Escolar Documentos
Profissional Documentos
Cultura Documentos
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)
Facilities
Fahrenheit -238 -4 32 36 46 59 77
(oF)
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
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
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
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
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
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
Custodial control
Speed
Reliability
Industry experts community
Departs in T W Th F Sa TF Su
the Su
morning
Letters
538,000 overnight
envelopes per day on Small
average within the US
parcels
Exceptional
Freight shipments
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
aft belly
forward belly
main deck
air supply along
the main deck on
the ceiling at a
height of about
3.5m
Aircraft
bellies
Main
deck
Systematic
Establishment of Thermal mapping collection and
default temperature of aircraft analysis of
settings temperature data
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)
B777F
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
Temperature (oC)
T092
Temperature 10
T018
T022
homogeneous 6
T094
T077
T098
T180
T100
4 T185
T142
T195
T165
2 T146
T (oC)
MD11 temperature profile 3h30 after departure
cockpit containers
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
• Reports
Compliance across the FedEx B777F fleet
Risk-based approach focusing on main transportation lanes for healthcare
shippers
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
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
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
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
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:
Temperature (oC)
30 MEM
Consequences: sudden or
prolonged exposure to direct 28
sunlight for general cargo
26
If shipping on Friday
• Night flight on Friday evening
• Tarmac on Saturday
• Day operations on Sunday
• Delivery on Monday morning
• Regulatory expertise
• Priority boarding
Paperwork moved ahead of the queue for international clearance
fedex.com/us/healthcare/temp-control/index.html
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