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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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM S/S 2015
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
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© 2015. Sensitech Inc. All rights reserved.
Melbourne
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//MAIN CONTENT
TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM S/S 2015
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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
14
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
20
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.
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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
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+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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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
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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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