SCA Cool Logistics - An Introduction to Control Temperature Packaging

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


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.


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


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.


Insulating Material: Polystyrene (EPS) Polyurethane (PUR) Polypropylene (EPP) Vacuum Insulation (VIP) Aerogel Natural Materials


Phase Change Material: Water Salt Paraffin Dry Ice Other Natural Materials

.


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


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


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


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


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


Customs Delay Design in extra duration

All Cold Stored Label / Un-label or design in the period


Lease entire vehicle space

Define vehicle type and monitor

Research weather data


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



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




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




Create the Protocol




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



Qualification Requirements / Protocol Requirements

Calibrate



Re-Probe

Calibrate



Re-Probe

Condition

Calibrate



Re-Probe

Condition

Run Test

Calibrate



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

Documents

SCA Cool Logistics - An Introduction to Control Temperature Packaging