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 Statements

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

Controlled Room Temperature(CRT)

20ºC to 25ºC (68ºF to 77ºF) excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF)

Cool Storage 8ºC to 15ºC (46ºF to 59ºF)

Refrigerator Storage 2ºC to 8ºC (36ºF to 46ºF)

Freezer Storage –25ºC to –10ºC (–13ºF to 14ºF)

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

• Storage and Handling› Gap Analysis› SOPs and Training› Documentation

• Distribution and Transport› Mapping/Qualification of Transport Units› Temperature Profile Study in Transport› Test, Design, and Qualification of

Packaging Systems

Storage & Handling

Distribution & Transport

› Storage Area Mapping› Qualification/Validation

› Monitoring

› Quality Agreements› SOPs and Training› Shipping Validation› Monitoring of Trucks/Trailers

There is only one way to assure temperature control

Storage & Handling

Distribution & Transport

There is only one way to assure temperature control

60% of the transport time for a healthcare package is spent at the airport54% of temperature excursion of healthcare products happens in the possession of airlines.

Points of intervention

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

shuts down EU airspaceVolcanic ash

Unprecedented Logistical Challenges

• April 14, 2010 Eyjafjallajökullvolcano 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

Physically block portsJanuary 17, 2012: Truckers strike in Sicily

• over 100,000 truck drivers, farmers, and fishermen protest

• ports, roads, and railways blocked

during global eventsStrategies to employ

(known triggers)

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

Elections – Olympics – Employment Strikes

Delays happen

Plan for them

Time is your enemy

in your processBuild contingency plans

Think outside the box

How do weget 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)

Priority loading of cargo on commercial aircraft

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

Cargo acceptance

• 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

triggers along the pathKnow the lane to be aware of

Should include

Roles and responsibilitiesRequirements and capabilities Assessment and evaluationTri-Party agreementsDocument validation Build-in redundancyIntervention options

Risk Mitigation plan

• It’s the Network that proactively mitigates excursions

• Plan for delays when selecting the packaging

• Avert risk rather than risk adverse

Conclusion