october 8, 2013 - bsma - bio supply · pdf fileof solution design and ... case study: ......

October 8th, 2013

Designing solutions for

healthcare shippers

Christelle Laot, PhD, MBA

Technical Fellow, Cold Chain Management

Life Sciences & Specialty Services, FedEx Express

Bio Supply Management Alliance

Conference

Foster City, California (USA)

October 8, 2013


Designing solutions for healthcare shippers

October 8th, 2013

www.fedex.com/healthcare

Molecular diagnostics & transportation ? Words that came to our mind to describe this unique segment within healthcare

• Small packages • Domestic business only until recently • Poor volume forecast (number of samples in a box often unclear)

• Location of pickup and delivery • Delivery time

• Price sensitive transportation • Not willing to contract specialized services within FedEx healthcare portfolio such as

Priority Alert™ or SenseAwareSM

• Temperature sensitive specimens • Pre-labelled packaging solutions

• Shipping labels • Advanced shipping information and pre-alerts • IT portal with minimum information to be entered

• Security • Traceability



October 8th, 2013


2013-08-20 12:00

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opened

in office

in Memphis

Tem

pera

ture

(oC

)

Day and time (ET)

Origin location:

Walnut Creek, CA

Phoenix, AZ

Dallas, TX

Jacksonville, FL

New York, NY

POD

scans

at address

PUP

scans

Small packages in normal FedEx network Which temperatures can be experienced by small packages during transportation?

FedEx Priority Overnight® (PO) shipments: Delivery next day by 10:30 AM local time

Temperature devices programmed for 1 data point every 4 minutes and placed inside FedEx boxes



October 8th, 2013



Scalability Standardization

of solution

Design and implementation of

unique solution

Specific customer

issue

Collaboration between transportation providers and shippers

leads to innovative solutions



October 8th, 2013


Case study: hub extract and re-induction Main condition for program: To be located near the Memphis international airport

Service requested by shippers to take advantage of location near FedEx Memphis superhub Competitive advantage: Send testing results ahead of competitors (some companies moved central laboratory testing facility to Memphis as a result) Re-induction and late pickup near Memphis hub also

Packages arrive at Memphis

airport around midnight

Normal sort

at the hub

PO delivery

by 10:30 AM

Special delivery

at around 02:00 AM

Packages are

segregated at the hub



October 8th, 2013


Case study: eliminate gel packs Temperature measurements on specific transportation lanes in the summer

Customer requirement: not to exceed temperatures of 38oC Collaboration on shipping studies from distribution center to main shipping locations Temperature data points collected and shown until proof of delivery (POD) scans FedEx Priority Overnight® (PO) shipments: delivery following day by 10:30 AM local time Priority Alert™ contracted on a seasonal basis

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Week 2

Tem

pera

ture

(oC

)

day and time (ET)

W1PT_anah

W1PT_sacr

W1PT_waln

W1MT_phoe

W1CT_sana

W1CT_chic

W1CT_hous

W1CT_dall

W1ET_jack

W1ET_rale

W1ET_newy

W1ET_miam

W2PT_anah

W2PT_sacr

W2PT_waln

W2MT_phoe

W2CT_sana

W2CT_chic

W2CT_hous

W2CT_dall

W2ET_jack

W2ET_rale

W2ET_newy

W2ET_miam

Week 1

PO packages placed in non-temperature controlled trailer at

shipper site once ready for pickup

PO packages stayed inside air conditioned building until 5:00 PM



October 8th, 2013


Trend: risk-based approaches As seen at regulatory agencies



October 8th, 2013


FedEx aircraft temperature control Overall approach

Customer complaints

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



October 8th, 2013


Aircraft temperature mapping Extensive research studies on actual flight temperatures

AFT FORWARD

Cargo

door

Cockpit

rigid cargo

barrier

2011-11-19 22:00

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landingtake-off

CDG-MEM

Tem

pera

ture

(oC

)

Zulu 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

Thermal mapping shows

that large temperature

differences can exist

within the cargo

B777F

main deck



October 8th, 2013


Aircraft default temperature settings

Temperature distribution within each

cargo compartment for each aircraft

model

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 (cold shipments, live

animals generating heat)

FedEx uses best practices based on scientific studies and thermal mapping of aircraft



October 8th, 2013


Contingency planning Cold storage, gel packs, and re-icing available for delayed cold chain shipments

Temperature controlled storage

Source:

http://www.fedex.com/us/healthcare/temp-control/index.html

Unexpected events could always arise while in transit: • 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



October 8th, 2013


Risk management: internal documents Example of thermal blanket solution for air freight transportation

Risk assessment - Identification of operational

parameters (fishbone diagram) - Failure mode and effects

analysis (FMEA) - Risk prioritization matrix

Risk control - Risk control approaches and

contingency plans

Sampling, improvement, corrective and preventive actions (CAPA) - Temperature measurements - Internal audits and customer

complaints



October 8th, 2013


Security measures FedEx security specifics cannot typically be disclosed, except for the following:

People

Employees undergo drug screening and criminal background checks

IT systems

Customer data restricted and not distributed to 3rd parties (unless required by law)

Premises / Vehicles / Aircraft

Controlled access and dedicated security workforce

Shipment

SenseAware™ devices can be programmed to receive alerts in case of:

- Light detection: - has the shipment been opened?

- Unexpected routing: - is the shipment outside the desired geofence?

- has a package gotten off pace or off track?



October 8th, 2013


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, thermal 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



October 8th, 2013


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

mailto:[email protected]

http://www.fedex.com/gb/healthcare

october 8, 2013 - bsma - bio supply · pdf fileof solution design and ... case study: ......

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