TLP Insight Spring Summer 2015

THE LOGISTICS PORTAL MAGAZINE

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TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE

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Spring/Summer 2015

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

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

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Protecting product quality AT EVERY STEP

One trusted partner for end-to-end temperature control and supply chain integrity Medicinal products demand special protection at every step in the supply chain—from the production line to the patient.

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

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.

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

SENSITECH CAN HELP YOU:

• 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

© 2015. Sensitech Inc. All rights reserved.

Melbourne

Santiago

Shanghai

//MAIN CONTENT

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MANAGING DIRECTOR Lee Atkinson MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright

8

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

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.

SENIOR DESIGNER Adam Tannous info@zzandd.com

EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson, Amy Firth ADMINISTRATION Katie Galelli WEBSITE DESIGN Knut Henriksen

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

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.

CONTACT US Sales: info@intensivemedia.co.uk Subscription: subscription@intensivemedia.co.uk TLP INSIGHT Is published 4 times a year March, June, September & December by Intensive Media Ltd. Printed by Premier Print & Direct Mail Group.

Send address changes to: 145 - 157 St Johns Street London

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The challenges of warehousing for clinical supplies companies

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.

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

Contents continue on page 4 »

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//FEATUREDCONTENT

26

Good Cold Chain Management Practices for controlled room temperature shipments

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.

32

As cold chain logistics demands grow, technology becomes critical

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

36

A sustainable solution for temperature controlled urban distribution

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.

4.

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a high technology smart box For highly secure shipping

STP is a division of Sofrigam www.sustainablethermalpackaging.com

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//TLP INSIGHT FOREWORD We 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

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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.

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Provide the best solution for the transportation of pharmaceuticals.

COOL CHAIN LOGISTICS

-SOLUTIONS PHARMA Constant Temperature Control

Dedicated Logistics Team

Contact: Cool Chain Logistics Team c/o Adrian Rayner Tel: +44-(0)1784 - 422- 637 adrian.rayner@jal.com www.jal.co.jp/en/jalcargo/ www.the-logistics-portal.com

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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

Additional

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

time is spent

expiry date or during its certified temperature accuracy period as

manually inspecting

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

and inventorying devices

methodology for handling these requirements. Often they are

to create a FEFO inventory

decentralized, off-line procedures that expose the company to

management

process.

Standard

lost certificates, lack of inventory rotation control and countless

ERP systems (SAP, Oracle) are helpful;

man-hours to store and retrieve calibration certificates even years

but are not robust enough to support the

after a device has been used.

Additionally, some data logger excursions can be classified as

cGDP practices of the biopharma industry.

Unwanted

temperature

events

that

occur

during

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

manufacturing, storage, transportation, and distribution are

Chain IQ group, the respondents who acknowledge temperature

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

excursions with products in transit, indicated excursions occurring

excursions outside acceptable temperature ranges captured

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

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

One common occurrence can be observed when temperature

intensive manner by a dedicated supply chain quality management

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

group or department. Emails are generated passing data logger

temperature-controlled environment, and the data logger

temperature information to be compared with the timing of

is turned off hours later. Biopharma firms have established

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

procedures for documenting these occurrences without launching

without a USB interface are transported back to someone with the

a full quality investigation. Yet even these simple procedural steps

necessary hardware and software to read the data. An additional

incur significant labor costs. The initiator must alert responsible

labor intensive process then begins to insure all the required data

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

is collected, that the responsible parties formally address the

right technical information to approve the use of the materials

data and the decision to move materials to the appropriate next

while documenting the decision for regulatory compliance files.

step is documented properly. These documents typically require

Delays occur when people do not respond to emails or while

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

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

take anywhere from 1 to 30+ days depending upon circumstances

calibration certificate).

associated with the specific materials involved to complete these steps. Indications are that the costs for administering an excursion

Current Methodology

event are between $10,000 - $100,000 per occurrence (Goff, 2008).

Of paramount importance for a compliant temperature monitoring program is the ability to effectively manage data logger inventories

The frequency and severity at which these excursions occur

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

varies from company to company depending on the complexity

are managing this process manually, through spreadsheets and/or

and structure of their logistics practices and the robustness of

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

their quality management systems. The documentation and sign-

cards for demand driven inventory management) that require

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

significant frontend organization and data entry. Seldom is the

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

data logger supplier leveraged for management of data logger

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

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

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

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

thousands or even millions of dollars every year.

tracking down these certificates (see Fig. 1).

Proposed Solution The Smartview® system enables work flow steps like excursion alerts and missing data loggers to be

(Fig. 1)

automatically generated and sent to the responsible person(s). Additionally, workflow steps for acknowledging

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Experience the power of control using

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

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.

Improve regulatory compliance and enhance Good Distribution Practices (GDP) with a system that allows you to manage excursion acknowledgements 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.

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.

Berlinger – Your reliable partner for hardware and software solutions.

Berlinger & Co. AG Mitteldorfstrasse 2 • CH-9608 Ganterschwil Phone +41 71 982 88 11 • Fax +41 71 982 88 39 info@berlinger.ch • 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 info.us@berlinger.ch • www.berlinger.com

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the review of temperature data, especially data with a recorded

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

excursion, can take place within the Smartview system. Notes

outside vendors to compile the data into trending reports and key

about the root cause and other information can be appended to

performance indicators (KPI).

®

the shipment data. Nonrelevant temperature data (e.g. warm temperatures recorded after delivery from an active data logger

Personnel with the appropriate user rights can access the

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

aggregate data through a Reports Module contained in

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

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

auditable trail based on the unique user ID and password and

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

meet 21 CFR, Part 11 & Annex 11 requirements.

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

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

(Fig. 2)

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

Easy to comprehend info-graphics allow the user to visually

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

determine where improvements are occurring and where more

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

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

®

and regulatory compliant control over temperature excursion Once Smartview® is integrated into a firm’s daily routine, the

investigations and remediation steps while substantially reducing

use of the system to acknowledge temperature shipment data

their time and administrative costs through implementation of the

or to document excursion issues will reduce the administrative-

Berlinger Smartview® system

hours needed for these activities. It also enhances accountability by automatically sending alerts to responsible individuals and

Conclusions

escalating the alert if action steps, like acknowledging the event, exceed pre-determined time limits.

• Current methodology for identifying, investigating and documenting temperature excursions within the pharmaceutical

With Smartview® operating in the cloud. Email communication of

supply chain are inadequate, time-consuming, inefficient and

excursion events are sent automatically to the responsible party

costly to an organization.

immediately after a data logger is uploaded. That person can sign into Smartview® via his/her smart phone or other enabled

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

wireless device to document the receipt of an alert notification,

manual filing systems to manage and document temperature

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

excursions.

root cause. By providing an audit trail for everyone who interacts with the system, Smartview® is designed to ensure regulatory

• Smartview® is a comprehensive temperature monitoring

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

software system that ensures reliability, accuracy, compliance,

compliant).

secure data visibility, accessibility, and efficiency of critical time and temperaturesensitive shipments.

Supply Chain Directors are often more interested in aggregate information for trending analysis and process improvement. By

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

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

reduction in time and labor cost of temperature deviation

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

investigations in the framework of a completely validated and

is impractical and grossly inefficient to rely on email, manual

regulatory compliant environment.

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

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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.

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

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?

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

you will also, hopefully, hear about additional requirements that

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

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

be that ‘CLP and REACH places the responsibility for hazard

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

classification and related provisions such as packaging, hazard

dangerous goods to carriers that have been properly identified.’

communication and SDS on the suppliers.’

Well, from each one’s perspective, both of the answers are Asking the same question to a Logistics Manager though, who has

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

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

answer from the Logistics Manager is highly dependent upon the

in him focusing on different elements than the ones the Chemist

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

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

big questions are WHY that dependency, and WHERE is that

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

presumed KNOWLEDGE GAP?

Name (PSN), hazard Class, Packing Group etc. for the classification part. And, depending on the transport mode, elements such as the

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

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

explanation to these questions.

Addresses and weights for the marking & labelling. Furthermore,

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Question 1: Why does logistics depend on the chemical

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

classification?

The SDS provides the results of the testing and classification procedure performed by the Chemist under prescribed GHS

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

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

dangerous goods, you most probably have followed training to

Model Regulations for Transport of Dangerous Goods, Manual of

make you either familiar with the applicable rules and regulations

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

regarding the storage and transport of dangerous goods or you

IMDG Code and ICAO TI).

have passed examinations which certify you to make, for instance, declarations for transport or even to become a Dangerous Goods

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

Safety Adviser.

you should be able to find all the relevant testing and other official information, including the transport classification, regarding a

The majority of regulations concerning the storage and transport

specific substance, mixture or article2 grouped under the following

of dangerous goods contain chapters or articles in which the

16 sections:

classification of dangerous goods is described. The scope of this

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

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

SECTION 2: Hazards identification

packing group or compatibility group within that class.

SECTION 3: Composition/information on ingredients

SECTION 4: First aid measures

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

SECTION 5: Firefighting measures

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

SECTION 6: Accidental release measures

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

SECTION 7: Handling and storage

if you do not have a laboratory environment including all the

SECTION 8: Exposure controls/personal protection

equipment and trained staff.

SECTION 9: Physical and chemical properties

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

company/undertaking

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

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

SECTION 10: Stability and reactivity

of the existent classification in order to properly prepare a shipment

SECTION 11: Toxicological information

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

SECTION 12: Ecological information

the transport regulations, should be found in these Sections whereby

SECTION 13: Disposal considerations

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

SECTION 14: Transport information

SECTION 15: Regulatory information

Because regulations are highly prescriptive, if someone follows the

SECTION 16: Other information

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

Ideally, all the information needed for a Consignor, when different to the manufacturer3, who wishes to verify for himself the correctness

1

he classification of both substances and mixtures is based on the relevant experimental data generated T in tests for physical, toxicological and ecotoxicological hazards. Following the classification process, certain hazard pictograms, signal words, hazard statements and precautionary statements should appear on the label.

2

3

F rom marketing and/or logistical aspects it may in certain cases be useful for suppliers to have Safety Data Sheets available for all substances and mixtures, including those for which there is no legal obligation to provide an SDS. In such cases it may be desirable to indicate in the document that the substance or mixture does not legally require an SDS to avoid unnecessary compliance and conformity issues arising. It is not generally desirable to compile SDSs for articles [Ref ECHA] The initial responsibility for drawing up the safety data sheet falls on the manufacturer, importer or only representative who should anticipate, so far as it is reasonably practicable, the uses to which the substance or mixture may be put [Ref ECHA]

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

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

with the same classification results prescribed under Section 14 of

producer/manufacturer of the goods, both the classification of

the SDS, being:

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

In this case, the Consignor has promptly available the information

14.1. UN number

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

14.2. UN proper shipping name

involved in classification of the products.

14.3. Transport hazard class(es)

14.4. Packing group

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

14.5. Environmental hazards

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

14.6. Special precautions for user

longer the owner of the goods nor involved in the classification

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

process.

and the IBC Code Indeed, what actually happens in most cases, is that the Consignor So, why not take the shortcut, just look at Section 14 and job done

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

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

manufacturer of the goods. A big question remains, however. How can a Consignor verify, in a case where the relevant information

Question 2: Where is that presumed knowledge gap?

on the received SDS is lacking, whether the classification under section 14 is correct?

Here’s where the ‘tricky’ part starts! As indicated earlier, the Consignor is the responsible (read ‘liable’) part in the logistics chain.

Another widespread phenomenon, especially in the 3PL business,

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

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

correctly packed, documented, marked and labelled, simply

the classification, and labelling. Regulations require that each

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

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

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

change is introduced in a mixture, suppliers MUST reconsider

information under section 14 is correct.

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

Train staff to be accurate, attentive and knowledgeable when dangerous goods are involved.

promptly share the new information with all the actors down the

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

supply chain to allow them to fulfill their obligations.

We have seen many examples of wrong SDSs delivered with goods

a. Train his staff to be accurate, attentive and knowledgeable when dangerous goods are involved.

like an SDS for a liquid delivered with a solid substance or an SDS based on old classification criteria where for instance a flammable

b. Have procedures in place with both owners and suppliers

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

of dangerous goods to make sure he receives accurate

for transport.

information and also receives timely the updated versions of SDSs once they become available.

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Complete peace of mind for your pharmaceutical and healthcare shipments

Flying with care It is essential that the quality and integrity of your high value and temperature sensitive pharmaceutical and healthcare products is protected throughout the entire transportation cycle.

Backed by our fleet of advanced Boeing 747-8 and 747-400 freighter aircraft and a brand-new purposebuilt 3,000 m2 warehouse facility with temperature- and humidity-controlled environments at our Luxembourg hub, we offer you speedy, reliable and tailored solutions to meet your sophisticated needs.

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+2°C to +8°C

+15°C to +25°C

keepcool@cargolux.com | www.cargolux.com

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The second factor affecting the knowledge gap is the knowledge

Options and solutions

level of the ‘competent person’ and his/her capability to ensure the consistency of the SDS. It is understood that any one single person

As indicated, the Owner/Manufacturer being Consignor as well

very rarely has extensive knowledge in all the fields covered

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

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

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

of substances and mixtures should be able to ensure that

integrated software system in which both chemical management

such competent persons have received appropriate training,

and logistics are connected and where information is shared in

including refresher training.’ Unfortunately, many times and

real time.

especially within smaller companies this role is also assigned to (production/QC) Chemists who are not always specialised in the

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

transport classification of dangerous goods.

immediately replacing the previous version. On the other hand, if the transport regulations change, this will be indicated in the list of

When you are involved in logistics, you know that regulations

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

regarding the transport of dangerous goods are changing constantly. In some cases new UN numbers are added, in other

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

cases classification of certain substances are changing. Besides

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

that, we have differences between the different modes of

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

transport or, mainly for road, differences between countries.

For the Consignor not producing his own products, a similar Not every chemist will go through his list of SDSs to verify if

software system is recommended but used in a way where the

something has changed for Section 14 when a new regulation is

Owner/Supplier and Consignor have shared responsibilities

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

regarding information provision. This can be managed by making

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

firm agreements between the parties involved or using a third

for the classification during transport…

party to make sure all information is as accurate as possible at all times, keeping the parties involved updated on changed

So, what to do?

documentation, regulations and labelling/marking.

Authors: Herman Teering Panos Drougas, MSc Managing Director

DGM Software Development Group

Senior Chemical Consultant

www.dgm-sdg.com

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TLPINSIGHT 19.

The challenges of warehousing for clinical supplies companies.

Rachel Griffiths

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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.

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

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

locations. These could be provided by using variable size racking

considered alongside the capital cost and practicality of providing

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

new storage warehousing.

location to subdivide the space. The product could then be placed within its original packaging, into the bins for storage. Each bin

The benefits of pallet vs. variable location size have been

would have a storage location within the stock control system and

considered for bulk unlabelled materials. However the use of

so be traceable.

smaller locations comes into its own when considering packed clinical trial materials that are serial numbered. Routinely, clinical

This allows good segregation of product, storage location sizes can

trial materials are packed in separate assembly operations for

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

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

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

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

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

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

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

(Example of bin locations in a vertical lift).

storage capacity can sell pallet locations relatively cheaply. The product is in single locations with a single price and calculating

the randomisation number assigned when the trial randomisation

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

was established. Routinely, orders are received for shipment

the number of pallet locations and multiplying it by the agreed

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

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

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

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

range of the available packed product and not in sequential order, as this helps maintain the trial blinding.

Using variable locations sold at variable prices becomes more complicated to administer, as each month the quantity and volume

If packed kits were palletised it would involve the whole pallet

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

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

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

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

warehouse staff physically counting used locations and location

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

sizes and finance departments converting these into capacity

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

charges. Therefore the administration costs for this method are

delays to complete picking operations for shipments and increases

potentially much higher.

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

Additionally, clients who pay by volume used rather than pallet

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

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

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

have shipped a large amount of product from the warehouse

or carousel systems with trays containing the product in a small

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

location can be utilised which allows kits to be quickly located

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

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

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

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

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

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

additional finance and project management time. Hence the direct and indirect administration of a variable size storage location

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Using smaller locations is ideal for serial numbered clinical trial

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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, www.the-logistics-portal.com Bridgend, CF31 3RT, UKTLPINSIGHT

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

Traceability of product in storage locations

pallet locations.

Traceability of product is an essential part of GMP. If you are Traditionally, proposals are prepared for clinical trial supplies with

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

an estimated cost for storage at different temperatures based

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

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

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

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

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

as manufacturing time scales change, regulatory approvals are

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

delayed and patient recruitment will be different to that planned.

every location needs to be assigned a volume in litres.

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

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

storage volumes for inclusion in proposals. Allocate one pallet per

or barcodes. Upon receipt each packaged unit of drug product

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

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

packed blinded product. These will be required throughout the

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

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

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

throughout the trial. Difficulties arise when variable storage

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

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

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

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

can then be generated per location or per product identifying the

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

location and assigning a volume being used. This removes some

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

the additional administration of using variable stock location sizes.

vertical lift. However, can the distribution of the costs between the two types of storage location be estimated on the proposal? It

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

may be that you have pallet locations until the predicted packing

administration costs for monthly billing to clients both for finance

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

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

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

then simple pallet locations would probably be the most cost

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

effective method of storage of bulk unpacked materials. Finished

calculate, but much more complicated and again adds to the

kits, particularly when they are serial numbered, require smaller

administration costs for using variable locations.

storage locations to enable efficient picking for shipment.

Where capacity is limited, variable size storage locations would

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

offer more efficient use of available warehouses and possibly

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

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

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

greater administration and can result in a greater number of

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

client queries both at the proposal stage and during projects as

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

accurate predictions of capacity across the duration of a project

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

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

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

may vary significantly from the original forecast.

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

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Road Transport and Thermo King

Head Towards Environmental Performance with

EcoWise™ Product Portfolio

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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

Thermo King keeps to its global climate commitment and helps

the source allowing the unit to reach PIEK-certified noise

distribution companies reduce the impact on the environment

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

Brussels, May 28, 2015 – Ingersoll Rand has created the EcoWise™ portfolio of products for its climate and industrial

- Patented geofencing controllers to automatically switch into low-noise mode when entering a controlled zone.

refrigerant-bearing products that are designed to lower environmental generation,

impact

low

global

with

next

The transport refrigeration solutions

warming

in the EcoWise portfolio build on the

potential (GWP) refrigerants and

overall climate commitment made

high efficiency operation.

by Ingersoll Rand in September 2014. The commitment includes

Already being delivered to customers

reducing greenhouse gas (GHG)

across Europe, the SLXe trailer

emissions related to its operations by

refrigeration units from Thermo

approximately 35 percent by 2020;

King, a manufacturer of transport

reducing GHG emissions related

temperature control solutions for a

to its products by 50 percent by

variety of mobile applications and a

2020; and investing $500 million

brand of Ingersoll Rand, are among

in product-related research and

the first products to be part of the

development over the next five years

EcoWise portfolio.

to fund the long-term reduction of GHG emissions.

“Environmentally cautious

and

business

transporters

demand

About Ingersoll Rand and Thermo King

high performance and look for pre-emptive compliance with the upcoming regulations,” said Dwight

Ingersoll Rand (NYSE:IR) advances

Gibson, vice president, Thermo King

the quality of life by creating

Europe, Middle East and Africa. “Thermo King

comfortable,

meets this demand and our goal is to continue leading the

sustainable

and

efficient environments. Our people

technological and environmental innovation race with further

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

expansion of the EcoWise product portfolio by offering truck

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

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

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

continued Gibson.

protect food and perishables; and increase industrial productivity and efficiency. We are a $13 billion global business committed

Thermo King products in the EcoWise portfolio meet the

to a world of sustainable progress and enduring results. Thermo

transportation companies’ needs for solutions that reduce

King Corp. was founded in 1938 and manufactures transport

their environmental impact by lowering greenhouse gas (GHG)

temperature control systems for a variety of mobile applications,

emissions while maintaining or improving performance, cooling

including trailers, truck bodies, buses, shipboard containers and

capacity, pull-down and fuel efficiency.

railway cars. For more information, visit www.ingersollrand.com or www.thermoking.com.

The new SLXe trailer units are compatible with the next generation DuPont™ Opteon® XP44 (R-452A) refrigerant which has about

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GOOD COLD CHAIN MANAGEMENT PRACTICES FOR CONTROLLED ROOM TEMPERATURE SHIPMENTS

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: •S hip purely according to label claims.

• Ship based on stability data.

•U se 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

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.

to allow the medicinal product to maintain its quality until the

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.

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

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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.

always straightforward or cost effective. Maintaining the USPdefined temperature range for CRT products is often deemed 1 European Commission “Guidelines on Good Distribution Practice of Medicinal Products for Human Use,” November 2013.

2 Ibid.

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more technologically challenging. The industry has also adopted

TLP

Product Value and Stability

different ranges to allow for some flexibility. When considering passive solutions, more protective packaging material will be

The organization should apply a risk assessment based on, but

needed, leading to higher volume/weight and higher shipping

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

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

product (i.e. if the product is adulterated what is the potential that a patient will experience a negative impact?), the value per

Ship based on stability data

shipment, product availability, manufacturing constraints, and the impact to the company if an excursion is experienced. Along

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

with product value, an analysis of product stability should also

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

be completed.

not been monitored by manufacturers or their supply chain partners, so often representatives of the pharmaceutical supply

Many products have stability data, but many transportation

chain will lack data to support uncontrolled conditions beyond

lanes will experience the effects of seasonality and will exceed

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

the available stability without adequate protection and

that the solutions used for transport actually maintain and

appropriately defined operating procedures. However, not all

guarantee product integrity. Should some temperature data be

ambient temperatures will exceed the stability requirements,

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

thus necessitating a cost effective approach for selecting

on the product?

the proper protection to maintain product temperature. The organization should develop a plan to test products, expand

Use a scientific and risk-based approach

their stability, and understand at what level their products fail due to extreme temperatures. Examples of detailed stability

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

protocols can be found in PDA Technical Report 53 “Guidance

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

for Industry: Stability Testing to Support Distribution of New

case for allowable predefined exceptions based on scientific

Drug Products.”

rationale. This position is the one adopted by the European Federation of Pharmaceutical Industries and Associations

The stability budget (time and temperature) for each product

(EFPIA).

should be allocated to the full lifecycle: manufacturing, storage, and distribution process. Fixed amounts of the budget are

While this model largely provides the most cost effective and

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

flexible program for managing CRT shipments, a number of steps

manufacturing and storage. The remaining budget can be

are required to provide appropriate documentation to support

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

such a model. This need for clear documentation includes

variable portion of the product lifecycle.

ongoing monitoring to prove that the conditions for the allowed excursions are respected, and the development of appropriate

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

Standard Operating Procedures (SOPs) along the supply chain.

along with conducting cycling tests that closely resemble real world temperature fluctuations, will enable the organization to

Goal

better understand the limitations of the products and compare those limitations to lane-specific temperature data.

The goal is to define a cost effective approach for controlled ambient logistics while ensuring patient safety, product

Shipping Study

quality and regulatory compliance. This includes defining product requirements, conducting shipping route analyses

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

and developing a decision-making methodology that defines

equipment that will be used during transportation. Analyzing

controlled ambient shipping and monitoring requirements.

the data collected from the thermal mapping will enable one to understand how the route, time of year, and other factors, such

Dataloggers can be a resourceful tool for controlled ambient

as load pattern, affect temperature throughout the space.

shipments. Initially, dataloggers should be used to analyze temperatures along a given route. There are several factors

This understanding of the data enables one to determine

to consider for both analysis and sensor selection including:

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

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

and variability. These locations are defined as the worst case

service level of transportation, and (4) seasonality.

locations and are used to define a monitor placement protocol used for ongoing monitoring programs. USP <1079> “Good

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Storage and Shipping Practices” recommends conducting

a shipment or route will spend above or below specific defined

three separate thermal mappings along a route to define the

temperature thresholds. The thresholds typically match to the

worst case scenarios. Once the thermal mapping is complete

same thresholds that are defined in the stability testing. Using

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

the same threshold will allow for comparisons between the

to gather temperature data along multiple shipping lanes. The

stability data and the temperature data collected along the

shipping lanes should be represented by origin and destination

routes.

geographies. With the involvement of a Quality Department, representation of the seasonal dynamics of each lane.

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

Most regulatory agencies require an analysis of peak hot and cold

After completing the first two primary tasks: defining and

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

improving stability knowledge for the products in question,

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

and understanding the ambient temperature expectations for

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

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

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

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

route. Shipments going from the northern hemisphere to the

against the TABT associated with the applicable routes will

southern hemisphere (and vice versa) typically see the most

result in groupings of products and routes. These groups will

extreme change in temperatures.

include products that have similar stability requirements.

it is possible to establish optimal targets to ensure a broad

Routes will also be grouped based on severity, some routes will Data from enough shipments should be collected to be

be more moderate and others more extreme during specific

considered statistically reliable. While the International Safe

times of the year.

Transit Association (ISTA) recommends a sample size of 25 shipments per variable such as: origin, destination, carrier, and

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

mode of transportation, statisticians, according to the central

where additional protection (specialty packaging or logistics

limit theorem, typically require a minimum of 30 samples to

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

attain minimum reliability. The ultimate goal of the shipping

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

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

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

product or shipment may experience and to quantify and predict

logistics department in planning transportation needs.

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

Depending on the amount of thermal variability along a given

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

route, a decision tree may be helpful in managing overall

newly developed Risk Controlled Ambient Thermal Profile

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

(RCATP) methodology provides a means of quantifying the risk

develop a process that allows the organization to make cost

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

effective decisions on distribution and monitoring requirements.

addition, this methodology uniquely allows for modifications to

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

the created profile based on risk tolerance.

solutions including: carrier, temperature control requirements, service level, and monitoring requirements.

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

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The decision tree (see Figure 2) can be enhanced with weather information to make a predictive model.

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 The decision tree allows the organization to see what

Ambient Temperature Profiles, Package Qualifications, Cold

temperatures are predicted along a given route, and predict

Chain Assessments, Gap Analysis, and Continuous Process

through the model what to expect for product temperatures.

Improvement through ongoing monitoring. These cold chain

From this predicted product temperature, the correct thermal

visibility solutions enable Sensitech customers to make decisions

protection can be selected.

that meet regulatory requirements, impact product quality and improve profitability.

Conclusion Mark worked previously at United Parcel Service for sixteen The steps required to cost effectively manage the distribution of

years as an Industrial Engineering and Operations Manager.

CRT products include:

While at UPS, Mark completed numerous projects as a Project Manager focused on supply chain and warehousing

• Evaluation of stability data

improvements.

• Expansion of stability data • Thermal mapping studies

Mark earned his Masters in Industrial Engineering and Bachelors

• Shipping lane studies

in Architecture from the University at Buffalo.

• Ambient temperature analyses • Time above and below analyses

Olivier Simonnot

• Product route matrix • Decision tree defining protection and monitoring requirements

Olivier Simonnot has been working for Sensitech Inc., UTC Building & Industrial Systems, a unit of United Technologies Corp., for eight years

Understanding the requirements of specific products and

and currently holds the position of Strategic Market Manager,

expanding the stability range for each product may be more

Life Sciences EMEA. He previously held several positions in

cost effective than temperature controlled logistics. Grouping

Marketing and Product Management in several international

products by similar stability requirements and comparing them

technology oriented companies. He holds a Master of Science

to the ambient temperature analysis from a Shipping Study

in Telecommunications from the French engineering school

enables an organization to implement a risk-based approach

ESIGETEL and a Master in Business Administration from the

to define the most effective protective logistics and monitoring

Rotterdam School of Management. He is an active member

schemes possible.

of the French Cold Chain Association, participated in the subcommission on Metrology and Risk Assessment and is currently active in the Last Mile and New EU GDP working groups.

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

Increased demand for generic pharmaceutical products and

increasing demand for daily products, fruit and vegetables, along

consumption of perishable foods in developing economies is going

with increased exports of these products has boosted the cold

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

chain market.

next few years. With this demand for better visibility of products in the logistics networks, to minimise wastage, and to ensure

In the Asia-Pacific region, various government initiatives are

product integrity, technology that enables better monitoring

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

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

opening mega food parks, which require temperature controlled

logistics networks.

vehicles and temperature controlled warehouses. In India, the government has also allowed 100 percent FDI (foreign direct

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

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

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

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

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

increased consumption of frozen foods.

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

increased investment in cost effective technologies in developing

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

markets, especially India, is motivating vendors to enter these

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

regions.

compound annual growth rate (CAGR) of 15.6 percent from 2014 to 2019, according to Research and Markets. It also suggests that

Technology becomes critical in enhancing and assuring product

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

integrity

cold chain market in 2013. The market is mature in regions such as North America and Europe, due to the technologically advanced

To meet these requirements, both in food and pharmaceuticals,

systems for refrigerated storage & refrigerated transport, the

there is growing investment in healthcare infrastructure and

rise in demand for perishable foods, and government initiatives

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

that encourage the export and import of perishable foods in these

of transport vehicles equipped with event logging and electronic

regions.

monitoring systems, to enhance the effectiveness of supply chains.

Healthcare logistics cold chain requirement grows too

In fact, this was a key area of discussion at the Cool Chain & Controlled Room Temperature Logistics Conference in Frankfurt,

Healthcare products, such as vaccines and blood plasma products,

Germany in January 2015. Among the discussions that took

frozen pharmaceuticals and insulin, require specific temperatures

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

to be maintained throughout storage and transportation. The

temperature data can be used to improve and better control the

increased demand in developing economies for these and

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

other pharmaceutical products has created a pressing need for

how implementing a centralised global database can enable an

temperature sensitive healthcare transportation with the use of

overview of all excursions and provide complete insight into the

temperature tags on products.

cold chain, and overcome fears of using â&#x20AC;&#x2DC;cloudâ&#x20AC;&#x2122; storage.

Recognising this, research firm TechNavio, says that the global

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

healthcare cold chain logistics market is expected to grow at a

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

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

use of machine to machine (M2M) communications, which

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allows sensors to send real time data via mobile and wireless

This will be especially significant as the volume of temperature

communications networks, will generate lots of data. This data

sensitive products that are shipped around the world grows;

might be continuous readings of temperature or other key

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

business critical parameters that need to be monitored.

prove integrity will become more important, since pharmaceutical companies will need the proof to be able to sell their products. The

Systems like Dyzleâ&#x20AC;&#x2122;s cold chain monitoring platform send the huge

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

volumes of data generated by these sensors to secure storage

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

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

interpret that data according to the market requirements.

and for reporting. This data is often used both for historic recording processes, as well as to produce automated reports

Nitin Dahad is Senior technology marketing

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

and media specialist at TechSpark Limited

helps to assure customers and consumers that the products are safe to use. Technology such as this will therefore become critical

Nitin is an established business communicator,

in reporting key business performance indicators (KPIs), and

knowing how to turn complex business/

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

technology issues into messages that can be

management process.

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A sustainable solution for temperature controlled urban distribution

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Growing environmental pressure for change

formation of dry ice in the evaporator. After the liquid R-744 vaporizes causing the temperature to lower in the insulated box,

Since the late 1930s, transporting temperature sensitive goods

the vapor is vented outside the box through an exhaust muffler

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

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

global warming potential (GWP) refrigerants to maintain cargo

safety of operators and goods.

at the optimum temperature. Today, internal combustion engines have become quieter, more fuel efficient and cleaner. Nevertheless

A system defined by what it lacks

the dependence on fossil fuel and hydrofluorocarbon (HFC) refrigerants remains.

The system is more notable for what it lacks rather than what it possesses. The truck or trailer unit is cooled with virtually no

Regulations and social pressure have dramatically changed the way

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

transporters operate in the European Union (EU). Environmental

HFC refrigerant.

sustainability is a top objective of legislators determined to phase out high GWP refrigerants, control exhaust emissions and limit noise in densely populated areas.

The recovered R-744 in the Thermo King CryoTech systems An alternative to fossil fuels and HFC refrigerants

is obtained as a by-product from industrial processes that would otherwise have been released into the atmosphere.

For the past 15 years, the manufacturer of transport temperature

As such there are no new carbon dioxide emissions during

control systems, Thermo King, has focused on developing a

operation of the CryoTech system.

solution that would meet the future need for an alternative to the fossil fuel or HFC technologies on which the transport industry

Operating costs similar to diesel

has depended for so long. In the 1930s, Thermo King pioneered transport temperature control and they have remained the leading

The cost of operating a CryoTech unit over its lifecycle is

innovator in this industry ever since.

broadly comparable to that of an equivalent conventional diesel powered unit, although specific applications may favor

How the system works

one or the other. The initial cost of the unit is likely to be slightly higher, due to current low manufacturing volumes.

The company’s alternative approach, which remains unique in

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

transport refrigeration today, involves the use of recovered and

components and fewer “wear” items.

commercially available liquid carbon dioxide (R-744) in an indirect open-cycle system. Unlike other ‘cryogenic’ approaches which

Cooling performance and noise

spray the refrigerant directly into the load space, the Thermo King CryoTech range uses fin-and-tube evaporators as heat exchangers

It has been proven that CryoTech evaporators deliver

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

significantly more cooling capacity than their diesel equivalent

before it is vented to the outside of the vehicle.

at both fresh and frozen box temperatures. Pull down of an empty box can be up to four times faster with R-744, making

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

it an excellent choice for distribution operations with a high

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

number of door openings.

It flows to the remote evaporators, one of which is installed in each compartment allowing up to three temperatures on one vehicle.

With more countries considering the introduction of noise

An electronic expansion valve managed by the electric control

limits on evening and night deliveries – following the example

module regulates the flow of liquid through each evaporator

of the PIEK standard in the Netherlands - urban distribution

thereby varying their cooling capacity to match the demands of

operations wanting to take advantage of low traffic volumes

the load and maintain a steady temperature.

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.

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

The environmental impact of the system

state (into a gas) as its pressure drops on leaving the expansion valve and rapidly absorbs heat energy in the process. A regulator

But is the CryoTech solution actually more environmentally

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

sustainable?

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Engineers at Thermo King performed a detailed carbon

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

footprint calculation on three equivalent systems. The

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

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

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

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

been made in this area.

to a different “alternative” approach using liquid nitrogen as a refrigerant. The study measures the environmental impact, or

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

“carbon footprint” of each solution.

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

The comparison took into account significant sources of carbon

filling stations were in operation in eight European countries and

dioxide emission from cradle to grave, including emissions

the number is expected to grow in the coming years.

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

Thermo King has demonstrated its commitment to this technology,

independent ATP test data only applicable to diesel units.

investing heavily in future product research and development, as well as the expansion of the filling station network.

As expected, the diesel unit’s carbon emissions were largely due to burning of this fossil fuel. Although the nitrogen unit

Over the past decades, the science of transport refrigeration has

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

advanced dramatically and the next years will no doubt bring about

itself requires about three times more energy to produce than

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

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

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

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

on traditional fuels and HFC refrigerants. Industry leaders like

as follows:

Thermo King are applying current and emerging technologies to help their customers achieve sustainable and quiet transport

• Diesel unit

166 tons

• Nitrogen unit

143 tons

• CryoTech unit

46 tons

refrigeration.

1 Engberg P., Widheden J., Eriksson E., Life Cycle Analysis of temperature controlled foods by truck transport, Report, CIT Ekologik AB, A Chalmers Indusriteknik Company.

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.

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

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

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

providing reduced noise levels and emissions, while maximizing

and pharmaceutical delivery companies are just a few businesses

performance, efficiency and

that benefit from rental vehicles for their temperature controlled

reliability. With a choice

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

of two or three blower remote evaporators that

To meet the growing demand for renting temperature controlled

can be used in a number of

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

different

recently expanded its national fleet with vehicles featuring leading

customers can additionally

edge refrigeration units from Thermo King, a manufacturer of

benefit from the flexibility

transport temperature control solutions for a variety of mobile

to accommodate different

applications and a brand of Ingersoll Rand.

distribution operations.

The new temperature controlled vehicles are equipped with the

The Thermo King V-Series

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

range of vehicle-powered

V-300 Max Spectrum on pharmaceutical specification Mercedes-

units provides customers

Benz Sprinter vans and the T-1000 Spectrum diesel powered

with highly flexible and

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

reliable solutions for vans

compliment the high standards expected by Enterprise Flex-E-

and trucks offering choice

Rent, offering customers unsurpassed versatility, efficiency and

of

ease of operation.

electric stand-by and multi-

configurations,

heating

capabilities,

temperature options.

The units have been delivered by Thermo King Northern, a member of the most extensive dealer network in the industry, and

Higher

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

performance

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

provide customers with the

maintenance contract from Thermo King Northern to ensure it is

required cooling capacity

maintained in the optimal condition for maximized uptime.

at all temperatures and

efficiency

and

standards

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

recovery

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

door

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

distribution

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

Continuous monitoring of

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

the load and temperature

UK and its approach to providing us with long term commitment

control is easy to operate

and a comprehensive nationwide support service is key in enabling

through the Direct Smart

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

Reefer microprocessor control.

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

About Ingersoll Rand and Thermo King

from

openings

multiple during

operations.

the latest Thermo King units and providing a whole life cost solution to support their flexible operation,” said Andrew Davis,

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

account manager at Thermo King Northern. “With decades of

comfortable, sustainable and efficient environments. Our people

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

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

our reputation as a trusted business partner to the temperature

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

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

transport temperature control industry providing sales and after-

food and perishables; and increase industrial productivity and

sales service. Thermo King Northern was the first Thermo King

efficiency.

dealership in the UK and one of the first in Europe to achieve Platinum status- the highest ranking award- in the company’s

Thermo King Corp. was founded in 1938 and manufactures

Progress to Excellence programme. As a committed customer

transport temperature control systems for a variety of mobile

focused company has strategic locations throughout the country.

applications, including trailers, truck bodies, buses, shipboard containers and railway cars. We are a $13 billion global

For more information visit www.thermokingnorthern.com

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 www.the-logistics-portal.com

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//INDEX OF ADVERTISERS IFC

Sensitech

5

Sofrigram

7

Softbox

9

JAL Cargo

11

Berlinger &Co AG

13

IATA

17

Cargolux

19

UPS

23

Biotech

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