every care is taken with artwork supplied, the Publisher cannot be held responsible for any loss or damage incurred, The entire content of this publication is protected by copyright. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form, by any means – electronic, mechanical, photocopying or otherwise – without prior permission of the Publisher.

Copyright© 2013 Intensive Media Ltd

TLPINSIGHT//MAIN CONTENT

Berlinger understands that the right temperature monitoring database option can reduce costs and gives us insight into the practices for improving common processes with particular reference to Berlinger Smartview® data management system.

Herman Teering, Manager Director and Panos Drougas MSc, both of DGM Software Development Group give us the benefit of their knowledge of the problems surrounding the correct classification and labelling/marking of dangerous goods.

Contents continue on page 4 »

Transforming temperature data management practices to reduce labor costs and improve visibility and control

8

The challenges of warehousing for clinical supplies companies20

Protecting product qualityAT EVERY STEP

Medicinal products demand special protection at every step in the supply chain—from the production line to the patient.

Sensitech can help. We combine industry-leading environmental monitoring and control with end-to-end logistics security. The result is a comprehensive solution for ensuring product quality and integrity across your entire supply chain.

One trusted partner for end-to-end temperature control and supply chain integrity

Learn how Sensitech can help protect your products— and the patients who rely on them.

SENSITECH CAN HELP YOU:

• Document specific Controlled Room Temperature (CRT) throughout your supply chain.

• Validate that your products have not been adulterated during transit.

• Satisfy regulatory expectations for chain of custody documentation.

www.sensitech.com

Amsterdam Bangalore Boston Hong Kong Melbourne Santiago Shanghai

© 2015. Sensitech Inc. All rights reserved.

Mark Maurice is the Sensitech Professional Services Senior Project Manager and Industrial Engineer. Oliver Simonnot is the Strategic Market Manager, Life Sciences EMEA for Sensitech Inc. UTC Building and Industrial Systems, a unit of United Technologies Corp. In their article they provide advice and methodology regarding how to best approach “Ambient”/Controlled Room Temperature shipments. The recommendations are based on two main concepts: Risk Assessment and Continuous Improvement.

The knowledge gap: classification and labelling/marking of dangerous goods

14

TLPINSIGHT www.the-logistics-portal.com4.



//FEATUREDCONTENT

Anthony Bour of Thermo King, industry leaders in transporting temperature sensitive goods, gives us an insight into how Thermo King are applying current and emerging technologies to achieve sustainable solutions for their customers, in what is a dramatically changed operating environment.

Nitin Dahid of Cold Chain IQ in his article, writes about how technology that enables better monitoring and analytics in real time will play a major part in many cold chain logistics networks, due to a variety of demands in the logistics networks.To read more, please go to www.coldchainiq.com

Mark Maurice is the Sensitech Professional Services Senior Project Manager and Industrial Engineer. Oliver Simonnot is the Strategic Market Manager, Life Sciences EMEA for Sensitech Inc. UTC Building and Industrial Systems, a unit of United Technologies Corp. In their article they provide advice and methodology regarding how to best approach “Ambient”/Controlled Room Temperature shipments. The recommendations are based on two main concepts: Risk Assessment and Continuous Improvement.

Good Cold Chain Management Practices for controlled room temperature shipments

26

As cold chain logistics demands grow, technology becomes critical32

A sustainable solution for temperature controlled urban distribution

36

a high technology smart boxFor highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com



//FEATUREDCONTENTa high technology smart box

For highly secure shipping

STP is a division of Sofrigamwww.sustainablethermalpackaging.com




//TLP INSIGHT FOREWORDWe are feeling really upbeat here at TLP Insight! It’s May 2015 and we are into our third year of publication. TLP Insight grew out of

our online presence, The Logistics Portal, a Pharmaceutical Logistics B2B directory, which provides an informed and comprehensive

information hub for the Life Science Logistics industry. Started in the dark days of the recession, The Logistics Portal is a shining light of

success, and we are pleased and proud to say the same about TLP Insight.

We put our success down to hard work, a dedicated, highly skilled team of professionals and sound knowledge of the industry and

industry needs, our loyal advertisers and our excellent contributors willing to share cutting-edge product and process knowledge. Oh,

and determination, determination, determination!

We set out our TLP Insight stall at the beginning of 2013 to publish a book that was unique, in that it was the only book in the industry, the

first one, to complete the whole market from technology and software to bulk shipment and air cargo. And unlike any other publication,

it would not be split into sections; rather our approach would be to present content in a more integrated, holistic format. This we believe

has been a key ingredient of our success, in that it allows our readers to gain a better overview of what is happening in the industry, a

wider knowledge of the ideas that are circulating and the products that are available and so helps them in their decision-making, both on

a strategic and daily level.

TLP Insight Spring/Summer again sees solutions being given to a range of different challenges. Rachel Griffiths, currently Associate

Director of Operations, gives us the benefit of her wide range of experience with Biotec Services International. Rachel explains how we

can achieve the balancing act between the need to establish warehousing systems which are flexible and affordable, but which at the

same time comply with Good Manufacturing Practice (GMP) regulations.

When it comes to finding environmentally sustainable solutions to the challenges of transporting temperature sensitive goods in urban

areas, Thermo King are true pioneers. Anthony Bour writes about how his company has innovated and developed systems in response to

the regulations and social pressures within the EU, which have brought about dramatic changes in our industry.

Nitin Dahad, in his article, touches upon the need to overcome fears in the move towards using ‘cloud’ storage. This need is driven by the

significant growth in the cold chain logistics market, a very fortunate position for us all to be in! We think that the collection and storage of

data, and how this can be optimised over a global cold chain will be critical and one of the hot topics for discussion in the coming months.

Watch this space.

Lee Atkinson

Managing Director

Intensive Media



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

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Transforming Temperature Data Management Practices to Reduce Labor Costs and Improve Visibility and Control

Abstract

There are a number of temperature monitoring database options

available to the biopharma supply chain professional and choosing the

right one can significantly improve workflow which will reduce administrative

time. This article will provide insight into practices for improving common processes

through enhanced database functionality in the areas of managing data loggers by expiry

date, storing and retrieving calibration certificates and acknowledging/documenting common

temperature excursion events. Additionally, it describes the unique features and benefits of the Berlinger

Smartview® data management system. Smartview® is a “Software as a Service” (SaaS) platform designed to

efficiently and accurately manage both workflow and data in a regulatory compliant manner (21 CRF Part 11 &

Annex 11). This comprehensive temperature data management system ensures reliability, accuracy, security, accessibility,

and visibility to supply chain professionals, enhancing Good Distribution Practices (GDP) of temperature sensitive shipments.

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



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

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

-SOLUTIONS PHARMA

[RELIABILITY]

Constant Temperature Control Dedicated Logistics Team

COOL CHAIN LOGISTICS

Provide the best solution

for the transportation of

pharmaceuticals.




Background Central to the Good Distribution Practices of

a biopharma company is the reliability and traceability of

temperature data associated with temperature sensitive

shipments. Compliance requires data loggers to have unique

serial numbers, calibration certificates and expiry dates. Current

and historic temperature information can be questioned for its

legitimacy if it is not clear that the data logger was used before it’s

expiry date or during its certified temperature accuracy period as

stated on the calibration report. Every organization has it’s own

methodology for handling these requirements. Often they are

decentralized, off-line procedures that expose the company to

lost certificates, lack of inventory rotation control and countless

man-hours to store and retrieve calibration certificates even years

after a device has been used.

Additionally, some data logger excursions can be classified as

routine occurrences. In a survey administered by IQPC’s Cold

Chain IQ group, the respondents who acknowledge temperature

excursions with products in transit, indicated excursions occurring

in more than 15% of their shipments (Cold Chain IQ 2012).

One common occurrence can be observed when temperature

sensitive materials are received in good order, moved to a secure/

temperature-controlled environment, and the data logger

is turned off hours later. Biopharma firms have established

procedures for documenting these occurrences without launching

a full quality investigation. Yet even these simple procedural steps

incur significant labor costs. The initiator must alert responsible

people to the issue, get them to take action and develop the

right technical information to approve the use of the materials

while documenting the decision for regulatory compliance files.

Delays occur when people do not respond to emails or while

files are searched looking for all the necessary information (e.g. a

calibration certificate).

Current Methodology

Of paramount importance for a compliant temperature monitoring

program is the ability to effectively manage data logger inventories

on a “First Expiry, First Out” (FEFO) methodology. Most companies

are managing this process manually, through spreadsheets and/or

a “kanban” system (employing the use of product identification

cards for demand driven inventory management) that require

significant frontend organization and data entry. Seldom is the

data logger supplier leveraged for management of data logger

expiry and certificates of calibration. When they are, it is typically

done on a case-by-case basis through email. Hours can be spent

tracking down these certificates (see Fig. 1).

A d d i t i o n a l

time is spent

manually inspecting

and inventorying devices

to create a FEFO inventory

management process. Standard

ERP systems (SAP, Oracle) are helpful;

but are not robust enough to support the

cGDP practices of the biopharma industry.

Unwanted temperature events that occur during

manufacturing, storage, transportation, and distribution are

commonly referred to as “excursions.” Within an organization,

excursions outside acceptable temperature ranges captured

with data loggers can be dealt with in a manual, extremely labor-

intensive manner by a dedicated supply chain quality management

group or department. Emails are generated passing data logger

temperature information to be compared with the timing of

logistics services of a shipment. In many instances, data loggers

without a USB interface are transported back to someone with the

necessary hardware and software to read the data. An additional

labor intensive process then begins to insure all the required data

is collected, that the responsible parties formally address the

data and the decision to move materials to the appropriate next

step is documented properly. These documents typically require

signature approval and must be filed in a retrievable manner. It can

take anywhere from 1 to 30+ days depending upon circumstances

associated with the specific materials involved to complete these

steps. Indications are that the costs for administering an excursion

event are between $10,000 - $100,000 per occurrence (Goff,

2008).

The frequency and severity at which these excursions occur

varies from company to company depending on the complexity

and structure of their logistics practices and the robustness of

their quality management systems. The documentation and sign-

off process is rarely streamlined, and can often be disjointed with

fragmented roles and responsibilities. If 5% – 10% of shipments

experience “common excursions”, as is often reported, it is easy

to see how these labor costs can quickly add up to hundreds of

thousands or even millions of dollars every year.

Proposed Solution

The Smartview® system enables work flow steps

like excursion alerts and missing data loggers to be

automatically generated and sent to the responsible

person(s). Additionally, workflow steps for acknowledging

(Fig. 1)



Experience the power of control using

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Mitteldorfstrasse 2 • CH-9608 Ganterschwil

Phone +41 71 982 88 11 • Fax +41 71 982 88 39

[email protected] • www.berlinger.ch

Berlinger USA LLC

222 Turnpike Road, Suite 3 • Westborough, MA 01581 • USA

Phone +1 508 366 0084 • Fax +1 508 366 0087

[email protected] • www.berlinger.com

Berlinger – Your reliable partner for hardware and software solutions.

SmartView is for everyone shipping valuable goods with temperature management issues, including manufacturers, logistic service providers, and wholesalers in the pharmaceutical and food supply chain.

Data is collected through our Q-tag® CLm doc USB family of data loggers designed for easy use in all temperature environments.

SmartView is an award-winning web platform for cold chain optimization that has proven to deliver significant value.

Improve regulatory compliance and enhance Good Distribution Practices (GDP) with a system that allows you to manage excursion acknow-ledgements and causes in a 21 CFR Part 11 database. Reduce time addressing excursion events when they occur and chasing down documents during audits.

Improve process efficiency by tracking data loggers and their expiry dates. Experience instant access to calibration reports.

Reduce IT time associated with validating and installing software or updates. Avoid common problems with ERP and operating systems due to a 100% online software based on the SaaS model.

Enjoy easy reporting and analysis tools contained within the smartview reports module. Spend less time due to integrated data and world wide access 24/7, automated workflow and E-Mail-/SMS notifications.




the review of temperature data, especially data with a recorded

excursion, can take place within the Smartview® system. Notes

about the root cause and other information can be appended to

the shipment data. Nonrelevant temperature data (e.g. warm

temperatures recorded after delivery from an active data logger

on someone’s desk) can be easily adjusted out of the relevant data

set to close out excursions. All of these workflow steps create an

auditable trail based on the unique user ID and password and

meet 21 CFR, Part 11 & Annex 11 requirements.

When a completely cloud based system that incorporates

both data storage and software service is introduced to

the biopharma supply chain, many costly administrative

steps and processes can move towards automation.

When data is generated and collected for the purpose of

facilitating decision making and trending over time, then

the opportunity for automated additional workflow steps

can be realized.

An employee with the appropriate user rights should be

able to access one portal, from any computer, anywhere in

the world, to review the inventory of devices by expiry, and

download the calibration certificates for individual data

loggers (see Fig. 1). This database should remain accessible

for a time period that is relevant to the customer’s requirements

instead of off-line in a data archive. The Smartview® system

enables a firm to do this with ease, at their discretion.

Once Smartview® is integrated into a firm’s daily routine, the

use of the system to acknowledge temperature shipment data

or to document excursion issues will reduce the administrative-

hours needed for these activities. It also enhances accountability

by automatically sending alerts to responsible individuals and

escalating the alert if action steps, like acknowledging the event,

exceed pre-determined time limits.

With Smartview® operating in the cloud. Email communication of

excursion events are sent automatically to the responsible party

immediately after a data logger is uploaded. That person can

sign into Smartview® via his/her smart phone or other enabled

wireless device to document the receipt of an alert notification,

journalize steps taken, and close out an excursion with an assigned

root cause. By providing an audit trail for everyone who interacts

with the system, Smartview® is designed to ensure regulatory

compliance for document control (21 CFR, Part 11 & Annex 11

compliant).

Supply Chain Directors are often more interested in aggregate

information for trending analysis and process improvement. By

storing all temperature data files in one, globally secure system,

it is possible to manage the data in unique ways (see Fig. 2). It

is impractical and grossly inefficient to rely on email, manual

filing systems or a vendor as the means to sift through historic

temperature data. It is also costly and time consuming to rely on

outside vendors to compile the data into trending reports and key

performance indicators (KPI).

Personnel with the appropriate user rights can access the

aggregate data through a Reports Module contained in

Smartview®. In this module, it is possible to trend data using data

base filters to reveal shifts in trends over time, between shipping

lanes, by product, customer, 3rd party service supplier, or other

metric.

Easy to comprehend info-graphics allow the user to visually

determine where improvements are occurring and where more

effort may be beneficial. An organization can gain full, documented

and regulatory compliant control over temperature excursion

investigations and remediation steps while substantially reducing

their time and administrative costs through implementation of the

Berlinger Smartview® system

Conclusions

• Current methodology for identifying, investigating and

documenting temperature excursions within the pharmaceutical

supply chain are inadequate, time-consuming, inefficient and

costly to an organization.

• It is unjustifiable to rely on communicating via email, phone and

manual filing systems to manage and document temperature

excursions.

• Smartview® is a comprehensive temperature monitoring

software system that ensures reliability, accuracy, compliance,

secure data visibility, accessibility, and efficiency of critical time

and temperaturesensitive shipments.

• Its imbedded web-based data analytic tools allow for a significant

reduction in time and labor cost of temperature deviation

investigations in the framework of a completely validated and

regulatory compliant environment.

(Fig. 2)




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

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

iata.org/dgr

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

Stay Compliant

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

TLPINSIGHT www.the-logistics-portal.com



T H E KNOWLEDGE G A PClassification and labelling/marking of dangerous goods

If, for example, the question is answered by a Chemist, who

actually produces/uses those chemicals, the answer will, hopefully,

be that ‘CLP and REACH places the responsibility for hazard

classification and related provisions such as packaging, hazard

communication and SDS on the suppliers.’

Asking the same question to a Logistics Manager though, who has

assumed the Consignor’s role down the supply chain, would result

in him focusing on different elements than the ones the Chemist

is mostly concerned with i.e. those that relate to the Transport of

Dangerous Goods, such as the UN number, the Proper Shipping

Name (PSN), hazard Class, Packing Group etc. for the classification

part. And, depending on the transport mode, elements such as the

relevant Hazard Label(s), UN number, PSN, Shipper/Consignee

Addresses and weights for the marking & labelling. Furthermore,

Why is it that you will receive two completely different answers to the question: ‘Who is responsible for the correct classification

and labelling1/marking (of hazards) of substances and mixtures?’ depending on the job of the person in front of you?

you will also, hopefully, hear about additional requirements that

need to be fulfilled, such as training and documentation etc. all

with the same start point, namely: ‘a Consignor shall only offer

dangerous goods to carriers that have been properly identified.’

Well, from each one’s perspective, both of the answers are

right but what's important to point out here, is that the ‘correct’

answer from the Logistics Manager is highly dependent upon the

correct answer being given in the first place by the Chemist. The

big questions are WHY that dependency, and WHERE is that

presumed KNOWLEDGE GAP?

In this article we’ll try to give you the background, answers and

explanation to these questions.

14.

www.the-logistics-portal.com TLPINSIGHT



Question 1: Why does logistics depend on the chemical

classification?

If you are in a logistics function and you are handling or transporting

dangerous goods, you most probably have followed training to

make you either familiar with the applicable rules and regulations

regarding the storage and transport of dangerous goods or you

have passed examinations which certify you to make, for instance,

declarations for transport or even to become a Dangerous Goods

Safety Adviser.

The majority of regulations concerning the storage and transport

of dangerous goods contain chapters or articles in which the

classification of dangerous goods is described. The scope of this

classification material is to explain to the user how he/she can

determine in which of the 9 hazard classes a substance/mixture or

article qualifies to be assigned and, if applicable, in which division,

packing group or compatibility group within that class.

By now you are probably thinking how you should be able to do

these tests in your warehouse? Indeed if you look through the

requirements there is no way you are able to perform these test(s)

if you do not have a laboratory environment including all the

equipment and trained staff.

Here is where the Safety Data Sheet (SDS) comes into the picture!

The SDS provides the results of the testing and classification

procedure performed by the Chemist under prescribed GHS

criteria. Many of those criteria are already based on the ‘UN

Model Regulations for Transport of Dangerous Goods, Manual of

Tests and Criteria’ and related legal instruments (ADR, RID, ADN,

IMDG Code and ICAO TI).

Thus, in the SDS, the primary use of which is for workplace users,

you should be able to find all the relevant testing and other official

information, including the transport classification, regarding a

specific substance, mixture or article2 grouped under the following

16 sections:

SECTION 1: Identification of the substance/mixture and of the

company/undertaking

SECTION 2: Hazards identification

SECTION 3: Composition/information on ingredients

SECTION 4: First aid measures

SECTION 5: Firefighting measures

SECTION 6: Accidental release measures

SECTION 7: Handling and storage

SECTION 8: Exposure controls/personal protection

SECTION 9: Physical and chemical properties

SECTION 10: Stability and reactivity

SECTION 11: Toxicological information

SECTION 12: Ecological information

SECTION 13: Disposal considerations

SECTION 14: Transport information

SECTION 15: Regulatory information

SECTION 16: Other information

Ideally, all the information needed for a Consignor, when different to

the manufacturer3, who wishes to verify for himself the correctness

of the existent classification in order to properly prepare a shipment

for a substance/mixture or article according to the requirements of

the transport regulations, should be found in these Sections whereby

Section 3, 9, 11 and 12 contain the most vital information.

Because regulations are highly prescriptive, if someone follows the

correct steps and, where needed, uses the Precedence of Hazards

15.

The big questions are WHY that dependency, and WHERE is that presumed KNOWLEDGE GAP?

1 Theclassificationofbothsubstancesandmixturesisbasedontherelevantexperimentaldatagenerated

intestsforphysical,toxicologicalandecotoxicologicalhazards.Followingtheclassificationprocess,

certainhazardpictograms,signalwords,hazardstatementsandprecautionarystatementsshouldappear

onthelabel.

2 Frommarketingand/orlogisticalaspectsitmayincertaincasesbeusefulforsupplierstohaveSafetyData

Sheetsavailableforallsubstancesandmixtures,includingthoseforwhichthereisnolegalobligation

toprovideanSDS.Insuchcasesitmaybedesirabletoindicateinthedocumentthatthesubstanceor

mixturedoesnotlegallyrequireanSDStoavoidunnecessarycomplianceandconformityissuesarising.It

isnotgenerallydesirabletocompileSDSsforarticles[RefECHA]

3 Theinitialresponsibilityfordrawingupthesafetydatasheetfallsonthemanufacturer,importeror

onlyrepresentativewhoshouldanticipate,sofarasitisreasonablypracticable,theusestowhichthe

substanceormixturemaybeput[RefECHA]




Table correctly, (almost) nothing can go wrong, he/she will end up

with the same classification results prescribed under Section 14 of

the SDS, being:

14.1. UN number

14.2. UN proper shipping name

14.3. Transport hazard class(es)

14.4. Packing group

14.5. Environmental hazards

14.6. Special precautions for user

14.7. Transport in bulk according to Annex II of MARPOL73/78

and the IBC Code

So, why not take the shortcut, just look at Section 14 and job done

for the Consignor, he can now continue with other work!

Question 2: Where is that presumed knowledge gap?

Here’s where the ‘tricky’ part starts! As indicated earlier, the

Consignor is the responsible (read ‘liable’) part in the logistics chain.

Thus, he should be able to make sure that the goods offered are

correctly packed, documented, marked and labelled, simply

because he has accepted the Consignor’s role further down the

supply chain. Though, this is practically possible only when the

information under section 14 is correct.

promptly share the new information with all the actors down the

supply chain to allow them to fulfill their obligations.

We have seen many examples of wrong SDSs delivered with goods

like an SDS for a liquid delivered with a solid substance or an SDS

based on old classification criteria where for instance a flammable

aerosol (Class 2) was still classified as Class 3 (Flammable liquids)

for transport.

16.

As we previously said, in cases where the Consignor is also

producer/manufacturer of the goods, both the classification of

the goods and the production of the SDS are in the same hands.

In this case, the Consignor has promptly available the information

on whatever he is shipping and has full control over all the aspects

involved in classification of the products.

It’s something else though when the Consignor is for instance a

trade organisation or a 3PL. In these cases the Consignor is no

longer the owner of the goods nor involved in the classification

process.

Indeed, what actually happens in most cases, is that the Consignor

is relying on the information received from either the owner or the

manufacturer of the goods. A big question remains, however. How

can a Consignor verify, in a case where the relevant information

on the received SDS is lacking, whether the classification under

section 14 is correct?

Another widespread phenomenon, especially in the 3PL business,

is: the ‘gap in time before becoming aware of updates’ regarding

the classification, and labelling. Regulations require that each

time there’s an amendment for a substance in CLP or when a

change is introduced in a mixture, suppliers MUST reconsider

the classification of that substance or mixture. Also, they should

In the above cases the Consignor has a job to do to:

a. Train his staff to be accurate, attentive and knowledgeable

when dangerous goods are involved.

b. Have procedures in place with both owners and suppliers

of dangerous goods to make sure he receives accurate

information and also receives timely the updated versions

of SDSs once they become available.

Train staff to be accurate, attentive and knowledgeable when

dangerous goods are involved.




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The second factor affecting the knowledge gap is the knowledge

level of the ‘competent person’ and his/her capability to ensure the

consistency of the SDS. It is understood that any one single person

very rarely has extensive knowledge in all the fields covered

by an SDS. That’s why the regulations require that ‘Suppliers

of substances and mixtures should be able to ensure that

such competent persons have received appropriate training,

including refresher training.’ Unfortunately, many times and

especially within smaller companies this role is also assigned to

(production/QC) Chemists who are not always specialised in the

transport classification of dangerous goods.

When you are involved in logistics, you know that regulations

regarding the transport of dangerous goods are changing

constantly. In some cases new UN numbers are added, in other

cases classification of certain substances are changing. Besides

that, we have differences between the different modes of

transport or, mainly for road, differences between countries.

Not every chemist will go through his list of SDSs to verify if

something has changed for Section 14 when a new regulation is

published. This leads not only to inaccurate SDSs but also to liability

issues for Consignors as, in the end, they are the responsible party

for the classification during transport…

So, what to do?

18.

Options and solutions

As indicated, the Owner/Manufacturer being Consignor as well

has the least problems as all is under one roof. The easiest way to

solve issues in this case, if there are any, is to make sure to use an

integrated software system in which both chemical management

and logistics are connected and where information is shared in

real time.

Meaning that when an SDS is changed, it will be published

immediately replacing the previous version. On the other hand, if

the transport regulations change, this will be indicated in the list of

SDS and forces an update to be processed by the Chemist.

Also a connection to the labelling for both chemical (GHS/CLP)

and transport (ADR/RID/IMDG/ICAO-TI/ADN/49CFR) should

be included to keep all marking and labelling for products updated.

For the Consignor not producing his own products, a similar

software system is recommended but used in a way where the

Owner/Supplier and Consignor have shared responsibilities

regarding information provision. This can be managed by making

firm agreements between the parties involved or using a third

party to make sure all information is as accurate as possible

at all times, keeping the parties involved updated on changed

documentation, regulations and labelling/marking.

Authors:

Herman Teering

Panos Drougas, MSc

Managing Director

Senior Chemical Consultant

DGM Software Development Group

www.dgm-sdg.com


The challenges of warehousing for clinical supplies companies.Rachel Griffiths

20.


All clinical supplies companies must supply storage

and warehousing which will comply with Good

Manufacturing Practice (GMP) regulations. It must

maintain temperature, be fully monitored and provide

product segregation. However, for clinical supplies

companies which provide this storage as a chargeable

service to its clients, the storage and warehousing must

also be billable and commercially viable.

Therefore companies need to establish warehousing

systems that are flexible and affordable. When clients

are paying for storage they do not want to pay for ‘air

space’. Equally the storage providers do not want to waste

storage space by placing a small quantity of product in a

large location as this reduces the volume of space available

for use by other customers.

One way of achieving the balancing act between what

clients will pay vs. maximisation of warehouse capacity is

to use variable location sizes.

Location, location, location

Within clinical trial supplies, particularly for cold chain

materials, there may be a relatively small volume of drug

product. This drug may also have various strengths and

placebo and each vial of product could be unlabelled and

virtually identical to other strengths and the placebo,

particularly if it is to be used in a blinded trial. These

materials must be segregated and fully traceable. Placing

them all within a pallet location would be a cheap storage

solution but a major non-compliance in terms of GMP as

the material would not be sufficiently segregated and

warehouse operators would be picking different drug

and placebo from the same location. Once picked these

materials are identical and the chance of mix up in this

situation is very high which could lead to catastrophic

results for the trial and place patient safety at severe risk.

For companies who have very large amounts of available

controlled temperature pallet storage space (e.g. at -20°C

and 2-8°C), they may be able to easily accommodate using

six pallet locations for half a pallet’s volume of material and

offer the storage at a low enough cost that the client can

afford it. However, there will come a time when they will

run out of space and either need to build additional storage

space, which is costly and may take a long period of time,

or maximise the capacity from the current warehouses.

For other providers, particularly those specialising in niche

products, they may have limited controlled temperature

storage capacity and separate pallet locations for each

product is not an option.




A simple solution is to have a number of different size storage

locations. These could be provided by using variable size racking

options or by placing different sized boxes or bins within a pallet

location to subdivide the space. The product could then be placed

within its original packaging, into the bins for storage. Each bin

would have a storage location within the stock control system and

so be traceable.

This allows good segregation of product, storage location sizes can

be selected based upon the volume of the product, it minimises the

‘wasted’ space of pallet locations for small volumes of materials

and therefore maximises the available space that can be used, and

therefore sold, within the warehouse.

The problem is solved!

If it were that simple even companies who have very large

amounts of available controlled temperature pallet storage

space would adopt this method. The difficulty comes in

accurately charging the client for the space they are using

and providing the client with an upfront estimation of storage

costs.

Charging variable size locations

Obviously, any business selling a service needs to ensure that it

can do so at a profit. Companies with large volumes of available

storage capacity can sell pallet locations relatively cheaply. The

product is in single locations with a single price and calculating

what to charge them at the end of the month involves adding up

the number of pallet locations and multiplying it by the agreed

cost. The profit per location may be small but the maintenance and

administration cost is small and so it can still be profitable.

Using variable locations sold at variable prices becomes more

complicated to administer, as each month the quantity and volume

of each location used by the client and the agreed charge for that

location has to be calculated. In some instances this can involve

warehouse staff physically counting used locations and location

sizes and finance departments converting these into capacity

charges. Therefore the administration costs for this method are

potentially much higher.

Additionally, clients who pay by volume used rather than pallet

location are more aware of the volume of their product; if they

have shipped a large amount of product from the warehouse

they expect to see a reduction in storage cost. Therefore you

may need to have a system in place to consolidate stock and

storage locations at agreed time points within a trial. You may

also have more invoice queries relating to capacity, which takes up

additional finance and project management time. Hence the direct

and indirect administration of a variable size storage location

system compared to a pallet location system is higher, but must be

considered alongside the capital cost and practicality of providing

new storage warehousing.

The benefits of pallet vs. variable location size have been

considered for bulk unlabelled materials. However the use of

smaller locations comes into its own when considering packed

clinical trial materials that are serial numbered. Routinely, clinical

trial materials are packed in separate assembly operations for

each drug strength, drug type and placebo. These packed products

are identical and are only identifiable by the serial number (kit

number) printed on their labels which will be directly linked to

the randomisation number assigned when the trial randomisation

was established. Routinely, orders are received for shipment

containing a list of kit numbers that need to be picked and sent to

the site. More often than not, the numbers selected are across the

range of the available packed product and not in sequential order,

as this helps maintain the trial blinding.

If packed kits were palletised it would involve the whole pallet

being taken apart to complete an order. Even if kits were placed

into sequential order in smaller boxes and then onto a pallet, all

the boxes on the pallet may need to be opened or moved to obtain

the kits required to complete the order. This results in large time

delays to complete picking operations for shipments and increases

the potential to mis-pick a kit. If kits are placed in relatively small,

adjacent, locations which can be identified on the pick list then it is

easier for the picking operator to find the required kits and select

them without moving large amounts of boxes. Ideally, vertical lift

or carousel systems with trays containing the product in a small

location can be utilised which allows kits to be quickly located

and easily removed. An additional benefit of a lift system is that

they take up a relatively small foot print for a very large storage

capacity and so are ideal where space may be a constraint.

Using smaller locations is ideal for serial numbered clinical trial

(Exampleofbinlocationsinaverticallift).




1003-Biotec-EPC-advert.indd 1 24/10/2011 11:33

Biotec Services International LtdBiotec House, Central Park, Western Avenue, Bridgend Industrial Estate, Bridgend, CF31 3RT, UK

Biotec Trusted Globally To DeliverHigh Quality Clinical Supplies ServicesBiotec has established itself as a truly international trusted partner delivering clinical supplies services.

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kits, but this model requires a different method of charging than

pallet locations.

Traditionally, proposals are prepared for clinical trial supplies with

an estimated cost for storage at different temperatures based

upon the client’s forecast for when products will be received,

packed and shipped to site. These forecasts will always be wrong

as manufacturing time scales change, regulatory approvals are

delayed and patient recruitment will be different to that planned.

Using the pallet method of storage, it is simple to predict the

storage volumes for inclusion in proposals. Allocate one pallet per

product, per batch for bulk materials and another one or two for

packed blinded product. These will be required throughout the

trial or can be aligned to packing operations at agreed time points

throughout the trial. Difficulties arise when variable storage

locations are used. For example materials may be received in pallet

quantities, but once packed they will be located into a vertical lift

system. There may be two cost lines on the proposal, one for pallet

storage at the agreed temperature and one for a location in the

vertical lift. However, can the distribution of the costs between

the two types of storage location be estimated on the proposal? It

may be that you have pallet locations until the predicted packing

times and then smaller locations in the vertical lift until the end of

the trial, but product in the lift will reduce over time as it is shipped

to site so this needs to be accounted for. It is not impossible to

calculate, but much more complicated and again adds to the

administration costs for using variable locations.

One method that has been used to try to simplify this issue is to

convert all unit pricing into litre costs. Therefore a pallet location

is 720 litres, each smaller location can be assigned its volume in

litres and based on the volume of product being delivered and the

volume of the packaged kits an estimate of the total number of

litres of storage can be calculated. This at least results in only one

cost line per storage temperature, but still involves a lot of guess

work to estimate the volume of storage required for a project. And

clients may find it difficult to visualise the storage requirements

when based upon litres and locations.

Rachel Griffiths – Associate Director

Rachel joined Biotec Services International in 2004. In her current role as Associate

Director of Operations, Rachel has overall responsibility for the warehouse, production

and project management. She has a wide range of experience previously acquired in roles

that include: Development Scientist, Technical Support Scientist and Product Support

Specialist at Ortho Clinical Diagnostics. Rachel holds a degree in Microbiology and Virology

from Warwick University.

twww.biotec-uk.com

Traceability of product in storage locations

Traceability of product is an essential part of GMP. If you are

using a method of charging clients based upon locations used, it is

essential that you know which client’s product is in which location

and the size of the location. Therefore upon receipt, the product

must be booked into its location and the specific location should be

assigned a volume. For example, where the unit costs are in litres

every location needs to be assigned a volume in litres.

One method for fast and secure location of stock is via 2D matrix

or barcodes. Upon receipt each packaged unit of drug product

(e.g. box or tray) has a barcode or matrix attached which details

part number, quantity and batch number. Each location and sub

location is barcoded, and so when the product is placed into

storage the barcode of the product and the barcode of the location

are scanned and linked in the stock system. Each month a report

can then be generated per location or per product identifying the

location and assigning a volume being used. This removes some

the additional administration of using variable stock location sizes.

In summary, where storage is a billable service there are additional

administration costs for monthly billing to clients both for finance

and warehouse. If a company has a large amount of spare capacity

then simple pallet locations would probably be the most cost

effective method of storage of bulk unpacked materials. Finished

kits, particularly when they are serial numbered, require smaller

storage locations to enable efficient picking for shipment.

Where capacity is limited, variable size storage locations would

offer more efficient use of available warehouses and possibly

provide better value to the client. However, these require far

greater administration and can result in a greater number of

client queries both at the proposal stage and during projects as

accurate predictions of capacity across the duration of a project

are virtually impossible to model and so the actual cost of storage

may vary significantly from the original forecast.




Thermo King keeps to its global climate commitment and helps

distributioncompaniesreducetheimpactontheenvironment

Brussels, May 28, 2015 – Ingersoll Rand has created the

EcoWise™ portfolio of products for its climate and industrial

refrigerant-bearing products that are designed to lower

environmental impact with next

generation, low global warming

potential (GWP) refrigerants and

high efficiency operation.

Already being delivered to customers

across Europe, the SLXe trailer

refrigeration units from Thermo

King, a manufacturer of transport

temperature control solutions for a

variety of mobile applications and a

brand of Ingersoll Rand, are among

the first products to be part of the

EcoWise portfolio.

“Environmentally and business

cautious transporters demand

high performance and look for

pre-emptive compliance with the

upcoming regulations,” said Dwight

Gibson, vice president, Thermo King

Europe, Middle East and Africa. “Thermo King

meets this demand and our goal is to continue leading the

technological and environmental innovation race with further

expansion of the EcoWise product portfolio by offering truck

transport solutions in Europe, the Middle East and Africa in 2015,”

continued Gibson.

Thermo King products in the EcoWise portfolio meet the

transportation companies’ needs for solutions that reduce

their environmental impact by lowering greenhouse gas (GHG)

emissions while maintaining or improving performance, cooling

capacity, pull-down and fuel efficiency.

The new SLXe trailer units are compatible with the next generation

DuPont™ Opteon® XP44 (R-452A) refrigerant which has about

Road Transport and Thermo King Head Towards Environmental Performance with EcoWise™ Product Portfolio

50 percent less GWP than the current refrigerant. The new units

further lower the environmental impact thanks to such innovative

enhancements from Thermo King like:

- Micro-channel condenser coils that allow for even lower

refrigerant charge and minimize the risk of leakage.

- Low-noise operation with specially designed acoustic package

that reduces the creation of sound energy and contains it at

the source allowing the unit to reach PIEK-certified noise

levels of 60dB or less at a 7-meter radius.

- Patented geofencing controllers to automatically switch into

low-noise mode when entering a controlled zone.

The transport refrigeration solutions

in the EcoWise portfolio build on the

overall climate commitment made

by Ingersoll Rand in September

2014. The commitment includes

reducing greenhouse gas (GHG)

emissions related to its operations by

approximately 35 percent by 2020;

reducing GHG emissions related

to its products by 50 percent by

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in product-related research and

development over the next five years

to fund the long-term reduction of

GHG emissions.

About Ingersoll Rand and

Thermo King

Ingersoll Rand (NYSE:IR) advances

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or www.thermoking.com.




Regulatory Environment

Some countries, such as Saudi Arabia, Ireland and Argentina,

have existing regulations in place requiring control of CRT

shipments. Globally, the latest changes in regulations have given

rise to increased discussion around concepts like maintaining

storage label claims during distribution, the use of stability data,

Risk Assessment and the need for documentation supporting

Continuous Improvement across the distribution environment.

The Parenteral Drug Association (PDA) was one of the first

to include CRT products in its guidelines. The PDA’s 2007

revised Technical Report 39 states that “these products may

be shipped outside of their respective label storage conditions

provided stability data or scientific/technical justifications exist

demonstrating that product quality is not affected and meets

the national and international requirements.” The United States

Pharmacopeia (USP) adopted a similar approach.

The recently published European Good Distribution Practices

guidelines dictate that “the required storage conditions for

medicinal products should be maintained during transportation

within the defined limits as described by the manufacturers or

on the outer packaging”1 and that “appropriate corrective and

preventive actions be taken to not only correct deviations but

also prevent them.”2

Options and Corresponding Challenges

As a result, three options are available:

• Ship purely according to label claims.

• Ship based on stability data.

• Use a scientific and risk-based approach.

Ship purely according to label claims

European regulators favor the option of shipping purely

according to label claims. Conditions on the label have been set

to allow the medicinal product to maintain its quality until the

expiry date. Relying on stability data to justify excursions that

will not impact overall product quality, including carrying the

product out to the expiration date, adds additional complexity.

Furthermore, the manufacturer is often the only actor in the

distribution chain who has access to such data.

Shipping CRT products, much like cold chain products, is not

always straightforward or cost effective. Maintaining the USP-

defined temperature range for CRT products is often deemed

GOOD COLD CHAIN MANAGEMENT PRACTICES FOR CONTROLLED ROOM TEMPERATURE SHIPMENTS

The pharmaceutical industry, currently under increasing global regulatory scrutiny, is expanding Good Cold Chain Management Practices (GCCMP) for standard Cold Chain Products (2°C to 8°C) to include the storage and transport of “Ambient”/Controlled Room Temperature (CRT) products.

After a thorough review of the current regulatory developments and key challenges, this article will provide advice and methodology regarding how to best approach CRT shipments. The recommendations are based on two main concepts: Risk Assessment and Continuous Improvement.

1EuropeanCommission“GuidelinesonGoodDistributionPracticeofMedicinalProductsforHumanUse,”

November2013.

2Ibid.


more technologically challenging. The industry has also adopted

different ranges to allow for some flexibility. When considering

passive solutions, more protective packaging material will be

needed, leading to higher volume/weight and higher shipping

costs for what are on average much lower retail valued products.

Ship based on stability data

This option offers the most flexibility, but data would have to

be shared if it is available at all. CRT shipments historically have

not been monitored by manufacturers or their supply chain

partners, so often representatives of the pharmaceutical supply

chain will lack data to support uncontrolled conditions beyond

label claim. Without such data, an organization cannot be sure

that the solutions used for transport actually maintain and

guarantee product integrity. Should some temperature data be

present, will it be enough to evaluate the impact of excursions

on the product?

Use a scientific and risk-based approach

Finally, using the principles of Risk Assessment, one could choose

to ship according to label claims with known data and build the

case for allowable predefined exceptions based on scientific

rationale. This position is the one adopted by the European

Federation of Pharmaceutical Industries and Associations

(EFPIA).

While this model largely provides the most cost effective and

flexible program for managing CRT shipments, a number of steps

are required to provide appropriate documentation to support

such a model. This need for clear documentation includes

ongoing monitoring to prove that the conditions for the allowed

excursions are respected, and the development of appropriate

Standard Operating Procedures (SOPs) along the supply chain.

Goal

The goal is to define a cost effective approach for controlled

ambient logistics while ensuring patient safety, product

quality and regulatory compliance. This includes defining

product requirements, conducting shipping route analyses

and developing a decision-making methodology that defines

controlled ambient shipping and monitoring requirements.

Dataloggers can be a resourceful tool for controlled ambient

shipments. Initially, dataloggers should be used to analyze

temperatures along a given route. There are several factors

to consider for both analysis and sensor selection including:

(1) product value and stability, (2) shipping lane, (3) mode and

service level of transportation, and (4) seasonality.

Product Value and Stability

The organization should apply a risk assessment based on, but

not limited to, the criticality of the ailment being treated by the

product (i.e. if the product is adulterated what is the potential

that a patient will experience a negative impact?), the value per

shipment, product availability, manufacturing constraints, and

the impact to the company if an excursion is experienced. Along

with product value, an analysis of product stability should also

be completed.

Many products have stability data, but many transportation

lanes will experience the effects of seasonality and will exceed

the available stability without adequate protection and

appropriately defined operating procedures. However, not all

ambient temperatures will exceed the stability requirements,

thus necessitating a cost effective approach for selecting

the proper protection to maintain product temperature. The

organization should develop a plan to test products, expand

their stability, and understand at what level their products fail

due to extreme temperatures. Examples of detailed stability

protocols can be found in PDA Technical Report 53 “Guidance

for Industry: Stability Testing to Support Distribution of New

Drug Products.”

The stability budget (time and temperature) for each product

should be allocated to the full lifecycle: manufacturing, storage,

and distribution process. Fixed amounts of the budget are

allocated to those areas that are most in control, such as

manufacturing and storage. The remaining budget can be

allocated where it is most needed, to distribution, the most

variable portion of the product lifecycle.

Defining stability at 40°C, 50°C, 60°C, etc., and testing to failure,

along with conducting cycling tests that closely resemble real

world temperature fluctuations, will enable the organization to

better understand the limitations of the products and compare

those limitations to lane-specific temperature data.

Shipping Study

The first step to analyzing a shipping lane is to thermally map the

equipment that will be used during transportation. Analyzing

the data collected from the thermal mapping will enable one to

understand how the route, time of year, and other factors, such

as load pattern, affect temperature throughout the space.

This understanding of the data enables one to determine

those locations in the space that have the greatest heat, cold,

and variability. These locations are defined as the worst case

locations and are used to define a monitor placement protocol

used for ongoing monitoring programs. USP <1079> “Good






Storage and Shipping Practices” recommends conducting

three separate thermal mappings along a route to define the

worst case scenarios. Once the thermal mapping is complete

and monitoring location(s) have been defined, the next step is

to gather temperature data along multiple shipping lanes. The

shipping lanes should be represented by origin and destination

geographies. With the involvement of a Quality Department,

it is possible to establish optimal targets to ensure a broad

representation of the seasonal dynamics of each lane.

Most regulatory agencies require an analysis of peak hot and cold

seasons. For most regions, studies are conducted in January and

February, and then again in July and August. Weather websites

can be used to determine peak times of the year. Temperature

should be checked at the origin and destination, and along the

route. Shipments going from the northern hemisphere to the

southern hemisphere (and vice versa) typically see the most

extreme change in temperatures.

Data from enough shipments should be collected to be

considered statistically reliable. While the International Safe

Transit Association (ISTA) recommends a sample size of 25

shipments per variable such as: origin, destination, carrier, and

mode of transportation, statisticians, according to the central

limit theorem, typically require a minimum of 30 samples to

attain minimum reliability. The ultimate goal of the shipping

study is to develop an analysis of the thermal variability a typical

product or shipment may experience and to quantify and predict

risk. There are two types of analysis: Ambient

Temperature Profile (ATP) and Time Above

and Below Thresholds (TABT).

The goal in developing an ATP is to document

the ambient conditions so that appropriate

thermal protection can be defined. There are

different methodologies available to develop

an ATP. This is typically done by measuring

and recording the distribution of ambient

temperatures over time and then analyzing

the information to produce a model used

to predict extremes. Actual shipments are

consequently matched against the model to

test its accuracy. Historical standard models

(such as the one from ISTA) essentially average temperature

records to create a single profile. However, using Sensitech’s

newly developed Risk Controlled Ambient Thermal Profile

(RCATP) methodology provides a means of quantifying the risk

of temperature excursions on both the upper and lower limits. In

addition, this methodology uniquely allows for modifications to

the created profile based on risk tolerance.

TABT is a useful analysis that defines the amount of time that

a shipment or route will spend above or below specific defined

temperature thresholds. The thresholds typically match to the

same thresholds that are defined in the stability testing. Using

the same threshold will allow for comparisons between the

stability data and the temperature data collected along the

routes.

Comparing stability to the shipping study for the production of decision tools

After completing the first two primary tasks: defining and

improving stability knowledge for the products in question,

and understanding the ambient temperature expectations for

specific routes, the next step is to compare the stability data

to the shipping study TABT. Comparing the product’s stability

against the TABT associated with the applicable routes will

result in groupings of products and routes. These groups will

include products that have similar stability requirements.

Routes will also be grouped based on severity, some routes will

be more moderate and others more extreme during specific

times of the year.

The outcome of the comparison will be a matrix that will define

where additional protection (specialty packaging or logistics

services) is required for each product, along each route, during

specific times of the year. The completed matrix (see Figure 1)

will serve as a decision support tool to assist an organization’s

logistics department in planning transportation needs.

Depending on the amount of thermal variability along a given

route, a decision tree may be helpful in managing overall

protective supply chain needs. The goal of a decision tree is to

develop a process that allows the organization to make cost

effective decisions on distribution and monitoring requirements.

The tree is based on the product-route matrix and defines the

solutions including: carrier, temperature control requirements,

service level, and monitoring requirements.




The decision tree (see Figure 2) can be enhanced with weather

information to make a predictive model.

The decision tree allows the organization to see what

temperatures are predicted along a given route, and predict

through the model what to expect for product temperatures.

From this predicted product temperature, the correct thermal

protection can be selected.

Conclusion

The steps required to cost effectively manage the distribution of

CRT products include:

• Evaluation of stability data

• Expansion of stability data

• Thermal mapping studies

• Shipping lane studies

• Ambient temperature analyses

• Time above and below analyses

• Product route matrix

• Decision tree defining protection and monitoring

requirements

Understanding the requirements of specific products and

expanding the stability range for each product may be more

cost effective than temperature controlled logistics. Grouping

products by similar stability requirements and comparing them

to the ambient temperature analysis from a Shipping Study

enables an organization to implement a risk-based approach

to define the most effective protective logistics and monitoring

schemes possible.

Contributors

Mark Maurice

As the Sensitech Professional Services Senior

Project Manager and Industrial Engineer, Mark

is responsible for working with a cross functional team of nine

Project and Assistant Project Managers with backgrounds

in Industrial Engineering, Packaging, Validation, Logistics,

Statistics, and Technical Writing. Mark has been with Sensitech

for ten years.

The team focuses on defining and executing projects such as

Storage Validations and Transportation Qualifications, along

with Thermal Mappings, Shipping Studies, Risk Controlled

Ambient Temperature Profiles, Package Qualifications, Cold

Chain Assessments, Gap Analysis, and Continuous Process

Improvement through ongoing monitoring. These cold chain

visibility solutions enable Sensitech customers to make decisions

that meet regulatory requirements, impact product quality and

improve profitability.

Mark worked previously at United Parcel Service for sixteen

years as an Industrial Engineering and Operations Manager.

While at UPS, Mark completed numerous projects as a

Project Manager focused on supply chain and warehousing

improvements.

Mark earned his Masters in Industrial Engineering and Bachelors

in Architecture from the University at Buffalo.

Olivier Simonnot

Olivier Simonnot has been working for Sensitech

Inc., UTC Building & Industrial Systems, a unit

of United Technologies Corp., for eight years

and currently holds the position of Strategic Market Manager,

Life Sciences EMEA. He previously held several positions in

Marketing and Product Management in several international

technology oriented companies. He holds a Master of Science

in Telecommunications from the French engineering school

ESIGETEL and a Master in Business Administration from the

Rotterdam School of Management. He is an active member

of the French Cold Chain Association, participated in the sub-

commission on Metrology and Risk Assessment and is currently

active in the Last Mile and New EU GDP working groups.




32.




AS COLD CHAIN LOGISTICS DEMANDS GROW, TECHNOLOGY BECOMES CRITICALContributor: Nitin Dahad

Increased demand for generic pharmaceutical products and

consumption of perishable foods in developing economies is going

to drive significant growth in the cold chain logistics market in the

next few years. With this demand for better visibility of products

in the logistics networks, to minimise wastage, and to ensure

product integrity, technology that enables better monitoring

and analytics in real time will play a major part in many cold chain

logistics networks.

It is not just developing markets that are seeing growth in the

cold chain. North America is the largest market for the cold

chain, according to Persistence Market Research. It says that the

increasing demand for daily products, fruit and vegetables, along

with increased exports of these products has boosted the cold

chain market.

In the Asia-Pacific region, various government initiatives are

also impacting the market, for example, the Indian government is

opening mega food parks, which require temperature controlled

vehicles and temperature controlled warehouses. In India, the

government has also allowed 100 percent FDI (foreign direct

investment) in the cold chain industry. The report also says that

in Europe, Germany is one of the largest markets due to the

increased consumption of frozen foods.

33.




In terms of potential size, in relation to the refrigerated storage

and refrigerated transport part of the global cold chain market, it

is expected to reach a value of US$ 233,476.7 million by 2019, at a

compound annual growth rate (CAGR) of 15.6 percent from 2014

to 2019, according to Research and Markets. It also suggests that

North America accounted for the largest share, 40 percent, of the

cold chain market in 2013. The market is mature in regions such as

North America and Europe, due to the technologically advanced

systems for refrigerated storage & refrigerated transport, the

rise in demand for perishable foods, and government initiatives

that encourage the export and import of perishable foods in these

regions.

Healthcare logistics cold chain requirement grows too

Healthcare products, such as vaccines and blood plasma products,

frozen pharmaceuticals and insulin, require specific temperatures

to be maintained throughout storage and transportation. The

increased demand in developing economies for these and

other pharmaceutical products has created a pressing need for

temperature sensitive healthcare transportation with the use of

temperature tags on products.

Recognising this, research firm TechNavio, says that the global

healthcare cold chain logistics market is expected to grow at a

CAGR of 13.31 percent from 2014-2019. In its report, it says

increased investment in cost effective technologies in developing

markets, especially India, is motivating vendors to enter these

regions.

Technology becomes critical in enhancing and assuring product

integrity

To meet these requirements, both in food and pharmaceuticals,

there is growing investment in healthcare infrastructure and

technologies. In the cold chain in particular, there is an emergence

of transport vehicles equipped with event logging and electronic

monitoring systems, to enhance the effectiveness of supply chains.

In fact, this was a key area of discussion at the Cool Chain &

Controlled Room Temperature Logistics Conference in Frankfurt,

Germany in January 2015. Among the discussions that took

place around supply chain integrity, there was a look at how

temperature data can be used to improve and better control the

cold chain. There was also a look at what to do with the data,

how implementing a centralised global database can enable an

overview of all excursions and provide complete insight into the

cold chain, and overcome fears of using ‘cloud’ storage.

This will be important, as big data analytics becomes an integral

part of many business processes in the coming years. The growing

use of machine to machine (M2M) communications, which




allows sensors to send real time data via mobile and wireless

communications networks, will generate lots of data. This data

might be continuous readings of temperature or other key

business critical parameters that need to be monitored.

Systems like Dyzle’s cold chain monitoring platform send the huge

volumes of data generated by these sensors to secure storage

in the cloud, which makes it accessible for real time monitoring

and for reporting. This data is often used both for historic

recording processes, as well as to produce automated reports

to demonstrate GDP compliance for example. In addition, it also

helps to assure customers and consumers that the products are

safe to use. Technology such as this will therefore become critical

in reporting key business performance indicators (KPIs), and

will become an integral part of the logistics as well as business

management process.

This will be especially significant as the volume of temperature

sensitive products that are shipped around the world grows;

hence the demand for proper cold chain logistics with the ability to

prove integrity will become more important, since pharmaceutical

companies will need the proof to be able to sell their products. The

only way this can be solved is to have sensors and be able to take

measurements, to handle lots of data, and to be able to record and

interpret that data according to the market requirements.

Nitin Dahad is Senior technology marketing

and media specialist at TechSpark Limited

Nitin is an established business communicator,

knowing how to turn complex business/

technology issues into messages that can be

understood by both financial and technical

audiences.




A sustainable solution for temperature

controlled urban distribution

36.




37.




Growing environmental pressure for change

Since the late 1930s, transporting temperature sensitive goods

by road and rail depended almost entirely on fossil fuels and high

global warming potential (GWP) refrigerants to maintain cargo

at the optimum temperature. Today, internal combustion engines

have become quieter, more fuel efficient and cleaner. Nevertheless

the dependence on fossil fuel and hydrofluorocarbon (HFC)

refrigerants remains.

Regulations and social pressure have dramatically changed the way

transporters operate in the European Union (EU). Environmental

sustainability is a top objective of legislators determined to phase

out high GWP refrigerants, control exhaust emissions and limit

noise in densely populated areas.

An alternative to fossil fuels and HFC refrigerants

For the past 15 years, the manufacturer of transport temperature

control systems, Thermo King, has focused on developing a

solution that would meet the future need for an alternative to the

fossil fuel or HFC technologies on which the transport industry

has depended for so long. In the 1930s, Thermo King pioneered

transport temperature control and they have remained the leading

innovator in this industry ever since.

How the system works

The company’s alternative approach, which remains unique in

transport refrigeration today, involves the use of recovered and

commercially available liquid carbon dioxide (R-744) in an indirect

open-cycle system. Unlike other ‘cryogenic’ approaches which

spray the refrigerant directly into the load space, the Thermo King

CryoTech range uses fin-and-tube evaporators as heat exchangers

through which the R-744 flows, absorbing heat from the load

before it is vented to the outside of the vehicle.

The recovered R-744 is stored under pressure in a vacuum

insulated tank under the chassis of the truck or articulated trailer.

It flows to the remote evaporators, one of which is installed in each

compartment allowing up to three temperatures on one vehicle.

An electronic expansion valve managed by the electric control

module regulates the flow of liquid through each evaporator

thereby varying their cooling capacity to match the demands of

the load and maintain a steady temperature.

Just like conventional HFC refrigerants, the liquid R-744 changes

state (into a gas) as its pressure drops on leaving the expansion

valve and rapidly absorbs heat energy in the process. A regulator

keeps gas pressures above the critical 5.5 bar point to avoid the

formation of dry ice in the evaporator. After the liquid R-744

vaporizes causing the temperature to lower in the insulated box,

the vapor is vented outside the box through an exhaust muffler

to minimize noise. This is important with regard to the health and

safety of operators and goods.

A system defined by what it lacks

The system is more notable for what it lacks rather than what it

possesses. The truck or trailer unit is cooled with virtually no

operating noise without the use of diesel engine, compressor, or

HFC refrigerant.

The recovered R-744 in the Thermo King CryoTech systems

is obtained as a by-product from industrial processes that

would otherwise have been released into the atmosphere.

As such there are no new carbon dioxide emissions during

operation of the CryoTech system.

Operating costs similar to diesel

The cost of operating a CryoTech unit over its lifecycle is

broadly comparable to that of an equivalent conventional

diesel powered unit, although specific applications may favor

one or the other. The initial cost of the unit is likely to be

slightly higher, due to current low manufacturing volumes.

This is offset by its longer service life due to its long life

components and fewer “wear” items.

Cooling performance and noise

It has been proven that CryoTech evaporators deliver

significantly more cooling capacity than their diesel equivalent

at both fresh and frozen box temperatures. Pull down of an

empty box can be up to four times faster with R-744, making

it an excellent choice for distribution operations with a high

number of door openings.

With more countries considering the introduction of noise

limits on evening and night deliveries – following the example

of the PIEK standard in the Netherlands - urban distribution

operations wanting to take advantage of low traffic volumes

need a vehicle that can perform at 60 dBA or less. All the

CryoTech units are PIEK tested and compliant offering sound

levels up to 90% lower than a standard diesel unit.

The environmental impact of the system

But is the CryoTech solution actually more environmentally

sustainable?




Engineers at Thermo King performed a detailed carbon

footprint calculation on three equivalent systems. The

CryoTech (R-744) system was first compared to the latest in

“conventional” technology (fossil fuel/HFC refrigerant) and

to a different “alternative” approach using liquid nitrogen as a

refrigerant. The study measures the environmental impact, or

“carbon footprint” of each solution.

The comparison took into account significant sources of carbon

dioxide emission from cradle to grave, including emissions

arising from the energy required to produce the fuels and

average annual operating hours. Also taken into consideration

were the fuel consumption and exhaust emissions based on

independent ATP test data only applicable to diesel units.

As expected, the diesel unit’s carbon emissions were largely

due to burning of this fossil fuel. Although the nitrogen unit

consumes a similar level of fuel to the R-744 unit, nitrogen

itself requires about three times more energy to produce than

the equivalent amount of recovered R-744. The total footprint

in tons of carbon dioxide over a ten year life was found to be

as follows:

• Diesel unit 166 tons

• Nitrogen unit 143 tons

• CryoTech unit 46 tons

The results, while strongly in favor of the R-744 solution,

were not entirely surprising. CIT Ekologik AB (Engberg et

al.) conducted a similar detailed Lifecycle Analysis in 2002

comparing diesel-powered units with CryoTech units. The

study showed that the carbon dioxide refrigerator contributes

considerably less to the environmental effects than the diesel

refrigerator during refrigeration as well as heating.1

The road ahead

The study demonstrates that the recovered R-744

solution used in the CryoTech range has a carbon footprint

approximately 75 percent less than a conventional diesel

system and 68 percent less than a nitrogen cryogenic

system. But carbon footprint alone will not make a solution

commercially viable. The CryoTech range has been shown to

also have a similar cost of ownership to an equivalent diesel

system while substantially outperforming diesel on both

noise and temperature pull down/recovery. These additional

features make it ideally suited for urban distribution.

One current limitation is the availability of R-744 filling stations.

In the early years, there was little to no infrastructure to support

the filling of CryoTech units. Since then great strides have already

been made in this area.

Existing diesel fuel stations were willing to have R-744 storage and

dispensing stations installed so the vehicles can be refueled at the

same time as the units. By the end of 2013, more than 40 R-744

filling stations were in operation in eight European countries and

the number is expected to grow in the coming years.

Thermo King has demonstrated its commitment to this technology,

investing heavily in future product research and development, as

well as the expansion of the filling station network.

Over the past decades, the science of transport refrigeration has

advanced dramatically and the next years will no doubt bring about

further innovations. The future promises to be an interesting time,

as it is clear that the industry cannot continue to solely depend

on traditional fuels and HFC refrigerants. Industry leaders like

Thermo King are applying current and emerging technologies

to help their customers achieve sustainable and quiet transport

refrigeration.

1EngbergP.,WidhedenJ.,ErikssonE.,LifeCycleAnalysisoftemperaturecontrolledfoodsbytrucktransport,

Report,CITEkologikAB,AChalmersIndusriteknikCompany.




Brussels, May 12, 2015 – Food service, catering, hotels, grocery

and pharmaceutical delivery companies are just a few businesses

that benefit from rental vehicles for their temperature controlled

applications, ranging from chill to heavy chill and to deep frozen.

To meet the growing demand for renting temperature controlled

vehicles, the dedicated division of Enterprise Flex-E-Rent has

recently expanded its national fleet with vehicles featuring leading

edge refrigeration units from Thermo King, a manufacturer of

transport temperature control solutions for a variety of mobile

applications and a brand of Ingersoll Rand.

The new temperature controlled vehicles are equipped with the

multi-temperature units from Thermo King: the vehicle-powered

V-300 Max Spectrum on pharmaceutical specification Mercedes-

Benz Sprinter vans and the T-1000 Spectrum diesel powered

truck model on the large rigid vehicles. These Thermo King units

compliment the high standards expected by Enterprise Flex-E-

Rent, offering customers unsurpassed versatility, efficiency and

ease of operation.

The units have been delivered by Thermo King Northern, a

member of the most extensive dealer network in the industry, and

one of the main Thermo King dealerships with over 30 years of

experience in UK and Ireland. Each unit is covered by a service and

maintenance contract from Thermo King Northern to ensure it is

maintained in the optimal condition for maximized uptime.

"In a short period of time, our temperature controlled product

line has grown tremendously, thanks to an extensive fleet of high

specification, state-of-the-art vehicles supported by the highest

levels of customer service,” said Danny Glynn, managing director at

Enterprise Flex-E-Rent. “Thermo King is a well proven brand in the

UK and its approach to providing us with long term commitment

and a comprehensive nationwide support service is key in enabling

us to maintain and grow our market-leading proposition.”

“We are delighted to partner with Enterprise Flex-E-Rent offering

the latest Thermo King units and providing a whole life cost

solution to support their flexible operation,” said Andrew Davis,

account manager at Thermo King Northern. “With decades of

experience as a Thermo King dealer, we have worked hard to earn

our reputation as a trusted business partner to the temperature

controlled transport industry providing sales and after-sales

service to keep the sector on the move.”

The Thermo King T-Series range has set new industry standards

for reliability, performance, efficiency and low cost of ownership,

delivering greater capacities at lower operating speeds and

enabling precise temperature control.

The T-Series Spectrum range units meet the customers’

demands of any multi-temperature distribution operation

providing reduced noise levels and emissions, while maximizing

performance, efficiency and

reliability. With a choice

of two or three blower

remote evaporators that

can be used in a number of

different configurations,

customers can additionally

benefit from the flexibility

to accommodate different

distribution operations.

The Thermo King V-Series

range of vehicle-powered

units provides customers

with highly flexible and

reliable solutions for vans

and trucks offering choice

of heating capabilities,

electric stand-by and multi-

temperature options.

Higher efficiency and

performance standards

provide customers with the

required cooling capacity

at all temperatures and

enable faster temperature

recovery from multiple

door openings during

distribution operations.

Continuous monitoring of

the load and temperature

control is easy to operate

through the Direct Smart

Reefer microprocessor control.

About Ingersoll Rand and Thermo King

Ingersoll Rand (NYSE:IR) advances the quality of life by creating

comfortable, sustainable and efficient environments. Our people

and our family of brands—including Club Car®, Ingersoll Rand®,

Thermo King® and Trane®—work together to enhance the quality

Enterprise Flex-E-Rent Expands its Temperature Controlled Rental Fleet with Thermo King Units




and comfort of air in homes and buildings; transport and protect

food and perishables; and increase industrial productivity and

efficiency.

Thermo King Corp. was founded in 1938 and manufactures

transport temperature control systems for a variety of mobile

applications, including trailers, truck bodies, buses, shipboard

containers and railway cars. We are a $13 billion

global business

committed to a world of sustainable progress and enduring

results. For more information, visit www.ingersollrand.com or

www.thermoking.com.

About Thermo King Northern

With over 30 years’ experience as a Thermo King main dealer,

Thermo King Northern is a trusted business partner to the

transport temperature control industry providing sales and after-

sales service. Thermo King Northern was the first Thermo King

dealership in the UK and one of the first in Europe to achieve

Platinum status- the highest ranking award- in the company’s

Progress to Excellence programme. As a committed customer

focused company has strategic locations throughout the country.

For more information visit www.thermokingnorthern.com




//INDEX OF ADVERTISERS

IFC

5

7

9

11

13

17

19

23

31

IBC

OBC

Sensitech

Sofrigram

Softbox

JAL Cargo

Berlinger &Co AG

IATA

Cargolux

UPS

Biotech

C Safe

DGM

UPS

FOR ADVERTISING INFORMATION CONTACT:

Sales: [email protected]

Subscription: [email protected]

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staying compliant with all of the many rules

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supported by DGOffi ce.net with its specifi c

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to Shipper’s Declaration and ‘NOtifi cation TO

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

Safety fi rstin Dangerous Goods Management

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

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

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

or on a stand-alone computer.

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



Dangerous Goods Management is all about

safety and minimizing risk. In air transpor tation,

staying compliant with all of the many rules

and regulations is not an easy task. However,

supported by DGOffi ce.net with its specifi c

modules for air transportation, it becomes a

clean cut operation. From Packing Instructions

to Shipper’s Declaration and ‘NOtifi cation TO

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

Safety fi rstin Dangerous Goods Management

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

automated where possible to save you time

and to reduce error rate to a minimum.

DGOffi ce.net was developed as an on-line

application, meaning you can access it anytime

from anywhere in the world. Alternatively,

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

or on a stand-alone computer.

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

tlp insight spring summer 2015

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