THE LOGISTICS PORTAL MAGAZINE
TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE
Issue 7 - 2014
KEEP YOUR
COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
TLP Insight: a journal for the life science logistics industry AIR CARGO - RFID - TEMPERATURE CONTROL - CLINICAL - BIO PHARMA - LOGISTICS
//MAIN CONTENT
TLPINSIGHT THE LOGISTICS PORTAL MAGAZINE
MANAGING DIRECTOR Lee Atkinson MANAGING EDITOR Bridget Langston CONSULTANT EDITOR Tony Wright
8
The challenges of warehousing for clinical supplies companies
Rachel Griffiths is Associate Director of Operations at Biotec Services International, where she has responsibility for the warehouse, production and project management. Here she shares her wide range of experience with us regarding the challenges clinical supplies companies face when they need to establish warehousing systems that are flexible and affordable.
SENIOR DESIGNER Joey Graham info@designedbyjoey.co.uk
EDITORIAL ASSISTANTS Nicholas Ridgman Jamie Ward CIRCULATION MANAGER Tony Williams SALES Rakesh Makwana, Lee Atkinson, Amy Firth
FEATURED ARTICLE
ADMINISTRATION Katie Galelli WEBSITE DESIGN Knut Henriksen
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 EC1V 4PW United Kingdom
13
Keep your cool: The ultimate guide to effective temperature control in refrigerated transport
David Thorley, Global Refrigeration Specialist for Navman Wireless outlines in this guide the general concepts of transport refrigeration systems plus current legislative requirements and also explores ways in which temperature monitoring systems can be used in practice to help improve temperature control and simultaneously drive down operating costs.
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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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 07 - 2014
//FEATUREDCONTENT
42
It’s a risky business
Brian Kohr is President and CEO of CSafe Global and in this September 2014 White Paper he looks at quality risk management in the distribution of temperature-sensitive pharmaceuticals, where there is an increasing emphasis on shippers and manufacturers taking ultimate responsibility for examining their supply chains using a ‘risk-based’ approach.
44
A sustainable solution for temperature controlled urban distribution
Anthony Bour of Thermo King provides us with a comparative study between Thermo King’s unique approach to temperature control and conventional diesel systems, demonstrating how industry leader Thermo King is applying current and emerging technologies to help their customers achieve sustainable and quiet transport refrigeration.
48
The knowledge gap: classification and labelling/marking of dangerous goods
Authors Herman Teering, Managing Director and Panos Drougas MSc, Senior Chemical Consultant of DGM Software Development Group give us the background, explanation and different answers to the question, ‘Who is responsible for the correct classification and labelling/marking (of hazards) of substances and mixtures?’
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//TLP INSIGHT FOREWORD September 2014 and we are heading here at TLP Insight, towards the end of our second successful year of publication. We are very pleased to have once again, a range of articles reflecting the challenges facing the life science logistics industry from different perspectives. From the world of clinical supplies companies, Rachel Griffiths, Associate Director of Operations at Biotec Services International, gives us the benefit of her experience in her article about the provision of billable and commercially viable warehousing systems. From the world of temperature control, specialist, David Thorley, from Navman Wireless gives us plenty to chew over in his thorough and informative guide to effective temperature control in refrigerated transport. And Anthony Bour from Thermo King provides a comparative study, which can assist companies with finding sustainable and quiet transport solutions when delivering in urban areas. Risky business is the order of the day for Brian Kohr, President and CEO of CSafe Global, giving us some timely information in the current climate of increased regulatory activity in Risk Management. And what can be riskier than the handling of dangerous goods? Herman Teering, Managing Director and Panos Drougas MSc, Senior Chemical Consultant of DGM Software Development Group need do little to persuade us of the merits of finding answers to the question of who has responsibility in the classification and labelling of hazardous substances! In our very first issue we were very clear about our intentions – we set out to create a unique publication that would promote understanding of the different problems different players in the market face – from technology and software to shipment and air cargo and we are proud at TLP Insight to have been able to maintain that vision.
Lee Atkinson Managing Director Intensive Media
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The
CHA ENGES
of warehousing for clinical supplies companies. Rachel Griffiths
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 clinical supplies companies must supply storage
all within a pallet location would be a cheap storage solution but
and warehousing which will comply with Good
a major non-compliance in terms of GMP as the material would
Manufacturing Practice (GMP) regulations. It must
not be sufficiently segregated and warehouse operators would be
maintain temperature, be fully monitored and
picking different drug and placebo from the same location. Once
provide product segregation. However, for clinical
picked these materials are identical and the chance of mix up in
supplies companies which provide this storage as
this situation is very high which could lead to catastrophic results
a chargeable service to its clients, the storage and
for the trial and place patient safety at severe risk.
warehousing must also be billable and commercially viable.
For companies who have very large amounts of available controlled temperature pallet storage space (e.g. at -20°C
Therefore companies need to establish warehousing
and 2-8°C), they may be able to easily accommodate using six
systems that are flexible and affordable. When clients
pallet locations for half a pallet’s volume of material and offer
are paying for storage they do not want to pay for
the storage at a low enough cost that the client can afford it.
‘air space’. Equally the storage providers do not want
However, there will come a time when they will run out of space
to waste storage space by placing a small quantity of
and either need to build additional storage space, which is costly
product in a large location as this reduces the volume
and may take a long period of time, or maximise the capacity from
of space available for use by other customers.
the current warehouses. For other providers, particularly those specialising in niche products, they may have limited controlled
One way of achieving the balancing act between
temperature storage capacity and separate pallet locations for
what clients will pay vs. maximisation of warehouse
each product is not an option.
capacity is to use variable location sizes. A simple solution is to have a number of different size storage
Location, location, location:
locations. These could be provided by using variable size racking
Within clinical trial supplies, particularly for cold
location to subdivide the space. The product could then be placed
chain materials, there may be a relatively small
within its original packaging, into the bins for storage. Each bin
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options or by placing different sized boxes or bins within a pallet
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would have a storage location within the stock control
new storage warehousing.
system and so be traceable. The benefits of pallet vs. variable location size have been This allows good segregation of product, storage
considered for bulk unlabelled materials. However the use of
location sizes can be selected based upon the volume
smaller locations comes into its own when considering packed
of the product, it minimises the ‘wasted’ space of pallet
clinical trial materials that are serial numbered. Routinely, clinical
locations for small volumes of materials and therefore
trial materials are packed in separate assembly operations
maximises the available space that can be used, and
for each drug strength, drug type and placebo. These packed
therefore sold, within the warehouse.
products are identical and are only identifiable by the serial number (kit number) printed on their labels which will be directly
The problem is solved!
linked to the randomisation number assigned when the trial randomisation was established. Routinely, orders are received for
If it were that simple even companies who have very
shipment containing a list of kit numbers that need to be picked
large amounts of available controlled temperature
and sent to the site. More often than not, the numbers selected
pallet storage space would adopt this method. The
are across the range of the available packed product and not in
difficulty comes in accurately charging the client for
sequential order, as this helps maintain the trial blinding.
the space they are using and providing the client with an upfront estimation of storage costs.
If packed kits were palletised it would involve the whole pallet being taken apart to complete an order. Even if kits were placed
Charging variable size locations:
into sequential order in smaller boxes and then onto a pallet, all
Obviously, any business selling a service needs to ensure that it can do so at a profit. Companies with large volumes of available storage capacity can sell pallet locations relatively cheaply. The product is in single locations with a single price and calculating what to charge them at the end of the month involves adding up the number of pallet locations and multiplying it by the agreed cost. The profit per location may be small but the maintenance and administration cost is small and so it can still be profitable. Using variable locations sold at variable prices becomes more complicated to administer, as each month the quantity and volume of each location used by the client and the agreed charge for that location has to be calculated. In some instances this can involve warehouse staff physically counting
(Example of bin locations in a vertical lift).
used locations and location sizes and finance departments converting these into capacity charges. Therefore
the boxes on the pallet may need to be opened or moved to obtain
the administration costs for this method are potentially much
the kits required to complete the order. This results in
higher. large time delays to complete picking operations for shipments Additionally, clients who pay by volume used rather than pallet
and increases the potential to mis-pick a kit. If kits are placed
location are more aware of the volume of their product; if they
in relatively small, adjacent, locations which can be identified
have shipped a large amount of product from the warehouse
on the pick list then it is easier for the picking operator to find
they expect to see a reduction in storage cost. Therefore you
the required kits and select them without moving large amounts
may need to have a system in place to consolidate stock and
of boxes. Ideally, vertical lift or carousel systems with trays
storage locations at agreed time points within a trial. You may also
containing the product in a small location can be utilised which
have more invoice queries relating to capacity, which takes up
allows kits to be quickly located and easily removed. An additional
additional finance and project management time. Hence the direct
benefit of a lift system is that they take up a relatively small foot
and indirect administration of a variable size storage location
print for a very large storage capacity and so are ideal where
system compared to a pallet location system is higher, but must be
space may be a constraint.
considered alongside the capital cost and practicality of providing
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Using smaller locations is ideal for serial numbered clinical trial
must be booked into its location and the specific location should
kits, but this model requires a different method of charging than
be assigned a volume. For example, where the unit costs are in
pallet locations.
litres every location needs to be assigned a volume in litres.
Traditionally, proposals are prepared for clinical trial supplies with
One method for fast and secure location of stock is via 2D matrix
an estimated cost for storage at different temperatures based
or barcodes. Upon receipt each packaged unit of drug product
upon the client’s forecast for when products will be received,
(e.g. box or tray) has a barcode or matrix attached which details
packed and shipped to site. These forecasts will always be wrong
part number, quantity and batch number. Each location and
as manufacturing time scales change, regulatory approvals are
sub location is barcoded, and so when the product is placed
delayed and patient recruitment will be different to that planned.
into storage the barcode of the product and the barcode of the location are scanned and linked in the stock system. Each month
Using the pallet method of storage, it is simple to predict the
a report can then be generated per location or per product
storage volumes for inclusion in proposals. Allocate one pallet per
identifying the location and assigning a volume being used. This
product, per batch for bulk materials and another one or two for
removes some the additional administration of using variable
packed blinded product. These will be required throughout the
stock location sizes.
trial or can be aligned to packing operations at agreed time points throughout the trial. Difficulties arise when variable storage
In summary, where storage is a billable service there are
locations are used. For example materials may be received in
additional administration costs for monthly billing to clients both
pallet quantities, but once packed they will be located into a
for finance and warehouse. If a company has a large amount of
vertical lift system. There may be two cost lines on the proposal,
spare capacity then simple pallet locations would probably be the
one for pallet storage at the agreed temperature and one for a
most cost effective method of storage of bulk unpacked materials.
location in the vertical lift. However, can the distribution of the
Finished kits, particularly when they are serial numbered, require
costs between the two types of storage location be estimated on
smaller storage locations to enable efficient picking for shipment.
the proposal? It may be that you have pallet locations until the
Where capacity is limited, variable size storage locations would
predicted packing times and then smaller locations in the vertical
offer more efficient use of available warehouses and possibly
lift until the end of the trial, but product in the lift will reduce over
provide better value to the client. However, these require far
time as it is shipped to site so this needs to be accounted for. It is
greater administration and can result in a greater number of
not impossible to calculate, but much more complicated and again
client queries both at the proposal stage and during projects as
adds to the administration costs for using variable locations.
accurate predictions of capacity across the duration of a project are virtually impossible to model and so the actual cost of storage
One method that has been used to try to simplify this issue is to
may vary significantly from the original forecast.
convert all unit pricing into litre costs. Therefore a pallet location
Rachel Griffiths – Associate Director Rachel joined Biotec is 720 litres, each smaller location can be assigned its volume in
Services International in
litres and based on the volume of product being delivered and
2004. In her current role
the volume of the packaged kits an estimate of the total number
as Associate Director of
of litres of storage can be calculated. This at least results in only
Operations, Rachel has
one cost line per storage temperature, but still involves a lot
overall responsibility for the
of guess work to estimate the volume of storage required for a
warehouse, production and
project. And clients may find it difficult to visualise the storage
project management. She has
requirements when based upon litres and locations.
a wide range of experience previously acquired in roles
Traceability of product in storage locations.
that include: Development Scientist, Technical Support Scientist
Traceability of product is an essential part of GMP. If you are
University.
using a method of charging clients based upon locations used, it is
www.biotec-uk.com
essential that you know which client’s product is in which location and the size of the location. Therefore upon receipt, the product
and Product Support Specialist at Ortho Clinical Diagnostics. Rachel holds a degree in Microbiology and Virology from Warwick
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Stay Compliant Effective immediately, use the 54th Edition of the DGR Manual or your shipments may be at risk. If you’re not using the 54th Edition of the DGR Manual your dangerous good shipment may not be compliant. Don’t risk having your shipment returned or being fined thousands of dollars because of faulty documentation, packing or labeling. Get the 54th edition of the DGR Manual today and be current with the latest regulations for completing the Shipper’s Declaration. Remember, if you use previous editions, you are knowingly putting yourself and your company at serious risk.
iata.org/dgr
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KEEP YOUR
COOL The Ultimate Guide to
Effective Temperature Control
in Refrigerated Transport Presented by
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TLPINSIGHT 13.
KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
Introduction Transporting temperature sensitive goods can be a very demanding task. Maintaining product at the correct temperature whilst meeting exacting delivery schedules is a challenge faced by all managers of refrigerated fleets. With the consequence of a rejected load being so expensive, many businesses can benefit enormously by utilising an effective temperature monitoring system to help mitigate their risk. The aim of this guide is to describe ways in which temperature
the temperature and location of this product provides peace of
monitoring systems can be used to improve temperature control
mind for fleet managers and instils confidence in their customers.
during transportation and simultaneously help to lower operating
Knowing as soon as the temperature deviates outside of
costs.
acceptable conditions can be the difference between an accepted or rejected load and this offers huge savings potential. In addition
Temperature monitoring for refrigerated vehicles can be
maintaining refrigerated foodstuffs at the optimum temperature
undertaken in a number of different ways. This includes individual
can help prolong shelf life and thereby reduce wastage.
battery operated data loggers that accompany the product, air temperature recorders that are permanently fitted to the vehicle
There are clear benefits in reacting to deviations in temperature;
and complete telematics systems that provide live updates of
however, to gain the most value from any temperature monitoring
temperature status and vehicle positional information.
system, businesses need to use the data to identify areas where improvements can be made and then drive operational change,
All these systems have value in helping to improve refrigeration
designed to prevent deviations from happening in the first place.
performance but when temperature monitoring is integrated with
This is probably the biggest challenge that operators face –
vehicle tracking and telematics, users can employ the combined
making effective use of the data collected in order to implement
system to gain a more complete picture of fleet performance. In
change and drive improvement.
addition the live data provided will help to anticipate temperature related issues and enable immediate remedial action to be taken.
However, this is another area where a live telematics based
This improves efficiency and simplifies record keeping whilst
monitoring system has clear benefits. Most operators will train
doing everything possible to ensure that temperature controlled
their drivers and employ standard procedures for them to follow
goods are delivered in the best possible condition.
but once the vehicle leaves the depot it is extremely difficult to confirm that the procedures are being followed. Live data capture
Nowadays it is not uncommon for the value of a trailer load of refrigerated foodstuffs to exceed ÂŁ100K. Having visibility of both
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can help overcome this issue.
ereby help to extend shelf life. This concept applies to frozen and chilled uff, pharmaceuticals and certain aspects of livestock. It can also apply us types of high value specialist products such as antiques and musical ments.
re controlConcepts in refrigerated appliesrefrigeration consumption. However the vehicle refrigeration system is oftransport transport systems nd chilled temperatures generally in the not designed to change the temperature of the products o Chain can be described as the processbeing involved in the storage distribution -30oC toThe +15Cold C. However since the ambient transported, it isand only intendedoftotemperature maintain the o sensitive perishables the temperature and/ or atmosphere shouldproducts be controlled to maintain product re can vary from lows of -20 where C in northern temperature of these during the transportation o quality, product safety and thereby shelf life. This concept applies to frozen and chilled foodstuff, e countries during winter to highs of +40help C into extend process. pharmaceuticals certain aspects of livestock. It can also apply to various types of high value specialist limates during summer itand is also advantageous Any Cold Chain should be managed by a quality such antiques and musical igerationproducts system to beasable to generate heatinstruments. as management system. This will require the process to ability to refrigerate. be analysed, measured, controlled, documented, and Temperature control in refrigerated transport applies to frozen However the vehicle refrigeration system is not designed to g temperature sensitive goods at the correct validated. The food industry uses the concepts of Hazard o and chilled temperatures generally in the range from -30 C to change the temperature of the products being transported, it re during+15 transport is necessary to prevent Analysis and Critical Control Point, HACCP, as a means o C. However since the ambient temperature can vary from is only intended to maintain the temperature of these products of pathogenic micro-organisms and countries the likeduring winter of undertaking these important quality management o C in northern hemisphere lows of -20 during the transportation process. o ld otherwise make unfit for use or it isprocedures (see section 3.1.1). C inproduct southern climates during summer also to highs of +40the advantageous for the refrigeration system to be able to generate
Any Cold Chain should be managed by a quality management
heat as well as the ability to refrigerate.
system. This will require the process to be analysed, measured, controlled, documented, and validated. The food industry uses the
Maintaining temperature sensitive goods at the correct
concepts of Hazard Analysis and Critical Control Point, HACCP,
temperature during transport is necessary to prevent the
as a means of undertaking these important quality management
growth of pathogenic micro-organisms and the like which would
procedures.
How the refrigeration system works otherwise make the product unfit for use or consumption.
How the refrigeration system works
ing to the Laws of Physics there is no such thing as cold, only heat or According to the Laws of Physics there is no such thing as cold, only heat or lack of it. Cold is a human sensation it. Cold is a human sensation that can be felt but cannot be measured. that can be felt but cannot be measured. However, it is possible to extract heat to make something colder. er, it is possible to extract heat to make something colder. A refrigeration system is essentially a heat pump. It does work to move heat from one location to
tion system is essentially a heat pump. It does another. The most common type of refrigeration ove heat from location to another. The system one employed in the transport industry is the mon typevapour/compression of refrigerationcycle system employed system. This uses a sport industry is thea hydrocarbon vapour/compression gas, typically compound, which can changeaphase gas is alternately m. This uses gas, repeatedly typicallyasathe hydrocarbon compressed and allowed to condense form a , which can change phase repeatedlyto as and is then expanded so that it evaporates lternatelyliquid compressed and allowed to back into a gas. The evaporation process draws in o form a liquid and is then expanded so that heat from the air surrounding the evaporator and es back into a gas. The evaporation process the condensation process gives out heat to the air eat from the air surrounding surrounding the condenser.the See evaporator Figure 1. ndensation process gives out heat to the air g the condenser. See Figure 1.
Compressor
Warm Air
Cold Air
Condenser
Evaporator Expansion Vale
Heat Transfer Figure 1 – Vapour compression refrigeration system
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KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
In a conventional vapour/compression transport refrigeration
In a conventional vapour/compression transport refrigeration system the compressor is located outside the compartment and the evaporator is located inside the refrigerated compartment and the evaporator is located refrigerated compartment. The cold air adjacent to the inside the refrigerated compartment. The cold air adjacent evaporator is then forced around load space by powerful to the evaporator is then forcedthe around the load space fans. Assuming that fans. the product is properly distributed the by powerful Assuming that the product isthrough properly load space to through allow thethe coldload air to circulate evenly, hasairthe distributed space to allow thethis cold to circulate evenly, this has the with effect of surrounding the effect of surrounding the product a blanket of temperature product with a blanket of temperature controlled air. controlled air. See Figure 2. See Figure 2. system the compressor is located outside the refrigerated
ItIttherefore that product loaded ontoonto the the vehicle at the thereforefollows follows that product loaded vehicle
at the correct temperature and which is surrounded correct temperature and which is surrounded by a blanket of air a blanket of air at the correct temperature, be atby the correct temperature, will be transported andwill delivered also and delivered also at the correct temperature. attransported the correct temperature. This is the main reason why air temperature and not product is measured in order tonot assess This is the temperature main reason why air temperature and product product quality. temperature is measured in order to assess product quality.
Refrigeration Unit
A typical thethe A typical refrigerated refrigeratedvehicle vehiclecomprises comprises following fundamental elements regardless of of following fundamental elements regardless whether itit is whether is aavan, van,truck truckorortrailer: trailer: • Insulated cargo space • Insulated cargo space • Internal or partitions to • Internalbulkhead(s) bulkhead(s) or partitions provide multiple compartments at different to provide multiple compartments at temperatures (optional) different temperatures (optional) • Insulated access door(s) which may be hinged or • Insulated access door(s) which may roller shutter operated be hinged or roller shutter operated • Refrigeration unit with single or multiple • Refrigeration unit with single or evaporators multiple evaporators
Air circulation
Insulation
Doors
Figure 2 – A typical single compartment refrigerated trailer showing air circulation
InInsummary thethe operating procedure for transporting summary operating procedure for transporting
temperature sensitive goods temperature sensitive goods is: is:• Pre-cool compartment and defrost if necessary • Switch off refrigeration unit before opening •S witch off refrigeration compartment door unit before opening compartment door • Insert product/load at the correct temperature • Insert product/load at the correct temperature • Distribute load properly • Distribute load properly • Surround load with air at the correct temperature • Surround load with air at the correct temperature • Minimise the time that the compartment door •M inimise the time that the compartment door spends open spends open at the point of delivery • Pre-cool compartment and defrost if necessary
at the point of delivery
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thingsbeing being equal, is followed, thenthen product AllAllthings equal,ififthis thisprocedure procedure is followed, product will be delivered at the correct temperature. will be delivered at the correct temperature. Accordingly the use of a suitable temperature and event monitoring system Accordingly the use of a suitable temperature and eventcan help confirm that the correct procedures have been followed and monitoring system can help confirm that the correct identify deficiencies or problems andidentify when they occur to assist procedures have been followedasand deficiencies orwith problems as and whenofthey occuraction. to assist with the the implementation corrective implementation of corrective action.
7
2.2 Overview of the type of refrigeration systems available As described sectionof2.1, the most common type ofavailable refrigeration system Overview of thein type refrigeration systems
employed in the transport industry is the vapour/compression system. This can be powered in the a number of ways whilst thesystem poweremployed source inmay from As described previously, most common typeand of refrigeration the differ transport industry is one model to another thecan principle of the process remains thesource may the vapour/compression system. This be powered in arefrigeration number of ways and whilst the power same. differ from one model to another the principle of the refrigeration process remains the same. However, other systems such as eutectic plates and cryogenics
However, other systems such as eutectic plates and
can be employed depending upon the specific operational cryogenics can be employed depending upon the specific
operational of the vehicle(s) concerned. requirements of the requirements vehicle(s) concerned. In addition for small refrigerated loads that are required to be for shipped mainly dry freight is the possibility In addition small with refrigerated loads that there are required to of using separate insulated containers. This is generally be shipped with mainly dry freight there is the possibility of
to volumes of less than 2000 litres for fairly short delivery
restricted to volumes of less than 2000 litres for fairly schedules. short delivery schedules.
The table in Figure 3 provides a comparison of the main The table in Figurerefrigeration 3 provides asystem comparison of the main types of transport and indicates the types of advantages and disadvantages of each. transport refrigeration system and indicates the advantages and disadvantages of each.
using separate insulated containers. This is generally restricted
Refrigeration System
Vehicle type
Advantages
Disadvantages
Direct Drive
Vans and small trucks
Low operating cost Lightweight Compact size Low emissions
Does not operate independently of the vehicle engine
Alternator Drive
Large trucks and semi-trailers
Low operating cost No emissions Lower service costs
Does not operate independently of the vehicle engine Reduces vehicle mpg
Independent Diesel Engine
Large trucks and semi-trailers
Operates independently of vehicle engine Electric operation when vehicle parked
Tend to be heavier/noisier than vehicle powered systems with higher maintenance costs
Eutectic
Vans and Trucks
Low noise No emissions when travelling
Heavy Requires depot power supply system for charging Limited range
Cryogenic
Large trucks and semi-trailers
Low noise Independent operation Rapid pull down Low maintenance
Limited range Relies on cryogenic gas being available at depots
Insulated Containers (<2000 litres)
Any
Small refrigerated loads when shipped with mainly dry freight
Generally restricted to short journeys
Figure 3 - Principal types of transport refrigeration systems
Environmental considerations There are several areas of major importance with respect to the environmental impact of transport refrigeration systems, including the following:Fuel Efficiency
Noxious Emissions
In the case of self powered refrigeration units most equipment
Transport refrigeration engines represent a very small percentage
manufacturers are actively investigating ways of increasing fuel
of the total amount of noxious gases emitted (probably less than
efficiency and utilising alternative fuel types such as bio diesel.
0.1%) even though these engines are classed as industrial rather
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KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
than automotive and have higher inherent emission levels than
Noise Levels
their automotive equivalent. There is a move towards the drive
The Piek Regulations, which originated in the Netherlands
unit complying with a Euro 5-6 type classification as this will help
in 1998 are now becoming more commonly accepted. The
minimise emission levels further.
regulations lay down maximum noise levels when loading and unloading vehicles during the night. These are 65dBA between
Global Warming Potential (GWP)
19:00 and 23:00 and 60dBA between 23:00 and 7:00. Many
There are specific EU proposals which intend to phase out the use
refrigeration equipment manufacturers now specify Piek
of so called F-gases (Fluorinated ozone friendly refrigerants) such
compliance as standard.
as R404a and R134a. This is currently most likely via a 2 stage approach covering new and existing equipment and will most likely result in the mandatory use of a natural refrigerant with low GWP by around 2020, although this is subject to confirmation.
Clearly all refrigeration systems driven from the vehicle engine will benefit from the vehicleâ&#x20AC;&#x2122;s lower polluting engine and this arrangement will result in an overall lower fuel consumption level. Of the mechanical options available utectic systems are certainly the best as far as on-road emissions and fuel consumption is concerned but such systems may not be suitable for many applications. In summary, when considering which type of refrigeration system to use it is recommended that the vehicle operator should take advice from the vehicle supplier/manufacturer and also from the refrigeration system manufacturer with respect to the most suitable technology for the application(s) concerned.
Legislation and Regulations Overview of current UK Regulations All UK food businesses should ensure that they are familiar with the Food Safety Act 1990 http://www.opsi.gov.uk/acts/acts1990/ukpga_19900016_ en_1.htm which, although has been subject to substantial change following the introduction of European food safety legislation, remains very important primary food safety legislation. It has provided the basis and a flexible framework for much domestic food law and applies to the whole of Great Britain. It concentrates on fundamental issues and leaves the detail to secondary legislation such as described below.
Hazard Analysis and Critical Control Points (HACCP) European Regulation (EC) 852/2004 on the hygiene of foodstuffs
It is therefore clear that as far as temperature sensitive products
describes the concept of HACCP. This involves identifying
are concerned, records of temperature should be made. This
any hazards that must be prevented and eliminating them or
applies both during transport and storage of the product.
reducing them to acceptable levels. This is done by identifying critical control points and setting critical limits, establishing effective monitoring procedures and implementing any necessary corrective action.
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The general requirement for temperature control is set out in (EC) 852/2004 Annex II, Chapter IX, which states:Raw materials, ingredients, intermediate products and finished products likely to support the reproduction of pathogenic micro-organisms or the formation of toxins are not to be kept at temperatures that might result in a risk to health. The cold chain is not to be interrupted. However, limited periods outside temperature control are permitted, to accommodate the practicalities of handling during preparation, transport, storage, display and service of food, provided that it does not result in a risk to health.
Food Hygiene Regulations (2006) & Due Diligence The Food Hygiene Regulations (2006) covers general food hygiene requirements for food business operators involved in foodstuff for human consumption. This involves all aspects of hygiene and includes temperature control requirements. The regulations stipulate a maximum holding temperature of 8oC with any upward variation above this maximum limited to 4 hours. It follows that when handling, storing or transporting foodstuffs for human consumption, that have to be held at specific temperatures, it will be unlikely that it will be possible to use the defence of Due Diligence for any temperature related offence unless appropriate temperature records are taken and maintained.
The Regulations also introduce the concept of Due Diligence, which is described as follows:In any proceedings for an offence under the Regulations, it shall be a defence for the accused to prove that he took all reasonable precautions and exercised all due diligence to avoid the commission of the offence by himself or by a person under his control.
Quick Frozen Food Regulations (EC) 37/2005 Regulation (EC) 37/2005 specifies the requirements for monitoring temperatures in the means of transport, warehousing and storage of quickfrozen foodstuffs intended for human consumption. It states that the means of transport, warehousing and storage shall be fitted with suitable recording instruments to monitor, at frequent and regular intervals, the air temperature to which the quick-frozen foodstuffs are subjected. (EC) 37/2005 applies to products labelled as quick-frozen or
stipulates that the recording equipment shall comply with EN
deep-frozen and this applies to all foodstuff held at a temperature
standard 12830. However a derogation currently exists for local
below -18oC. It excludes ice cream. The regulation also
distribution where a recorder need not be fitted and an easily
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TLPINSIGHT 19.
temperatures in the means of transport, warehousing and storage of quickfrozen foodstuffs intended for human consumption. It states that the means KEEPofYOUR COOL transport, warehousing and storage shall be fitted with suitable recording THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE TRANSPORT instruments to monitor, at frequent and regularCONTROL intervals, IN theREFRIGERATED air temperature to which the quick-frozen foodstuffs are subjected. (EC) 37/2005 applies to products labelled as quick-frozen or deep-frozen and this applies to all foodstuff held at a temperaturewhich belowcomplies -18oC. Itwith excludes ice cream. The is visible thermometer EN Standard 13485 regulation also stipulates that the recording equipment acceptable. shall comply with EN standard 12830. However a derogation currently exists for local distribution where a recorder is need not be and an Local distribution defined as fitted movement ofeasily goodsvisible from a thermometer which complies with EN Standard 13485 is distribution centre to a retail or catering outlet and primary acceptable. distribution generally covers deliveries from the manufacturer to
Local distribution is defined movement of goodsisfrom a regional distribution centre (RDC).asPrimary distribution also a distribution centre to a retail or catering outlet and sometimes referred to as long distance transport. primary distribution generally covers deliveries from the manufacturer to a regional distribution centre (RDC).
Primary distribution is also sometimes referred to as long distance transport. it is the responsibility of13485 the manufacturer the equipment to EN Standards 12830 and are type testofstandards and it is the responsibility of the manufacturer of the ensure that products supplied comply with the relevant standard. equipment to ensure that products supplied comply In addition all temperature monitoring equipment whether with the relevant standard. In addition all temperature a recorderequipment or an indicator should have its or accuracy verified monitoring whether a recorder an periodically in accordance with EN Standard 13486 (see indicator should have its accuracy verified periodically in section accordance with EN Standard 13486 (see section 5.9) 5.9)
The table in figure 4 summarises the regulations described and4their relevance food type described above The tableabove in figure summarises thetoregulations (frozen/chilled) and distribution sector (primary/local). and their relevance to food type (frozen/chilled) and distribution
EN Standards 12830 and 13485 are type test standards and
sector (primary/local).
Chilled Food Primary Distribution
Local Distribution
Frozen Food Primary Distribution
Local Distribution
HACCP 852/2004 Food Hygiene Regulations 2006 Frozen Food Regulations 37/2005 Due Diligence Temperature Data Records Required Data Logger (EN 12830 compliant) Indicator EN 13485 compliant)
Figure 4 â&#x20AC;&#x201C; Summary of regulations applicable to the transport of foodstuffs
UK Requirements for transporting Chilled Food Chilled foods, for reasons of safety and quality, are designed to be stored at temperatures at or below 8 oC, targeting 5oC throughout their entire life. However an upward variation above 8oC is allowed providing that this is limited to a total of 4 hours maximum. Chilled foods generally receive minimal processing and
In England, Wales and Northern Ireland food that is likely to
temperature is the principal controlling factor in their safety. The
support the growth of pathogenic micro-organisms or the
commercial storage of chilled foods must comply with The Food
formation of toxins must be kept at a temperature of 8oC or
Hygiene (England) Regulations 2006 (SI 2006/14); The Food
below. The requirement applies to foods, including raw materials
Hygiene (Wales) Regulations 2006 (SI 2006/31 (W.5)); and; The
and ingredients, at all stages of preparation, processing,
Food Hygiene Regulations (Northern Ireland) 2006 (SR 2006
transport, storage and display for sale within the manufacture,
No 3).
retail and catering sectors.
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to a total of 4 hours maximum. Chilled foods generally receive minimal processing and temperature is the principal controlling factor in their safety. The commercial storage of chilled foods must comply with The Food Hygiene (England) Regulations 2006 (SI 2006/14); The Food Hygiene (Wales) Regulations 2006 (SI 2006/31 (W.5)); and; The Food Hygiene Regulations (Northern Ireland) 2006 (SR 2006 Nothe 3). requirements are different. Any person in In Scotland respect of commercial or food premises whoiskeeps Inany England, Wales operation and Northern Ireland food that likely
to support the growth of pathogenic micro-organisms food outwith a refrigerator, a refrigerated chamber or a cool or the formation ofof toxins must be kept the at afood temperature ventilated place is guilty an offence unless is held atof o
8 C or below. The requirement applies to foods, including over 63 C. As there is no specific temperature mentioned for the raw materials and ingredients, at all stages of preparation, chilling ofprocessing, foods that transport, are likely to support bacterial is storage and display growth for sale itwithin the manufacture, retail and catering sectors. recommended that if the food storage place chosen exceeds 8oC o
then the shelf life of the foodstuff may need to be reduced. Food
In Scotland the requirements are different. Any person in respect of any commercial operation or food premises who keeps food outwith a refrigerator, a refrigerated chamber or a cool ventilated place is guilty of an offence unless the food is held at over 63oC. As there is no specific temperature mentioned for the chilling of foods that are likely to support bacterial growth it is recommended if the food storage place chosen should be kept that at ambient temperature for the shortest time o C then the shelf life of the foodstuff may exceeds 8 possible. need to be reduced. Food should be kept at ambient temperature for the shortest time possible.
There is no specific regulation concerning mandatory fitment or
There is no specific regulation concerning mandatory use of temperature monitoring devices (indicators or recorders) fitment or use of temperature monitoring devices for the transport of chilled howeverof the Due Diligence (indicators or recorders) forfood, the transport chilled food, however the Due Diligence aspect of the Food aspect of the Food Hygiene Regulations impliesHygiene that temperature Regulations implies that temperature records should be records should be maintained. maintained (see section 3.1.2 above).
Product
Temperature
Fresh fish (in ice), crustaceans and shellfish
+2oC
Cooked dishes, prepared foods, pastry creams, fresh pastries, sweet dishes and egg products
+3oC
Meat and cooked meats pre-packaged for consumer use
+3oC
Offal
+3oC
Poultry, rabbit and game
+3oC
Non-sterilised, untreated, unpasteurised or fermented milk, fresh cream, cottage cheese and curd
+4oC
Milk for industrial processing
+6oC
Cooked meats other than those which have been salted, smoked, dried or sterilised
+6oC
Butter, soft or blue cheeses
+6oC
Meat
+7oC
Figure 5 â&#x20AC;&#x201C; Recommended transport temperatures for chilled food products
UK Requirements for transporting Frozen Food Quick Frozen (or Deep Frozen) Food should be processed from food which is sound, genuine and of merchantable quality and which is fit for human consumption. The food must be frozen and have crossed the zone of maximum crystallisation as rapidly as possible for that type of product. In addition only air, nitrogen or carbon dioxide may be used as the cryogenic medium in contact with the food. The temperature on thermal stabilisation must be -18oC or colder.
with European Norm EN 12830. Records so produced must be
This temperature must be maintained except for brief periods
dated and stored for at least one year or longer, depending on the
during transport (including local distribution) where it may reach
nature and shelf-life of the food.
up to -15 C, or when in retail display cabinets where it may reach o
up to -12oC.
When transporting frozen food in local distribution an exemption exists concerning the fitment of a temperature recorder. In
To comply with Regulation (EC) 37/2005 transporters must
this case at least one easily visible thermometer complying
keep records of air temperature using a device which complies
with European Norm EN 13485 must be used. All temperature
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TLPINSIGHT 21.
When transporting frozen food in local distribution an The temperature on thermal stabilisation must be exemption exists concerning the fitment of a temperature -18oC or colder. This temperature must be maintained recorder. In this case at least one easily visible except for brief periods during transport (including local thermometer complying with European Norm EN 13485 where it may reach up to -15oC, or when in KEEPdistribution) YOUR COOL o retail display cabinets where it may reach up to -12 C. must be used. THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT To comply with Regulation (EC) 37/2005 transporters must keep records of air temperature using a device which complies with European Norm EN 12830. This is described in more detail in section 3.1.3 above. Records so produced must be dated and stored for at least one year or longer, depending on the nature and shelf-life of monitoring equipment, whether a recorder or an indicator, should the food.
All temperature monitoring equipment, whether a recorder or an indicator, should have its accuracy verified periodically in accordance with EN standard 13486 (see section 5.9).
have its accuracy verified periodically in accordance with EN standard 13486.
Product
Temperature
Ice and Ice cream
-25oC
Deep frozen foods
-18oC
Fishery products
-18oC
Butter and edible fats, including cream to be used for butter making
-14oC
Egg products, offal, rabbit, poultry and game
-12oC
Meat
-10oC
Figure 6 - Recommended transport temperatures for frozen food products
Pharmaceuticals Pharmaceutical manufacturers and distributors are required to adhere to defined legislation or guidelines covering the production, packaging, storage and distribution of medicinal products for human use. It is the responsibility of the product licence holder to ensure that the product is handled, stored and transported under conditions which will not adversely affect the quality and efficacy of the product. The primary aim being to guarantee patient safety. There are numerous and varied legislative procedures for the pharmaceutical industry which cover Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP). However, whilst none of these is specific in terms of defining the type of monitoring equipment that is to be used, the very nature of the pharmaceuticals business almost guarantees that sophisticated monitoring systems including temperature recording and tracking will be employed by virtually all distribution companies. European Council Directive 92/25/EEC of March 1992 describes the requirements and process to be followed in order to obtain authorisation to distribute pharmaceuticals and states that
Most pharmaceutical transporters in Europe will only secure
records must be produced and kept for 5 years.
contracts to carry goods following an audit by the manufacturer or product licence holder. This will entail temperature profiling
The EU Guidelines on Good Distribution Practice of Medicinal
of the refrigerated compartment and regular calibration checks
Products for Human Use, document 94/C 63/03 underlines the
of the temperature recorder equipment. The use of a tracking
5 year period of retention and states that records should ensure
system is not mandatory and usually depends on the length of the
that â&#x20AC;&#x153;all significant activities or events are traceableâ&#x20AC;?.
journey and/or critical nature of the goods.
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Livestock The regulations concerning temperature control during the transportation of livestock in conjunction with a business or commercial activity are very specific. European Regulation EC 1/2005 specifies mandatory requirements for temperature control and the fitment of a â&#x20AC;&#x153;Navigation Systemâ&#x20AC;?. The latter term is used to describe what is, in effect, a tracking system since it covers the requirement to produce an automated journey log. Derogations exist in the UK for journeys of less than 12 hours
DEFRA has produced guidelines on the requirements of the
duration to the final destination.
tracking/temperature monitoring system which can be found here:
The regulation states that a ventilation system must be fitted to the vehicle and that this must be designed, constructed and
http://www.gov.uk/government/uploads/system/uploads/
maintained in such a way that, at any time during the journey,
attachment_data/file/193680/pb13550- wato-guidance.pdf
whether the vehicle is stationary or moving, it is capable of maintaining a range of temperatures from 5oC to 30oC within the vehicle, for all animals, with a Âą5oC tolerance, depending on the outside temperature.
Refrigerated vehicle construction and ATP requirements Many factors have to be taken into account in the design and construction of a refrigerated vehicle. Extremes of exterior weather conditions, desired interior temperatures, insulation properties, infiltration of air and moisture, trade-offs between construction cost and operating costs and physical deterioration from shocks and vibration all have to be considered. A rigid semi-trailer bodywork normally consists of expanded foam
Another popular insulation material is extruded polystyrene
insulation sandwiched between two external skins. The most
(styrofoam). The thermal conductivity of this insulation is higher
popular insulation is expanded polyurethane (PU) foam. For side
than PU foam but in floor and roof construction where there
walls where thickness is constrained by the maximum permissible
are fewer constraints for overall thickness, vehicle bodybuilders
insulated vehicle width of 2.60m and metric pallet dimensions
can offset thermal losses by using thicker panels. Roofs and
(a metric pallet is 1.0m deep by 1.20m wide), this construction
floors often have 100 mm or more insulation. For side walls, the
can accommodate 2 metric pallets side by side but insulation
constraints mean the insulation is rarely more than 45-60mm
thickness is limited.
thick. The performance of insulation materials deteriorates with time due to the inherent characteristics of the foam. A typical loss of insulation value of between 3% and 5% per year is not uncommon and this can lead to considerable rises in the thermal conductivity after just a few years. This will result in an increase in energy consumption and CO2 emissions for the refrigeration system employed.
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KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
Specifying a Refrigerated Vehicle When specifying a refrigerated vehicle many factors have to be taken into account. For example:• The type and quantity of products being transported • The temperature range(s) of operation • The range of ambient temperatures that will apply • The number of compartments required • The type of compartment partition required (fixed or adjustable) • Number of compartment doors and frequency of opening • The type and performance capability of the refrigeration system • The type of use (local or long distance) A competent bodybuilder will analyse the vehicle operator’s
Care must be taken when using air ducting with
requirements and specify a vehicle type and refrigeration system
multicompartment vehicles as transverse partitioning bulkheads
capable of meeting or exceeding these requirements. It is unlikely
can dramatically affect air flow through the duct. However in
that a “one size fits all” approach will work. A vehicle/refrigeration
many cases the combination of strip curtains on compartment
system combination that is suitable for long journey single drop
doors and air ducting can have a major impact on both improving
operation may be completely unsuitable for short journey multi-
air temperature stability and maintaining temperature throughout
drop deliveries and vice versa.
the delivery cycle.
The fundamental requirement of good refrigerated vehicle design is that the combination of the insulation properties of the vehicle and the refrigeration capacity of the refrigeration system should be capable of overcoming the anticipated heat gain inside the refrigerated compartment. Heat gain will be through the insulated bodywork (good insulation will minimise this but cannot prevent heat transmission entirely), through opening the compartment doors when loading/unloading and from the product itself (although this should be minimal if the product is loaded at the correct temperature). The more the doors are opened and the longer they are left open during the delivery cycle the more heat gain will occur and the harder the refrigeration system has to work to recover the compartment temperature. It is generally advantageous to install strip curtains or similar inside the doors to help minimise the movement of air and therefore help reduce heat gain when the doors are opened. Another important component of a refrigerated vehicle is the air duct system. This is particularly useful on large single compartment trucks and trailers and usually consists of a flexible duct of fabric or nylon which is fitted to the compartment ceiling and is designed to distribute the temperature controlled air more evenly throughout the compartment.
Figure 7 – Flexible air ducting fitted to the ceiling of a refrigerated trailer
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ATP The agreement on the International Carriage of Perishable Foodstuffs and on the special equipment to be used for such carriage, known as the ATP agreement (after its French initials) was drawn up by the Inland Transport Committee of the United Nations Economic Committee for Europe in 1970-71. The UK acceded to the agreement on the 5 October 1979, and it
that are signatories to the agreement unless the vehicle has an
entered into force one year later 5 October 1980.
ATP certificate. If you do this you could be stopped, turned back and even incur a substantial fine!
ATP provides a multi-lateral agreement between Signatory Countries (Contracting Parties) for overland cross-border
In France, Spain, Portugal and Italy, where refrigerated vehicles
carriage of perishable foodstuffs. The purpose is to facilitate
are found carrying perishable produce without a valid ATP
international traffic by setting common internationally recognised
certificate or plate, they are heavily fined on the spot, and in some
standards.
cases are forced to transfer the load to a vehicle which is carrying its certificate or displaying its ATP plate.
Fruit and vegetables unless processed are outside the scope of ATP, as is air transport.
The countries that are signatories to the ATP agreement are as follows:-
The agreement details the following: • Lists foodstuffs to be carried in accordance with the ATP agreement and sets the warmest permissible temperature for types of cargo. • Lays down common standards for temperature controlled transport vehicles such as roadvehicles, railway wagons and (for sea journeys under 150km) sea containers. • Sets down the tests to be done on such equipment to ensure that they meet the required standards. • Provides the system of certification for equipment that conforms to the standards. • Requires all contracting parties to recognise certificates issued in accordance with the agreement by the competent authorities of other contracting parties.
In the UK, The Refrigerated Vehicle Test Centre (RVTC), a division
Albania, Andorra, Austria, Azerbaijan, Belarus, Belgium, Bosnia
of Cambridge Refrigeration Technology (CRT), are contracted by
and Herzegovina, Bulgaria, Croatia, Czech Republic, Denmark,
the Department for Transport (DfT) to be the certifying authority
Estonia, Finland, France, Georgia, Germany, Greece, Hungary,
of vehicles.
Ireland, Italy, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Luxembourg, Monaco, Montenegro, Morocco, Netherlands,
RVTC produce on behalf of the UK government’s Department for
Norway, Poland, Portugal, Republic of Moldova, Romania, Russian
Transport ATP certificates, ATP plates, replacement certificates
Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, The former
and carry out type approvals and factory inspections. CRT also
Yugoslav Republic of Macedonia, Tunisia, Turkey, Ukraine, United
provides relevant testing facilities for insulated vehicles and
Kingdom, United States of America, Uzbekistan.
refrigeration machinery in their environmental chambers and calorimeters.
There are two classifications for insulated equipment, six for total-loss refrigerated, twelve for mechanical refrigerated and
For the road haulage operator only delivering foodstuffs in the
three for heated equipment. The most used classifications are
UK, there is no legislative requirement for ATP. However for
insulated and insulated mechanically refrigerated. Common ATP
operators travelling on international journeys an ATP certificate
Classifications are as shown in figure 8.
is nearly always essential. It is illegal to transport perishable foodstuffs across an international boundary between countries
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THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT 19
Type
K Coeff W/m2/K
Temperature oC
Classification
Normal Insulated
≤ 0.7
N/A
IN
Heavy Insulated
≤ 0.4
N/A
IR
Mechanically Refrigerated Normal Insulated
≤ 0.7 > 0.4
0 to +12
FNA
Mechanically Refrigerated Heavy Insulated
≤ 0.4
-20 to +12
FRC
Figure 8 – Common ATP classifications
Equipment certified according to testand results, Equipment is certifiedis according to test results, eachand ATPeach
ATP certificate issued states the classification to which the certificate issued states the classification to which the equipment equipment is approved. is approved.
Mechanical refrigeration equipment fitted to insulated bodies must be rated by testing.
Mechanical refrigeration equipment fitted to insulated bodies
The agreement says that the refrigeration plant must be shown to have a heat extraction capability at the class limit temperatures of at least 1.75 times the heat flowing The agreement says the refrigeration plant must be through thethat insulation at those temperatures if ashown type to approval is to be granted. have a heat extraction capability at the class limit temperatures must be rated by testing.
of at leastWhilst 1.75 times the specifies heat flowing through body the insulation the ATP refrigerated thermal at those temperatures if a type approval is to be granted. Whilst the ATP specifies refrigerated body thermal efficiency it is not intended to be used to specify refrigeration systems
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efficiency it is not intended to be used to specify for distribution vehicles, particularly those used in multi-drop
refrigeration systems for distribution vehicles, particularly those used in multi-drop applications with a large number itofisdoor recommended that from the refrigeration openings. In thisadvice case itisissought recommended that equipment manufacturer most suitable system for advice is sought from theconcerning refrigerationthe equipment manufacturer the applicationconcerning intended. the most suitable system for the application intended. applications with a large number of door openings. In this case
For further further information For information on on ATP ATP refer referto toCambridge Cambridge Refrigeration Refrigeration Technology and their document toHauliers Technology and their document “Guide to ATP “Guide for Road ATP for Road Hauliers and Manufacturers”
and Manufacturers”
http://www.crtech.co.uk/pages/ATP/ATP-Guide.pdf
http://www.crtech.co.uk/pages/ATP/ATP-Guide.pdf
What should be monitored and why Air temperature monitoring The monitoring of temperature inside the refrigerated compartment of a delivery vehicle is generally based on air temperature readings. There are some situations where monitoring product temperature via specially designed product probes or through the use of product simulators can be beneficial but for the vast majority of applications it is an air temperature measurement system that is used. Although most of the current refrigerated systems fitted to
straightforward and the probe will not get easily damaged during
delivery vehicles offer a powerful refrigeration capacity, the
normal loading/unloading operations.
fundamental concept of such a refrigeration system is that it is designed to maintain the temperature of a pre-cooled and
To ensure that adequate circulation of refrigerated air exists in
thermally stable load. The refrigeration system normally does
the compartment it is recommended to measure air temperature
this by circulating air at the chosen temperature (also called “Set
in at least two locations. One sensor in the air return to the
Point”) around the load/product.
refrigeration unit and the other about two thirds of the way along the compartment towards the rear. Temperature data so collected
It therefore follows that if the product is at the correct
will help to give a better understanding of refrigeration system
temperature when it is placed in the vehicle’s compartment and
performance, air circulation and load distribution than just a
stowed in such a way that air from the refrigeration unit, also at
single air return reading.
the correct temperature, can circulate freely around the product during transit, then, all things being equal, the product will be at
The air return location is where the control sensor to the
the correct temperature when it is removed from the vehicle at
refrigeration system is normally located and it helps if one of
the point of delivery.
the monitoring probes is positioned as close as possible to this sensor (Figure 9). This will then give good correlation between
Measuring the air temperature inside the refrigerated
the monitored temperature and the temperature shown on the
compartment can therefore provide a good indication of the
control panel of the refrigeration unit. The compartment sensor
performance of the refrigeration system as a whole but this is
should be positioned so as to be in free air and not in contact with
largely dependent on the number of sensors installed and where
the compartment sidewall or ceiling (Figure 10 & 11). Using cable
they are located within the compartment.
trunking and a junction box for probe installation will normally result in the sensing tip being spaced around 120mm from the
Air temperature involves positioning the probe(s) securely in free
sidewall and 15mm from the ceiling.
air at various locations within the refrigerated compartment. In most cases this will include either suspending the probe from
Air temperature sensor installations should preferably include a
the sidewall/ceiling of the compartment or attaching the probe
length of spare cable, which can be coiled and stored inside the
to the air return grille of the evaporator. The probe therefore
cable trunking or junction box. This will facilitate subsequent
needs to be small, light and unobtrusive so that installation is
accuracy verification checks.
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KEEP YOUR COOL THE GUIDE TO EFFECTIVE TEMPERATURE FigureULTIMATE 9 – Temperature probe attached to the air return grille of an evaporator CONTROL IN REFRIGERATED TRANSPORT
Figure 10 – Compartment Probe in free air – with a junction box
Figure 10 – Compartment Probe in free air – with a
Figure 11 – Compartment Probe in free air – without a junction box
Figure 11 – Compartment Probe in free air – without a
junction box
junction box
Air Return
Compartment
Figure 12 – Typical temperature probe locations for a single compartment vehicle
Product temperature Product temperature measurement involves either an insertion probe with pointed tip (e.g. for insertion into a meat carcass) or a between pack probe with flat blade for positioning between packs of product on a pallet or roll cage. These devices need to be designed so that they are easily handled, robust and capable of being stored out of harm’s way in a holder or clip arrangement fastened to the compartment sidewall, when not in use. They should include a cable which is capable of extending up to at least 3m in length. Most temperature monitoring systems used in the refrigerated
For the reasons stated above the sensing element used in
transport industry rely on air temperature measurement
refrigerated transport applications should be as compact as
readings. However, in certain circumstances operators may
possible to enable both air temperature probes and product
require both air and product temperature readings as part of the
temperature probes to be manufactured. The ideal shape is a
dataset that they collect. This is typically the case with multi-drop
small cylindrical bead such as a single element transistor a few
delivery vehicles.
millimetres in diameter. This lends itself to a simple cylindrical air probe around 6mm in diameter and can easily be used in insertion
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and between pack product probes as well. Various materials can be used to encapsulate the sensing element for the air probe. Rubberised tip and stainless steel tube are the two most common. A flexible cable of at least 3m length per probe is essential. To ensure that the product probe only provides readings of product temperature when it is inserted into or between packs of product , some monitoring systems provide the facility for the
Figure 14 â&#x20AC;&#x201C; Typical Flat (between pack) probe
driver to activate the product probe through a simple switch/ push button or similar. This then allows the probe to be stored in a holder within the compartment in a deactivated state and therefore not reporting air temperature and then activated to measure the product temperature only when required, typically at the point of delivery. The normal operating temperature range within refrigerated vehicles is between -30oC and +30oC and resistance sensing elements such as thermistors or platinum resistance detectors offer good accuracy and reproducibility in this range (and beyond) at a very modest cost and in the formats indicated above. Thermistors tend to be much lower cost than their platinum counterpart and for this reason are the most common type of sensing element used in transport refrigeration data capture
Figure 13 â&#x20AC;&#x201C; Typical Insertion probe
systems.
Alternative sensor types Recently certain suppliers of temperature monitoring systems have departed from the normal thermistor probe concept in favour of a temperature data bus system. There are good reasons for this. Multiple probes using resistive or similar sensing technology involve multiple wires being routed back to the data capture electronics. The data bus system utilises just 2 or 3 wires and the measurement probes are daisy chained together, meaning that just a single cable needs to be routed within the refrigerated compartment to facilitate probe installation. The sensing element in the data bus system offers comparable
this approach also spaces the sensing element away from both
accuracy to a thermistor within the normal operating temperature
sidewall and ceiling of the compartment to provide a true reading
range of a refrigerated vehicle and is of very similar size.
of free air temperature.
Probe installation is generally made easier by using a junction box
The junction box has to be Ingress Protection rated IP65 or better
adjacent to the probe location. This enables simple connection
to withstand the condensation, low temperatures and pressure
and re-connection (in the event of damage/failure or de- and re-
washing that can take place within the compartment.
installation) without the need for soldered or crimped joints, plus
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Interchangeability and traceability It is advantageous if the temperature probe can be identified with a unique serial number and this identifier can be read both locally by visual inspection of the probe itself and remotely through the data capture system that it is connected to. Certain types of data bus system read the unique identifier and
both confirmation of the source of the temperature data and
use this to not only address the probes but also “lock” them into
accuracy verification purposes.
position in preferred locations on the bus. This enables specific probes to be located in designated areas within the refrigerated
Most conventional electronic data logger systems can include
compartment and also enables faulty or damaged probes to be
probes identified with a unique serial number but this is not
replaced easily.
recognised by the data logger itself so traceability to the exact source of the temperature reading is much harder to prove or
The other advantage of the unique identifier is that it confirms
guarantee.
identification/traceability through the data capture system for
Interchangeability and traceability EN standard 12830 specifies that the thermal response of a recorder with external sensor used for transport applications should be 10 minutes maximum. The response is defined as the time needed to reach 90% of a 20oC step change in air temperature with an air speed of 1m/s. Most data recorders utilise probes with a thermal response
temperature, such devices can only really represent the thermal
value of around 5 to 8 minutes. This permits appropriate air
characteristics of a single type of product of a specific weight,
temperature measurement and also includes a certain amount
packaged in a particular way. It is generally much better (and
of damping to provide correlation with the slower thermal
easier) to ensure that the product is loaded onto the vehicle
response of the products that are being transported. Electronic
at the correct temperature and then surrounded by air at the
damping, by including averaging of the temperature data during
correct temperature rather than trying to simulate the thermal
the recording interval, will also help to provide further correlation
characteristics of the product.
with the thermal response of the product itself. The combination of air temperature readings, from suitably In certain circumstances product simulators can also be used.
damped air temperature sensors plus the provision of out of
These normally comprise a temperature sensor embedded in
range air temperature alerts, which incorporate a suitable
an inert medium of gel or plastic. Whilst these do have some
time delay, is considered to be the most effective temperature
advantages for multi-drop delivery regimes, particularly when
monitoring regime.
the ambient temperature is much higher than the compartment
Don’t just measure air temperature at a single point Many temperature monitoring systems just measure the air temperature in the air returning to the refrigeration unit. Some also include a probe that monitors the air supply blowing directly off the evaporator (“air supply”). However the main reason for air temperature monitoring in refrigerated vehicles is to confirm that temperature controlled air is circulating throughout the compartment. This requires that compartment probes are fitted towards the rear of the loadspace.
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Compartment probes should be positioned so as not to be in still
the load space into separate areas according to the position of the
air pockets nor in the air blowing directly off the refrigeration
evaporator(s) (Figure 15). Where possible 2 temperature probes
system (“air supply”). They should be at least 0.5m from any
should be installed for each compartment, one monitoring air
internal light and clear of any moveable partition or internal door.
return and one compartment temperature providing that this is not directly in the air supply stream. For very small compartments
Multi-compartment vehicles utilise additional evaporators that
where it is not possible to fit two probes then a single probe
are driven by the same compressor but will have their own
should be installed and this should be located in the air return to
temperature control capability. Bulkheads are then used to divide
the evaporator.
Figure 15a – Single Compartment Truck
Figure 15b – Dual Compartment Truck (Transverse bulkhead)
Figure 15c – Dual Compartment Trailer (Longitudinal bulkhead)
5.7 Event monitoring Event monitoring Whilst it is important to monitor air temperature inside the compartment this alone will not normally provide aWhilst completeitpicture of the performance of theair refrigeration system. inside There arethe several key status events which is important to monitor temperature compartment this in combination withnormally temperatureprovide will help toaunderpin the data collected explain any variations alone will not complete picture of and thehelp performance of theor temperature excursions. The most common of these events are refrigeration unit on/off, door open/closed and refrigeration system. There are several key status events which in combination defrost on/off.
with temperature will help to underpin the data collected and help explain any variations or temperature excursions. Thecompartment most common of these events are Air temperature readings should indicate quite clearly when the at normal operating temperature (chill or frozen), refrigeration unit on/off, open/closed andoffdefrost on/off. refrigeration unit is switched on. Normallydoor the air temperature switching the refrigeration unit e.g. when making a delivery, at switch on is much higher than the control temperature and
will have only a minor effect on temperature variation in the short
consequently the air temperature will indicate fall quite quickly during Air temperature readings should quite clearly
term. Temperatures should remainrefrigerated stable for many minutes but at However for a well-insulated compartment
the pullthe down phase beforeunit eventually stabilising the Set Point when refrigeration is switched on. at Normally
this will depend on factors such as the quality of insulation, the normal operating temperature (chill or frozen), switching
the airMost temperature at switch onsystems is much higher thanon/ value. transport refrigeration provide simple
off the refrigeration unitinside e.g.the when making a the delivery, refrigerated temperature compartment, ambient
thecontrol control temperature andfront consequently the air off which results in the (return air) temperature temperature will fall quite quickly during the pullwith down cycling about the chosen Set Point in a regular manner a phase before eventually stabilising at the Set Point o variance of ± 1 or 2 C. However for a well-insulated refrigerated value. Most transport refrigeration systems provide simple on/off control which results in the front (return air) temperature cycling about the chosen Set Point in a regular manner with a variance of ± 1 or 2oC.
will have only a minor effect on temperature variationand in temperature outside the compartment and the temperature the short term. remain stable for distribution of theTemperatures load within the should compartment.
many minutes but this will depend on factors such as the quality of insulation, the refrigerated temperature inside the compartment, the ambient temperature outside the compartment and the temperature and distribution of the load within the compartment.
5.7.1 Refrigeration unit on/off
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Refrigeration unit on/off
26
Knowing when the refrigeration unit is on or off is a valuable
is normally possible to monitor the unit on/off state by simply
piece of information which can enhance the temperature data
picking up a feed from the unit on/off switch and connecting
set in a number of ways. What happens if the driver switches the
this to a relevant input on the temperature monitoring system
refrigeration unit off but forgets to switch it back on again, for
hardware. It is recommended to do this whenever possible and
example? Is it better to open the compartment door (to make a
for whatever type and size of vehicle is being monitored. However
delivery) with the unit on or off? Should out of range temperature
it is recommended to always consult the refrigeration system
alerts be disabled when the unit is switched off (e.g. at the end
supplier for details of an appropriate connection point for an on/
of the day or weekend when the vehicle is out of service)? It
off signal.
The ultimate guide to effective temperature control in refrigerated transport
Door open / closed
5.7.2 Door open / closed
This event can sometimes be detected by simply observing an
Another downside of opening the compartment door(s) with the
excessive temperature excursion on the rear (compartment)
unit running is that drawing warm, generally humid, air into the
probe. However monitoring the operation of the compartment
compartment can cause the evaporator to ice over. This is more
door is recommended this data providesby other This event canbecause sometimes be detected simply
common with frozenair loads loads but incan anycause case will generally humid, intothan the chill compartment
substantial benefits. in the refrigeration system to defrostwith mode in observing an excessive temperature excursion on the rear result the evaporator to ice over. Thisswitching is more common
(compartment) probe. However monitoring the operation order frozen loadsthe than loads but in any caseawill resultcycle the to melt ice chill on the evaporator. During defrost of the compartment door is recommended because this in the refrigeration system switching to defrost mode inlocal For example drivers should be educated to keep door open fans of the unit are switched off and the unit generates heat data provides other substantial benefits. order to melt the ice on the evaporator. During a defrost frequency and duration to the minimum possible to avoid to the evaporator in order to melt the ice. This process usually cycle the fans of the unit are switched off and the unit Foramounts example should be educated to keep door excessive ofdrivers warm air entering the refrigerated takes about 15 -20 minutes and during this time cold air is not generates heat local to the evaporator in order to melt the open frequency and duration to the minimum possible compartment. being around the takes load. Ifabout the vehicle being used ice. circulated This process usually 15 -20isminutes andfor to avoid excessive amounts of warm air entering the multi-drop deliveries thisaircan result in several defrost operations during this time cold is not being circulated around the refrigerated compartment. load. If the vehicle is being used for multi-drop deliveries Knowing when and where the door is opened can be valuable during the delivery process. This can lead to higher fuel usage, Knowing when and where thelocation door is opened can be canwear result intear several defrost operations during in confirming precise delivery time and and can also farthis more and on the refrigeration system andthe a far valuable in confirming precise delivery time and location delivery process. This can lead to higher fuel usage, far enhance security by providing an alert if the door is opened less effective temperature control within the refrigerated and can also enhance security by providing an alert if more wear and tear on the refrigeration system and a far outside the of adoor designated area or site location. compartment. is opened outside of a designated area or site less effective temperature control within the refrigerated location. compartment. However, perhaps the most valuable use of door event monitoring
However, perhaps the most valuable use of door event is whenmonitoring this is used in combination with refrigeration unitwith on/ is when this is used in combination off data.refrigeration Many driversunit assume that leaving the unit system on/off data. Many drivers assume that thedoors unit system when doors are open runningleaving when the are openrunning is the best waythe to maintain is the bestinside way the to maintain the temperature the temperature refrigerated compartment.inside In factthe refrigerated compartment. In fact quite the reverse is quite the reverse is true. The unit has powerful fans to circulate true. The unit has powerful fans to circulate temperature temperature controlled air around the load. Opening the controlled air around the load. Opening the compartment compartment with therunning unit running haseffect the effect of door(s)door(s) with the unit has the of pushing pushingthis thisair airout outof of the the compartment compartment and thereby replacing and thereby replacing it with warmer airthe from the outside. When theare doors are it with warmer air from outside. When the doors closed closed again thewill compartment then again the compartment then containwill warm aircontain and the warm air and the refrigeration system to workthe hard tofrom remove refrigeration system has to work hardhas to remove heat the heat from this air so that the load is once again being this air so that the load is once again being covered in a blanket of covered in a blanket of air at the correct temperature.
A number of different options exist as far as door monitoring
A number of different options exist as far as door
hardware is concerned the most commonly used system monitoring hardwarewith is concerned with the most
being a non-contact magnetically reed switch. The commonly used system being operated a non-contact magnetically switch is positioned on theThe door frameisand the magnet operated reed switch. switch positioned on on thethe
door and the magnet theabout door aso10mm that the door soframe that the two are aligned,on with gaptwo between are aligned, a 10mm gap between them, when them, when thewith doorabout is closed. The switch is then provided with a the door is closed. The switch is then provided with a 12V feed which is switched into the monitoring hardware the doorthe is operated. when door is operated.
12V feed which is switched into the monitoring hardware when
air at the correct temperature.
Switching the unit off, or at least the fans off, before opening the doors helps to prevent this happening and Switching the unit off, or at least the fans off, before opening the will result in better overall temperature control with less doors helps to prevent this happening and will result in better fuel being used. overall temperature control with less fuel being used.
Another downside of opening the compartment door(s) with the unit running is that drawing warm,
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Figure 16 â&#x20AC;&#x201C; Door sensor with door open
Figure 17 â&#x20AC;&#x201C; Door sensor with door closed
Defrost This event can usually be detected by a sudden rise and fall in air
to the control system in order to pick up a signal representative of
return temperature with corresponding small or unnoticeable
defrost operation.
change in compartment temperature. Unless there is a specific requirement to monitor defrost on/off It is therefore not so essential to monitor this event separately,
it should be considered that this event is an option rather than a
indeed on some refrigeration systems it can be difficult to connect
definite requirement.
Monitoring refrigeration system specific data Some data management systems provide the capability to connect
example, adjusting the Set Point value.
to the refrigeration unit micro-processor to extract specific detailed information. This can include temperature data and also
These systems can simplify fleet operation and allow refrigeration
information such as Set Point, unit run status (diesel or electric
system maintenance schedules to be automatically generated.
standby), hours run and unit engine alarm data. It is even possible
They are more ideally suited to very large fleets.
through some systems to operate the unit remotely by, for
Temperature Alert Monitoring Most temperature monitoring systems include a mechanism to provide a warning when temperatures fall outside of acceptable limits. Alerts can normally be provided when the temperature deviates by a specific amount from a nominated value (typically the Set Point) or fall outside of an acceptable range. For a stand-alone data logger system the alert can notify the
the unit control temperature (Set Point) value. Additionally whilst
driver of a potential problem and for a telematics system both the
changes in air temperature are relatively quick, the temperature
driver and the vehicle’s operation centre will be provided with
probe has a deliberately slower thermal response and the load in
warnings. There is then the option to carry out further checks
the refrigerated compartment is considerably slower to respond
on load condition and refrigeration system operation in order to
to temperature changes.
decide on appropriate corrective action. A meaningful alert breach time is in the order of 15- 30 minutes. Alert monitoring can in some cases include the option to be
If the air temperature is out of range and has stayed out of range
triggered by a power state. This is normally the unit on state. This
for this period of time it is safe to assume that there is a genuine
has the effect of enabling the alert when the refrigeration unit
problem that needs addressing. It is unlikely that the product
is operational and disabling the alert when the unit is switched
quality or safety will have been compromised during a breach
off or the vehicle is otherwise not in use e.g. overnight or at
time of this magnitude.
weekends. Whilst it is possible to apply alerts to any of the temperature If unit on/off is not being monitored as part of the temperature
sensors being used to collect data it is prudent to apply alerts to
application then care has to be taken when using out of range
the Rear or Compartment sensor rather than the Front or Air
alerts since “false” alert messages will be generated when the unit
Return sensor. The Compartment temperature is generally more
is switched off at the end of the day and the temperature rises out
indicative of the temperature of the load and alerts will also be
of range.
generated if air flow to the rear of the compartment is poor or restricted due to incorrect stowage of the load. In addition the Air
It is also important to ensure that an adequate delay or “breach”
Return temperature can vary considerably from the normal value
time is allowed before a temperature alert is generated. The air
during a defrost cycle and this could produce false alerts.
temperature inside the refrigerated compartment cycles around
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Door alert Alerts associated with compartment door operation are
For a live telematics system the door alert can inform when a
also a very useful feature. This would generally only work
load is being delivered and alert in real time if the door is open
retrospectively for a stand-alone system, providing the transport
for too long. This system can also provide warnings when doors
manager with data to check length of door openings at delivery
are opened outside of designated delivery locations thereby
locations.
enhancing load security.
Temperature Accuracy Verification The verification of the accuracy of an installed temperature measurement system consists of performing a check that determines that the combination of the measurement device and its temperature sensor(s), measure within specified limits of error. It is recommended that the verification procedure is undertaken
The frequency of the verification check depends on the
in accordance with the requirements of European Standard EN
requirements of the user, taking account of the manufacturer’s
13486 (Periodic Verification). This is a ‘checking’ procedure
recommendations. If the temperature measuring system is
only, since most measurement devices do not include the facility
mounted on a vehicle which is subjected to an annual or periodic
for user adjustments to either the measuring instrument or its
maintenance inspection then the verification of the system should
sensor(s). If the temperature measurement system fails to meet
be done at the same time.
the required accuracy of measurement then either the measuring instrument or its sensor(s) or both should be replaced.
Equipment Required • A Reference Thermometer with a valid calibration certificate, traceable to National Standards, with an accuracy of 0.2 °C at the required temperature. • A supply of tie wraps. • Ice, water and vacuum flask (for ‘Ice Point’ check only). • A supply of blank Verification Certificates for completion during the procedure.
Method The Verification Check should preferably be carried out within
at any other temperature. In each case the procedure is to check
± 5 C of the temperature of use of the refrigerated compartment.
the sensors one at a time and record the sensor serial number and
For chilled applications the optimum test temperature is 0oC.
the results of the check on a Verification Certificate.
o
There are two temperature checking methods available, one of which is for use at 0oC (the ‘Ice Point’ check) and the other for use
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‘Ice-Point’ Check An ‘Ice-Point’ (0oC) check is made by immersing each of the
is stirred regularly to ensure a uniform temperature distribution.
vehicle’s temperature sensors, one at a time, in a mixture of crushed ice and water. The temperature sensor of the Reference
The sensor serial number, the readings of the measurement
Thermometer is tie-wrapped to the sensor under test. It is most
system under test and those of the Reference Thermometer
important to ensure that the sensors are immersed to a depth of
are then recorded on the Verification Certificate after the
at least 100mm from their tips and that the ice and water mixture
temperatures have been stable for at least five minutes.
Other Temperatures If a Verification Check is required at a temperature other than
between the Reference Thermometer sensor and the Reference
0oC, a comparison should be made between the temperature as
Thermometer should be taken under the door seal.
measured by the system under test and that measured by the Reference Thermometer.
When the desired temperature has been reached the refrigeration system should be switched off and the temperature
For frozen temperatures a check at -20oC is appropriate, whilst
inside the compartment allowed to stabilise. This will normally
for chill temperatures 0 C is suitable.
take a few minutes.
The temperature sensor of the Reference Thermometer is tie-
The sensor serial number, the readings of the measurement
wrapped to the sensor under test. If it is necessary to achieve a
system under test and those of the Reference Thermometer are
o
temperature below ambient then the refrigeration system should recorded on ain refrigerated Verification The ultimate guidethen to effective temperature control transport Certificate after the temperatures 30 be switched on and the coupled sensors physically supported in a
have been stable for at least five minutes.
convenient position with the vehicle’s door(s) closed. The wiring
5.9.5 (continued)
Verification Certificate
TEMPERATURE VERIFICATION CERTIFICATE Measurement system details Customer
Results should be entered by hand onto a Verification Certificate at the time of the test. A separate Verification Certificate is required for each installation. A ‘Pass’ is entered in the Result column if the temperatures as
Location/Vehicle ID Instrument type Serial Number Number of temperature channels
Reference Thermometer details Type
indicated by the system under test deviate from that
Ref Thermometer Serial Number
of the Reference Thermometer by less than 1.0oC.
Calibration Due Date
Otherwise a ‘Fail’ is entered in the Result column.
Calibration Certificate Number
Temperature probe description
Figure 18 shows an example of a temperature verification certificate.
Calibration traceable to National Standards
Yes/No
First Verification Temperature Serial Number
Probe Temperature Reference Temperature (A) (B)
Deviation (A-B)
Result (Pass/Fail)
Probe Temperature Reference Temperature (A) (B)
Deviation (A-B)
Result (Pass/Fail)
1 2 3 4 5
Evaluation
6
Second Verification Temperature Temperature probe description
If a sensor fails a Verification Check then that sensor
1
should be replaced and the Verification Check repeated.
3
If this still results in a failure then the measuring instrument should be replaced and the Verification Check repeated once again.
Serial Number
2
4 5 6
Test Carried out by
Signature
Date
Figure 18 – example temperature verification certificate
5.9.6 Evaluation If a sensor fails a Verification Check then that sensor
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6.0 Examples Examples of Temperature Data of Temperature Data Transport refrigeration systems are intended to maintain the temperature of properly pre-cooled and Transport refrigeration systems are intended to maintain the temperature of thermally stable product. properly pre-cooled and thermally stable product. Transport refrigeration systems are not designed refrigerate is loaded intocompartment. the compartment the product refrigeration Transportto refrigeration systems areproduct not designed to When a warm is loadedsystem into the refrigerate (extract a harder compartment the refrigeration system will muchto (extract heat from) a warm product i.e. a product with a heat from) a warm willproduct work i.e. much but the product temperature is work unlikely product with a temperature several degrees warmer than
harder but the product temperature is unlikely to change
temperature several degrees warmer than the therequired required control change during a normal journey period. will waste fuel.fuel. control temperature inside the refrigerated during a normal journeyThis period. This will waste temperature inside the refrigerated compartment. When a warm
6.1 Warm Product
Warm Product
ational Standards
Yes/No
Open/On
A - Signifies a warm product.
Close/Off
Fridge
eviation (A-B)
Door
Result (Pass/Fail)
The unit is controlling at around -20oC (front probe cycling evenly about this
20.0
temperature) but the rear probe is stable at around -14oC.
10.0
Temperature Celsius (0C)
B – Signifies a product at the correct temperature.
eviation (A-B)
Result (Pass/Fail)
The temperature of the front and
0.0
A
-10.0
B
rear are almost identical with lower -20.0
frequency of cycling (longer period between cycles) than example A. This signifies that the product loaded is
32
-30.0
04:00
08:00
12:00
thermally stable at a temperature close The ultimate guide to effective temperature control in refrigerated transport to -20 C. o
16:00
20:00
00:00
Time Front
Rear
Figure 19 – Typical graph of temperature when transporting a warm product
6.2 Graph without digital data A - event Signifies a warm product. Graph without digital event data The unit is controlling at around -20 C (front probe
xample temperature verification certificate
o
cycling evenly about this temperature) but the rear probe is stable at around -14oC. 20.0
6.3 Graph with d
B – Signifies a product at the correct temperature.
The temperature of the front and rear are almost identical with lower frequency of cycling (longer period between cycles) than example A. This signifies that the product loaded isFigure thermally at a temperature to -20oC. 20stable demonstrates theclose difficulty Fridge
replaced and the Verification Check
in analysing temperature data when it Door
is not accompanied with simultaneous
10.0
difficult to determine the reason for
0.0
D
A -10.0
B
10.0 temperature excursions without the
benefit of digital event data such as compartment door open/closed 0.0
C
Temperature Celsius (0C)
Temperature Celsius (0C)
20.0 event data. For example it is very
and refrigeration unit on/off. What
-20.0
is the reason for the 3 rapid rises in -10.0
A
temperature for the Front probe at -30.0
04:00
08:00
12:00
16:00
20:00
00:00
time A? Is the reason the same as for -20.0
Time Front
Rear
the single rapid rise at B? or C? or D? See Figure 21.
Figure 20 – Graph of temperature without event data
-30.0
Figure 20 demonstrates the difficulty in analysing
36. TLPINSIGHT www.the-logistics-portal.com temperature data when it is not accompanied with simultaneous event data. For example it is very difficult to determine the reason for temperature excursions without
04:00
What is the reason for the 3 rapid rises in temperature for the Front probe at time A? Is the reason the same as for the single rapid rise at B? or
Figure 21 – Graph of temperature data show
33
6.3 Graph with digital event data
Graph without digital event data
Open/On
Close/Off
Fridge Door
20.0
Temperature Celsius (0C)
10.0
0.0
D
A -10.0
B
C
-20.0
-30.0
04:00
08:00
12:00
16:00
20:00
00:00
Time Front
Rear
Figure 21 – Graph of temperature data showing simultaneous event data
Figure 21 shows exactly the same data as shown in Figure 20 but
unit is switched off here that there is a 10oC difference between
Figure 21information shows exactly the same data monitoring as shown inevent Figure with the added provided by digital
B –Front Frontand andRear Reartemperatures temperaturesuggesting both rise because the the that the product is
20unit buton/off with the information provided by digital data for andadded door open/ closed. It is now possible to monitoring event data for unit on/off and door open/ determine that: closed. It is now possible to determine that:-
A repeated – The repeated in temperature of the front A – The rises in rises temperature of the front probe areprobe
are due to defrost cycles. The reason for the numerous defrosts is that the compartment door has been left that the compartment been left opened with the (humid) unit opened with thedoor unithas running. This causes warm running. to be drawn over thein rapid airThis to becauses drawnwarm over(humid) the unitairevaporator resulting ice build-up. The defrost is instigated to meltcycle this unit evaporator resulting in rapidcycle ice build-up. The defrost ice on the evaporator. The Rear air temperature stays is instigated to melt this ice on the evaporator. The Rear air fairly stable the Front airthe temperature increases temperature stays whilst fairly stable whilst Front air temperature more before the unit returns to normal by 10oC or increases by 10oC or more before the unit returns to normal operation. Multiple rapid defrosts result in extreme operation. defrosts result insystem extremeand wear and tear wearMultiple and tearrapid on the refrigeration much on thehigher refrigeration system and much higher fuel fuel consumption. It is possible to consumption. prevent this It fromtohappening byfrom switching the unit off whenthe theunit is possible prevent this happening by switching compartment doors are open. off when the compartment doors are open. due to defrost cycles. The reason for the numerous defrosts is
unit isLoading switched off and the door opened. When warm. a warm product will is further increase the number
the unit is switched back on it has been set to a 2 compartment operation, controlling Frozen at the front and Chill at the rear. Note that before the unit is switched o unit is on so any rapid rise and fall Coff & here D – Doors are closed that there is a 10and C difference between the Front inand temperature is probably a defrost. Note thatproduct for D the Rear temperatures suggesting that the is unit has warm. Loading a warm product will further increase theand the now been changed so that the Front compartment is Chill number of defrost cycles that take place. Rear Compartment Frozen. of defrost cycles that take place.
C & D – Doors are closed and unit is on so any rapid rise and fall in temperature is probably a defrost. Note that for D the unit has now been changed so that the Front compartment is Chill and the Rear Compartment Frozen.
B – Front and Rear temperature both rise because the unit is switched off and the door is opened. When the unit is switched back on it has been set to a 2 compartment operation, controlling Frozen at the front and Chill at the rear. Note that before the
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6.4 Excessive defrost operation Excessive defrost operation Open/On
Close/Off
Fridge Door 30.0
20.0
Temperature Celsius (0C)
10.0
0.0
-10.0
B
-20.0
-30.0 00:00
04:00
A
08:00
12:00
16:00
Time Front
Rear
Figure 22 – Excessive defrost operation
Figure 22 demonstrates the effect of operating the unit with the
evaporator which produces automatic defrost operation. The
Figure 22 demonstrates the effect of operating the unit compartment doors open. with the compartment doors open.
defrost operation. The localised to melt coils the ice on localised heating to melt the ice onheating the evaporator causes
A – When compartment doors are closed the unit A – the When the compartment doors areand closed andisthe unit
tries to pull down to the set point value once the defrost cycle is
switched on the temperature pulls downpulls quickly. Thequickly. front probe is switched on the temperature down The
probe cycles Setprobe Pointwhich and the rear probe cyclesfront around its Set Pointaround and theits rear pulls down pulls downthe slower also value. approaches the Set Point slowerwhich also approaches Set Point This seems to be
value. This seems to be reasonably satisfactory operation.
thefront evaporator coils causes the front temperature tounit rise the temperature to rise and then fall again as the
and then fall again as the unit tries to pull down to the set point value once the defrost cycle is completed. Note that completed. Note that the rear temperature remains fairly stable the rear temperature remains fairly stable throughout this o throughout period temperature at an elevatedabove temperature period at anthis elevated 0oC. above 0 C. Leaving the unit running when the compartment doors are opened for loading and unloading will cause opened for loading and unloading willcertainly cause unnecessary fuel unnecessary fuel burn and almost result in worse burn and almost certainly worse control temperature control thanresult if theinunit wastemperature switched off.
reasonably satisfactory operation.
Leaving the unit running when the compartment doors are
B – The compartment doors are opened with the unit running and leftdoors openare foropened severalwith hours. is B – The compartment theThe unitresult running rapid icing of the evaporator which produces automatic
than if the unit was switched off.
and left open for several hours. The result is rapid icing of the
Save fuel, reduce maintenance costs and improve temperature control This example relates to the following operation:• Large van (box body) delivery vehicle with 2 litre diesel engine. • Direct drive refrigeration system • Dual compartment operation (front, frozen and rear, chilled) • Rear and Side doors to access each compartment separately • Multi-drop operation making around 15 deliveries per day
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Open/On
Close/Off
This example relates to the following operation:• Large van (box body) delivery vehicle with 2 litre diesel engine. • Direct drive refrigeration system • Dual compartment operation (front, frozen and rear, chilled) • Rear and Side doors to access each compartment separately • Multi-drop operation making around 15 deliveries per day
B
The direct drive refrigeration system The is powered by refrigeration the vehicle system engineissopowered the engine has to beengine running direct drive by the vehicle so for the the engine has to be running for the unit to work. Ignition on/off is monitored as unit to work. Ignition on/off is monitored as indicative of unit on/off. The driver normally leaves the engine/unit indicative of unit on/off. The driver normally leaves the engine/unit running running at the point of delivery because hepoint believes that this helpshe tobelieves keep the compartments refrigerated. at the of delivery because that this helps to keep the compartments refrigerated.
12:00
16:00
Open/On
Figure 23 shows that the ignition
Close/Off
Side Door
is left on, with engine running,
Rear Door Ignition
throughout the day. Temperatures
20.0
vary wildly with numerous
eration. The localised heating to melt the ice on o C in the above 10 rator coils causesexcursions the front temperature to rise all again as the unit tries to pull down to the set rear (chilled) compartment and e once the defrost cycle is completed. Note that mperature remains fairly stable throughout this to -10oC in temperatures rising up an elevated temperature above 0oC.
Temperature Celsius (0C)
10.0
the front (frozen) compartment. Also
e unit running when the compartment opened for loading and unloading will cause leaving the engine running at each ary fuel burn and almost certainly result in worse (and re control than ifstop the unit wastherefore switched off.driving the unit)
0.0
-10.0
-20.0
means highly excessive idling of the vehicle engine.
01:00
02:00
03:00
04:00
5:00
06:00
07:00
08:00
09:00
10:00
11:00
Time
The ultimate guide to effective temperature control in refrigerated transport
Front
Rear
Figure 23 – Data for direct drive unit with engine left running at point of delivery
23 shows that the ignition is left on,(continued) with engine 6.5 Save fuel, reduce maintenance costs andFigure improve temperature control
running, throughout the day. Temperatures vary wildly with numerous excursions above 10oC in the rear (chilled) compartment and temperatures rising up to -10oC in Open/On
Close/Off
Side Door Rear Door Ignition
7.0 Conclusions and R
the front (frozen) compartment. Also leaving the engine running at each stop (and therefore driving the unit) means highly the driver vehicle engine. Figure 24excessive showsidling thatofthe has been
Continued over
instructed to switch the ignition/unit off
7.1 Ensure that the veh at every delivery point. As a result the system are properly sp chill temperatures cycle nicely around 5oC and frozen temperatures remain
10.0
below -20oC. This clearly demonstrates
The fundamental of far superior temperature control whenrequirement the
0.0
combination of the insulation prop the refrigeration system should be addition the idle time has been reduced by heat gain inside the refrigerated c about 2 hours over an approximately 8 hour insulated bodywork (good insulat delivery period. Assuming a fuel burn duringthrough op transmission entirely), andper from the product it idling for this vehicleunloading of 1.25 litres hour product is loaded at and a net fuel cost of £1.00 per litre this the correct te unit is switched off at the delivery point. In
Temperature Celsius (0C)
36
-30.0 00:00
-10.0
-20.0
-30.0 00:00
01:00
02:00
03:00
04:00
5:00
06:00
07:00
08:00
09:00
10:00
Time Front
Rear
11:00
represents a saving Operators of approximately £2.50 should consult with their chosen body refrigeration system manufacturer to ensure per day or, assumingand a 20 days per month operational requirements are clearly understood
delivery operation, around £50.00 per
Figure 24 - Data for direct drive unit with engine switch off at point of delivery
month per vehicle. Figure 24 shows that the driver has been instructed to switch the ignition/unit off at every delivery point. As a result the chill temperatures cycle nicely around 5oC and frozen temperatures remain below -20oC. This clearly demonstrates far superior temperature control when the unit is switched off at the delivery point.
The overall result is
In addition the idle time has been reduced by about 2 hours•over an approximately 8 hour delivery control period. Improved temperature
7.2 Operate the vehicl
The overall result is • Improved temperature control • A substantial saving in fuel cost • A 25% reduction in refrigeration system operating time
• Less wear and tear on vehicle and refrigeration system Assuming a fuel burn during idling for this vehicle of 1.25 • A substantial saving in fuel cost litres per hour and a net fuel cost of £1.00 per litre this • Increased vehicle and refrigeration represents a savingreduction of approximately per day or, • A 25% in£2.50 refrigeration system operating unit service interval time assuming a 20 days per month delivery operation, around • per Less wear and tear on vehicle and refrigeration system £50.00 month per vehicle.
• Increased vehicle and refrigeration unit service interval
No matter how good the design a how suited it is for the application encountered in the day-to-day op
The critical MUST DO stages in refrigerated ve operation are:-
• Pre-cool compartment and defrost if neces
• Switch off the refrigeration unit before op the compartment door • Insert the product/load at the correct temperature • Distribute the load properly • Surround the load with air at the correct
TLPINSIGHT 39.
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• Minimise the time that the compartment d
KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT
Conclusions and Recommendations Ensure that the vehicle and refrigeration system are properly specified The fundamental requirement of good refrigerated vehicle design is that the combination of the insulation properties of the vehicle and the capacity of the refrigeration system should be capable of overcoming the anticipated heat gain inside the refrigerated compartment. Heat gain will be through the insulated bodywork (good insulation will minimise this but cannot prevent heat transmission entirely), through opening the compartment doors when loading/ unloading and from the product itself (although this should be minimal if the product is loaded at the correct temperature). Operators should consult with their chosen bodybuilder and
and refrigeration system capable of meeting or exceeding these
refrigeration system manufacturer to ensure that operational
requirements are specified.
requirements are clearly understood and that a vehicle type
Operate the vehicle in the best possible way No matter how good the design and manufacture of the refrigerated vehicle, nor how suited it is for the application concerned, it will not overcome bad practice encountered in the day-to-day operation of the vehicle. The critical MUST DO stages in refrigerated vehicle operation are:• Pre-cool compartment and defrost if necessary • Switch off the refrigeration unit before opening the compartment door • Insert the product/load at the correct temperature • Distribute the load properly • Surround the load with air at the correct temperature • Minimise the time that the compartment door spends open at the point of delivery
In addition:• Load on pallets wherever possible as this will improve overall air flow • Do not load above the red (maximum height) load line • Never mix different temperature loads (e.g. chill and frozen) in a single compartment Drivers and warehouse staff responsible for loading/ unloading should be trained to understand and comply with these requirements some of which may appear to be counter-intuitive.
Monitor temperature and events Using a data monitoring system will allow compilation of data to satisfy HACCP and Due Diligence requirements. A wide range of systems are available but it is strongly recommended that any system used includes monitoring of air temperature at several points within the loadspace plus monitoring of critical events such as door open/closed and refrigeration unit on/off. The incremental cost for adding event monitoring will usually be
operational cost.
relatively small. The enhanced dataset so produced will be far more beneficial in monitoring the refrigeration system as a whole
To simplify data analysis and focus on areas that need
in order to optimise performance and make tangible savings in
improvement and which can generate savings, utilise a monitoring
40. TLPINSIGHT
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system that can provide live out of range alerts. This might be
duration and location of door openings can be a highly useful
a temperature alert, a door open alert or a combination of both
feature to help improve temperature control and thereby
such things. An early warning of a potential problem can help
maintain product temperature. When data concerning door
minimise wastage or spoilage of the product.
operation is reported live it can also have a direct beneficial effect on load security which can also help to reduce insurance
When combined with positional data (e.g. on a combined tracking/
premiums.
temperature monitoring system), knowledge of the frequency,
Check equipment function on a regular basis To maintain the performance of a refrigerated vehicle it is essential that the refrigeration system is serviced regularly by a competent organisation. The vehicle bodywork should also be inspected for any damage and this should be repaired as quickly as possible. Water ingress through damaged bodywork will severely reduce the insulation properties and cause local “hot-spots”. Temperature monitoring equipment should also be checked for accuracy on an annual basis or as otherwise specified by the equipment manufacturer.
Maintain records and use the data to drive improvements Whichever type of data recording system is used it is important that records are kept for at least 12 months. In the case of pharmaceuticals this may need to be extended further, in some cases up to 5 years. Vehicle owners should maintain a dialogue with their data
a marked improvement of fuel consumption. Automatic data
monitoring system provider and if necessary solicit their help
collection saves on administration costs associated with HACCP
on how to use the data being collected to make improvements.
and Due Diligence compliance, plus an improved risk profile
Operators should not assume that because they have always
should reduce load liability insurance costs.
operated in a particular way that there is no alternative. Making simple operational changes can often deliver improvements which
Improving temperature control and increasing operational
will result in a substantial return on investment.
efficiency can result in numerous tangible benefits and enable direct and indirect savings to be made. The confidence that this
Improved temperature control should yield fewer load rejections
can bring should place the vehicle operator in a better position to
and less product wastage, saving costs and enhancing customer
win respect from customers and help to secure more business.
service levels. Optimising temperature control can also have
Acknowledgments Navman Wireless would like to thank the following for their invaluable help in the compilation of this guide:• Maurice Young Consulting • The Food Storage and Distribution Federation • Transfrigoroute UK • Thermo King UK • Marshall Fleet Solutions Ltd • Cambridge Refrigeration Technology Ltd • Frigoblock UK Ltd • TM Electronics (UK) Ltd www.the-logistics-portal.com
TLPINSIGHT 41.
BY BRIAN KOHR, PRESIDENT AND CEO
It is evident when reviewing the Good Distribution Practice guidelines that there has been a shift in emphasis towards Risk Management in the distribution of temperaturesensitive pharmaceuticals. Whether it's the publication of the recent EU guidance, the revisions from USP or the PDA's technical report 58, there can be no mistaking one thing - shippers and manufacturers are ultimately responsible for examining their supply chains using a 'risk-based' approach. Let's be clear what risk is by using the definition from the International Conference on Harmonization [ICH] and its Q9 document: Risk is defined as 'The combination of the probability of occurrence of harm and the severity of
Adopting a culture of quality risk management will provide a platform for continous improvement.
that harm'. Harm is defined as 'Damage to health, including the damage that can occur from loss of product quality or availability'. Hazard is defined as 'The potential source of harm'. This might sound straightforward but a 'risk-based' approach warrants an in-depth analysis including an evaluation of the elapsed time since the validation of the current temperaturesensitive shipping and packaging solutions. Some suppliers have utilized the same solutions for decades although technology, regulations and guidelines have continued to evolve. The production process also has challenges related to contract manufacturing, multiple vendors and locations that are distant from the point of sale. Identifying the potential sources of harm to a product being transported through several temperature zones, multiple transit points and a variety of modes can be an exacting task. During all of these stages, patient safety is of course paramount, but we also recognize that the pressures for more cost-effective supply chains can be immense. It is not surprising therefore, that managing risk has attracted a more aggressive regulatory stance both at GMP and GDP levels. It is also a good explanation for the additional call from regulators for written agreements between manufacturers and their logistics supply chain partners. Risk Management is designed to assist organizations in safeguarding the quality and supply of product to customers and ultimately the end user. It is about anticipating hazards and controlling risk through an ongoing process of risk awareness, reduction and I or acceptance, and review. This approach can help justify needed improvements and investments, and prevent both potential problems for customers [e.g. product recalls or even patient harm] and loss of business. Moreover, though implementing risk management might well be initially linked to a single product or supply chain process, it should not be considered as a one time action. Adopting a 'culture' of quality risk management that is embedded in the processes and procedures used by manufacturers and their supply chain partners will have long-term benefits. The level of awareness to risk will inevitably improve and provide a platform for continuous improvement.
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In their recently revised GDP guidelines (2013/C 343/01) the European Commission has a relatively simple statement regarding the distribution of temperature-sensitive products: "'Risk assessment of delivery routes should be used to determine where temperature controls are required'." The first part of any 'route qualification' process should start with the creation of a Qualification Master Plan that sets out stages, processes and responsibilities. And sometimes, simplest is best - use the power of your internal team and your external Logistics suppliers to initially map out every distribution and handling stage for your product. Additional detail should be added considering both the physical and documentary processes and conditions. Through the various transport modes, identify those steps and handover points that are most at risk. Look at this from a seasonally adjusted temperature environment and quality control processes, and consider how to mitigate the risk to your product. Is the route and transport supplier capable of managing that risk? Is there a contingency plan in place? Are there written agreements and SOP's in place? What importance is placed on process control and process measurements versus measuring end results when it is too Late to prevent an unsuccessful shipment? Identifying the physical steps and risk points is important to maintain the efficacy of any drug. But what about qualifying your supplier of thermal protection and having more than one validated solution to further mitigate the risk of failure? Just like good cold chain management starts with the manufacturer, having a range of validated solutions 'ready-to-use' will provide you with the means to maintain that correct thermal protection, regardless of the distribution challenges. The market for both passive and active solutions has expanded over recent years and there is now a comprehensive array of suppliers. Shippers should validate their choice of solution providers by predetermined criteria: •
Availability - is the solution always available at seasonal peaks and internationally?
•
Solution range - does the supplier provide both active and passive solutions?
•
Performance - have their solutions been validated to your needs?
•
Re-usability - does the supplier have a program for packaging re-use?
•
Custom-built solutions - new/different products may need new solutions and thus, can the supplier respond to new requirements?
All of these considerations will provide you with a far more comprehensive risk assessment of your supply chain and provide a built-in confidence that a product will not be compromised regardless of whether it has been transported 5 miles or 5000 miles. It also creates contingency plans that can really make a difference to successful transportation. Risk management should not be centered only upon the choice of which route, which logistic provider and which type of packaging solution to use. Key to minimizing risk is to qualify more than one thermal shipping solution and preferably utilizing a provider that can offer both active and passive solutions to meet the specific needs of your product.
www.CSafeGlobal.com
info@CSafeGlobal.com
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A sustainable solution for temperature controlled urban distribution
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Advert to change?
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. On and off ground, your pharmaceutical products are in the best hands with our dedicated team of highly trained and experienced professionals. And, as you would expect from true pioneers, we are the first GDP certified airline in the world.
+2째C to +8째C
+15째C to +25째C
keepcool@cargolux.com | www.cargolux.com
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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, the vapor is vented outside the box through an exhaust muffler
Since the late 1930s, transporting temperature sensitive
to minimize noise. This is important with regard to the health and
goods by road and rail depended almost entirely on fossil
safety of operators and goods.
fuels and high global warming potential (GWP) refrigerants to maintain cargo at the optimum temperature. Today, internal combustion engines have become quieter, more fuel efficient and cleaner. Nevertheless the dependence on fossil fuel and hydrofluorocarbon (HFC) refrigerants remains.
A system defined by what it lacks The system is more notable for what it lacks rather than what it possesses. The truck or trailer unit is cooled with virtually no
Regulations and social pressure have dramatically changed
operating noise without the use of diesel engine, compressor, or
the way transporters operate in the European Union (EU).
HFC refrigerant.
Environmental sustainability is a top objective of legislators determined to phase out high GWP refrigerants, control exhaust
The recovered R-744 in the Thermo King CryoTech systems is
emissions and limit noise in densely populated areas.
obtained as a by-product from industrial processes that would otherwise have been released into the atmosphere. As such there
An alternative to fossil fuels and HFC refrigerants
are no new carbon dioxide emissions during operation of the
For the past 15 years, the manufacturer of transport temperature
Operating costs similar to diesel
control systems, Thermo King, has focused on developing a solution that would meet the future need for an alternative to the
CryoTech system.
fossil fuel or HFC technologies on which the transport industry
The cost of operating a CryoTech unit over its lifecycle is broadly
has depended for so long. In the 1930s, Thermo King pioneered
comparable to that of an equivalent conventional diesel powered
transport temperature control and they have remained the
unit, although specific applications may favor one or the other.
leading innovator in this industry ever since.
The initial cost of the unit is likely to be slightly higher, due to current low manufacturing volumes. This is offset by its longer
How the system works
service life due to its long life components and fewer “wear” items.
The company’s alternative approach, which remains unique in transport refrigeration today, involves the use of recovered and commercially available liquid carbon dioxide (R-744) in an indirect open-cycle system. Unlike other ‘cryogenic’ approaches which
Cooling performance and noise
spray the refrigerant directly into the load space, the Thermo
It has been proven that CryoTech evaporators deliver significantly
King CryoTech range uses fin-and-tube evaporators as heat
more cooling capacity than their diesel equivalent at both fresh
exchangers through which the R-744 flows, absorbing heat from
and frozen box temperatures. Pull down of an empty box can be
the load before it is vented to the outside of the vehicle.
up to four times faster with R-744, making it an excellent choice for distribution operations with a high number of door openings.
The recovered R-744 is stored under pressure in a vacuum insulated tank under the chassis of the truck or articulated trailer.
With more countries considering the introduction of noise limits
It flows to the remote evaporators, one of which is installed in
on evening and night deliveries – following the example of the
each compartment allowing up to three temperatures on one
PIEK standard in the Netherlands - urban distribution operations
vehicle. An electronic expansion valve managed by the electric
wanting to take advantage of low traffic volumes need a vehicle
control module regulates the flow of liquid through each
that can perform at 60 dBA or less. All the CryoTech units are
evaporator thereby varying their cooling capacity to match the
PIEK tested and compliant offering sound levels up to 90% lower
demands of the load and maintain a steady temperature.
than a standard diesel unit.
Just like conventional HFC refrigerants, the liquid R-744 changes state (into a gas) as its pressure drops on leaving the expansion valve and rapidly absorbs heat energy in the process. A regulator keeps gas pressures above the critical 5.5 bar point to avoid the
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The environmental impact of the system
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One current limitation is the availability of R-744 filling stations. In the early years, there was little to no infrastructure to support the filling of CryoTech units. Since then great strides have already
But is the CryoTech solution actually more environmentally
been made in this area.
sustainable? Existing diesel fuel stations were willing to have R-744 storage Engineers at Thermo King performed a detailed carbon footprint
and dispensing stations installed so the vehicles can be refueled
calculation on three equivalent systems. The CryoTech (R-
at the same time as the units. By the end of 2013, more than
744) system was first compared to the latest in “conventional”
40 R-744 filling stations were in operation in eight European
technology (fossil fuel/HFC refrigerant) and to a different
countries and the number is expected to grow in the coming
“alternative” approach using liquid nitrogen as a refrigerant. The
years.
study measures the environmental impact, or “carbon footprint” of each solution.
Thermo King has demonstrated its commitment to this technology, investing heavily in future product research and
The comparison took into account significant sources of carbon
development, as well as the expansion of the filling station
dioxide emission from cradle to grave, including emissions arising
network.
from the energy required to produce the fuels and average annual operating hours. Also taken into consideration were the fuel
Over the past decades, the science of transport refrigeration
consumption and exhaust emissions based on independent ATP
has advanced dramatically and the next years will no doubt
test data only applicable to diesel units.
bring about further innovations. The future promises to be an interesting time, as it is clear that the industry cannot continue to
As expected, the diesel unit’s carbon emissions were largely due
solely depend on traditional fuels and HFC refrigerants. Industry
to burning of this fossil fuel. Although the nitrogen unit consumes
leaders like Thermo King are applying current and emerging
a similar level of fuel to the R-744 unit, nitrogen itself requires
technologies to help their customers achieve sustainable and
about three times more energy to produce than the equivalent
quiet transport refrigeration.
amount of recovered R-744. The total footprint in tons of carbon dioxide over a ten year life was found to be as follows: • Diesel unit
166 tons
• Nitrogen unit
143 tons
• CryoTech unit 46 tons The results, while strongly in favor of the R-744 solution, were not entirely surprising. CIT Ekologik AB (Engberg et al.) conducted a similar detailed Lifecycle Analysis in 2002 comparing diesel-powered units with CryoTech units. The study showed that the carbon dioxide refrigerator contributes considerably less to the environmental effects than the diesel refrigerator during refrigeration as well as heating.1
The road ahead The study demonstrates that the recovered R-744 solution used in the CryoTech range has a carbon footprint approximately 75 percent less than a conventional diesel system and 68 percent less than a nitrogen cryogenic system. But carbon footprint alone will not make a solution commercially viable. The CryoTech range has been shown to also have a similar cost of ownership to an equivalent diesel system while substantially outperforming diesel on both noise and temperature pull down/recovery. These additional features make it ideally suited for urban distribution. 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.
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TLPINSIGHT 47.
The knowledge gap Classification and labelling/marking of dangerous goods
Why is it that you will receive two completely different answers to
Consignor shall only offer dangerous goods to carriers that
the question: ‘Who is responsible for the correct classification
have been properly identified.’
and labelling1/marking (of hazards) of substances and mixtures?’ depending on the job of the person in front of you?
Well, from each one’s perspective, both of the answers are right but what's important to point out here, is that the ‘correct’
If, for example, the question is answered by a Chemist, who
answer from the Logistics Manager is highly dependent upon the
actually produces/uses those chemicals, the answer will,
correct answer being given in the first place by the Chemist. The
hopefully, be that ‘CLP and REACH places the responsibility for
big questions are WHY that dependency, and WHERE is that
hazard classification and related provisions such as packaging,
presumed KNOWLEDGE GAP?
hazard communication and SDS on the suppliers.’ In this article we’ll try to give you the background, answers and Asking the same question to a Logistics Manager though, who
explanation to these questions.
has assumed the Consignor’s role down the supply chain, would result in him focusing on different elements than the ones the
Question 1: Why does logistics depend on the chemical
Chemist is mostly concerned with i.e. those that relate to the
classification?
Transport of Dangerous Goods, such as the UN number, the Proper Shipping Name (PSN), hazard Class, Packing Group etc.
If you are in a logistics function and you are handling or
for the classification part. And, depending on the transport mode,
transporting dangerous goods, you most probably have followed
elements such as the relevant Hazard Label(s), UN number,
training to make you either familiar with the applicable rules and
PSN, Shipper/Consignee Addresses and weights for the marking
regulations regarding the storage and transport of dangerous
& labelling. Furthermore, you will also, hopefully, hear about
goods or you have passed examinations which certify you to
additional requirements that need to be fulfilled, such as training
make, for instance, declarations for transport or even to become a
and documentation etc. all with the same start point, namely: ‘a
Dangerous Goods Safety Adviser.
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.
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The majority of regulations concerning the storage and transport of dangerous goods contain chapters or articles in which the
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The big questions are WHY that dependency, and WHERE is that presumed KNOWLEDGE GAP?
TLP
Ideally, all the information needed for a Consignor, when different to the manufacturer3, who wishes to verify for himself the correctness of the existent classification in order to properly prepare a shipment for a substance/mixture or article according to the requirements of the transport regulations, should be found in these Sections whereby Section 3, 9, 11 and 12 contain the most vital information.
classification of dangerous goods is described. The scope of this classification material is to explain to the user how he/she can
Because regulations are highly prescriptive, if someone follows
determine in which of the 9 hazard classes a substance/mixture or
the correct steps and, where needed, uses the Precedence of
article qualifies to be assigned and, if applicable, in which division,
Hazards Table correctly, (almost) nothing can go wrong, he/she
packing group or compatibility group within that class.
will end up with the same classification results prescribed under Section 14 of the SDS, being:
By now you are probably thinking how you should be able to do these tests in your warehouse? Indeed if you look through
14.1. UN number
the requirements there is no way you are able to perform these
14.2. UN proper shipping name
test(s) if you do not have a laboratory environment including all
14.3. Transport hazard class(es)
the equipment and trained staff.
14.4. Packing group
14.5. Environmental hazards
Here is where the Safety Data Sheet (SDS) comes into the
14.6. Special precautions for user
picture! The SDS provides the results of the testing and
14.7. Transport in bulk according to Annex II of
classification procedure performed by the Chemist under
MARPOL73/78 and the IBC Code
prescribed GHS criteria. Many of those criteria are already based on the ‘UN Model Regulations for Transport of Dangerous Goods,
So, why not take the shortcut, just look at Section 14 and job done
Manual of Tests and Criteria’ and related legal instruments (ADR,
for the Consignor, he can now continue with other work!
RID, ADN, IMDG Code and ICAO TI). Question 2: Where is that presumed knowledge gap? Thus, in the SDS, the primary use of which is for workplace users, you should be able to find all the relevant testing and
Here’s where the ‘tricky’ part starts! As indicated earlier, the
other official information, including the transport classification,
Consignor is the responsible (read ‘liable’) part in the logistics
regarding a specific substance, mixture or article2 grouped under
chain. Thus, he should be able to make sure that the goods
the following 16 sections:
offered are correctly packed, documented, marked and labelled, simply because he has accepted the Consignor’s role
SECTION 1: Identification of the substance/mixture and of the company/undertaking
further down the supply chain. Though, this is practically possible only when the information under section 14 is correct.
SECTION 2:
Hazards identification
SECTION 3:
Composition/information on ingredients
As we previously said, in cases where the Consignor is also
SECTION 4:
First aid measures
producer/manufacturer of the goods, both the classification of
SECTION 5:
Firefighting measures
the goods and the production of the SDS are in the same hands.
SECTION 6:
Accidental release measures
In this case, the Consignor has promptly available the information
SECTION 7:
Handling and storage
on whatever he is shipping and has full control over all the aspects involved in classification of the products.
SECTION 8:
Exposure controls/personal protection
SECTION 9:
Physical and chemical properties
SECTION 10:
Stability and reactivity
It’s something else though when the Consignor is for instance a
SECTION 11:
Toxicological information
trade organisation or a 3PL. In these cases the Consignor is no
SECTION 12:
Ecological information
longer the owner of the goods nor involved in the classification
SECTION 13:
Disposal considerations
process.
SECTION 14:
Transport information
SECTION 15:
Regulatory information
SECTION 16:
Other information
From 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] 3 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] 2
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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 07 - 2014
Indeed, what actually happens in most cases, is that the
constantly. In some cases new UN numbers are added, in other
Consignor is relying on the information received from either the
cases classification of certain substances are changing. Besides
owner or the manufacturer of the goods. A big question remains,
that, we have differences between the different modes of
however. How can a Consignor verify, in a case where the
transport or, mainly for road, differences between countries.
relevant information on the received SDS is lacking, whether the classification under section 14 is correct?
Not every chemist will go through his list of SDSs to verify if something has changed for Section 14 when a new regulation
Another widespread phenomenon, especially in the 3PL business,
is published. This leads not only to inaccurate SDSs but also to
is: the ‘gap in time before becoming aware of updates’ regarding the classification, and labelling. Regulations require that each time there’s an amendment for a substance in CLP or when a
liability issues for Consignors
Train staff to be accurate, attentive and knowledgeable when dangerous goods are involved.
as, in the end, they are the responsible party for the classification during transport… So, what to do?
change is introduced in a mixture, suppliers MUST reconsider the classification of that substance or
Options and solutions
mixture. Also, they should promptly share the new information with all the actors down the supply chain to allow them to fulfill
As indicated, the Owner/Manufacturer being Consignor as well
their obligations.
has the least problems as all is under one roof. The easiest way to solve issues in this case, if there are any, is to make sure to use an
We have seen many examples of wrong SDSs delivered with
integrated software system in which both chemical management
goods like an SDS for a liquid delivered with a solid substance
and logistics are connected and where information is shared in
or an SDS based on old classification criteria where for instance
real time.
a flammable aerosol (Class 2) was still classified as Class 3 (Flammable liquids) for transport.
Meaning that when an SDS is changed, it will be published immediately replacing the previous version. On the other hand, if
In the above cases the Consignor has a job to do to:
the transport regulations change, this will be indicated in the list of SDS and forces an update to be processed by the Chemist.
a. Train his staff to be accurate, attentive and knowledgeable when dangerous goods are involved.
Also a connection to the labelling for both chemical (GHS/CLP) and transport (ADR/RID/IMDG/ICAO-TI/ADN/49CFR) should be
b. H ave procedures in place with both owners and suppliers
included to keep all marking and labelling for products updated.
of dangerous goods to make sure he receives accurate information and also receives timely the updated versions of
For the Consignor not producing his own products, a similar
SDSs once they become available.
software system is recommended but used in a way where the Owner/Supplier and Consignor have shared responsibilities
The second factor affecting the knowledge gap is the knowledge
regarding information provision. This can be managed by making
level of the ‘competent person’ and his/her capability to ensure
firm agreements between the parties involved or using a third
the consistency of the SDS. It is understood that any one single
party to make sure all information is as accurate as possible
person very rarely has extensive knowledge in all the fields
at all times, keeping the parties involved updated on changed
covered by an SDS. That’s why the regulations require that
documentation, regulations and labelling/marking.
‘Suppliers of substances and mixtures should be able to ensure that such competent persons have received appropriate
Authors:
training, including refresher training.’ Unfortunately, many
Herman Teering
Managing Director
times and especially within smaller companies this role is also
Panos Drougas, MSc
Senior Chemical Consultant
assigned to (production/QC) Chemists who are not always specialised in the transport classification of dangerous goods. When you are involved in logistics, you know that regulations regarding the transport of dangerous goods are changing
50. TLPINSIGHT
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THE LOGISTICS PORTAL MAGAZINE
//EVENTS
Issue 07 - 2014 WWW.THE-LOGISTICS-PORTAL.COM
TLP
SMI COLD CHAIN DISTRIBUTION December 2 - 3, 2014 London, United Kingdom www.smi-online.co.uk/pharmaceuticals/uk/cold-chain-distribution
5TH ANNUAL COLD CHAIN MENA SUMMIT January 11 - 14, 2015 Marriott Al Jaddaf, Dubai, United Arab Emirates www.coldchainmiddleeast.comt
CLINICAL TRIAL SUPPLY EUROPE January 21 - 23, 2014 Germany, Frankfurt www.clinicalsupplyeurope.com
CLINICAL TRIAL SUPPLY EUROPE January 26 - 29, 2014 Messe Frankfurt Venue GmbH, Frankfurt am Main, Germany www.coolchaineurope.com
13TH COLD CHAIN GDP & TEMPERATURE MANAGEMENT LOGISTICS SUMMIT - CANADA February 23 - 26, 2014 Hilton Montreal Bonaventure, Montreal, Canada www.coldchainpharm.com
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WWW.THE-LOGISTICS-PORTAL.COM Issue 07 - 2014
Professional team and well executed” EVENT ATTENDEE 2013
SMi Presents the 9th Annual Conference on…
Cold Chain Distribution Enhance Temperature Management for an Efficient Supply Chain
Marriott Regents Park Hotel, London, UK CHAIRS FOR 2014:
2014
Benchmark and reflect on the implementation of the GDP directive with case studies from IATA, AbbVie and the Dutch Health Care Inspectorate
Alan Dorling, Global Head - Pharmaceutical & Life Sciences, IAG Cargo Andrea Gruber, Senior Manager, Specialised Cargo, IATA
Enhance your understanding of the challenges of transport qualification for temperature sensitive pharmaceutical products with a round table discussion led by Tony Wright, Managing Director, Exelsius Cold Chain Management and an opening address from Alan Dorling, Global Head Pharmaceutical & Life Sciences, IAG Cargo
Tony Wright, Managing Director, Exelsius Cold Chain Management
KEY SPEAKERS INCLUDE:
• David Spillett, Business Development Manager, Biopharm Services, World Courier • Tim Wood, Technical Service Manager, GSK • Gianpiero Lorusso, Supply Chain Manager, Merck Serono • Michelle Goodyear, QA Manager, AbbVie • Chris Wallace, Distribution Director, Genzyme • Didier Basseras, Vice President Global Head of Clinical Supplies and Supply Chain, Sanofi Aventis R&D • Thomas Grubb, Manager, Cold Chain Strategy, American Airlines
Lead Sponsor:
DEC
BUSINESS BENEFITS FOR 2014:
Cheryl Blake, GDP Inspector, MHRA
Current attendees include: • AAH Pharmaceuticals • Allergan • Alliance Healthcare • Eli Lilly
2nd - 3rd
• F. Hoffmann-La Roche Ltd • Mundipharma • Priority Freight LHR Ltd • Public Health England
Strengthen your supply chain through management and efficiency insights from Merck Serono and Genzyme
• Roche Pharmaceuticals • Sanofi-Aventis • Takeda Pharma International
• The Saudi FDA • The Blood Transfusion Centre of Slovenia • plus many more…
Sponsored by:
a TCP Company
How to Register
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Cold Chain Distribution Attendees 2011-2013 by Industry Sector
Who should attend this conference:
ACADEMIA 7% You should attend this event if you work in the Pharmaceutical Industry with responsibilities in Quality Assurance, Quality Compliance, Regulatory, Supply Chain, Manufacturing, Packaging, Distribution, Operations.
Job titles include: • GMP Compliance Specialist • GMP Inspector • Director, Global Demand Planning & Customer Operations • Director, Purchasing and Distribution • General Manager, Distribution and Logistics • Director, Regulatory Affairs, Corporate GMP Officer • Head of Packaging • VP, Clinical Logistics • International Supplies Manager • Quality Assurance and Quality Compliance Manager • Head of Corporate Supply Chain Operations
REGULATORY 9%
SERVICES/PRODUCT SUPPLIERS 33%
PHARMACEUTICAL 51%
Cold Chain Distribution Attendees 2011-2013 by Region MIDDLE EAST 6% USA 4%
UK AND EUROPE 90%
Tuesday 2nd December Evening Dinner World Courier will be hosting a unique and exciting evening dinner at the end of Day 1. This event will be hosted at Gordon Ramsay’s Maze Restaurant and the Routemaster will pick up from the Marriott Regents Park at 7.30pm. It promises to a fantastic experience. Places are strictly limited, visit our website for further details.
Platinum Media Partner
Supported by
Silver Media Partner
BOOK BY 30TH SEPTEMBER 2014 TO RECEIVE £300 OFF BOOK BY 31ST OCTOBER TO RECEIVE £100 OFF Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 www.the-logistics-portal.com
@SMIPHARM
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//INDEX OF ADVERTISERS IFC
CSAFE
5
Sofrigram
7
Softbox
9
Berlinger &Co AG
12
IATA
45
Cargolux
52
SMI
IBC
DGM
OBC
UPS
54. TLPINSIGHT
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Safety first in Dangerous Goods Management
Dangerous Goods Management is all about
automated where possible to save you time
safety and minimizing risk. In air transpor tation,
and to reduce error rate to a minimum.
staying compliant with all of the many rules and regulations is not an easy task. However,
DGOffice.net was developed as an on-line
supported by DGOffice.net with its specific
application, meaning you can access it anytime
modules for air transportation, it becomes a
from anywhere in the world. Alternatively,
clean cut operation. From Packing Instructions
run it as you see fit: within your own network
to Shipper’s Declaration and ‘NOtification TO
or on a stand-alone computer.
Caption’: it’s all in the software and highly
DGM SDG A/S, Kokholm 3b, DK 6000 Kolding, +45 75 575 790, info@dgm-sdg.com, www.dgoffice.net