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Insights into cold chain

and air transportation

Christelle Laot, PhD, MBA - Technical Fellow


Latin American Supply Chain Expo 2014
San Juan, Puerto
fedex.com/healthcare ChristelleRico, October 16-17, 2014
Laot, PhD, MBA October 17 , 2014 th

Insights into cold chain and air transportation Page 1


What is included in “cold chain”?
Term can be misleading since it does not refer to “cold” temperatures in particular

• “cold chain” is a term used to characterize


temperature-controlled storage, distribution and
transportation

• Products that are sensitive to temperature variations,


whether they be perishables such as fruits and
vegetables or more sophisticated drugs and medical
devices, are included in the term “cold chain”

• However, “cold chain” is often more narrowly used in


reference to temperature and time-sensitive high value
healthcare products

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 2
Why is cold chain getting so important?
Factors driving growth and interest

• Manufacturing in countries with


lower production costs
• Growth in biological products
• Stricter regulatory environment
• Increased scrutiny on quality
aspects
• Deficiencies in supply chain
visible and/or invisible damages
• Profitable business for service
providers

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 3
Good Distribution Practices (GDP)
From sections in Good Manufacturing Practices (GMP) to standalone GDP guidelines

Many GDP guidelines,


but no true international GDP accepted standard

Product Geography
Medicinal Country Regional International
Pharmaceutical
Biological USA European WHO
Canada Commission
China IATA
For human use Ireland
Veterinary … PDA

Active pharmaceutical
ingredients (APIs)

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 4
Evolving regulatory environment
Example of USP <1079>

USP 36 in 2013 Former USP 35

Title Good storage and Good storage and


distribution practices for shipping practices
drug products

Introduction Describes good storage Intended to provide


and distribution practices general guidance

Overall 8 pages, including 6 pages


document extensive section on
environmental
management systemEquipment

Facilities

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 5
Common temperature ranges
No general or universal glossary commonly accepted by all regulatory agencies

Fahrenheit -238 -4 32 36 46 59 77
(oF)

Celsius -150 -20 0 2 8 15 25


(oC)

Main ranges
Frozen Cold or Controlled Room
Other Refrigerated Temperature (CRT)
ranges
Cryogenic Cool

Brief excursions outside of desired temperature ranges are typically allowed for a
well-defined time and temperature extent but remain product specific

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 6
Selecting packaging solutions
Shippers are responsible for selecting appropriate packaging materials

FedEx guideline for temperature-controlled packaging solutions


Active and passive solutions (which could include gel packs, phase change materials,
dry ice) should remain effective for:
Expected transit time + 24 hours for domestic transportation
Expected transit time + 48 hours for international transportation

Be aware that validated packaging materials were tested in


environmental chambers under well-defined temperature profiles
Validated packages can fail under severe winter weather conditions
Understand optimal conditions

Instructions matter!
If you do not follow instructions provided by packaging supplier, then solution may fail
(for instance when gel packs are missing in insulated box)
Pre-conditioning of the products is often critical

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 7
Planning temperature measurements
Shippers are responsible for placing temperature devices

Different technologies available on the market


Devices often calibrated by batch
Check accuracy of devices

Document setup of temperature devices (records, pictures)


Type of devices?
Number of devices per shipment?
Placement on shipment: in / out, top / bottom, which side?
Advice: be consistent with your methodology!

Temperature monitoring for regulatory requirements


Risk-based approach towards temperature monitoring vs. temperature
monitoring of each shipment

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 8
Greenhouse effects
Direct sun exposure created heat buildup under clear plastic
Clear transparent
58 plastic pouch
56 White padded pak
Do not place 54 Direct sun
White pak
clear plastics 52
White envelope
50 Brown small box
on 48 White small box

Temperature (oC)
In shadow
46
temperature 44
devices (no 42
40
clear tape, no
38
transparent 36
pouch) 34
32
30
or shipments
28
(no shrink wrap) 26

0 0 0 0 0 0 0 0 0 0 0 0
0 1 09:0 01 10:0 01 11:0 01 12:0 01 13:0 01 14:0 01 15:0 01 16:0 01 17:0 01 18:0 01 19:0 01 20:0
- - - - - - - - - - - -
4-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09
201 2 2 2 2 2 2 2 2 2 2 2

Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 9
Time interval between data points
How much information do you want to capture in transit?

56
Events and Data collection:
3 minutes
activities take 52 1 hour
place for short 2 hours
In shadow
periods of time in 48

Temperature (oC)
an express
transportation 44
network
40

36
Suggestion for
air transportation: 32

to capture 1 data
28
point every 15
minutes
0 0 0 0 0 0 0 0 0 0 0 0
0 1 09:0 01 10:0 01 11:0 01 12:0 01 13:0 01 14:0 01 15:0 01 16:0 01 17:0 01 18:0 01 19:0 01 20:0
- - - - - - - - - - - -
4-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09 014-09
201 2 2 2 2 2 2 2 2 2 2 2

Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 10
Account for device equilibrium time
Temperature devices may need time to adjust to sudden temperature changes
43 taken in
42
house
Clear transparent
41 plastic pouch
You may be White padded pak
40
overestimating Direct sun outside
39 White pak
duration of 38 White envelope
temperature Brown small box
37

Temperature (oC)
White small box
excursion 36 In shadow outside
35
34
33
32 placed in
Account for time lag: car trunk
31
here it took 30
TempTales about 1 29
hour to get readings 28 ideal
back to ambient 27 reading
conditions 26
0 0 0 0 0 0 0 0
17:1 17:3 17:5 18:1 18:3 18:5 19:1 19:3
9-01 4-09
- 0 1
4-09
- 0 1
4-09
- 01
4-09
- 0 1
4-09
- 0 1
4-09
- 01
4-09
- 01
20 14-0 201 201 201 20 1 201 201 201

Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 11
Save raw data, not only report
Think of potential further analysis

Transportation providers may want to


obtain your raw data for further
analysis
Keep temperature measurements in
raw data format, not only saved in pdf
format

Reported temperature excursions may


be investigated internally by service
providers for continuous improvement
Raw data are easier to work with for
corrective and preventive actions (CAPA)

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 12
Selecting transportation provider

White glove,
specialty
high
couriers Integrators
Focus

Transportation companies:
truck, ocean, rail,
air (commercial, cargo)
Freight
forwarders, global
low

third party
logistics (3PLs)

low high
Scale
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 13
Puerto Rico
Available transportation modes: air versus ocean

AIR OCEAN

Main Speed Cost


transportation
advantage

Cold chain Portfolio of active Reefer container


solutions and passive
solutions

Temperature Gray zone Known in advance


excursions Not well
understood

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 14
FedEx Express
The largest express transportation company in the world (revenues of $27B)

Links 99% of the world’s GDP

Custodial control
Speed
Reliability
Industry experts community

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 15
FedEx Express flights in Puerto Rico
Wide-body aircraft routes

Airport city Aguidilla San Juan


IATA code BQN SJU
ICAO code TJBQ TJSJ
Local time (vs. GMT) -4:00 -4:00

SJU BQN to BQN


to MEM MEM to IND
Departs in M T W Th F M T W Th F M T W Th
the evening

Departs in T W Th F Sa TF Su
the Su
morning

Plane type MD11 MD10-30 MD 10-10


MD10-10

Routing and schedule subject to change at any time


As of Sept 2014

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 16
What goes in cargo planes?
Variety of shipment types

Letters
538,000 overnight
envelopes per day on Small
average within the US
parcels

Exceptional
Freight shipments

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 17
Airlines can control / stabilize in-flight
temperatures!
Reproducible environments can be created

Airline objective:
To avoid freezing (0oC and below)
To minimize fuel consumption associated
with temperature control

Aircraft
Container (ULD or active / passive solutions)
Packaging material
Manufacturer packaging

Product

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 18
3 cargo compartments within B777F
Location and distribution points for air supply differ between compartments

aft belly

forward belly
main deck
air supply along
the main deck on
the ceiling at a
height of about
3.5m

air supply on the


wall panels at
various openings
at a height of
about 40cm
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 19
Temperature settings in B777F cockpit
Temperatures need to be manually selected by pilots using temperature selectors

Aircraft
bellies

Main
deck

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 20
FedEx aircraft temperature control
Overall approach
Scientific
Temperature
Customer Literature approach
measurements
feedback review towards research
to confirm
studies
reported issues

Systematic
Establishment of Thermal mapping collection and
default temperature of aircraft analysis of
settings temperature data

Design and testing


Development of of innovative FedEx Compliance and
standard temperature corrective
procedures software measures

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 21
Temperature devices on the main deck
2 types of re-usable temperature devices purchased from:
ACR Systems Inc. (8 channels per data logger)
SensiTech Inc.
Also of importance to technical study:
Plane internal sensors

84 cm or 33 inches
185 cm
or
Total of 46 sensors 73 inches 110 cm or 43 inches
1 data point every 10 minutes
70 cm or 27.5 inches 48 cm or 19 inches

cargo
door
Data logger channels 1, 2, 3 (on the sidewall panels on the side of “L” signs)
Data logger channels 5, 6, 7 (on the sidewall panels on the side of “R” signs)
Data logger channel 4 (next to plane internal sensor at the ceiling)
Data logger channel 0 (located within the SmartReader Plus box at the ceiling)
TempTales located at 70cm from the floor (total of 30 TempTales) cockpit

end
wall rigid
AFT FORWARD cargo
barrier
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 22
Results with selectors on mid-position
Both main deck selectors placed on mid-position (temperatures expected to be around 16oC)

CDG-MEM lane (flight duration of 9h30)

B777F

Location ID (IATA code) MEM CDG


City Memphis Paris
Country USA France

ICAO code KMEM LFPG

Local vs. GMT winter -6:00 +1:00


summer -5:00 +2:00
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 23
Large temperature gradients
Temperatures at the top level of ULDs 10oC greater than those at 50cm from the floor

20 F-ceiling-plane A-ceiling-plane
F-L-top A-L-top
Mid-position for both
F-L-bottom A-L-bottom
selectors in the 18
F-R-top A-R-top
cockpit F-R-bottom A-R-bottom
16

Temperature (oC)
Similar temperatures
(around 15oC) are 14
recorded near the
plane’s internal 12
sensors at the ceiling
for both sections of 10
the aircraft
8
However, the aft
6 CDG-MEM
section of the main
deck is colder than
4
the forward section
22 :00 :00 :00 :00 :00 :00 :00
1-19 1- 20 00 1- 20 02 1- 2 0 04 1- 2 0 06 1- 2 0 08 1- 2 0 10
11 -1 1-1 1-1 1-1 1-1 1-1 1-1
20 201 201 201 201 201 201
take-off landing
GMT date and time
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 24
Temperature distribution
As much as 10oC difference at the same height level (70cm from the floor)

18

Mid-position for both 16


selectors in the 14
cockpit CDG-MEM
T020
12 T053
T044

Temperature (oC)
T092
Temperature 10
T018
T022

distribution around T041


T007
T179
the main deck not 8 T151
T177

homogeneous 6
T094
T077
T098
T180
T100

4 T185
T142
T195
T165
2 T146

Temperature can T187


T136
T131
get below the 0 T111
T191

freezing point near T190


T144
-2 T170
the sidewall panels T172

6 hours after take-


2 2:00 00:0
0
02:0
0
04:0
0
06:0
0
08:0
0
10:0
0
off 1-19 - 20 - 2 0 - 2 0 - 2 0 - 2 0 - 2 0
1 - 1 1-11 1-11 1-11 1-11 1-11 1-11
201 201 201 201 201 201 201
take-off landing
GMT date and time
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 25
Thermal mapping of B777F main deck
Contour graphs help in visualizing temperature distribution at 70cm from the floor
cargo door

departure (15min T (oC)


before take-off) containers cockpit
CDG-MEM flight (both selectors on mid-position)

45min after take-off


containers
2h15 after take-off
containers
5h15 after take-off
containers
8h45 after take-off Areas around
containers and in front of the
cargo door are
10min after landing the coldest within
containers the cargo

50min after arrival


containers
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 26
Outcome: controlled temperatures
Default temperature settings implemented for the whole B777F fleet on all routes

Temperature profile around containers after 9 hours in the air:


Main deck: 8oC (bottom level) to 20oC (top level of containers)
Forward belly: 7oC to 15oC
Aft belly: 2oC to 8oC

• Time and temperature sensitive shipments are typically placed on


the main deck
• If needed, temperature settings in the B777F bellies can be
adjusted to accommodate healthcare shipments

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 27
Aircraft temperatures
Determination of hot and cold spots within cargo compartment
Temperature gradients along the height of shipments (top warmer than bottom)

Conditions vary slightly for each flight:


• temperature at departure
• time and conditions on tarmac
• mixture of shipments within the cargo

FedEx determines its best practices through scientific studies


leading to thermal mapping of aircraft

T (oC)
MD11 temperature profile 3h30 after departure

cockpit containers

cargo door MD11 main deck

Mid-position temperature setting; devices placed at 70cm from the floor panel
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 28
Access to aircraft temperatures
B777F temperature data accessible in near-real time and archived

• Proprietary FedEx B777F temperature software designed by


FedEx aircraft engineers

• Information in near-real time during B777 flights


ACARS messages

• Temperature data archived on internal server

• Reports
Compliance across the FedEx B777F fleet
Risk-based approach focusing on main transportation lanes for healthcare
shippers

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 29
Environmental conditions in flight
BOS MEM KIX SIN
0oC 13oC 6oC 29oC
SenseAware®
powered by FedEx
MD10 B777F B777F offers near-real time
Temperature (oC)

30
monitoring of:
20 Temperature
10 Pressure
Relative humidity
0
Position
Light
Pressure (mbar)

1000

900

800

60 Multi-sensor devices
Humidity (%)

40 can be programmed to
send alerts if a
20 shipment travels off-
route or is exposed to
0
unexpected conditions
0:00 4:00 8:00 2:00 6:00 0:00 0:00 4:00 8:00
1- 31 0 1- 31 0 1-31 0 1-31 1 1- 31 1 1-31 2 1-31 0 2-01 0 2-01 0
20 12-0 20 12-0 20 12-0 20 12-0 20 1 2 -0 20 12-0 20 1 2 -0 20 12-0 20 1 2 -0

Learn more at
GMT date and time
senseaware.com
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 30
Thinking of lane mapping?
Risk-based approaches towards shipping solutions
Temperature measurements and analysis can lead to a comprehensive
strategic risk-based approach towards shipping

Elements to consider:
• Transportation mode (air / ocean / road / rail)
• Shipment type (parcels, freight)
• Carrier
• Transit time
• Origin / destination
• Packaging solutions

Develop a methodology, such as:


• High volume lanes
• Nature of products being shipped
• Specific origin and destination
• Regions or zones

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 31
Risk of temperature excursion by air?
The highest risk is sometimes near shipment origin rather than near final destination
42
40 Origin location:
Example of temperatures experienced Walnut Creek, CA
by small packages without special 38 Phoenix, AZ
Dallas, TX
thermal protection in FedEx Express® 36 New York, NY
air transportation network 34
opened

Temperature (oC)
32 in office
in Memphis
30
Temperature
devices 28
programmed for 1 26
data point every 4
minutes and placed 24
inside FedEx® 22
boxes PUP
20 POD
scans scans
18 at address
16
FedEx Priority Overnight® US shipments: 0 0 0 0 0 0 0
2 0 16:0 20 20:0 20 00:0 21 04:0 21 08:0 21 12:0 21 16:0
- - - - - - -
Delivery next business day by 10:30am local 3-08 013-08 013-08 013-08 013-08 013-08 013-08
201 2 2 2 2 2 2
time to most areas
Eastern date and time
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 32
Example of shipping lane study
Transportation providers can act as consultants
Packages placed in Packages
Collaboration with healthcare non-temperature stayed inside air
controlled trailer at conditioned
shipper on lane mapping 40 shipper site once building until
studies in the summer 38 ready 5:00 PM
Outcome: keep shipments 36
34
under controlled 32
environmental conditions until 30

Temperature (oC)
latest possible time 28
26
• From main distribution center in 24
Florida to various locations all over 22

the US 20

• No special thermal protection 18

• FedEx Priority Overnight® US 16


14 First flight
shipments: delivery next business Week 1 Week 2
12 to MEM
day by 10:30am local time in most
10
areas
0 0 0 0 0 0 0 0
11:0 19:0 03:0 11:014:0 22:0 06:0 14:0
8-12 8 -12 8 -13 8-1-038-19 8 -19 8 -20 8 -20
20 13-0 201
3 - 0
201
3 -0 -
3 3
201 201
0
201
3 -0
201
3 - 0
201
3 - 0

Eastern date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 33
Air transportation parameters
• Plane-related:
Plane type, cargo compartment
Temperature gradient, draft by the door
• Shipment type: letters / parcels / freight
• Container-related:
Type, material
Shipment position, mix
Sort impact
• Service level
• Day versus night operations
• Day of the week for shipping
• Seasonality
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 34
Plane-related parameters (type, compartment)
Temperature differences 14

B777F flight
Additional shipment aspects: 12 MEM-CGN
Top vs. bottom forward belly
Sides 2-8oC compartment
10
Exterior, Side 4
Interior, Side 4

Temperature (oC)
8 Exterior, Top
Interior, Top
Exterior, Side 2
6

2
FedEx® thermal blanket solution

0
Side 4 placed in
front of cargo door -2
with temperature 07:0
0
09:0
0
11:0
0
13:0
0
15:0
0
17:0
0
- 1 1 - 1 1 -1 1 -1 1 - 1 1 - 1 1
device at the 2-09 2-09 2-09 2-09 2-09 2-09
201 201 201 201 201 201
bottom level take-off landing
GMT date and time
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 35
Shipment type: letters
Letters are handled in a separate automated sort system

Dedicated sort
system: conveyor
belts and bags,
which are placed
in containers
Buildings are typically
temperature
controlled

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 36
Shipment type: small parcels
From conveyor belts to containers

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 37
Shipment type: freight
Palletized freight is
placed on cookie
sheets (PMC, PAG, …)

Comment: bypass containers are handled as freight


shipments and do not go through sort at all transit
locations

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 38
Container type, position and mix
Letters and small parcels travel in containers 48
MEM
46
reported
44
weather
42 of 37oC

40 Sunday
38 afternoon

Temperature (oC)
36
34
32
30
28
ULD made of:
26 clear plastic
Unit Load device (ULD) clear plastic
24
Standard IATA codes: AYY, AKE, AMJ, … aluminum
22 aluminum
Different materials: aluminum, polycarbonate aluminum
20
Shipment position within container 0 0 0 0
2 4 07:0 2 4 11:0 2 4 15:0 2 4 19:0
Other shipments within the container 4-08
-
4-08
-
4-08
-
4-08
-
201 201 201 201

Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 39
Sort impact
Journey of small parcels sent together for same final destination
different containers different cities
36 36
MEM MEM
Sunday
Case study:
34
afternoon • Friday shipping 34 Sunday
• Bypass afternoon
32 container 32
• Staged in MEM
Temperature (oC)

Temperature (oC)
over the
30 weekend in 30
temperature-
28 controlled facility 28
(not available for MD11
general cargo) main deck
26 MD11 flight • Sort in MEM on 26
Transit through
AKE container Sunday morning different airports:

24 in aft belly • Tarmac 24


FLL
AYY container (AYY container)
on main deck
exposure for a MIA
few hours (AMJ container)
22 22
0 0 0 0 0 0 0 0 0 0 0 0 0 0
1 7 08:0 17 10:0 17 12:0 17 14:0 17 16:0 17 18:0 17 20:0 1 7 08:0 17 10:0 17 12:0 17 14:0 17 16:0 17 18:0 17 20:0
- - - - - - - - - - - - - -
4-08 014-08 014-08 014-08 014-08 014-08 014-08 4-08 014-08 014-08 014-08 014-08 014-08 014-08
201 2 2 2 2 2 2 201 2 2 2 2 2 2

Local date and time Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 40
Service level
Various transit times depending on chosen speed of transportation

Options offered to shippers:


Domestic transportation: overnight vs. deferred
International transportation: priority vs. economy

Different boarding priorities onboard FedEx planes

Think of consequences related to:


Exposure to outside environmental conditions
Tarmac time

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 41
Day vs. night operations
Red flag: sun exposure on tarmacs during daytime 36
Tarmac time:
30min
Commercial airlines and 34 1h30
freight forwarders are most Sunday
likely to operate during the 32 afternoon
day

Temperature (oC)
30 MEM

Consequences: sudden or
prolonged exposure to direct 28
sunlight for general cargo
26

FedEx Express priority 24


reported weather
services typically fly of 32oC
22
overnight
7 0 9:00 7 11:00 7 13:00 7 15:00 7 17:00 7 19:00
-1 -1 -1 -1 -1 -1
4-08 014-08 014-08 014-08 014-08 014-08
201 2 2 2 2 2

Local date and time


fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 42
Day of the week
Monday-Thursday vs. Friday shipping

Example for FedEx


Priority Overnight® US
shipments
If shipping from Monday
through Thursday
• Night flight
• Delivery on next morning day

If shipping on Friday
• Night flight on Friday evening
• Tarmac on Saturday
• Day operations on Sunday
• Delivery on Monday morning

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 43
Seasonality
Winter versus summer profiles to fulfill regulatory requirements
When to plan temperature tests?
• Be ready to test under worst conditions (not always same time during the year)
• Profiles are never completely reproducible
• Weather forecasts are the most important decision-making parameters whenever you
want to ship

Complexity of global shipments


Shipment could experience winter in one region of the world and summer in another one

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 44
Recommendations
• Evaluate risk of temperature excursions

• Consider contracting special products and


services:
On a seasonal basis
For lanes with high risk of temperature excursions

• Speak to technical experts

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 45
Full portfolio for temperature control
Transportation provider know-how and expertise will help you design appropriate solutions

• Global transportation capabilities and technical expertise

• Monitoring and visibility

• Regulatory expertise

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 46
Special operational features
Healthcare transportation products and services differ from general cargo

Features of service for FedEx Priority Alert®:


• Contract-based service available for a few industries
Single point of contact at FedEx
Customized communication preferences

• Special handling code


Shipments easily identified at FedEx locations

• Priority boarding
Paperwork moved ahead of the queue for international clearance

• Shipments stored in temperature-controlled facilities over


weekends
Cold storage, re-icing and gel pack replenishment for delayed shipments

fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014


Insights into cold chain and air transportation Page 47
Contingency planning
Ongoing investment in cold chain infrastructure
Temperature-controlled
storage

fedex.com/us/healthcare/temp-control/index.html

Unexpected Missed plane connection


Plane mechanical failure
events could Bad weather
always arise Lack of proper documentation for customs clearance
while in transit Clearance backlog at regulatory agencies (such as FDA)
Dry ice capacity constraints
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 48
Leveraging technical experts is key!
Speak to subject matter experts prior to shipping
Project engineers
trained in cold chain area
Packaging solutions
Planned routing
Special requests

Packaging engineers
Guidance on packaging
Testing laboratory

Technical fellow
Research studies
Temperature profiles and mapping
FedEx has an
Knowledge of cold chain quality and regulatory aspects
of Good Distribution Practices (GDP) associated with
impressive
transportation internal network
of experts
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 49
Key takeaways
• Puerto Rico is connected to the US daily by FedEx
Express® cargo flights out of San Juan and Aguidilla

• Air transportation is complex and inside knowledge is


often needed to interpret temperature results
• FedEx cold chain experts seek to understand your
business and can help you design appropriate solutions

• Shipments handled as general cargo could stay on


tarmacs for many hours
• Special products and services are available to minimize
risk of temperature excursions in transit
fedex.com/healthcare Christelle Laot, PhD, MBA October 17th, 2014
Insights into cold chain and air transportation Page 50
Questions?
Direct contact (christelle.laot@fedex.com) or fedex.com/healthcare

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