Thermal Risk - Hanse

Thermal Risk - Hanse
Thermal Risk
HAVE YOU GOT IT
A look at the process of coolchain component
qualification in the context of thermal protection and
overall transport qualification.
Malik Zeniti, DuPont Protection Technologies
2
The EU GDP makes it obligatory for manufacturers to ensure
that their supply chain partners have the plans, processes
and procedures in place to ensure compliance with prevailing
regulations relating to product safety. With industry sources*
suggesting that up to 5% of pharma transport events
are being affected by unwanted temperature excursions
there is an urgent need for a better understanding of the
role of component qualification to improve temperature
management during product distribution.
* ‘Handling Temperature Excursions and the Role of Stability Data’. Claude Ammann; Pharmaceutical Outsourcing, September 25, 2013
Thermal risk - have you got it covered?
3
CONTENTS
■ INTRODUCTION 4
■ COOLCHAIN ROUTE QUALIFICATION - WHY IT’S NEEDED 5
■C
OOLCHAIN COMPONENT QUALIFICATION 6
- Operational Qualification
- Pre-Qualification
- Performance Qualification
- Transport GDP Verification - Repeatability and Consistency
■ VALIDATION OR QUALIFICATION? 10
■ TYVEK AIR CARGO COVERS
an Example of a Product Qualification Exercise as Part of an Overall Transport Validation Plan
- Methodology
- Tyvek Operational Qualification OQ Test Design
- Solar Radiation Impact
- The Danger of Stretchwrap
- Greenhouse Effects
- Tyvek Performance Qualification
- PQ Purpose
- Performance Measurement
®
11
®
®
■ ARE YOUR COOLCHAIN SOLUTIONS VALIDATED? 18
■ ABOUT THE AUTHOR Thermal risk - have you got it covered?
Back Cover
4
Thermal risk - have you got it covered?
A WHITE PAPER FOR PHARMA LOGISTICS
A look at the process of coolchain component qualification
in the context of thermal protection and overall transport
qualification.
With the manufacture of pharmaceuticals now a global
industry and with the new EU GDP and other regulated
quality control measures in place, there is a critical need for
a structured and stringent validation of the components and
solutions used in the transport of pharmaceutical products.
One area of particular concern is that of Controlled Room
Temperature (CRT) logistics, otherwise known as controlled
ambient temperature. The nominal CRT temperature band
of 15 to 25° C covers a large proportion of the finished
pharmaceuticals that are transported across the world
and for this there is a pressing need to put in place CRT
management systems that are dependable, effective and
affordable. The regulations governing CRT storage and
transportation basically require pharmaceutical companies
and their distribution partners to take the appropriate
Thermal risk - have you got it covered?
validation and qualification measures to demonstrate
coolchain component and system performance and
regulatory compliance. The difference between qualification
and validation is often confused (see Fig 3 ‘Validation or
Qualification’) but in essence they are analogous terms
relating to the evidential assurances required as part
of a quality management system (QMS) governing the
protection of pharmaceutical products during their transport
to market.
TANGLED WEB
To bring certainty, consistency and control to the often
tangled web of outsource parties involved in pharma
distribution requires a coolchain strategy that embraces
proven, reliable, thermal-protective technology. With much
of the post-production life-cycle of a pharmaceutical product
being being literally out of the hands of the manufacturer,
it is essential that rigorous carrier and 3PL qualification
systems are in place throughout the distribution chain as
part of an overall coolchain qualification programme.
5
To achieve this, the protective component parts and
systems used during physical distribution must be suitably
qualified and an appropriate control and monitoring
programme covering all the possible conditions that might
be encountered during each stage of transportation put into
effect. Together with other key elements such as dependable
tracking systems and certified operative training, a major part
of any such a strategy relates to the specification, selection
and validation of the discrete coolchain components,
equipment and systems that are brought together to form an
overall ‘qualified shipping lane’ or ‘GDP compliant’ logistical
solution.
lanes to demonstrate that the necessary controls are in
place to ensure product and, ultimately, patient safety.
This means that all coolchain packaging systems, vehicles and
storage facilities, together with all attendant methodologies and
operating procedures, need to be approved and performancevalidated through a rigorous programme of pre-testing, field
trials and ongoing data capture.
Transportation validation is part of the overall pharmaceutical
quality control process. It is essentially a systematic
approach to collecting and analysing the necessary data to
give reasonable assurance and documented evidence that
a specified coolchain system and protocol will consistently
operate as expected within specified parameters.
COOLCHAIN ROUTE QUALIFICATION WHY IT’S NEEDED
Regulatory obligations make it necessary for producers to
validate cool chains and qualify their associated shipping
TEMPERATURE EXCURSIONS - WHERE DO THEY OCCUR?
Manufacturer
Trucker
Freight
Forwarder
Airline
Airline Cargo
Handler
Airline
Airline
Airline Cargo
Handler
Regulatory
Authority
Airline Cargo
Handler
Airline
Trucker
Freight
Forwarder
Fig 1
ORIGIN
TRANSFER
Trucker
DESTINATION
Low Risk
Thermal risk - have you got it covered?
Medium Risk
High Risk
Consignee
6
Weak Links
There are a number of recognised weak links in the pharma
cool chain (Fig 1). Moving pharma products from A to B has
the potential to affect the efficacy and quality of a product or
even to render it ineffective or, at worst, dangerous, so it is is
important that adequate controls are in place to control risk.
Pharma producers bear a heavy responsibility, both legal
and moral, to enact and enforce the most appropriate
control measures during the shipping stages of the product
life cycle. It is a responsibility which cannot simply be
abrogated by transferring it along the supply chain and any
organisation that neglects product safety is in breach of the
law and taking an unacceptable gamble on both its own
future and on the safety of the public.
By specifying the service levels required from 3PLs and
by participating in key component validations and the
development of qualified shipping routes, a pharmaceutical
company is able to exercise control of its transport lanes
and provide documented evidence that its products are
being maintained within acceptable temperature limits
throughout their entire journey from factory to pharmacy.
Critical Control Points
In establishing these controls the prevailing laws around
GDP provide guidance to pharma companies. However,
they are not prescriptive. It is down to the manufacturer,
usually in partnership with its logistics partners and
component suppliers, to develop and test the appropriate
validation measures necessary to prove that their
distribution arrangements are under control and ‘fit for
purpose’. In other words, transport validation has to cover
the entire pharma distribution process inclusive of all third
party involvements.
This involves establishing the critical control points in the
Thermal risk - have you got it covered?
distribution chain and qualifying each individual step. It is
a process that must embrace the entire mix of methods
and SOPS relating to personnel, equipment, packaging,
transport, storage, measurement, monitoring and recording.
Steps
The individual steps are developed, tested and documented
(qualification) followed by testing and documentation of
the resulting end-to-end process (validation). The resulting
coolchain system with all its component products, processes
and procedures must then be actively monitored in use
(verification) to ensure it remains relevant to changing
operating and environmental conditions.
COOLCHAIN PRODUCT QUALIFICATION
When it comes to the individual components that are used
to manage temperature sensitive products in a cool chain,
Product Qualification is achieved by subjecting the equipment
to two different types of test; fully controlled static tests
(Operational Qualification or ‘OQ’) and dynamic ‘in-use’ tests
(Performance Qualification or ‘PQ’).
In the case of OQ, this step is conducted under both ‘normal’
and ‘worst-case’ environmental conditions to determine
the operational parameters of the individual components
and to evaluate how they function as part of an overall
cool chain system. The overall objective is to control the
variations that result from the predictable interplay of all
the known coolchain elements in order to ensure pharma
product quality and patient safety.
Both OQ and PQ elements of the Product Qualification
feed into an overall Transport Validation which, in turn, will
typically form part of a manufacturer’s overall GDP
Process Validation Plan (see Fig 2).
7
Operational Qualification
cover such as DuPont Tyvek , the OQ testing needs to
consider not only the effects of ambient temperature
extremes, but also the importance of solar radiation and its
related effects on the potential temperatures experienced
by pharma merchandise in transit.
®
Designed to explore and document the functional envelope
for a coolchain component, Operational Qualification (OQ)
tests are a vital part of the qualification programme. The
OQ tests evaluate the correct functioning of the coolchain
components under both the expected and extreme operating
conditions that have been identified in a comprehensive GDP
risk analysis. Such an analysis includes the identification
of hazards and the analysis and evaluation of all risks
associated with exposure to those hazards.
It is essential that this risk analysis is rigorous and thorough
because, if and when an unacceptable temperature violation
occurs, it will be necessary to demonstrate that the qualification
process was appropriate to the risks under consideration.
This preliminary risk analysis therefore establishes the
technical parameters of the component’s performance, i.e.
its ability to meet or exceed reasonably expected worstcase operating conditions, together with its operating limits.
In the case of a coolchain component such as a cargo
cover, this preliminary risk analysis must consider all the
potential variables at play. For example, with a thermal
Fig 2
PHARMA COOLCHAIN RISK MANAGEMENT
cGMP / cGDP COOLCHAIN PROCESS VALIDATION
SHIPPING ROUTE QUALIFICATION
TRANSPORT QUALIFICATION
PRODUCT PERFORMANCE QUALIFICATION
PRODUCT OPERATIONAL QUALIFICATION
USER REQUIREMENT SPECIFICATION
RISK ANALYSIS
Thermal risk - have you got it covered?
8
Pre-Qualification
In some lower-risk cases, OQ tests results may be deemed
sufficient to ‘pre-qualify’ a coolchain component product
for ‘off-the-shelf’ operational use. These ‘one-size fit all’
solutions reduce costs and save time and for some specific
needs can be appropriate. A situation where a pre-qualified
coolchain component might be considered appropriate, for
example, might involve a regular short-haul route within a
single climatic zone using a reliable logistics partner and with
a known coolchain infrastructure at journey start and end.
However, a reliance on ‘pre-qualified’ component products
brings its own risks and can lead to protection for temperaturesensitive pharma merchandise that is either under- or overspecified for a given use or situation. Operating conditions
can vary enormously even within a given shipping lane.
Environmental extremes, different pharma merchandise
characteristics and densities, changing loading patterns,
varying payload sizes etc. are just some of the factors that
can easily lead to ‘out of spec’ conditions.
Similarly, ‘pre-qualified’ status is of very little value when
it comes to the selection of coolchain components since it
confers no recognised standard of quality or performance
and there are no normalised test regimes to enable
like-for-like comparisons between competing coolchain
component products.
Performance Qualification
The Performance Qualification (PQ) determines that both
a coolchain component’s specified performance and the
results from its OQ are achieved consistently when the
component forms part of an overall coolchain protocol.
Thermal risk - have you got it covered?
The purpose of the PQ is to verify and document that the
coolchain component concerned is functioning correctly
and reproducibly within the entire specified working range
and limits i.e. its ‘fitness for purpose’. Therefore, for PQ
purposes the component is always tested as part of an
overall coolchain process or process step. This requires the
PQ stage to be based around field studies demonstrating
how the component performs under actual conditions of use.
However, it must be clear that the PQ part of a transport
qualification is designed to demonstrate that the component
will function as expected under normal operating conditions.
It is not intended as a test against environmental extremes,
which by their very nature are unexpected and unpredictable
events and consequently cannot be planned for and built-in
to this part of the qualification.
Transport GDP Verification Repeatability and Consistency
Transport verification involves conducting several repetitions
of a validated solution to confirm its efficacy in the field.
Verification then continues as an ongoing process which is
carried out continuously or periodically while the component
product remains ‘in-service’ to ensure that it remains
appropriate and effective in use and to accommodate
planned and unplanned changes that may have occurred
in the distribution chain. In this respect, a clearly defined
change control policy must be in place and the principles of
corrective and preventive actions (CAPA) applied wherever
necessary.
Verification also identifies opportunities for new and upgraded
component products and procedures to be introduced. In
real-life situations, of course, many of these adjustments
9
may not become apparent until an acceptable temperature
deviation occurs. A system must be in place to ensure that
any such excursions are not only recorded but are brought to
the attention of the appropriate quality management.
Summary
The latest EU Good Distribution Practice has extended
regulatory measures to cover the CRT temperature band
and, at a stroke this has substantially increased the volume
of pharma products that are now within regulatory scope.
Most pharmaceutical merchandise requires storage and
transportation at ambient temperature and a failure to take
fully validated thermal protection measures could amount to
a catastrophic mistake.
So, the burning question is: «Can YOU vouch for the integrity
of the key components being used in your coolchain?»
Thermal risk - have you got it covered?
10
VALIDATION OR QUALIFICATION?
Much confusion surrounds the terms “Qualification”
and “Validation” when it comes to good coolchain
practice. The terms ‘validation’ and ‘qualification’
are often used interchangeably and both relate,
essentially, to the process of proving that a process
or equipment is ‘fit for purpose’. Certainly the most
important thing of all is to ensure that something
is fit for purpose rather than get bogged down in
semantics.
However, the International Conference on
Harmonisation (ICH) provides the following
definitions* which are mirrored in the latest EU
GMP guideline**:
Qualification
The action of proving and documenting that equipment
or ancillary systems are properly installed, work
correctly, and actually lead to the expected results.
Qualification is part of validation, but the individual
qualification steps alone do not constitute process
validation.
Validation
A documented program that provides a high degree
of assurance that a specific process, method, or
system will consistently produce a result meeting predetermined acceptance criteria.
Fig 3
So a product such as Tyvek ACC needs to be
qualified to show:
®
1. that it consistently meets its quality and design
performance specification - thermal properties,
breathability, strength, etc. (Operational Qualification);
and
2. that it meets its performance specification
under controlled conditions to demonstrate
its performance behaviour in the volatility of
changeable, real life situations (Performance
Qualification).
These component qualification exercises are
normally carried out by the product manufacturer i.e.
DuPont in the case of Tyvek air cargo covers. This
qualification exercise will normally include an overall
analysis of all the relevant elements and procedures
of the distribution chain - route, handling, aircraft,
airport facilities etc. followed by static ‘worst case’
tests and, lastly, by an empirical ‘in-situ’ service
analysis where the outcomes are benchmarked
against the static results.
®
This product qualification then forms part of the
overall validation of a shipping route or other
coolchain solution. These route validation exercises
are normally carried out by the pharma company and/
or its 3PL partners.
What this means in practice is that all components
or equipment used in a ‘validated’ coolchain must be
individually ‘qualified’. The scope and extent of the
necessary qualification steps should be determined
using a documented risk-assessment approach.
*International Conference on Harmonisation (ICH) Good
Manufacturing Practice Q7 2000
**EU Guidelines on Good Distribution Practice of medicinal
products for human use (2013/C 343/01)
Thermal risk - have you got it covered?
11
TYVEK AIR CARGO COVERS - an Example of a Component Product Qualification Exercise as Part of an
Overall Transport Validation Plan
®
The new generation, Tyvek Air Cargo covers from DuPont
are a typical low-bulk and lightweight passive protection
component. Designed to provide cost-effective off-the-shelf
CRT protection for pharmaceuticals, these cargo covers
employ a unique triple-action approach to temperature
control which renders them a very effective and costefficient solution to CRT control (see Fig 4).
®
It is this three-stage protection which differentiates Tyvek
from other cargo covers on the market and DuPont has
conducted a number of generic and lane-specific validation
exercises to demonstrate their superior performance in the
field. Thermal testing of Tyvek covers is a vital element of
the overall qualification process and these tests started
with a series of operational qualification (OQ) studies. This
involved chamber testing to subject the covers to simulated
environmental conditions of a sufficiently extreme nature to
demonstrate performance under relatively harsh conditions.
®
®
These simulation exercises were then replicated to
demonstrate repeatability and consistency and the result
was a robust data set which confirmed the expected
performance boundaries of the Tyvek product and
provided a benchmark for subsequent validation under
dynamic field conditions.
®
Scope of Programme
The scope of the temperature validation plan was to establish
proper distribution and product handling requirements, for
the purpose of ensuring the maintenance of appropriate
product temperature in transit.
Purpose of Programme
The purpose of the Tyvek temperature validation plan was to
use thermal mapping data to provide documented evidence
that a cargo pallet protected with a Tyvek cover provides
robust protection against exterior environmental conditions
including exposure to both high and low ambient temperatures
and the effects of direct solar radiation.
®
®
TYVEK TRIPLE PROTECTION ®
Fig 4
➊ Reflective outer surface minimises
solar heat gain
➋ L ow-e metallic surface reduces
thermal transfer to cargo
➌ Microporous structure permits
evacuation of excess moisture
and condensation
Thermal risk - have you got it covered?
12
ROUTE PROFILE TEST CONDITIONS
5- Offloaded cold climate -20°
10 hours
1- Warehouse storage 20°
3 hours
2- Apron tarmac 31°
3 hours
4- Offloaded cold climate -20°
10 hours
3- Aircraft 10°
10 hours
Methodology
The methodology involved assessing the impact of different
hazards to enable the degree of risk to be defined. The
results were referenced against a selection of contemporary
materials currently in widespread use for the passive
protection of pharma merchandise.
Tyvek Operational Qualification
®
The first part of the temperature validation exercise involved
conducting a series of static tests designed to measure
the performance of the Tyvek covers in both summer and
winter conditions. The effects of prolonged exposure to the
sun were also measured along with the ability of the covers
to protect against cold.
®
Thermal risk - have you got it covered?
Fig 5
The following temperature cycles were conducted:
1. Acclimatise test pallets with load at +4°C for 72
hours. Add covers and expose pallets to sunshine for
48 hours
2. Acclimatise test pallets at 23°C and insert into
container at -20°C for 15 hours
3. Acclimatise test pallets at 4°C and insert into
container at +20°C for 24 hours
4. Acclimatise test pallets at +20°C and insert into
container at 4°C for 24 hours
5. Acclimatise test pallets at +20°C and insert into
container at -5°C for 24 hours
6. Acclimatise test pallets at +20°C and insert into
container at -0°C for 24 hours
13
These static tests were a vital part of the qualification
programme since they were designed to explore and
document the technical characteristics of the Tyvek
product. In other words, they identified the range of
operating parameters under which the product will function
effectively.
®
The dynamic tests on the other hand were designed to
demonstrate that the Tyvek component functions as
intended under real-life conditions as part of an overall
coolchain system. These dynamic tests are not therefore
devised in order to prove the operating envelope (although
they may serve to do so if ‘out of specification’ conditions
are encountered during the measured validation runs).
®
External solar radiation test
Operation Qualification Test Design
The OQ test programme was designed to the measure the
following material properties:
■ Strength/weight
■ Water repellency
Cool chamber test
■ Breathability
■ Emissivity
■ Recyclability
■ Conductivity
The OQ test programme was designed to measure the
following product properties:
■ Thermal performance - ambient temperatures
■ Thermal performance - solar radiation exposure
■ Thermal properties - cooling characteristics
Medium density test loads
■ Ease of use
■ Comparison with competitive alternatives
Test pallets at Luxembourg Pharma Hub
Thermal risk - have you got it covered?
14
PROTECTION FROM COLD EXPOSURE
Fig 6
GRAPH SHOWING TOP PRODUCT TEMPERATURE USING TYPICAL ROUTE PROFILE
An example of the route profile test conditions is shown
in Fig 5 and an example of the results from these tests
in Fig 6.
Solar Radiation Impact
The Tyvek qualification programme took particular recognition
of the effects of solar radiation during the airport apron transfer
step since this is widely recognised as the biggest weakness
in the pharmaceutical coolchain. During the controlled tests
on Tyvek covers, and in virtually all independent trials, these
damaging, but oft-ignored, solar effects were clearly evident.
during these ‘uncontrolled’ air-cargo stages of the distribution
process. During such intervals, pharma merchandise can be
exposed to exceptional temperature extremes as a result
of the ‘greenhouse’ effect of solar radiation, the very same
heating phenomenon associated with global warming.
And the resulting temperature excursions are not rare
®
Fig 7
AIRPORT APRON ‘HEAT ISLAND’ EFFECT
®
Direct sunlight can cause exposed surface temperatures to
rise as high as 70°C or more and these are temperatures that
can be further magnified by local conditions including the ‘heat
island’ effects of solar-heated asphalt pavement (see Fig 7)
and the ‘mirror’ effects of nearby glass and metal clad buildings.
According to IATA, 57% of temperature excursions occur
Thermal risk - have you got it covered?
Incoming solar radiation
Heat emitted back into space
10% reflected
90% HEAT ABSORBED
Convection currents
heat surrounding air
ASPHALT PAVEMENT
15
occurrences. It has been estimated by one authoritative
source that up to 5% of all transport events involve a
temperature deviation from plan with external air handling
operations, such as loading, unloading, marshalling and
transfer, accounting for a high proportion of the temperature
spikes encountered during the transportation of drugs.
SOLAR RADIATION EFFECTS WITH
DIFFERENT COVER MATERIALS
Fig 8
In the past, many pre-qualification tests for cargo covers
ignored this important phenomenon and relied solely on
temperature profiles based on ambient temperatures when
conducting risk analyses and undertaking performance
tests. However, it is clear that, in practice, exposure to
direct sunlight is a very common and very serious cause
of temperature excursions and must be addressed
accordingly.
The Danger of Stretchwrap
Initial trials on Tyvek covers in India had shown
temperature differences of as much as 25°C between
standard stretch-wrapped pallets and identical pallets
cloaked with Tyvek covers when both were subjected to
solar radiation over a 3-day period. Similar measurements
were subsequently repeated in many other geographical
zones in Europe, Asia and the Americas.
®
®
In another Tyvek qualification test, four pallets of pharma
products, two using Tyvek covers and the other two covered
with standard plastic stretchwrap, were temperaturemonitored throughout a six and a half day door-to-door
shipment from Brazil to France. This journey involved wide
ambient temperature fluctuations from as low as 5°C to a
peak of nearly 40°C.
®
®
In this particular test the Tyvek pallets remained within the
desired 15°C temperature envelope throughout the test
whilst, in contrast, both the stretch-wrapped pallets rapidly
breached the predetermined temperature band. In fact some
temperature sensors positioned within the stretchwrap pallets
indicated, alarmingly, ‘out of limit’ temperatures for periods
exceeding 24 hours.
®
Greenhouse Effects
The static OQ trials compared the use of clear and black cargo
coverings with Tyvek to determine their relative behaviour
under identical environmental stimuli. The results were
striking. Transparent cover materials were found to exhibit
®
Thermal risk - have you got it covered?
an alarming degree of heat entrapment and magnification,
the so-called ‘greenhouse effect’, as the sun’s rays were
captured and trapped. Common packaging materials
such as stretchwrap and bubblewrap did not provide any
protection against solar radiation, but rather amplified its
warming effects way beyond the surrounding “ambient” air
temperature, and often to a potentially dangerous degree.
Similarly, black and coloured materials gained heat energy
by absorbing the sun’s rays and increased the surface
temperature of the ‘protected’ packages way beyond the
surrounding “ambient” air temperature (see Fig 8.) The
Tyvek air cargo covers, on the other hand, were found to
sharply restrict this solar heat gain due to their exceptional
reflective properties in both the visible and infrared radiation
wavelengths.
®
Yet more OQ tests were conducted at the Atlas Weatherisation
Test Facility in Florida during punishing ambient conditions
in March 2013. This part of the programme also involved
comparative tests against alternative cover materials and
16
systems and again demonstrated the striking superiority of
the Tyvek covers especially under exposed, high solar-gain,
‘tarmac’ conditions. Again, these tests showed that standard
clear and black stretch-wraps, although cheap and widely
used, tend to act like a greenhouse by trapping heat and
continuously increasing the entrapped air temperature way
beyond the surrounding ambient temperature.
®
Tyvek Performance Qualification
®
The Performance Qualification part of the validation
exercise involved a dynamic transport test measuring
representative pallets of material during conveyance over a
demanding return freight route involving a number of steps
and a range of typical, but not extreme, environmental
stresses. The route chosen and its various phases are
shown in the illustration (Fig 8).
Decisions that had to be made when selecting the route
included the length and duration of the route together with
the coolchain facilities, the number of transit steps, the
logistics suppliers, the mode of flight, the shipping and
airport coolchain facililties, the potential impact of delays and
the anticipated weather conditions.
Performance Measurement
The decision as to what needed to be measured, and
how, were fundamentals of the validation design. Three
dataloggers per pallet were placed inside carton boxes and
a further datalogger was placed on top of the cargo outside
the cover to measure external temperature.
Purpose of performance qualification
It is important to note that the purpose of the Tyvek PQ
was to demonstrate that the Operational Qualification
results were applicable to real-life conditions and that
the measured performance patterns were mirrored
in the field. The PQ was not, per se, an exercise to
demonstrate the technical performance capabilities of
the product under extreme or unexpected conditions.
It is not realistic from a practical or economic
perspective to attempt to run sufficient performance
qualification runs to experience and measure random
temperature extremes.
®
Thermal risk - have you got it covered?
Fig 9 shows the designated pallet configuration and the
location of the thermal sensors in the corners of the pallet,
regarded as the most sensitive place to temperature
excursions during shipment. The sensors used were
calibrated model EBI 300 / EBI 310 loggers from EBRO.
The test was conducted with standard Euro pallets
loaded with a total of 32 boxes in 4 layers. The boxes
were made of double-walled corrugated board and each
of these contained three 1.5 litre plastic bottles of water
representing a typical medium mass pharma product. The
air/water ratio of each pallet was approximately 80%. The
pallet was consolidated on the pallet with standard plastic
strapping.
Two versions of Tyvek were tested. One of these was the
standard (uncoated) ‘WW’ Tyvek cover, normally used
for the protection of perishable foods and flowers. The
other was the internally silver-coated Tyvek ‘’WS’ version,
normally used for high-value pharmaceutical products. A
control pallet of identical size and content was included
and this was covered with a clear stretchwrap film.
®
®
®
The test run was designed to illustrate the performance
of the covers as part of a coolchain system under typical
real-life conditions. In this case there were no out-of-theordinary extremes of temperature, there were no undue
tarmac delays and there was little exposure to solar
radiation. Nonetheless, the PQ was an unqualified success.
The Tyvek covers performed exactly as expected and
demonstrated a consistent and significant improvement
over conventional wrapping materials.
®
17
PERFORMANCE QUALIFICATION - TRANSPORT VALIDATION RUN
➋
Truck
Transport
➌
Luxair
Cargo
➍
Cargolux
Boeing 747-8
S
6 HO UR
➏
➊
➎
Dubai
World Central
➐
Dubai
International
Truck
Transport
DuPont
Luxembourg
S
9 HO UR
➓
Truck
Transport
Thermal risk - have you got it covered?
➒
Frankfurt
International
➑
Emirates
SkyCargo
Fig 9
18
ARE YOUR COOLCHAIN SOLUTIONS VALIDATED?
The results of this first phase of the Tyvek qualification
exercise were unequivocal and proved conclusively that when
used in accordance with the manufacturer’s instructions,
Tyvek air cargo covers provide a significant improvement
in product temperature stability and can be used with
confidence to meet current regulatory requirements.
The qualification also demonstrated the technical superiority
of the Tyvek cover compared to alternatives in common use.
®
®
®
PALLET BUILD AND SENSOR POSITIONNING
Fig 6
Top of the carton boxes
Inside upper level
Opposite corner
Inside mid-level centre
Inside lower level corner
Euro Pallet 80 x 120 cm, 120 cm high
Carton boxes: 29 cm x 39 cm x 29 cm high
Thermal risk - have you got it covered?
19
ABOUT THE AUTHOR AND
DUPONT PROTECTION TECHNOLOGIES
Malik Zeniti was Manager of Business Development at DuPont
Protection Technologies (DPT) in Luxembourg, focused on the market
development and sales of the thermal air cargo covers business
branded Tyvek in EMEA.
®
He is also an active Member of the Cool Chain Association.
We have published this white paper to help pharmaceutical quality,
safety and logistics executives understand some of the issues
surrounding the successful qualification of thermal cargo covers for
air freight applications.
If you have any comments or would like to find out more about coolchain
management and thermal control please feel free to contact:
● Yves Le Minor, DuPont France
(tel: +33 6 15 25 48 52, yves.le-minor-1@dupont.com)
● Alain Weimerskirch, DuPont Luxembourg (for technical requests)
(tel: +352 3666 7074, alain.weimerskirch-1@dupont.com)
Thermal risk - have you got it covered?
®
®
®
®
TM
®
L-80015 - Copyright © 2015 DuPont. All rights reserved. The DuPont Oval Logo, DuPont and Tyvek are trademarks or registered trademarks of E.I. du Pont de Nemours and Company or its affiliates.
All technical information set out herein is provided free of charge and is based on technical data which DuPont believes to be reliable. It is intended for use by persons having skill, at their own discretion and risk. The handling
precaution information contained herein is given with the understanding that those using it will satisfy themselves that their particular conditions of use present no health or safety hazards. Since conditions of product use are
outside of our control we make no warranties express or implied in relation thereto and therefore cannot accept any liability in connection with any use of this information. Nothing herein is to be taken as a license to operate
under, or a recommendation to infringe any patents. DuPont™ Tyvek Air Cargo Covers for Pharmaceuticals must be properly secured to the ULD if exposed to strong winds or turbines while on the tarmac. To maintain efficacy,
DuPont™ Tyvek Air Cargo Covers for Pharmaceuticals must be stored in the original package under dry, normal temperature conditions. New and used covers are expected to deteriorate if not properly protected from heat and
humidity for long periods of time. DuPont is not liable for the efficacy of DuPont DuPont™ Tyvek Air Cargo Covers for Pharmaceuticals beyond a limited period of time, as noted on the product label. DuPont™ Tyvek Air Cargo
Covers for Pharmaceuticals have been designed for one-time or limited use in line with sanitary regulations and pest management best practices. Sufficient pre-cooling and correct temperature management from start of the
cool chain is essential for optimum performance. DuPont is not liable for product damage during the use of the cover.
DuPont de Nemours (Luxembourg) S.à r.l.
Rue Général Patton
L-2984 Luxembourg
www.aircargocovers.dupont.co.uk
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertising