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COLD CHAIN
Pre Agusta Siswantoro
COLD CHAIN
in Pharmaceutical Product
Pre Agusta S
(Supply Chain-Logistic Director Kalbe Group)
Why vaccine management ?
5
What is Cold Chain Logistics?
TEMPERATURE
COLD CHAIN
LOGISTICS CONTROL
(REFRIGERATION)
LOGISTICS
•Precooling System •Refrigerated Trucks •Cold Storage •Refrigerated Trucks •Retail, Terminal,
•Farms (Rural •Refrigerated Railway •Warehouses •Refrigerated Railway Markets, Factory,
Markets) Wagons Wagons Ports, Airport
•Manufacturers •Refrigerated Cargo •Refrigerated Cargo
Containers Containers
COLD CHAIN PRODUCTS GROWING FASTER
Global Biopharma Sales 2008-2011
$877bn
Total Market
$773bn +13%
$ Billions
by Berty Argiyantari 7
Global Cold Chain Facts: Bio-Pharmaceutical
source: www.coldchainpharm.com/
THE REQUEST
Physicians request a means to verify the efficacy of delivered biologics
9
Origin-Destination
Thermal Solution
Air Carrier
Providers
Origin
Forwarders
Airport Airport
& Distributors
Ground Ground
Trucking
Handlers Handlers
Co’s.
Destination
Forwarders &
Trucking Co’s
13
COLD CHAIN ISSUE..
The wastage….
An estimated 17% to 37% of healthcare
providers expose vaccines to improper
storage temperatures.
Handling cost…..
Cold Chain, which is used to keep the
temperature cool for hormones,
vaccines and antibiotics from production
to be used in a hospital or clinic, is an
expensive process, can reach about
80% of the selling price of the vaccine.
COLD CHAIN ISSUE.. (con’t)
Product recall
Product safety
lead to
Product quality
Risk for patients health
Chiller
Electrical Storage Equipment
20
STORAGE REQUIREMENT
21
Cold Chain storage units must be selected carefully and used properly.
Any refrigerator or freezer used for storage must:
by Berty Argiyantari
STORAGE SECURITY
24
by Berty Argiyantari
STORAGE SECURITY
25
Non electrical
Uses
by Berty Argiyantari
Temperature Management
28
by Berty Argiyantari
TEMPERATURE REQUIREMENT
29
Temperature record
Temperature
should identify any
record should
temperature deviations
be taken by well
and give details of
trained person
corrective actions taken as
a result.
DAMAGE PRODUCT, by
exposure to heat or
freezing is not easy to
detect. No change color
or appearance occurs, so
visual indicators are
unavailable.
STORAGE TEMPERATURE
by Berty Argiyantari 30
TEMPERATURE MONITORING DEVICES
31
Digital
Strip Monitors
Thermometer
Min Max
Thermometer Data Logger
by Berty Argiyantari
DATA LOGGERS
32
by Berty Argiyantari
THERMOMETER PLACEMENT
33
by Berty Argiyantari 34
STORAGE TEMPERATURE
35
Temperature Monitoring
The calibrated temperature data logger should indicate and record:
When
How Long
What
Was the temperature at the exact time period it
was not maintain?
Warmest,
High humidity
by Berty Argiyantari
FACTORS AFFECTING TEMPERATURE VARIATIONS
36
Avoid unnecessarily opening the refrigerator door. The World Health Organization recommends
door openings be minimized to not more than four times a day.
DISTRIBUTION
TRACEABILITY
by Berty Argiyantari 38
SHIPMENT CONDITION
39
by Berty Argiyantari 40
FROZEN PACKS
41
Ice packs
Ice packs that are filled with tap water and frozen are
the safest type for maintaining the recommended
vaccine storage temperature of +2°C to +8°C
inside a cold box.
Gel packs
Endurotherm
Use validated
insulating
containers
shipping container
by Berty Argiyantari
INSULATED FOAM BOXES
43
MAINTAINING TEMPERATURE DURING TRANSPORTATION
44
Must be maintained
between 2°C- 8°C
by Berty Argiyantari
TRANSPORTATION OUTLET
45
INSULATED VAN
46
• Truck + Refrigerator
• Temperature control/monitor
• Min-max Thermometer
• Temperatur Data Logger
• RFID Temperatur data logger
COLD CHAIN
SYSTEM
KEY POINT TO REMEMBER
49
by Berty Argiyantari
KEY POINT TO REMEMBER
50
by Berty Argiyantari
51
THANK YOU….
TERIMA KASIH