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Materi Kuliah SCM modul #5

COLD CHAIN
Pre Agusta Siswantoro
COLD CHAIN
in Pharmaceutical Product

Pre Agusta S
(Supply Chain-Logistic Director Kalbe Group)
Why vaccine management ?

 The vaccine supply chain is the most critical element of an


immunization system

 Poor vaccine management and supply chain practices


and/or equipment failure can cause loss of large quantities
of vaccine

 Financial loss can run to millions of dollars and children


can miss being immunized

 Growing concern with new more costly and more bulky


vaccines
Agenda
• Introduction to Cold chain
• Cold Chain Storage management
• Temperature Management
• Cold Chain Distribution
WHAT IS THE COLD CHAIN?

Goods are sensitive to heat and must be kept


cold from the time they are manufactured until
they are used.

The equipment and people that keep the goods


cold during their journey are together called the
“Cold Chain”.

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What is Cold Chain Logistics?
TEMPERATURE
COLD CHAIN
LOGISTICS CONTROL
(REFRIGERATION)
LOGISTICS

Major Sectors : Food and Beverages, Bio-Pharmaceutical

The Cold chain logistics infrastructure


Supply
Transport Storage Transport End Customer
Procurement

•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

$187bn Cold Chain


$147bn Products +27%

Source: Pharmaceutical Commerce

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Global Cold Chain Facts: Bio-Pharmaceutical

Pharmace Biotech Vaccines Blood Clinical


utical Products Trials
Global Bio-Pharma Cold-chain market
2010 : $5.1 billion 2011 : $6.6 billion
2014 : 7 of the top 10 global pharma products in will require cold-chain handling
Vaccines growing on average 8% per year for the next five years
Source: www.fiercebiotech.com/press-releases/

source: www.coldchainpharm.com/
THE REQUEST
Physicians request a means to verify the efficacy of delivered biologics
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The medicine they prescribe


The trust of their patients to
are qualified, to maintain
provide effective treatment
their patients’ trust

Every shipped package should The request is 100%


contain a history that reflects verification of delivered
the proper treatment at product
the package level
REGULATORY REQUIREMENTS
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The WHO working document QAS/04.068 states:

Where special storage conditions are required during transit,


these should be provided, checked, monitor and recorded.

Temperature mapping of vehicles should support niformity


of the temperature across the vehicles. Recorded
temperature monitoring data should be available for review

Objective of the guideline:


Ensure the quality and integrity of pharmaceutical
products during all aspects of the distribution process
THE CONSTRAIN…
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Popular temperature monitors are too expensive for


comprehensive use in all shipped packages

100% monitoring and verification of all packages is


needed

Distribution is broadening, with more clinics, retail


pharmacies, and end customer deliveries

Smaller packages require an inexpensive


solution to track from distribution to final
delivery

Best practice is to cover ALL shipped


packages, but cost is an issue
KEY COMPONENTS OF COLD CHAIN
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HOW LONG IS THE COLD CHAIN ?
Manufacturers
& Shippers

Origin-Destination
Thermal Solution
Air Carrier
Providers

Origin
Forwarders
Airport Airport
& Distributors
Ground Ground
Trucking
Handlers Handlers
Co’s.
Destination
Forwarders &
Trucking Co’s

Need collaboration for getting the entire cold


chain working together to improve the way it Hospital
operates
Product should be kept at correct
temperature during “All” session along
the “Distribution Channel” End user

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COLD CHAIN ISSUE..

The wastage….
An estimated 17% to 37% of healthcare
providers expose vaccines to improper
storage temperatures.

Refrigerator temperatures are more


commonly kept too cold rather than too
warm

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)

Compounding the Issues is the Lack of Management


Process:

Inability to properly set standards

Inability to monitor the standards

Inability to predict when something may go


wrong
Inability to control Cold Chain distribution

The case for action is compelling – economic loss, customer loyalty


and brand integrity are at stake
UNSAFE SUPPLY CHAIN
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Lead to huge risk related:

Product recall
Product safety
lead to
Product quality
Risk for patients health

Once lost, product’s potency


cannot be reversed
STORAGE MANAGEMENT
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STORAGE CONDITION
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STORAGE EQUIPMENT
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electrical Non electrical

Chiller
Electrical Storage Equipment
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STORAGE REQUIREMENT
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Cold Chain storage units must be selected carefully and used properly.
Any refrigerator or freezer used for storage must:

Be able to maintain required product storage


temperatures through all seasons.

Be large enough to hold the year’s highest


monthly inventory, including special
season.
Have a calibrated thermometer or data logger
inside each storage compartment

Be dedicated to the storage of cold chain


product only.

Be placed in a secure location away from


unauthorized and public access.
ORGANIZING THE STORAGE
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Never store foodbyor beverages


Berty Argiyantariinside vaccine storage units.
PREPARING THE STORAGE
FOR VACCINE (Con’t)
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STORAGE SECURITY
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Data Loggers and Alarm Systems

To alert staff of after-hour emergencies and power failures

Data logger and continuous-monitoring alarm

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STORAGE SECURITY
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ALARM SYSTEM Help prevent substantial financial loss in the


event of a cold chain break
Continuous-monitoring temperature
alarm should be considered Help alert staff to after hours emergencies

Simple systems sound audible alarms when the


temperatures inside the storage units exceed the
recommended ranges

A system sounds an audible alarm and


alerts one or more designated person(s) at a
specified phone

For larger or centralized depots, alarms


should be monitored 24 hours a day and 7
days a week by external sources that
maintain a fan-out list of contacts
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BACK UP GENERATOR
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Automatically provide power to the storage units


to maintain the recommended storage
temperatures in the event of power outages

Backup generators should be tested


quarterly and should receive maintenance
at least
annually

Backup generators should be of a sufficient


capacity to run continuously for 72 hours if
necessary
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STORAGE EQUIPMENT
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Non electrical

Uses

• Store vaccines for transfer up to five days,


if necessary for outreach sessions or when there
is power cut.
Cold boxes • Store products in case of breakdown of ILR
How to pack

Place Stack Place Place ice Secure the


conditioned products in packing pack over lid tightly,
ice pack side the box material the top and don’t open if
by side between cover ed not required
products and with plastic
ice packs sheet

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Temperature Management
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TEMPERATURE REQUIREMENT
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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

Maintain temperature between 2°- 8°C (35°-46°F)

Exceed 8ºC or fall below 2ºC

Aim for 5ºC


Aim to maintain fridge as close as possible to 5˚C as
this gives a safety margin of + or – 3˚c

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TEMPERATURE MONITORING DEVICES
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Digital
Strip Monitors
Thermometer

Min Max
Thermometer Data Logger

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DATA LOGGERS
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THERMOMETER PLACEMENT
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Proper placement of the thermometer is important since it helps the


staff to most accurately identify the actual vaccine vial temperatures
and to take appropriate corrective actions if necessary

Freezer thermometer placement

Refrigerator thermometer placement


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TEMPERATURE MONITORING

Conduct twice daily documentation


of temperature checks even with an
installed data logger and/or alarm
system

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STORAGE TEMPERATURE
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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?

Should be located in the worst case locations in the validation stage

Warmest,
High humidity

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FACTORS AFFECTING TEMPERATURE VARIATIONS
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Storage Load Power


Opening interruption
the door

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

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SHIPMENT CONDITION
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"Container closure systems shall provide


adequate protection against foreseeable
external factors in storage and use that can
cause deterioration or contamination of the
drug product”
INSULATED FOIL ENVELOPES

Thermally Superior Insulated Transit Bag


• Multi-layered metalized film composite exterior that
reflects 97% of heat
• Airtight payload chamber with heavy duty FDA
approved zip lock closure and a flap down sealing
tape.
• Insulated with entangled, multi denier fibers in air
still bladders
• Superior seam strength creating airtight
construction and crush resistant bladders.
• Available in Standard & Custom Sizes

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FROZEN PACKS
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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

Contain coolants that depress the melting


point and ensure the coolant remains cooler
than 0°C for longer than water-filled ice packs
PACKING FOR SHIPPING
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Attach labels Use insulating


Place thermometer
to identify contents barrier to protect
near the product
as vaccine vaccine

Endurotherm
Use validated
insulating
containers
shipping container

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INSULATED FOAM BOXES

• INSULATED FOAM THICK WALL BOXES


• CRAFTED WITH AN INTERLOCKING LID SET INTO THE
CENTER TO ALLOW FILLING RIGHT UP TO THE TOP
• FOAM BOXES ARE AVAILABLE WITH OR WITHOUT
CORRUGATED BOXES

• PRE-LOADED IN A 32 ECT WHITE CORRUGATED BOX


THAT IS BOTTOM SEALED
• BOXES ARE CONVENIENTLY PACKED IN BUNDLES WITH
TOP AND BOTTOM CAPS AND THEN STRETCH WRAPPED
FOR PROTECTION

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MAINTAINING TEMPERATURE DURING TRANSPORTATION
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Must be maintained
between 2°C- 8°C

Stored in an insulated container

The number and placement of refrigerated or


frozen packs inside the container will depend
on container size, the ambient temperature,
the volume of vaccine and jurisdictional
variations
.

A thermometer must be kept in the container with the


vaccines, and temperatures checked and recorded
periodically to ensure that the cold chain is not broken

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TRANSPORTATION OUTLET

Use validated cool boxes (with max-


min thermometers) and cool packs
from a medical supply company.

Validated storage devices approved


for
shipping and/or transport include
Endurotherm insulating shipping
boxes,
Thin walled Styrofoam™ coolers, such hard-sided plastic and/or
as those purchased at grocery stores Styrofoam™
to hold beverages, are not acceptable Product must be kept in original
packaging, wrapped in bubble wrap (or
similar)

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INSULATED VAN
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Used for the transportation of the vaccine by


road in bulk quantity

Products should only be transported in cold boxes with


desired number of frozen/conditioned ice packs

The loading of the cold boxes should be done at the


coldest place available

Loading should be in minimum possible time

Close the rear door of the vaccine van immediately


after the loading

Start for destination immediately, same precaution


may be taken during unloading

Shift the vaccine in the cold chain equipments


immediately after reaching the destination point
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Cold Chain & Logistics for Vaccine:

• Truck + Refrigerator

• Temperature control/monitor
• Min-max Thermometer
• Temperatur Data Logger
• RFID Temperatur data logger
COLD CHAIN
SYSTEM
KEY POINT TO REMEMBER
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KEY POINT TO REMEMBER
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THANK YOU….
TERIMA KASIH