a new approach - tpma
TRANSCRIPT
A New Approach Predictive Packaging Optimization Solutions Through Science
Thai Pharmaceutical Manufacturers Association (TPMA)
Bangkok 28 October 2016 Guy Calcagno
Business Director, Pharmaceutical Films, Asia
Kevin J. Carter
Global Business Development Manager, Pharmaceutical Films Division
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Packaging Trends
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Key trends for Packaging in Asia
• Rising labour income and health projects will lead to higher drug use per
capita, most of them in climate zones 3 and 4
• Change in nutritional habits will accelerate the number of obese people
• Critical pollution levels lead to higher incidence of cancer /pulmonary diseases
• Lower priced, affordable drugs for a higher number of population. Major
playground for domestic/regional pharma companies
• Better informed patients (Internet), access and “care about health/quality of life” attitude
Increase of spending power
Increase in lifestyle
diseases
Continued Generics growth
Strong growth in OTC
• Transfer to and capacity increase in Asia Region to cope with the growth (e.g. AZ, BHC, E. Merck, MSD, Pfizer, Roche, Sanofi)
• The «Golden Egg» for the Healthcare Industry, globally. World population of
65+ increases by 200 million within 10 years
Western Pharma companies going East
Ageing population
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Ageing population is a fact
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Consumption of Pharma Blister Packs is increasing in all regions
Source: Allied Development Corp. 2014
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Consumption of Pharma Blister Packs by Geographic Region (billion units)
Source: Allied Development Corp. 2014
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Global Forming Web Consumption by Structure
Source: Allied Development Corp. 2014
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Installed Base of Blister Packaging Equipment (number of machines)
Source: Allied Development Corp. 2014
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Asia Consumption of Pharma Blister Packs by End-use (billion units)
Source: Allied Development Corp. 2014
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Predictive Packaging Optimization Solutions
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Predictive Packaging Optimization Solutions Throughout the Product Lifecycle
Objective is to maximize value and efficiency of customers’ packaging design & operations, with capability to expand to a global scope
Technical & Educational
Services
ASAP shelf life
modeling software and
ASAP laboratory-based
studies provide fast-
paced simulation of drug
stability to reduce
guesswork and risk of
failure
In-house CNC
machine and Uhlmann
blister line allow for
rapid creation of
sample tooling and
blister packages for
customers
Blister simulation
software uses finite
element analysis to
optimize barrier
properties
and form, as well as
tool design
Consulting/support in
initial material selection
for new drugs, off-
patent drugs by
generics producers,
cold-form to
thermoform switch-
outs, etc.
On site technical
support
Resin to Blister
educational program
to support
engineering, quality
and operations onsite
or at the kp i.center
Value engineering
analysis to maximize
efficiency of
packaging operations
Prototyping
Material Selection
Blister
Design
Fast-track Drug Stability
Modeling
ASAP : Accelerated Stability Assessment Program
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ASAP Accelerated Stability Modeling Software and Lab Testing
Material Selection
Fast-track Drug Stability
Modeling
Blister
Design Prototyping
Technical & Educational
Services
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ASAP Accelerated Stability Modeling Software and Lab Testing
INPUTS
• Product formulation, type, dose, size, packaging preferences, planned regions of release
OUTPUTS
• Stability profile of drug across multiple climate zones from highly accelerated conditions using FreeThink Technologies’ ASAP modeling software and lab services
• Recommended kp film types to confidently achieve shelf life requirements
• Customer can now proceed to blister design and sampling, knowing their product’s actual requirements
Material Selection
Fast-track Drug Stability
Modeling
Blister
Design Prototyping
Technical & Educational
Services
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Stability Assessment Platform
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Stability Assessment Platform
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• The leading technology for accurate determination of package design and material
combinations through scientific analytical processes for successful stability packaging under
ICH Stability Guidelines
• Drug product characterization
• Cavity and blister design
• Material identification
What
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Stability Assessment Platform
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• Speed to market
• The stability assessment process takes approximately 8 weeks
• Reduces actual stability requirements
• By identifying the correct packaging needs based on the product characteristics, less
materials will be used in actual stability packaging for accelerated and long-term
• Develop packaging strategies
• Eliminate stability failures and over-packaging
• Identifies materials required for all ICH climate zone conditions
Why
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Stability Assessment Platform
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• Stability assessment process
• Perform laboratory conditioning on dosage form and evaluate using existing stability
methods
• Laboratory conditioning and ASAP modeling to determine MVTR requirement
• Design and optimize thermoformed blister cavities for each dosage
• BlisterPro modeling to identify materials to align with ASAP MVTR
• Option to perform total cost and capacity modeling study for global packaging demand
• Work with OEM and site operations to determine packaging equipment limitations
How
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Stability Assessment Platform
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• Stability Assessment Platform can identify multiple packaging strategies
• Traditional strategy: One material all Zones with 2 year dating
• Product and package modeling for accelerated and all ICH zones for 2 years
• Lifecycle management 1: One material all Zones with 3 year dating
• Product and package modeling to for accelerated and all ICH zones for 3 years
• Lifecycle management 2: Zone specific packaging
• Identify specific materials for individual climate zones for 2 or 3 years
Results
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Multiple Design Analysis Capabilities and Applications
Packaging Design
MVTR Comparisons of Different Designs
Evaluation of New Pack Design
Design of New Packaging
Comparison of New & Existing Film Properties
Evaluation of Multi-capsule Designs
Evaluation of Multi-capsule Designs
• Comparison of design options for multi-capsule doses
• Optimization of blister geometry and card density
• Shelf life extension options without changing film type
CLOSE
Comparison of New & Existing Film Properties
• Thermoformability and MVTR comparisons
• Expert advice on switching production issues
• Determination of most economical solution to meet requirements
CLOSE
Design of New Packaging
• Optimize blister shape and barrier material
• 3D modeling of blisters and molds
• Ability to produce physical samples to test design suitability
CLOSE
Evaluation of New Pack Design
• Determination of thermoformability of existing designs
• Optimization steps to improve efficiency
• Check for under- or over-packaging
CLOSE
MVTR Comparisons of Different Designs
• BlisterPro® Fine Element Analysis (FEA) software accurately predicts MVTR for different film types
• Effects of blister geometry on permeability
• Influence of capsule density and film types on MVTR
CLOSE
Fast-track Drug Stability
Modeling
Blister
Design
Material Selection
Prototyping Technical & Educational
Services
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INPUTS
• Dosage, size, form of drug; stability/permeability from ASAP study; required geometry, packaging format, etc.
OUTPUTS
• Optimized design for blister cavity and card; CAD model of thermoforming tools
• Finite element analysis of blister cavity to precisely determine barrier level
• Simulations and expertise in thermoforming best practices allow optimal design to be recommended
Fast-track Drug Stability
Modeling
Blister
Design
Material Selection
Prototyping Technical & Educational
Services
Packaging Design
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Fast-track Drug Stability
Modeling
Blister
Design
Material Selection
Prototyping Technical & Educational
Services
Packaging Design
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Data Driven Material Selection for Product
Fast-track Drug Stability
Modeling
Blister
Design
Material Selection
Prototyping Technical & Educational
Services
Material Selection
• ASAP permeation threshold analysis considered for multiple climate zones
• Cost structure, operational and utilization metrics analyzed in total cost modeling
Zone IVb test conditions of 30°C/75%RH simulated at 2 and 3 years
Years Degradant
Threshold
MVTR
Material
recommendation
Cavity
MVTR
3 Total Imp 0.0113 PA400 0.0086
2 Total Imp 0.0300 PA200 0.0223
Zone II test conditions of 25°C/60%RH simulated at 3 years
Years Degradant
Threshold
MVTR
Material
recommendation
Cavity
MVTR
3 Total Imp >3.0 PH M570/01 or P250/40 0.1741
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Packaging Portfolio Analysis - Current packaging cost estimation
• Total cost of current packaging (single/double)
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Packaging Portfolio Analysis - Thermoformed packaging options
• 10ct single and double configurations
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Packaging Portfolio Analysis - Packaging Capacity Overview
• Thermoformed packaging capacity review
Production hours
Total Annual
Production Doses/hour
Capacity increase
(doses)
New annual
capacity
Current packaging 8,694 271,405,834 31,218 0 271,405,834
Thermoform (existing) 6,421 271,405,834 42,268 96,076,228 367,482,062
Thermoform (new line) 3,864 271,405,834 70,240 339,257,293 610,663,127
Thermoform w/12ct (new line) 3,658 271,405,834 74,195 373,646,741 645,052,575
Annual Capacity estimation
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Design & Productivity
Optimization
The Case Problem
• James is currently packaging a drug in
both a pouch and a desiccant, because
he knows it needs to be well protected
from humidity
• He wants to find a way to eliminate the
need for these to improve productivity,
cost and yield, without sacrificing shelf
life stability
The Approach
• It is agreed that an ASAP lab study
from FreeThink Technologies would be
a necessary first step to understand
the drug’s needs and moisture uptake
behavior
• The requirements predicted from the
ASAP study were then used in a
Blister simulation analysis to
determine the optimal film and blister
cavity design to deliver that level of
protection
Permeability Recommendation and Modeling Prediction
-0.5
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2.5
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Ch
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Ma
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(%
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Re
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Sample RH (%)
DVS Isotherm Plot
© Surface Measurement Systems Ltd UK 1996-2013DVS - The Sorption Solution
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1.5
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0 10 20 30 40 50 60 70
Ch
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Ma
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(%
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Sample RH (%)
DVS Isotherm Plot
Cycle 1 Sorp Cycle 1 Desorp
© Surface Measurement Systems Ltd UK 1996-2013DVS - The Sorption Solution
(0.013)
Conclusion
• James being able to remove the pouch and desiccant
from his production, resulting in a 44% increase in
productivity and a 23% decrease in materials used
• James realized he’s not in it alone – technology and
teamwork can eliminate many of the resource-
wasting trials inherent in packaging design
• Getting products to market quicker with greater
confidence in shelf life stability is a win-win, making
your first choice the right choice, every time
Thank you