This document summarizes the key characteristics of different transport modes for pharmaceuticals requiring temperature control, including road, air, and sea freight. It discusses temperature excursion risks, recommended temperature monitoring and control equipment like Envirotainers and data loggers, and roles and responsibilities in the supply chain. Weak points are identified for each mode and potential solutions are proposed, such as using audited trucking companies, sealed pods for air freight, and directly loading and sealing sea containers.

1. British Association of Cargo
Surveyors / Manchester Marine
Insurance Association
Manchester 12th July 2012
Mark Edwards – Global Freight Manager
The Carriage of Temperature
Sensitive
Pharmaceuticals

2. What will we look at today?
• Road freight characteristics
• Air freight characteristics
• Sea freight characteristics
• Temperature excursions
• Temperature control equipment
• Temperature monitoring equipment
• Weak points and potential solutions
• Roles and responsibilities
• Summary

3. Road freight characteristics - 1
• Typically used for trans-continental movements
• Well set up hub and spoke systems
• Temperature-controlled “groupage” services
becoming widely available
• Security risk higher than other modes – primarily
through theft

4. Road freight characteristics - 2
• Tends to be low cost
• Wide variation is equipment quality and
standards
• Risk of damages through handling and cross-
docking activities

5. Air freight characteristics - 1
• Typically used for inter-continental movements
• Primarily point-to-point operations but some hub
and spoke systems
• Varying degree of “pharma” services offered by
airlines
• Ground handling often of a poor quality
• Fast transit times
• Commensurately expensive

6. Air freight characteristics - 2
• Temperature difficult to control during ground
handling and cross-docking activities
• 3rd party temperature control systems are
available but:
• limited availability (eg Envirotainers);
• or practical difficulties such as too big for
airport x-ray machines (eg pod
systems)
• Risk of damages through handling and
cross-docking activities

7. Air freight characteristics - 3
• Most cargo flies in the belly of passenger aircraft
• Therefore, cargo is regularly off-loaded and does
not fly due to capacity constraints
• Freight only services tend to be block booked by
large shippers or freight forwarders

8. Sea freight characteristics - 1
• Typically used for inter-continental movements
• Primarily hub and spoke systems through
“feeder” and “mother” vessels
• Slow transit times
• Commensurately less expensive
• Large volumes can be shipped

9. Sea freight characteristics - 2
• Enhanced security compared to other transport
modes
• Few parties are involved
• Containers can be loaded and sealed at your
own site
• Containers stay sealed through to unloading
destination
• Negotiable documentation

10. Temperature excursions - truck
• Equipment quality is the key factor
• Use only audited trucking companies which
meet Good Distribution Practice (GDP)
guidelines
• Understand how and where the product will be
cross-docked
• Ask for proof of temperature upon delivery of
the product

11. Temperature excursions - air
• Irrespective of any promises made by airlines,
and their “pharma” services, always assume that
you will have a temperature excursion
• Use a 3rd party solution such as Envirotainers or
Silverpods (other systems are available)
• Use data-loggers so that stability data can be
consulted and product need not necessarily be
destroyed when an excursion occurs

12. Temperature control equipment
- Envirotainers

13. Temperature control equipment
- Envirotainers
• Active temperature control solutions such as
Envirotainers
• Advantages
• Reliability
• High quality
• Support
• Disadvantages
• Cost
• Availability
• Require intervention

14. Temperature control equipment
- Silverpods

15. Temperature control equipment
- Silverpods

16. Temperature control equipment
- Silverpods
• These seal the product from the outside
environment
• They are validated for 4 to 5 days irrespective of
outside temperature
• They protect the product from handling damages
• They can be re-used but “reverse” logistics can
prove tricky

17. Temperature control equipment
- Silverpods
• They are relatively inexpensive to purchase
(compared to the cost of stock which could be
lost to temperature excursions)
• They are easy to build and dismantle
• They double the air freight charge because of
their size
• Other systems are available

18. Temperature control equipment
- Silverpods
• So far we have experienced only one excursion on
our 15 to 25 degree product
• Product went from Germany to Dubai and was left
in error in a normal warehouse for 2 weeks
• Temperature was maintained below 25 for the
validated period plus 2 days
• Warehouse temperature was +65 for long parts of
the day
• Internal temperature rose to 36 and stayed there
• The combination of data on the shipment and the
control on the maximum temperature allowed us to
put a case for release to our Quality.

19. Temperature monitoring equipment
- dataloggers
• Most trucks we use have their own logging
systems but these can be unreliable or data only
available when the truck returns to the depot
(sometimes many weeks)
• Aircraft do not typically have any logging systems
• Temperature controlled sea containers (reefers)
have their own logging systems but the shipping
line will only give you the data in the event of an
insurance claim
• Consequently, we need to log temperature data
ourselves

20. Temperature monitoring equipment
- dataloggers
• We need data to be available at the point of
product delivery, irrespective of systems used to
download data from the logger
• We need loggers to be:
• very accurate
• capable of measuring a wide temperature range
• of proven reliability
• We need the data to be CFR21 compliant such
that it cannot be tampered with after it has been
gathered

21. Temperature monitoring equipment
- dataloggers
• We have chosen the Sensitech TT4USB but other
loggers are available

22. Temperature monitoring equipment
- dataloggers
• Single use logger
• Easy to start and stop
• Minimal risk of accidental stoppage
• No “reading” software required at destination
• Instant PDF available for reading on site or
emailing back to originator
• Full data file can easily be emailed back to
originator

23. Temperature monitoring equipment
- dataloggers
• Show datalogger report pdf file

24. Weak points – road
• Variable Equipment
• Agree with provider what types of equipment
are acceptable
• Turn away unsuitable trucks
• Do this even if you are not paying for
transport – they are still your products!
• Route Selection
• Agree routes with your provider
• Ensure drivers use secure truck parks – seek
evidence of this

25. Weak points - road
• Minimal Customs / Documentary Checks
• Use providers with full track and trace
capability
• Avoid non-specialist groupage services
• Check trailer numbers noted on CMR
(international transport delivery note)

26. Weak points - sea
• Container Seals
• Load and seal the container at your premises
• Use bolt seals rather than plastic ones
• Check seal numbers prior to unloading
container
• Fully investigate seal number discrepancies

27. Weak points - air
• Multiple hand offs
• Use a sealed unit such as the pod pictured
previously
• Use airlines with direct services rather than
connecting flights
• Tell your freight forwarder which airline you
want them to use
• Book your shipment as a non-consolidated
shipment

28. Roles and responsibilities
• Truck company / airline / shipping line
• Provision of equipment
• Freight forwarders
• Liaison with equipment provider
• Customs & documentation services
• You
• Liaison with your supplier
• Temperature information
• No different to current supply chain!!

29. Summary
• Each mode has advantages and drawbacks
• Have a full understanding of those before you
make your choice
• Your choice will be a trade off between lead
time, transport cost and transport quality
• Finding the right freight forwarder is a
critical factor in your success