An Introduction to Control Temperature Packaging

Clive Wheeldon
President and CEO
Cool Logistics South Asia and MENA


April 2012

Overview
What is Control Temperature Packaging?

Who needs Control Temperature Packaging?

What does a solution look like?

Creating the brief

Developing the system

Post implementation



What is Temperature Control Packaging?

An ancillary system of packaging that combines materials
with specific thermal characteristics to ensure the thermal
integrity of the payload is maintained for a defined journey
time

These types of systems are most commonly qualified within a
laboratory environment

What is Temperature Control Packaging?

Temperature control packaging can be broken down into two
key components:

The insulator creates a barrier between the payload and the
external environment

The phase change materials that react to the internal
temperature and cause temperature change
Who needs Control Temperature Packaging?
Temperature controlled pharmaceutical
products are increasing faster than none
temperature controlled

Growing at a compounded 20% yearly

A Heavily regulated market


Who needs Control Temperature Packaging
The food industry has a growing demand
for control temperature packaging

The regulators are not as stringent when
compared to Pharma (this is changing)

The knowledge base still needs increasing



Who needs Control Temperature Packaging
Some specialist Automotive paint and
varnish products exist that require some
temperature control, but no regulation
exists for correctly maintaining these
products at temperature during
transportation.



Who needs Control Temperature Packaging
99% of SCA Cool Logistics solutions are
developed to maintain the temperature of
pharmaceutical products in transport.

This however can be through many
channels


Who needs Control Temperature Packaging - Clinical Trials
Development
Company site A
Clinical Trials
Company
+
Specialist
Transport
Company
Development
Company site B
Hospital/GP
Hospital/GP
Hospital/GP
Hospital/GP
Who needs Control Temperature Packaging - Commercialization
Manufacturer
Pharmaceutical
Wholesaler
Pharmacy
Pharmaceutical
Wholesaler
Pharmaceutical
Wholesaler
Pharmacy
Pharmacy
Pharmacy
Pharmacy
Pharmacy
Pharmacy
Pharmacy
Pharmacy
Who needs Control Temperature Packaging
What does a solution look like
Current Control Temperature Packaging can be broken
into two component parts; insulation and phase change
material.

These two parts work together to create a pre-specified
environment where a product can maintain integrity for a
pre-determined period of time.


What does a solution look like
Insulating Material:
Polystyrene (EPS)
Polyurethane (PUR)
Polypropylene (EPP)
Vacuum Insulation (VIP)
Aerogel
Natural Materials



What does a solution look like
Phase Change Material:
Water
Salt
Paraffin
Dry Ice
Other Natural Materials
.


What does a solution look like
This diagram illustrates how a solution using insulation and
phase change components could be configured.

The space designated for payload is often small in
comparison to the overall size. This issue along with the
issues of suitable materials is where the drive for innovation
begins


Creating the Brief


The Journey
The Product
+

Developing the Correct Solution
Developing the Correct Solution
Understanding the Product
Product Criteria Response Example
Storage
temperature
+2C to +8C
Excursion ability >+8C for no longer than
12hours
Product type Liquid
Primary package Vial
Single volume 1.0ml
Payload quantity 50x bundles of 10
Product orientation Upright only
Developing the Correct Solution
Understanding the Shipment
Shipment Criteria Response Example
Shipping duration 96 hours
Shipping
frequency
All year round
Origination Dublin Ireland
Destination ROW
Cross hemisphere Yes
Developing the Correct Solution
Other Considerations
Other Criteria Response Example
Mixed payloads Minimum 1x Bundle, Max 50x
Size limitations 1.5metres high inc. pallet
Recycle-ability Must be easily recyclable
components
Re-usability Single use, no return network
Configuration
options
Seasonal solutions
Handling Must have pallet feet
Developing the Correct Solution (Summer)
Ch:1
Ambient 1
Ch:2
Ambient 2
Ch:3
BottomL
Ch:4
BottomC
Ch:5
BottomR
Ch:6
Centre
Ch:7
Top L
Ch:8
Top C
Ch:9
Top R
T1488-20 (488-20c)
00:00:00 2 days 00:00:00 4 days 00:00:00
30
15
0
30
15
0
(Real Time - Quick plot) Minor interval = 12:00:00
U
L
Ch:1
Ambient 1
Ch:2
Ambient 2
Ch:4
BottomL
Ch:5
BottomR
Ch:6
Top L
Ch:7
Top R
T1488-12 (488-12c)
00:00:00 2 days 00:00:00 4 days 00:00:00
30
15
0
30
15
0
(Elapsed Time - Quick plot) Minor interval = 12:00:00
U
L
Developing the Correct Solution (Winter)
Ch:1
'C
Ch:2
'C
Ch:3
BottomL
Ch:4
BottomC
Ch:6
Centre
Ch:7
Top L
Ch:8
Top C
Ch:9
Top R
T1488-21 (488-21e)
00:00:00 2 days 00:00:00 4 days 00:00:00
21
9
-3
21
9
-3
(Elapsed Time - Quick plot) Minor interval = 12:00:00
U
L
Ch:1
Ambient 1
Ch:2
Ambient 2
Ch:8
BottomL
Ch:9
BottomC
Ch:10
BottomR
Ch:11
Centre
Ch:12
Top L
Ch:13
Top C
Ch:14
Top R
T1488-13 (528-2d)
00:00:00 2 days 00:00:00 4 days 00:00:00
21
9
-3
21
9
-3
(Elapsed Time - Quick plot) Minor interval = 12:00:00
U
L
Product requirements
Product Presentation Volume Of Product Primary Packaging Type
Dimensions Per Pack
Other Product Sensitivities
Product Temperature
Thresholds
Orientation Restrictions
Will Products Be Bundled Can Bundles Be Split
Bundle Dimensions Product Quantity per shipper
Usable Threshold Excursion
Periods
Journey Requirements
Load Size
Primary Location Destination
Road Transportation
Rail Transportation Sea Transportation Air Transportation
Flight Changes
Customs issues
Season at Prime Loc
Season at Destination
Total Duration Shipping
Frequency
Journey Requirements (Risks)


Machine Failure
Warehouse
Storage +5C (3C) Controlled N/A
Pack off 3 hour
Risks
Door Left Open
Preventative maintenance & servicing
Operator training / Alarm systems
Heating System
Risks
Hot & Cold Spots
Seasonally aware / Quality controlled
Warehouse temperature mapping
Speed vs. Quality Operator training and documentation
Return to Store Operator training and documentation
Controllable
Journey Requirements (Risks)


Uncontrollable
Loading Time
Airport
Pickup Road Vehicle Set Standard 3hour
Un/Load 3hour
Risks
Multi Pickup
Increase pickups to reduce quantities
Lease entire vehicle space
All Cold Stored
Risks
Miss-handled
Create very specific labelling or remove
Label packaging i.e. orientation
Outside Exposure Research weather data
Inspected Supply repack documentation
Vehicle Type Define vehicle type and monitor
Journey Requirements (Risks)


Uncontrollable
Heating Off
Airport
Flight Aeroplane Uncontrollable 4hour
Unload 12hour
Risks
Cold & Hot Spots
Data Monitor / Design in resistance
Data Monitor / Design in resistance
Outside Exposure
Risks
Miss-handled
Research weather data
Label packaging i.e. orientation
Customs Delay Design in extra duration
All Cold Stored Label / Un-label or design in the period
Journey Requirements (Risks)


Lease entire vehicle space
Define vehicle type and monitor
Research weather data
Label packaging i.e. orientation
Left Unattended
All Cold Stored
Miss-handled
Uncontrollable
Loading Time
Warehouse
Collection Road Vehicle Set Standard 6hour
Destination 1hour +
Risks
Multi Drops
Increase pickups to reduce quantities
Outside Exposure
Risks
Ensure clear labelling
Labelling & remind on receipt with a call
Vehicle Type
The Ambient Profile (weather data)
www.weatherbase.com

www.bbc.co.uk/weather

www.eurometeo.com

www.worldclimate.com


The Ambient Profile (weather data)


The Ambient Profile (live trials)
Results of a 3 year global
Study sending portable
monitors


The Ambient Profile (live trials)
Temptale
Hobo
iButton
Sgt Temp
Libero
Smart Button
Temp Tag
Q Tag


Develop the solution
Probe
the
Products
Monitor for
the Entire
Required
Duration
Simulate
Specified
Temperature
Conditions
Configure the
Packaging
Create the Protocol


Form the Team
And
Define Responsibilities
Defined Product
Requirement
Defined Journey
Requirement
Create the Protocol
Defined Product
Requirement
Defined Journey
Requirement
Define Development Procedure
Title
Defines the
document
Contents
Defines all pages
& page numbers
Summary Brief summary
Scope
Defines the limits
of the scope
Assumptions
Excludes other non
thermal testing etc.
Create the Protocol
Definitions
Defines terminology
used
To avoid ambiguity
Material &
Equipment.
Defines equipment
to be used
Inc placebo product
and sundries.
Responsibilities
Who is responsible
for what.
Key player?
Testing Procedure
Precise definition of
testing procedure
ISO9000-2000 or
other process doc
Defined Product
Requirement
Defined Journey
Requirement
Define Development Procedure
Create the Protocol
Ambient Profile
Defines ambient
profile/s
Reference source of
ambient profile
Product Storage
Temperature
Defines storage
temp prior to testing
Format of Results
Defines agreed
format of results
Acceptance Criteria Defines pass criteria
Define permissible
errors
Defined Product
Requirement
Defined Journey
Requirement
Define Development Procedure
Create the Protocol
Defined Product
Requirement
Defined Journey
Requirement
Define Development Procedure
Traceability to
National Standard.
Traceability
certificates
Equipment Register
List of equipment
to be used
Calibration
certificates
Deviations
Define how
deviation is reported
Who is
responsible?
SIGNATURES
Signed by those
defined responsible
Sign hard copies.
Wet or electronic
Do Regulations and Guidelines Affect Design?

Each of the below examples would have an effect
on the final design

Instructional labelling considerations
Inclusion of data monitoring devices
Pre-defined test methodology
Pre-defined material options
Pre-defined ambient profiles
Worst Case development plans
System Qualification

The actual product is probed using T-Type
thermocouples that attach directly to the surface
of the primary packaging or can be invasively
located

Several probes are used to map the entire payload
System Qualification

The number of probes used will vary
dependant on the size of the payload / the
number of products within the payload space
Develop the solution


Develop the solution


Qualification Requirements / Protocol Requirements
Calibrate
Develop the solution


Qualification Requirements / Protocol Requirements
Re-Probe
Calibrate
Develop the solution


Qualification Requirements / Protocol Requirements
Re-Probe
Condition
Calibrate
Develop the solution


Qualification Requirements / Protocol Requirements
Re-Probe
Condition
Run Test
Calibrate
Develop the solution
Qualification Requirements / Protocol Requirements
Re-Probe
Condition
Run Test
Report
Calibrate
Post implementation support services
Full Qualification Reports
Performance Summaries
Large Assembly Posters
Custom Print Parts
Personalised Web Space
Customized Animations
Onsite System Training


Thank you for listening
Do you have any questions?

If you would like to learn more about
Cool Logistics please visit

www.cool-logistics.com