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Temperature Control, not just a cool idea.


Volume vs Value


Increase in Temperature Control requirements


Count the black circles

Regulatory guidelines are a moving target Working with experts can reduce headaches both perceived and otherwise


Implications for Transport • IATA Perishable Cargo Regulations, Chapter 17 • USP1079 • WHO TRS No 937 Annex 5 • 21 CFR Part 210/211/600 • Canada Health guide 0069 • PDA Technical Report 39


IATA Chapter 17 “Perishable Cargo Regulations (PCR) Air Transport Logistics for Time & Temperature Sensitive Healthcare Products • Known gap in temperature control – Airlines identified as highest risk in the supply chain for transporting time and temperature sensitive health care products – Issues • Healthcare products highly regulated for manufacture, storage and elements of distribution.(Good Practices) • 60% of the transport time for a healthcare package is spent at the airport • 54% of temperature excursion of healthcare products happens in the possession of airlines.


USP 1079 Good Storage and Distribution Practices Labeling Room Temperature Storage

Statements 20ยบC to 25ยบC (68ยบF to 77ยบF) excursions permitted between 15ยบC and 30ยบC (between 59ยบF and 86ยบF) Brief exposure to temperatures up to 40ยบC (104ยบF) may be tolerated provided the mean kinetic temperature does not exceed 25ยบC (77ยบF); however, such exposure should be minimized

Controlled Room Temperature (CRT)

20ยบC to 25ยบC (68ยบF to 77ยบF)

Cool Storage

8ยบC to 15ยบC (46ยบF to 59ยบF)

Refrigerator Storage

2ยบC to 8ยบC (36ยบF to 46ยบF)

Freezer Storage

โ€“25ยบC to โ€“10ยบC (โ€“13ยบF to 14ยบF)

excursions permitted between 15ยบC and 30ยบC (between 59ยบF and 86ยบF)


Keep your eyes on the box The moment you shift your focus is when things seem to change


Think about the box Most Common CRT solutions • Credo Cubes • Intelsius ORCA • Modified seasonal Gel Pack Systems • Cooler style insulated boxes

Don’t forget the temp Monitor


Selecting the right packaging What you see is not always what you get.


Phase Change OR Gel packs


There is only one way to assure temperature control


There is only one way to assure temperature control • Storage and Handling › Gap Analysis

› Storage Area Mapping

› SOPs and Training

› Qualification/Validation

› Monitoring

› Documentation Storage & Handling

Distribution & Transport

• Distribution and Transport › Mapping/Qualification of Transport Units

› Quality Agreements

› Temperature Profile Study in Transport

› SOPs and Training

› Test, Design, and Qualification of Packaging Systems

› Shipping Validation › Monitoring of Trucks/Trailers


There is only one way to assure temperature control Storage & Handling

Distribution & Transport

Points of intervention

60% of the transport time for a healthcare package is spent at the airport 54% of temperature excursion of healthcare products happens in the possession of airlines.


Best Practices to ensure Supply Chain Continuity •

Risks assessment starts by knowing • Your Supply Chain • Your limitations

But risk assessment is different for each product, temperature, shipping methodology and destination

Variation by seasons, regulations, quantities, configurations, turn-around time requirements


Contingency Plan Triggers • Weather • Social activity (employment strikes, sporting events) • Natural Disasters • Political unrest


Volcanic ash

shuts down EU airspace Unprecedented Logistical Challenges •

April 14, 2010 Eyjafjallajökull volcano erupts

ash from Iceland stops air traffic in N. Europe for 6 days

More than 1000 in transit impacted being clinical time & temperature sensitive shipments


January 17, 2012: Truckers strike in Sicily

Physically block ports

• over 100,000 truck drivers, farmers, and fishermen protest • ports, roads, and railways blocked


Strategies to employ

during global events

(known triggers)

Elections – Olympics – Employment Strikes Advance planning • Pre book flight space for cargo • Account for security inspection backlog • Account Customs/Agency clearance delays • Account for transport delays on roads • Make arrangements for special resources like TCVs Additional Considerations • Upgrade box to longer validation time • Consider active vs. passive solutions


Build contingency plans

in your process

Delays happen Plan for them Time is your enemy


Think outside the box How do we get it there successfully? •

Look at each step of the journey : •

E.g.TCV is on a ferry (no external power source and engine cannot be run), how long is the journey?

Distance from collection to airport

External temperature

Security delays (x-ray screening time)


Cargo acceptance Priority loading of cargo on commercial aircraft • • • • • • •

AOG spare parts Passenger’s luggage Live Animals Perishables Temperature controlled shipments Courier/ express cargo General cargo


Know the lane to be aware of

triggers along the path

• To get to Singapore from New York, a stop is required in Frankfurt If there is a strike in Frankfurt the shipment may be impacted •Road feeder service (RFS) often used by airlines as smaller aircraft cannot accommodate larger shipments


Risk Mitigation plan 9Should include

9Roles and responsibilities 9Requirements and capabilities 9Assessment and evaluation 9Tri-Party agreements 9Document validation 9Build-in redundancy 9Intervention options


Conclusion • It’s the Network that proactively mitigates excursions • Plan for delays when selecting the packaging • Avert risk rather than risk adverse


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