15.15 Milan Sue Lee.pptx

Transcription

15.15 Milan Sue Lee.pptx
Case study for the transport of samples from Africa
Sue Lee
World Courier Management
London
Challenges
Shipping of samples
Training of investigators
Dealing with customs and airlines
Cold chain packaging supply & cold
chain en route
Shipments from Africa
Sample Shipments
Pharmaceuticals inter site shipments
TB cultures from Africa to UK
Sputum samples from Africa to UK
Blood samples from Harare to Cape
Town
Samples were taken from relapsed
patients so defined as infectious
materials Class 6.2
Cultures
Categorised as UN 2814, packing
instruction 620 Category A
Sent at 2-8°C
Dangerous Goods declaration
Require shippers to be trained
Blood & Sputum samples
Categorised as UN 3373 packing
instruction 650 Category B
Blood sent at -80°C on dry ice
Sputum sent at 2-8°C on gel packs
No Dangerous Goods declaration
Require shippers to be trained to
ship the dry ice.
Training
Required under national and
international laws
International Air Transport
Association
Required for all TB cultures and for
dry ice.
Training
12 investigators travelled to
Johannesburg for training
2 days both theory and practical and
hands on.
In addition staff from World Courier
South Africa attended the
investigator meetings
Challenges – dealing with airlines and customs
Prebooking shipments
Getting clearance on documents
Dangerous Goods checks
Temperature at airports before
loading
Temperature at airports en route
Challenges – packaging supply
Compliant packaging
On demand study – no certainty of
shipments
Preconditioning gel packs
Dry ice supply
Replenishing dry ice / changing gel
packs
Priorities
Timeliness
Zero temperature excursions
Zero loss
Product integrity & security
Cost efficiency
Stakeholders
Everybody: shipper, consignee, shareholder, professionals, patients.
Regulatory authorities, customs, brokers
Airlines, 3PL, Handlers, etc.
Lines, forwarder, port x 2, haulage, clearance agent.
Transport company, driver, controller(s) multi-modal interfaces, border
control = long clearance times
Warehouse conditions
Multiple handling agents in the airline chain
Success?
30 patients relapsed
30 patient cultures sent to London
No temperature excursions
Collaboration and partnership with St
George’s.
New Challenges
Patient Samples from developing
world
Education of regulatory authorities
and approval bodies
Cost constraints
Reduced temperature bands