Insights into cold chain and air transportation - FedEximages.fedex.com/.../Insights_into_Cold_Chain_and_Air_Transportation.pdf · transportation advantage Cold chain solutions Temperature

Page 1

October 17th, 2014 Christelle Laot, PhD, MBA

Insights into cold chain and air transportation

fedex.com/healthcare

Insights into cold chain

and air transportation

Latin American Supply Chain Expo 2014

San Juan, Puerto Rico, October 16-17, 2014

Christelle Laot, PhD, MBA - Technical Fellow

Page 2




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

Page 3




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

Page 4




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

Pharmaceutical

Biological

For human use

Veterinary

Active pharmaceutical

ingredients (APIs)

Country Regional International

USA

Canada

China

Ireland

…

…

European

Commission

WHO

IATA

PDA

Page 5




Evolving regulatory environment Example of USP <1079>

USP 36 in 2013

Good storage and

distribution practices for

drug products

Describes good storage

and distribution practices

8 pages, including

extensive section on

environmental

management system

Former USP 35

Good storage and

shipping practices

Intended to provide

general guidance

6 pages

Title

Introduction

Overall

document

Equipment

Facilities

Page 6




Common temperature ranges No general or universal glossary commonly accepted by all regulatory agencies

Celsius

(oC)

Fahrenheit

(oF)

-150 -20 0 2 8 15 25

Controlled Room

Temperature (CRT)

Cold or

Refrigerated

Frozen

Cryogenic

-238 36 32 -4 46 59 77

Cool

Main ranges

Other

ranges

Brief excursions outside of desired temperature ranges are typically allowed for a

well-defined time and temperature extent but remain product specific

Page 7




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

Page 8




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

Page 9




Greenhouse effects Direct sun exposure created heat buildup under clear plastic

Do not place

clear plastics

on

temperature

devices (no

clear tape, no

transparent

pouch)

or shipments

(no shrink wrap)

2014-09-01 09:00

2014-09-01 10:00

2014-09-01 11:00

2014-09-01 12:00

2014-09-01 13:00

2014-09-01 14:00

2014-09-01 15:00

2014-09-01 16:00

2014-09-01 17:00

2014-09-01 18:00

2014-09-01 19:00

2014-09-01 20:00

26

28

30

32

34

36

38

40

42

44

46

48

50

52

54

56

58

Te

mp

era

ture

(oC

)

Local date and time

Clear transparent

plastic pouch

White padded pak

Direct sun

White pak

White envelope

Brown small box

White small box

In shadow

Page 10




Time interval between data points How much information do you want to capture in transit?

Events and

activities take

place for short

periods of time in

an express

transportation

network

Suggestion for

air transportation:

to capture 1 data

point every 15

minutes

2014-09-01 09:00

2014-09-01 10:00

2014-09-01 11:00

2014-09-01 12:00

2014-09-01 13:00

2014-09-01 14:00

2014-09-01 15:00

2014-09-01 16:00

2014-09-01 17:00

2014-09-01 18:00

2014-09-01 19:00

2014-09-01 20:00

28

32

36

40

44

48

52

56

Te

mp

era

ture

(oC

)

Local date and time

Data collection:

3 minutes

1 hour

2 hours

In shadow

Page 11




Account for device equilibrium time Temperature devices may need time to adjust to sudden temperature changes

taken in house

placed in car trunk

You may be

overestimating

duration of

temperature

excursion

Account for time lag:

here it took

TempTales about 1

hour to get readings

back to ambient

conditions

ideal reading

2014-09-01 17:10

2014-09-01 17:30

2014-09-01 17:50

2014-09-01 18:10

2014-09-01 18:30

2014-09-01 18:50

2014-09-01 19:10

2014-09-01 19:30

26

27

28

29

30

31

32

33

34

35

36

37

38

39

40

41

42

43

Te

mp

era

ture

(oC

)

Local date and time

Clear transparent

plastic pouch

White padded pak

Direct sun outside

White pak

White envelope

Brown small box

White small box

In shadow outside

Page 12




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)

Page 13




Selecting transportation provider

low high

Scale

low

hig

h

Fo

cu

s

Integrators

Freight forwarders, global

third party logistics (3PLs)

Transportation companies: truck, ocean, rail,

air (commercial, cargo)

White glove, specialty couriers

Page 14




Puerto Rico Available transportation modes: air versus ocean

Main

transportation

advantage

Cold chain

solutions

Temperature

excursions

Speed

Portfolio of active

and passive

solutions

Gray zone

Not well

understood

Cost

Reefer container

Known in advance

AIR OCEAN

Page 15




FedEx Express The largest express transportation company in the world (revenues of $27B)

Custodial control

Speed

Reliability

Industry experts community

Links 99% of the world’s GDP

Page 16




FedEx Express flights in Puerto Rico Wide-body aircraft routes

Routing and schedule subject to change at any time

San Juan

SJU

TJSJ

-4:00

Aguidilla

BQN

TJBQ

-4:00

Airport city

IATA code

ICAO code

Local time (vs. GMT)

SJU

to MEM

BQN to

MEM

BQN

to IND

Departs in

the evening

M T W Th F M T W Th F

M T W Th

Departs in

the

morning

T W Th F Sa

Su

T F

Su

Plane type MD11 MD10-30

MD10-10

MD 10-10

As of Sept 2014

Page 17




Variety of shipment types

What goes in cargo planes?

Letters 538,000 overnight

envelopes per day on

average within the US

Freight

Exceptional

shipments

Small

parcels

Page 18




Airlines can control / stabilize in-flight temperatures! Reproducible environments can be created

Product

Manufacturer packaging

Packaging material

Container (ULD or active / passive solutions)

Aircraft

Airline objective:

To avoid freezing (0oC and below)

To minimize fuel consumption associated

with temperature control

Page 19




3 cargo compartments within B777F Location and distribution points for air supply differ between compartments

main deck forward belly

air supply on the

wall panels at

various openings

at a height of

about 40cm

air supply along

the main deck on

the ceiling at a

height of about

3.5m

aft belly

Page 20




Temperature settings in B777F cockpit Temperatures need to be manually selected by pilots using temperature selectors

Main

deck

Aircraft

bellies

Page 21




FedEx aircraft temperature control Overall approach

Customer

feedback

Temperature

measurements

to confirm

reported issues

Establishment of

default temperature

settings

Thermal mapping

of aircraft

Systematic

collection and

analysis of

temperature data

Scientific

approach

towards research

studies

Literature

review

Compliance and

corrective

measures

Design and testing

of innovative FedEx

temperature

software

Development of

standard

procedures

Page 22




Temperature devices on the main deck

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)

Total of 46 sensors

1 data point every 10 minutes

AFT FORWARD

cargo

door

cockpit

rigid

cargo

barrier

end

wall

48 cm or 19 inches

110 cm or 43 inches

84 cm or 33 inches

185 cm

or

73 inches

70 cm or 27.5 inches

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

Page 23




Results with selectors on mid-position Both main deck selectors placed on mid-position (temperatures expected to be around 16oC)

B777F

CDG

Paris

France

LFPG

MEM

Memphis

USA

KMEM

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

Location ID (IATA code)

City

Country

ICAO code

CDG-MEM lane (flight duration of 9h30)

winter

+2:00 -5:00 summer

Page 24




Large temperature gradients

Mid-position for both

selectors in the

cockpit

Similar temperatures

(around 15oC) are

recorded near the

plane’s internal

sensors at the ceiling

for both sections of

the aircraft

However, the aft

section of the main

deck is colder than

the forward section

Temperatures at the top level of ULDs 10oC greater than those at 50cm from the floor

2011-11-19 22:00

2011-11-20 00:00

2011-11-20 02:00

2011-11-20 04:00

2011-11-20 06:00

2011-11-20 08:00

2011-11-20 10:00

4

6

8

10

12

14

16

18

20

landingtake-off

CDG-MEM

Tem

pe

ratu

re (

oC

)

GMT date and time

F-ceiling-plane A-ceiling-plane

F-L-top A-L-top

F-L-bottom A-L-bottom

F-R-top A-R-top

F-R-bottom A-R-bottom

Page 25




Temperature distribution

Temperature can

get below the

freezing point near

the sidewall panels

6 hours after take-

off

Mid-position for both

selectors in the

cockpit

Temperature

distribution around

the main deck not

homogeneous

As much as 10oC difference at the same height level (70cm from the floor)

2011-11-19 22:00

2011-11-20 00:00

2011-11-20 02:00

2011-11-20 04:00

2011-11-20 06:00

2011-11-20 08:00

2011-11-20 10:00

-2

0

2

4

6

8

10

12

14

16

18

landing

Tem

pe

ratu

re (

oC

)

GMT date and time

T020

T053

T044

T092

T018

T022

T041

T007

T179

T151

T177

T094

T077

T098

T180

T100

T185

T142

T195

T165

T146

T187

T136

T131

T111

T191

T190

T144

T170

T172

CDG-MEM

take-off

Page 26




departure (15min

before take-off)

45min after take-off

2h15 after take-off

5h15 after take-off

8h45 after take-off

10min after landing

50min after arrival

Thermal mapping of B777F main deck Contour graphs help in visualizing temperature distribution at 70cm from the floor

containers

containers

containers

containers

containers

containers

containers

cargo door

CD

G-M

EM

fli

gh

t (b

oth

sele

cto

rs o

n m

id-p

osit

ion

)

Areas around

and in front of the

cargo door are

the coldest within

the cargo

T (oC) cockpit

Page 27




Outcome: controlled temperatures Default temperature settings implemented for the whole B777F fleet on all routes

• 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

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

Page 28




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

containers

Mid-position temperature setting; devices placed at 70cm from the floor panel

cockpit

cargo door

MD11 temperature profile 3h30 after departure T (oC)

MD11 main deck

FedEx determines its best practices through scientific studies leading to thermal mapping of aircraft

Page 29




• 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

Access to aircraft temperatures B777F temperature data accessible in near-real time and archived

Page 30




0

10

20

30

800

900

1000

2012-01-31 00:00

2012-01-31 04:00

2012-01-31 08:00

2012-01-31 12:00

2012-01-31 16:00

2012-01-31 20:00

2012-01-31 00:00

2012-02-01 04:00

2012-02-01 08:00

0

20

40

60

Te

mpe

ratu

re (

oC

)

Pre

ssure

(m

bar)

Hum

idity (

%)

GMT date and time

Environmental conditions in flight

BOS

0oC

SIN

29oC

KIX

6oC

MEM

13oC

B777F B777F MD10

SenseAware®

powered by FedEx

offers near-real time

monitoring of: Temperature

Pressure

Relative humidity

Position

Light

Multi-sensor devices

can be programmed to

send alerts if a

shipment travels off-

route or is exposed to

unexpected conditions

Learn more at

senseaware.com

Page 31




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

Page 32




Risk of temperature excursion by air? The highest risk is sometimes near shipment origin rather than near final destination

FedEx Priority Overnight® US shipments:

Delivery next business day by 10:30am local

time to most areas

Temperature

devices

programmed for 1

data point every 4

minutes and placed

inside FedEx®

boxes

Example of temperatures experienced

by small packages without special

thermal protection in FedEx Express®

air transportation network

2013-08-20 16:00

2013-08-20 20:00

2013-08-20 00:00

2013-08-21 04:00

2013-08-21 08:00

2013-08-21 12:00

2013-08-21 16:00

16

18

20

22

24

26

28

30

32

34

36

38

40

42

opened

in office

in Memphis

Te

mp

era

ture

(oC

)

Eastern date and time

Origin location:

Walnut Creek, CA

Phoenix, AZ

Dallas, TX

New York, NY

POD

scans

at address

PUP

scans

Page 33




2013-08-12 11:00

2013-08-12 19:00

2013-08-13 03:00

2013-08-13 11:00

2013-08-19 14:00

2013-08-19 22:00

2013-08-20 06:00

2013-08-20 14:00

10

12

14

16

18

20

22

24

26

28

30

32

34

36

38

40

Week 2

Tem

pera

ture

(oC

)

Eastern date and time

Week 1

Example of shipping lane study Transportation providers can act as consultants

Collaboration with healthcare

shipper on lane mapping

studies in the summer

Outcome: keep shipments

under controlled

environmental conditions until

latest possible time

• From main distribution center in

Florida to various locations all over

the US

• No special thermal protection

• FedEx Priority Overnight® US

shipments: delivery next business

day by 10:30am local time in most

areas

First flight to MEM

Packages

stayed inside air

conditioned

building until

5:00 PM

Packages placed in

non-temperature

controlled trailer at

shipper site once

ready

Page 34




• 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

Air transportation parameters

Page 35




2012-09-11 07:00

2012-09-11 09:00

2012-09-11 11:00

2012-09-11 13:00

2012-09-11 15:00

2012-09-11 17:00

-2

0

2

4

6

8

10

12

14

Exterior, Side 4

Interior, Side 4

Exterior, Top

Interior, Top

Exterior, Side 2

Tem

pe

ratu

re (

oC

)

GMT date and time

B777F flight

MEM-CGN

forward belly

2-8oC compartment

Plane-related parameters (type, compartment) Temperature differences

Additional shipment aspects: Top vs. bottom

Sides

Side 4 placed in

front of cargo door

with temperature

device at the

bottom level take-off landing

FedEx® thermal blanket solution

Page 36




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

Page 37




Shipment type: small parcels

From conveyor belts to containers

Page 38




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

Page 39




Container type, position and mix Letters and small parcels travel in containers

Unit Load device (ULD)

Standard IATA codes: AYY, AKE, AMJ, …

Different materials: aluminum, polycarbonate

Shipment position within container

Other shipments within the container

MEM

Sunday

afternoon

2014-08-24 07:00

2014-08-24 11:00

2014-08-24 15:00

2014-08-24 19:00

20

22

24

26

28

30

32

34

36

38

40

42

44

46

48

Tem

pera

ture

(oC

)Local date and time

ULD made of:

clear plastic

clear plastic

aluminum

aluminum

aluminum

reported

weather

of 37oC

Page 40




2014-08-17 08:00

2014-08-17 10:00

2014-08-17 12:00

2014-08-17 14:00

2014-08-17 16:00

2014-08-17 18:00

2014-08-17 20:00

22

24

26

28

30

32

34

36

Te

mp

era

ture

(oC

)

Local date and time

Transit through

different airports:

FLL

(AYY container)

MIA

(AMJ container)

MD11

main deck

2014-08-17 08:00

2014-08-17 10:00

2014-08-17 12:00

2014-08-17 14:00

2014-08-17 16:00

2014-08-17 18:00

2014-08-17 20:00

22

24

26

28

30

32

34

36

MD11 flight

Te

mp

era

ture

(oC

)

Local date and time

AKE container

in aft belly

AYY container

on main deck

Sort impact

Case study: • Friday shipping

• Bypass

container

• Staged in MEM

over the

weekend in

temperature-

controlled facility

(not available for

general cargo)

• Sort in MEM on

Sunday morning

• Tarmac

exposure for a

few hours

MEM MEM

Sunday

afternoon

Sunday

afternoon

Journey of small parcels sent together for same final destination

different containers different cities

Page 41




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

Page 42




Day vs. night operations Red flag: sun exposure on tarmacs during daytime

Commercial airlines and

freight forwarders are most

likely to operate during the

day

Consequences: sudden or

prolonged exposure to direct

sunlight for general cargo

MEM

Sunday

afternoon

FedEx Express priority

services typically fly

overnight

reported weather

of 32oC

2014-08-17 09:00

2014-08-17 11:00

2014-08-17 13:00

2014-08-17 15:00

2014-08-17 17:00

2014-08-17 19:00

22

24

26

28

30

32

34

36

Te

mp

era

ture

(oC

)

Local date and time

Tarmac time:

30min

1h30

Page 43




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

Page 44




Seasonality Winter versus summer profiles to fulfill regulatory requirements

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

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

Page 45




• 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

Recommendations

Page 46




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

Page 47




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

Page 48




Contingency planning Ongoing investment in cold chain infrastructure

Temperature-controlled

storage

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

Missed plane connection

Plane mechanical failure

Bad weather

Lack of proper documentation for customs clearance

Clearance backlog at regulatory agencies (such as FDA)

Dry ice capacity constraints

Unexpected

events could

always arise

while in transit

Page 49




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

Knowledge of cold chain quality and regulatory aspects

of Good Distribution Practices (GDP) associated with

transportation

FedEx has an

impressive

internal network

of experts

Page 50




• 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

Key takeaways

Questions? Direct contact ([email protected]) or fedex.com/healthcare

Insights into cold chain and air transportation - FedEximages.fedex.com/.../Insights_into_Cold_Chain_and_Air_Transportation.pdf · transportation advantage Cold chain solutions Temperature

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