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TRANSCRIPT
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GDCC_P.PARDON
GSK Biologicals Distribution & Cold Chain
October, 2008
Muriel Balthazar
Global Distribution Leader
Sébastien Wins
Cold Chain Strategy Specialist
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Purpose of this talk
Present an example of how a vaccine manufacturer manages his cold chain
distribution
Express what our expectations from the suppliers are and what limitations
we face (suppliers’ constraints)
… and above all, exchange views to understand what the future cold chain
transport could be like
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Topics
Short introduction on who we are…
Explain our cold chain strategy
Questions and discussion
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GSK Biologicals in 2007
1.1 billion vaccine doses produced
Over 30 marketed vaccines available worldwide
Over 20 vaccines in clinical development
Over 9,000 employees worldwide
Over 1,600 passionate scientists
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GSK Biologicals Network
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GSK Biological distribution out of belgium
2006 total transportation ex-Wavre - 70% air / 30% road – DIRECT but some MMW
To 170 countries
#deliv Tons
Asia 927 626
Europe Road 1 167 1 220
Europe Air 599 169
MENA/SSA 1 059 554
Latin America 577 497
Canada 60 41
USA 277 503
4 666 3 609
deliv tons
road = 25% 34%
EUR= 38% 38%
US= 6% 14%
200 Tons
200 deliveries
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Cold Chain Importance for GSK Biologicals
Why Cold Chain Strategy is important for
GSK Biologicals?
Our products are all sensitive to temperature
variations
Regulators are increasingly focused on Good
Distribution Practices
All vaccine doses exposed to temperature deviations cannot
be replaced in due time ���� Patients not protected in due time
���� Ethical responsibility
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Cold Chain Importance for GSK Biologicals
Why Cold Chain Strategy is important for
GSK Biologicals?
Many manufacturing sites worldwide
could be involved in the different steps
of the production of our products
We ship our products to more than 170
destinations worldwide
Distribution includes many sequences,
involves many parties and many processes.
All these need to be controlled to ensure a proper
distribution of our products in adequate conditions
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1. KNOW YOUR PRODUCT – i.e. VACCINES
All vaccines produced by GSK Biologicals are temperature sensitive products:
Vaccines are sensitive to heat at different degrees – but some excursions can be accepted
Most vaccines are sensitive to freeze – Frozen vaccine has to be rejected
Structure of a normal adsorbed vaccine Structure of a frozen adsorbed vaccine
* Pictures from: Temperature Sensitivity of Vaccines from WHO. Version: WHO/IVB/06.10
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1. KNOW YOUR PRODUCT – i.e. STABILITY(PDA-TR39/2007 Revised version)
Temperature sensitive products must be
shipped in a manner to ensure products will
be maintained within an acceptable
temperature range
Products can be shipped outside their
respective label storage conditions provided
stability data or scientific/technical
justification exists demonstrating that the
Product Quality is not affected
Stability studies should be available to
demonstrate the « robustness » of a product
in case of temperature deviation
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CEVA as worldwide LSP
On site CEVA dedicated team
SLR/LSP frame work describing quality standards
GSK Bio has relationship with air carriers
We believe in a tri-partite partnership to bring cold chain
under control
Concentrate the activities with preferred carriers
Technical Assessment of facilities
Route selection
Prefer direct flights or transits in Europe
Special process handling for Routes at risk (i.e. Thermal
covers, unloading supervision, …)
2. KNOW TRANSPORT – Air Strategy
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2. KNOW TRANSPORT – General overview
General overview of Air Transportation :
we need to understand this complex process to each destination in order to select the proper
route & carrier to that destination
We run a risk assessment of the process to implement adequate solutions/improvements
(SOP’s, packaging, …)
Consolidate shipments
and deliver to
airport
Build/ figure/ Weigh Pallets
Load Aircraft
Offload Re-Config
Transfer DeliveryShipper Consignee
AirlineHandling Agent
Onload Airport
Handling Agent
Offload Airport
Forwarder
Origin Trucking
Forwarder
DestinationTrucking
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2. KNOW TRANSPORT – Process flows
Description of the Distribution Routes (Physical Process Flows)
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Measures
Big gradient depending on position of the recorder!
Temperature stability duringflight
cooler truck cooler Tarmac Flight tarmac/HO coolertransfer
2. KNOW TRANSPORT – Mapping of Routes
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2. KNOW TRANSPORT – Risk assessment
The transport process is a succession of steps which are reoccurring along the
distribution route, transferable from one route to another, unlinked to the carrier and
any other specific details:
PREPARATION
ROAD transport
AIR transport
STORAGE in-transit
RECEPTION
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2. KNOW TRANSPORT – Run Risk Assessment
For each step and activity in the process, a risk assessment matrix defines potential
threats, risks, current measures and additional mitigation plan to bring the route under
control.
Risk Nbr Threats Description Risk description Existing controlsPotential
impact
Likelyh
ood
(L)
Concequenc
e (C )
RPN
(LxC)
Shipment preparation (Reefer truck selection)
Temperature deviation leading to destruction of
part/total truck load
C1 From GSK plant direct to customer
0. Only temperature controlled trucks are used
1. Strong monitoring to correctly assess the quality of the load
and to limit loss in case of localized freeze
2. Use of approved carriers according to SOP
3. For specific business some truck &/or van are v
Business risk 1 1 1
C2 From GSK plant to airport of departure
CEVA trucks are dedicated and validated according to GSKBio
SOP; packaging used for air transportation protects from minor
excursions; monitoring in the shipping boxes
Business risk 1 1 1
C3 From airport to airport or from airport to customerno general rule; packaging is protecting the load for minor
excursions; Monitoring inside the shipping boxes.Business Risk 1 1 1
Truck technical features enables temperature inside
to fluctuates outside required Temperature for period
of time or in places
(inadequate cooling unit, wrong calibration,
unfrequent maintenance, weak insulation, …)
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2. KNOW TRANSPORT – Know the Transport Means
AIRCRAFTS AIR-CONDITIONING OVERVIEW B747-400F
Understand the temperature control/regulation in the aircraft used to ship your goods
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2. KNOW TRANSPORT – Know the Transport MeansTRUCKS
26°C
1.7°C
1.7°C1.1°C 2.8°C 3.9°C
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3. DETERMINE APPROPRIATE – Packaging
Ancillary packaging components/systems must be identified according to the amount
of thermal mass that must be temperature-controlled. The greater the thermal mass,
the less reactive it is to ambient temperature variation.
Ancillary packaging components/systems can be used with the basic transportation
unit to maintain the required temperature
Active systems: systems with active temperature control
Air / Sea freight containers
Refrigerated trucks, …
Passive systems: systems without active temperature control
Insulated containers – expanded polystyrene with or without refrigerants, …
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Contains:
-3 trays of cold packs
-20 x cardboard boxes that containsproducts
External dimensions of the pallet :
Length : 120 cmWidth : 80 cmheight : 158 cm
Internal dimensions of the (20) box :
Dims : 34.2 x 25.1 x 43.1 cm
Weight of shipper : 64.4 kg
Main material
Pallet : polyurethane and
cardboardInternal box : cardboard.
3. DETERMINE APPROPRIATE – PackagingPALLET-SHIPPER CONCEPT – SB20
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Contains:
-trays of cold packs
-2 x cardboard boxes that containsproducts
External dimensions of the pallet :
Length : 66 cmWidth : 59 cmheight : 75 cm
Internal dimensions of the (2) box :
Dims : 34.2 x 25.1 x 43.1 cm
Weight of shipper : 19 kg
Main material
Pallet : polyurethane and cardboard
Internal box: cardboard.
3. DETERMINE APPROPRIATE – PackagingPALLET-SHIPPER CONCEPT – SB2
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Contains:
-trays of cold packs
-7 x cardboard boxes that containsproducts
External dimensions of the pallet :
Length : 118 cmWidth : 71 cmheight : 87 cm
Internal dimensions of the (7) box :
Dims : 34.2 x 25.1 x 43.1 cm
Weight of shipper : 52 kg
Main material
Pallet : polyurethane and cardboard
Internal box: cardboard.
3. DETERMINE APPROPRIATE – PackagingPALLET-SHIPPER CONCEPT – SB7
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3. DETERMINE APPROPRIATE – Monitoring Devices
Different monitoring devices can be used to assess the proper maintain of
temperature during shipments
According to the sensitivity of the products shipped, the route, the mean of
transportation, the ancillary packaging and Regulation requirements, a
combination of monitors can be used
Different types of temperature monitors exist:
Mechanical Monitors
Electronic Monitors
Chemical Monitors
They are the “key” to assess the Quality of a shipment regarding the
temperature during a shipment
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Mapping with several probes
Empty load during OQ
Full load during PQ and requalification (each year)
Calibrated probes
Regulation probes (near compressor)
Monitoring probes (within the room)
Continuous monitoring
Electronic chart
Mechanical chart
System Alarmed
Contingency procedure
Training practice (door closed,….)
Preventive maintenance – anticipate issues
3. DETERMINE APPROPRIATE – Facilities
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3. DETERMINE APPROPRIATE – Assessments/Trainings
• Audits of airports and handling agents are a key factor for a better understanding of the route used
and issues that could occur during shipment of your products
• Examples of topics that can be checked during these audits:
• Cold Rooms ( validation, calibration, cleaning, records, …)
• Process flow (inbound, outbound, storage, handling, …)
• Documentation (temperature records, validation, …)
• Training
• Facilities
• Training of the different parties involved in the distribution chain about the importance of the Cold
Chain maintain is also an important factor to consider in order to decrease the risk of temperature
deviations
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• Fly as booked
• Ship sooner/later ���� transit could be put at risk or Local not ready
• Split of the shipments ����no consistency of batch or no proof of
Temperature
• Have cold chain under control
• Minimum time on tarmac
• Immediately in cool room with right T° setting
• Temperature controlled truck with correct loading practices
3. DETERMINE APPROPRIATE – Logistics & communication process
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• Adequate track and trace system
• report immediately any deviation and wait for GSK “GO” to act
• details are needed (time&T°) when deviation reported
• Have a good pre-advise system
• … to allow for a quick pick-up of the goods at destination
• if possible anticipate customs clearance
• Efficient local organization
• Quick pick-up - shorter time at airport as possible
3. DETERMINE APPROPRIATE – Logistics & communication process