Thechallengesofcoldchain logistics

Ensuringtemperaturecontrolalongthe Ensuring temperature control along the totalsupplychain

DrSilviaEstradaFlores PrincipalConsultant Principal Consultant
PharmaMedLogisticsConference 9Sept2008

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Summary of presentation
Logistics operations for Life Science products Business and corporate responsibility drivers Packaging systems Temperature monitoring systems Containment systems (reusable containers and pallet systems) Transport systems: road air, sea road, air
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PharmaLogistics
Deals with the handling, movement and storage of pharma products from t f h d t f supplier to consumer
Packaging Transportation Inventory Service/ support/ maintenance Materials handling Warehousing/storage Orders Disposal Di l Forecasting Value-added services Site

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Temperature groups

Source: WHO Technical report Series No. 908, 2003 S T h i l t S i N 908 Food Chain Intelligence
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Business drivers
Of the greater than AUD$1,120 B of pharmaceutical product sold worldwide in 2005, about 10% biopharmaceuticals Biopharma prods are temperature sensitive Short time frame to realise profits Cost reduction (inventory) Global Gl b l supply chain ( l h i (manufacture site packaging site f t it k i it market) Expansion to new markets (eg. China, India) Expansion to urban operations

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Overall
Re-inspection R i ti Delays Product itt P d t written off ff Cash loss Breach i GMP SOP GDP 21 CFR P t B h in GMP, SOPs, GDP, Part 11, WHO, USP

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CSR case
Indonesia:T<0duringvaccinetransport(50%offreezingoccurrencesperyear)

NorthAustralia:T<0invaccinesaredetected4timesmorethanheatexposureduring transport&storage SouthAustralia:During2001/2002,9,700vaccinedoses($128,500)werewastedin duetocoldchainissues NewZealand:Temperatureabuseofvaccinesmayhavebeentheculpritinmeasles epidemics(1991) Someproducts(epinephrine,diazepam,Lorazepam)showareductioninpotency aftertemperatureabuse

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

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Weakest links in the cold chain

Lackofprotocols (auditing/emergency/ QA) Inadequate q auditing/emergency systems

Pooreducationand Poor education and training

Inadequatedistribution Inadequate distribution routes

Inadequate Inadequate equipment/packaging

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What is needed?
Safe temperature guidelines for pharmaceutical products d t Systematic risk assessments of temperature abuse y during the whole chain Define specific storage/transport guidelines and level of Define public intervention in regulatory matters Holistic regulations on th t H li ti l ti the transport of pharmaceutical t f h ti l products. This is especially true for international trade regulations Food Chain Intelligence
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Packaging systems

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Thermal Package
Shouldcomprise: Should comprise: (1)Outercontainer (2)Insulationcoveringall6faces (2) Insulation covering all 6 faces (3)Temperaturecontrolagent (4)Productlocatedatthecentre (4) P d t l t d t th t ofthepackage (5)Temperaturemonitor
5 4

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Characteristics of thermal packaging systems

Normally used once, th di N ll d then discarded d d Stand-alone cooling system Usually, no means t add h t if required U ll to dd heat i d 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. RFID, hi h/l RFID high/low oxygen concentrations) t ti )
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Temperature monitoring technology

ESCORT iLog Manufacturer/Supplier ESIS PTY LTD http://www.esis.com.au/ Thermistor -40 to +70 0.3 0.1 32,000 samples 1 sec to 255 min

HOBO H8 ONSET http://www.onsetcomp.com/ Thermistor -20 to +70 0.7 0.4 7,943 samples 0.5 sec to 9 hrs

JR RECORDER AVATEL http://www.avatel.com/ Thermistor -45 to +125 0.5 0.5 64,000 samples 1 sec to 24 hrs

NOMAD OM-41 OMEGA http://www.omega.com/ Thermistor -20 to +70 0.7 0.4 7,943 samples 0.5 sec to 9 hrs

DS1923 THERMOCHRON I-BUTTON DALLAS SEMICONDUCTOR http://www.maxim-ic.com Thermistor -20 to +85 0.5 0.5 8,192 samples 1 to 255 min

Sensor type Measurement range (C) Claimed accuracy (+/- C) Resolution (C) Capacity (memory) Sampling frequency

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Temperature monitoring technology

VERITEC KOOLTRACK FOURIER SYSTEMS

TEMPTALE 4 LOGTAG TINYTAG

COLE-PARMER

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TI and TTI monitoring technology

Name and type Change in TTI noticed by user Upper limit 3M Monitor Mark 9860A Diffusing blue front along the length of a porous wick Diffusion of coloured substance if temperature measured is higher than melting point of octyl octanoate 15 oC Principle Temperature or time limits Lower limit 20 oC 95 mm x 19 mm; thickness= 2 mm Dimensions

VITSAB CheckPoint labels

Colour change of label, caused by a decrease in acidity of active substance

Enzymatic hydrolysis of a lipid substrate (occurs at 18 oC)

4 days

Variable1

22 mm x 36 mm; thickness= 0.8 mm

WarmMark 51034

Colour change of label, label caused by a decrease in acidity of active substance

Enzymatic hydrolysis of a lipid substrate (occurs at 18 oC)

12 hrs

Variable1

19 mm x 46 mm; thickness 1.5 thickness= 1 5 mm)

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Wireless monitoring technology

Electronic Track & Trace Technologies RFID and wireless i l Wireless systems that y allow for noncontact reading

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Wireless monitoring technology

Company Envirotainer (Sweden) DHL (Europe) (E ) ASD Healthcare (US) TNT (The Netherlands) Supply chain link Air freight Delivery and logistics l i ti company Pharmaceutical manufacturer Logistics and global express services Application Tracking air shipments of temperature sensitive goods Monitoring temperatures of t t f refrigerated vans Monitoring of refrigerators and individual packages at hospitals Tracking temperatures of health-care, pharmaceutical and chemical goods as they g y move along the supply chain (Asia only) Pilot trial year 2002 2007 2007 Approximate Implementation Costs Unknown Unknown Unknown Reason for RFID uptake Competitive advantage Quality assurance for pharmaceuticals h ti l Quality assurance throughout the chain Supply chain of TNT's Life Science Regional DC in Singapore to a distribution hub in Bangkok, Thailand, plus shipments flown from the Singapore DC to a hub in Shanghai.

2006

$500,000

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Packaging systems
The Greenbox (Entropy Solutions Inc) Solutions, Pre-molded urethane and molded channels that disperse internal air more uniformly (Envirocooler) NanoCoolTM (sorption cooling device) Radiant barrier + 2 PCM (2 phase changes at 2 different temperatures) Chip-vacua: 1st flexible VIP (Matsushita) Chip vacua:

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Containment systems

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Containment systems
Reusable Stand-alone/hybrid cooling system Able to travel by road, sea or air (120 or more hrs) y , ( ) Medium capacities (eg. less than 400 L) Can include embedded temperature control/recoding means Suitable for integration with ot e tec o og es (eg Su tab e o teg at o t other technologies (eg. RFID, high/low oxygen concentrations)
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Containment systems
Thermal container (Kodiak):Hard plastic casing enclosing foam-encased vacuum insulation panels Th Thermo ChillTM: pallet i ll t insulated covers l t d TCP Reliable: thermal control panels Cold Chain Technologies: KoolTempTM insulated pallet containers A ti H t : L i M di (15 t 30C ) ActivHeat Lamina Medica to QpodTM: Refrigeration unit mounted into pallet
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Transport systems
TRANSPORT MODE
VAN OR COMPARTMENT IN MULTITEMPERATURE TRUCK (URBAN/SHORTDISTANCE DISTRIBUTION)

TYPICAL VOYAGE TIMES

1 TO 12 HRS

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

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SHIP (LONG-DISTANCE DISTRIBUTION)

Road Transport

Refrigeration System

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Doors

Multi temperaturetrucks Multitemperature trucks

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Urban multi-temperature vehicles

Multi-compartment Multi compartment distribution offers financial rewards for small shipments with different temperature requirements As shipments decrease in si e m lti size, multicompartment distribution benefits increase Global b Gl b l boost of online (internet) shopping t f li (i t t) h i
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Containers

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Containerconfiguration Container configuration

Airdeliveryandreturnatoneend Air delivery and return at one end Airdeliveryatfloor Floorsdesignedtodistributeair

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Rail Transport

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

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Smart-Trace Field Trials

Thermographics 4

video

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Air freight systems e g t syste s

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Innovation in service
FEDEX Temp-Assure Validated AirSM: validated airfreight process for temperature-sensitive shipments temperature sensitive

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Conclusion: a pharmaceutical supply chain

Requires more than just technology Entire change in culture and mindset Will consist of a verified and inspecification supply chain p pp y

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Thankyou

FoodChainIntelligence Food Chain Intelligence POBox1789 NorthSydney2059,NSW Australia Silvia@foodchain.com.au Tel.0404353571 Fax+61294601239 www.foodchain.com.au

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