TLP Issue 7 September/October 14

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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//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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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 07 - 2014

//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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THE LOGISTICS PORTAL MAGAZINE WWW.THE-LOGISTICS-PORTAL.COM Issue 07 - 2014

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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TLP

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.

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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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TLPINSIGHT 15.

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.

Figure 9 – Temperature probe attached to the air return grille of an evaporator www.the-logistics-portal.com

TLPINSIGHT 27.

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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KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT

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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KEEP YOUR COOL THE ULTIMATE GUIDE TO EFFECTIVE TEMPERATURE CONTROL IN REFRIGERATED TRANSPORT

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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TLPINSIGHT 35.

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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.

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info@CSafeGlobal.com

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A sustainable solution for temperature controlled urban distribution

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Advert to change?

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TLPINSIGHT 45.

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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

THE LOGISTICS PORTAL MAGAZINE Issue 07 - 2014 WWW.THE-LOGISTICS-PORTAL.COM

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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THE LOGISTICS PORTAL MAGAZINE

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

www.coldchain-distribution.com 52. TLPINSIGHT

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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

TLPINSIGHT 53.

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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

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TLP

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