Cold Chain Pharma Med 08 Web

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The

challenges

of

cold

chain

logistics total supply chain

Dr Silvia Estrada‐Flores

PharmaMed Logistics Conference

9 Sept 2008

Food Chain IntelligenceKNOWLEDGE...INNOVATION...ACTION




Summary of presentation

• Logistics operations for Life

• Business and corporate

• Packaging systems

• Temperature monitoring systems

containers and pallet systems)


• : , ,



PharmaLogistics

• Deals with the handling, movement and

storage o p arma pro ucts romsupplier to consumer

Transportation

Packaging

Value-added

Warehousing/storage

Inventory

Site

Service/support/

services

Materials Orders

maintenance


ForecastingDisposal



Temperature groups


ource: ec n ca repor er es o. ,



Business drivers

•

sold worldwide in 2005, about 10% biopharmaceuticals• Biopharma prods are temperature sensitive

• Short time frame to realise profits

• Cost reduction (inventory)• o a supp y c a n manu ac ure s e pac ag ng s e

market)

• Ex ansion to new markets e . China India

• Expansion to urban operations




Overall…

• e- nspec on• Delays• ro uc wr en o

• Cash loss• reac n , s, , ar 11, WHO, USP




CSR case

Indonesia: T<0 during vaccine transport (50% of freezing occurrences per year)

North Australia: T<0 in vaccines are detected 4 times more than heat exposure during

transport & storage

South Australia: During 2001/2002, 9,700 vaccine doses ($128,500) were wasted in

due to cold chain issues

New Zealand: Temperature abuse of vaccines may have been the culprit in measles

epidemics (1991)

Some products (epinephrine, diazepam, Lorazepam) show a reduction in potency

after temperature abuse

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WHO: “Overcoming freezing in the cold chain”, Feb 2003; CDC Bulletin, Aug 2002



Weakest links in the cold chain

•Lack of protocols (auditing/emergency/

•Inadequate training auditing/emergency

systems

•• equipment/packaging

routes




What is needed?

•Safe temperature guidelines for pharmaceuticalpro uc s

•Systematic risk assessments of temperature abuse•during the whole chain

•public intervention in regulatory matters

• o s c regu a ons on e ranspor o p armaceu caproducts. This is especially true for international traderegulations




Packaging systems




Thermal Package

(1) Outer container4

5

u v

(3)

Temperature

control

agent ro uct ocate at t e centre

of the package

(5) Temperature monitor 2


1



Characteristics of thermalpackaging systems

• orma y use once, en scar e

• Stand-alone cooling system

• sua y, no means o a ea requ re

• Able to travel by road, sea or air (40-120 hrs)• Small capacities (eg. less than 100 L)

• Can include embedded temperature control/recoding

means• Suitable for integration with other technologies (eg.


, g ow oxygen concen ra ons



Temperature monitoring

ESCORT iLog HOBO H8 JR RECORDER NOMAD OM-41 DS1923 THERMOCHRON I-BUTTON

Manufacturer/Supplier ESIS PTY LTD ONSET AVATEL OMEGA DALLAS SEMICONDUCTOR

http://www.esis.com.au/ http://www.onsetcomp.com/ http://www.avatel.com/ http://www.omega.com/ http://www.maxim-ic.com

Sensor type Thermistor Thermistor Thermistor Thermistor Thermistor

Measurement range (ºC) -40 to +70 -20 to +70 -45 to +125 -20 to +70 -20 to +85

Claimed accuracy (+/- ºC) 0.3 0.7 0.5 0.7 0.5

Resolution (ºC) 0.1 0.4 0.5 0.4 0.5

Capacity (memory) 32,000 samples 7,943 samples 64,000 samples 7,943 samples 8,192 samples

Sampling frequency 1 sec to 255 min 0.5 sec to 9 hrs 1 sec to 24 hrs 0.5 sec to 9 hrs 1 to 255 min




Temperature monitoring

VERITEC KOOLTRACK FOURIER SYSTEMS

COLE-PARMERTEMPTALE 4

TINYTAG




TI and TTI monitoring

Temperature or time

limits

Name and type Change in TTI

noticed by user

Principle Dimensions

Upper

limit

Lower

limit

3M Monitor Diffusing blue front Diffusion of coloured −15 oC −20 oC 95 mm x 19 mm;

thickness=

porous wick measured is higher than

melting point of octyl

octanoate

VITSAB

CheckPoint™

Colour change of

label, caused by a

Enzymatic hydrolysis of a

lipid substrate (occurs at

4 days Variable1 22 mm x 36 mm;

thickness= 0.8

mm

labels decrease in acidity of

active substance

−

18

o

C)

WarmMark™

51034

Colour change of

label caused b a

Enzymatic hydrolysis of a

li id substrate occurs at

12 hrs Variable1 19 mm x 46 mm;

thickness= 1 5


,

decrease in acidity of

active substance

−18 oC)

.

mm)



Wireless monitoring technology

Electronic Track &

Technologies • RFID and

w re ess

• Wireless

systems that

allow for non-

contact reading




Wireless monitoring technology

Company Supply chain

link

Application Pilot

trial

Approximate

Implementa-

Reason for RFID

uptake

Envirotainer

(Sweden)

Air freight Tracking air shipments

of temperaturesensitive goods

2002 Unknown Competitive advantage

DHL Delivery and Monitoring 2007 Unknown Quality assurance for urope og s cs

companyempera ures o

refrigerated vans p armaceu ca s

ASD

Healthcare(US)

Pharmaceutical

manufacturer

Monitoring of

refrigerators andindividual packages at

2007 Unknown Quality assurance

throughout the chain

hospitalsTNT (The

Netherlands)Logistics andglobal expressservices

Tracking temperaturesof health-care,

pharmaceutical andchemical oods as the

2006 $500,000 Supply chain of TNT'sLife Science RegionalDC in Singapore to adistribution hub in

move along the supplychain (Asia only)

Bangkok, Thailand, plusshipments flown fromthe Singapore DC to ahub in Shanghai.




Packaging systems

,

• Pre-molded urethane and molded channels that

• NanoCoolTM (sorption cooling device)

different temperatures)

• - st




Containment systems




Containment systems

• Reusable

• Stand-alone/hybrid cooling system• Able to travel b road sea or air 120 or more hrs

• Medium capacities (eg. less than 400 L)

•means

• Suitable for inte ration with other technolo ies e .RFID, high/low oxygen concentrations)




Containment systems

• Thermal container (Kodiak):Hard plastic casingenclosing foam-encased vacuum insulation panels

• ermo : pa e nsu a e covers

• TCP Reliable: thermal control panels• Cold Chain Technologies: KoolTempTM insulated

pallet containers

• ct v eat : am na e ca to• QpodTM: Refrigeration unit mounted into pallet




TYPICALTransport systems

TRANSPORT MODE VOYAGE TIMES

1 TO 12 HRS

VAN OR COMPARTMENT IN MULTI- TEMPERATURE TRUCK (URBAN/SHORT- DISTANCE DISTRIBUTION)

12 HRS TO

3 DAYS

TRUCK/TRAILER/SEMI-TRAILER (SHORT/ LONG-DISTANCE DISTRIBUTION)

3 TO 16 DAYS

RAIL (LONG-DISTANCE DISTRIBUTION)

1 TO 100 HRS

AIRPLANE (LONG-DISTANCE DISTRIBUTION)

3 DAYS TO 2

MONTHS


SHIP (LONG-DISTANCE DISTRIBUTION)



Road Transport

Refrigeration System


Doors



‐




Urban multi-temperature

-

financial rewards for small shipments withiff r n m r r r ir m n

m n n z , mu -

compartment distribution benefits

Food Chain IntelligenceKNOWLEDGE...INNOVATION...ACTIONFood Chain IntelligenceKNOWLEDGE...INNOVATION...ACTION

o a oos o on ne n erne s opp ng



Containers






Rail Transport




Smart-Trace Field Trial 4Example: Field Trial with mixed loads




Smart-Trace Field Trials Thermographics 4 video




Air frei ht s stems




Innovation in service

FEDEX Temp-Assure Validated AirSM: validated airfreight-


C l i h i l



Conclusion: a pharmaceutical

• Requires more than just technology

• Entire change in culture and mindset

• Will consist of a verified and ‘in-

s ecification’ su l chain


Th k



Thank you

PO Box 1789North Sydney 2059, NSW

Australia

Silvia@food‐chain.com.au

Tel. 0404 353 571Fax +61 2 9460 1239

www.food‐chain.com.au


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