The challenges of cold chain  logistics

Ensuring temperature control along the  Ensuring temperature control along the total supply chain
Dr Silvia Estrada‐Flores Principal Consultant Principal Consultant
PharmaMed Logistics Conference 9 Sept 2008

Food Chain Intelligence
KNOWLEDGE...INNOVATION...ACTION

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
Food Chain Intelligence
KNOWLEDGE...INNOVATION...ACTION

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

Food Chain Intelligence
KNOWLEDGE...INNOVATION...ACTION

..ACTION .Temperature groups Source: WHO Technical report Series No...INNOVATION. 2003 S T h i l t S i N 908 Food Chain Intelligence KNOWLEDGE. 908.

..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.Business drivers • • • • • • • Of the greater than AUD$1.ACTION . India) Expansion to urban operations Food Chain Intelligence KNOWLEDGE.INNOVATION.

SOPs.. WHO.ACTION .. USP Food Chain Intelligence KNOWLEDGE... GDP.INNOVATION.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. Part 11.

...700 vaccine doses ($128. Feb 2003. 9.. CDC Bulletin.INNOVATION.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. Aug 2002 Food Chain Intelligence KNOWLEDGE.ACTION . diazepam. Lorazepam) show a reduction in potency  after temperature abuse WHO: “Overcoming freezing in the cold chain”.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.

....INNOVATION.ACTION .Weakest links in the cold chain •Lack of protocols  (auditing/emergency/ QA) •Inadequate  q auditing/emergency  systems • Poor education and  • Poor education and training  • Inadequate distribution  • Inadequate distribution routes •Inadequate  •Inadequate equipment/packaging Food Chain Intelligence KNOWLEDGE.

.ACTION ...INNOVATION.. This is especially true for international trade regulations Food Chain Intelligence KNOWLEDGE.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.

.Packaging systems Food Chain Intelligence KNOWLEDGE.ACTION ...INNOVATION..

.INNOVATION.Thermal Package Should comprise: Should comprise: (1) Outer container (2) Insulation covering all 6 faces (2) Insulation covering all 6 faces (3) Temperature control agent (4) Product located at the centre (4) P d t l t d t th t of the package (5) Temperature monitor 5 4 3 2 Food Chain Intelligence 1 KNOWLEDGE.ACTION ....

..ACTION .INNOVATION. hi h/l RFID high/low oxygen concentrations) t ti ) Food Chain Intelligence KNOWLEDGE.Characteristics of thermal packaging systems • • • • • • Normally used once. no means t add h t if required U ll to dd heat i d Able to travel by road. th di N ll d then discarded d d Stand-alone cooling system Usually. RFID.. 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.

3 0..5 64.omega.5 0.4 7.5 8.4 7.5 sec to 9 hrs JR RECORDER AVATEL http://www.onsetcomp.ºC) Resolution (ºC) Capacity (memory) Sampling frequency Food Chain Intelligence KNOWLEDGE.Temperature monitoring technology ESCORT iLog Manufacturer/Supplier ESIS PTY LTD http://www.maxim-ic.com Thermistor -20 to +85 0.esis..ACTION .INNOVATION.000 samples 1 sec to 24 hrs NOMAD OM-41 OMEGA http://www.com.1 32.5 sec to 9 hrs DS1923 THERMOCHRON I-BUTTON DALLAS SEMICONDUCTOR http://www.192 samples 1 to 255 min Sensor type Measurement range (ºC) Claimed accuracy (+/.com/ Thermistor -45 to +125 0.943 samples 0.com/ Thermistor -20 to +70 0.avatel...com/ Thermistor -20 to +70 0.7 0.au/ Thermistor -40 to +70 0.943 samples 0.000 samples 1 sec to 255 min HOBO H8 ONSET http://www.5 0.7 0.

ACTION ..Temperature monitoring technology VERITEC KOOLTRACK FOURIER SYSTEMS TEMPTALE 4 LOGTAG TINYTAG COLE-PARMER Food Chain Intelligence KNOWLEDGE...INNOVATION..

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.INNOVATION..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. 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. thickness= 2 mm Dimensions VITSAB CheckPoint™ labels Colour change of label..ACTION ..5 thickness= 1 5 mm) Food Chain Intelligence KNOWLEDGE.8 mm WarmMark™ 51034 Colour change of label. thickness 1..

INNOVATION.ACTION .....Wireless monitoring technology Electronic Track & Trace Technologies • • RFID and wireless i l Wireless systems that y allow for noncontact reading Food Chain Intelligence KNOWLEDGE.

ACTION . 2006 $500.000 Food Chain Intelligence KNOWLEDGE. Thailand....INNOVATION. 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..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. plus shipments flown from the Singapore DC to a hub in Shanghai.

INNOVATION. • 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: Food Chain Intelligence KNOWLEDGE....ACTION .Packaging systems • The Greenbox (Entropy Solutions Inc) Solutions..

...INNOVATION.Containment systems Food Chain Intelligence KNOWLEDGE.ACTION ..

.Containment systems Reusable Stand-alone/hybrid cooling system Able to travel by road.INNOVATION.. ( ) Medium capacities (eg. high/low oxygen concentrations) Food Chain Intelligence KNOWLEDGE. 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.ACTION • • • • • . sea or air (120 or more hrs) y ...

INNOVATION.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 30°C ) ActivHeat Lamina Medica to • QpodTM: Refrigeration unit mounted into pallet Food Chain Intelligence KNOWLEDGE...ACTION ...

ACTION SHIP (LONG-DISTANCE DISTRIBUTION) ..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 Food Chain Intelligence KNOWLEDGE...INNOVATION..

..INNOVATION...Road Transport Refrigeration System Food Chain Intelligence KNOWLEDGE.ACTION Doors .

INNOVATION.Multi temperature trucks Multi‐temperature trucks Food Chain Intelligence KNOWLEDGE.ACTION .....

..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.INNOVATION.ACTION ... multicompartment distribution benefits increase Global b Gl b l boost of online (internet) shopping t f li (i t t) h i Food Chain Intelligence KNOWLEDGE.

INNOVATION...Containers Food Chain Intelligence KNOWLEDGE.ACTION ...

INNOVATION.Container configuration Container configuration • • • Air delivery and return at one end Air delivery and return at one end Air delivery at floor Floors designed to distribute air Food Chain Intelligence KNOWLEDGE..ACTION ....

INNOVATION.ACTION .....Rail Transport Food Chain Intelligence KNOWLEDGE.

Example: Field Trial with mixed loads Smart-Trace Field Trial 4 Food Chain Intelligence KNOWLEDGE....ACTION ..INNOVATION.

INNOVATION.Smart-Trace Field Trials Thermographics 4 video Food Chain Intelligence KNOWLEDGE....ACTION ..

ACTION ...Air freight systems e g t syste s Food Chain Intelligence KNOWLEDGE...INNOVATION.

.INNOVATION..Innovation in service FEDEX Temp-Assure Validated AirSM: validated airfreight process for temperature-sensitive shipments temperature sensitive Food Chain Intelligence KNOWLEDGE.ACTION ...

.INNOVATION..ACTION ..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 Food Chain Intelligence KNOWLEDGE..

com. NSW Australia Silvia@food‐chain. 0404 353 571 Fax +61 2 9460 1239 www.food‐chain.au Food Chain Intelligence KNOWLEDGE...Thank you Food Chain Intelligence Food Chain Intelligence PO Box 1789 North Sydney 2059.INNOVATION.com.ACTION ...au Tel.

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