An Introduction to Control Temperature Packaging
Clive WheeldonPresident and CEOCool 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 nonetemperature 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
DevelopmentCompany site A
Clinical TrialsCompany
+ SpecialistTransportCompany
DevelopmentCompany site B
Hospital/GP
Hospital/GP
Hospital/GP
Hospital/GP
Who needs Control Temperature Packaging - Commercialization
Manufacturer PharmaceuticalWholesaler
Pharmacy
PharmaceuticalWholesaler
PharmaceuticalWholesaler
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 JourneyThe Product
+
Developing the Correct Solution
Developing the Correct SolutionUnderstanding the Product
Product Criteria Response Example
Storage temperature
+2°C to +8°C
Excursion ability >+8°C 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 SolutionUnderstanding 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 SolutionOther 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:1Ambient 1
Ch:2Ambient 2
Ch:3Bottom L
Ch:4Bottom C
Ch:5Bottom R
Ch:6Centre
Ch:7Top L
Ch:8Top C
Ch:9Top 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:1Ambient 1
Ch:2Ambient 2
Ch:4Bottom L
Ch:5Bottom R
Ch:6Top L
Ch:7Top 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:3Bottom L
Ch:4Bottom C
Ch:6Centre
Ch:7Top L
Ch:8Top C
Ch:9Top 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:1Ambient 1
Ch:2Ambient 2
Ch:8Bottom L
Ch:9Bottom C
Ch:10Bottom R
Ch:11Centre
Ch:12Top L
Ch:13Top C
Ch:14Top 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 BundledCan Bundles Be Split
Bundle Dimensions Product Quantity per shipper
Usable Threshold Excursion Periods
Journey Requirements
Load Size
Primary Location Destination Road Transportation
Rail TransportationSea TransportationAir Transportation
Flight Changes Customs issues Season at Prime Loc
Season at DestinationTotal Duration Shipping Frequency
Journey Requirements (Risks)
Machine Failure
Warehouse
Storage +5°C (±3°C) Controlled N/A
Pack off 3 hour
RisksDoor Left Open
Preventative maintenance & servicing
Operator training / Alarm systems
Heating System
RisksHot & 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
RisksMiss-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
RisksCold & Hot Spots
Data Monitor / Design in resistance
Data Monitor / Design in resistance
Outside Exposure
RisksMiss-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
RisksEnsure 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 globalStudy sending portablemonitors
The Ambient Profile (live trials)
TemptaleHoboiButtonSgt TempLiberoSmart ButtonTemp TagQ 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 TeamAnd
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 equipmentto be used
Inc placebo productand sundries.
Responsibilities Who is responsible for what. Key player?
Testing Procedure Precise definition of testing procedure
ISO9000-2000 orother 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 StorageTemperature
Defines storagetemp 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
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