Post on 05-Oct-2020
6/13/2017
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Thermal Analysis and Stability of Biomaterials
Louis Waguespack
Applications Laboratory Manager
TA Instruments – Waters LLC
lwaguespack@tainstruments.com
©2017 TA Instruments
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Agenda
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• 9 - 10:15am: Thermal analysis and stability of biomaterials
• 10:15-10:30am: Break
• 10:30-noon: Using rheology to characterize flow and
viscoelastic properties of hydrogels, adhesives and biopolymers
• 12-1pm: Lunch
• 1-2:15pm: Mechanical testing of medical devices
• 2:15-2:30 - break
• 2:30-3:15pm: Mechanical testing of engineered tissues and
biomaterials
• 3:15-4pm – Q&A with TA Instruments Applications Engineers
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What is a Biomaterial?
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• Any synthetic material used to replace or restore function to a body tissue
� Biomaterials are continuously in contact with body fluids
� Exposure to body fluids implies that the biomaterial is placed within the interior of the body
� This places restrictions on the types of biomaterials used
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Ideal Biomaterial Properties
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• Ideal material combination for biomaterials exhibits these qualities
� A biocompatible chemical composition to avoid negative tissue reactions
� Resistance to degradation
� Corrosion resistance for metals
� Resistance to biological degradation in polymers
� Acceptable strength to sustain cyclic loading by the joint
� A low modulus to minimize bone resorption
� High wear resistance to minimize wear-debris generation
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Types of Biomaterials
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• Metals
� Select metals are biocompatible and capable of long-term success as bodily implants
� Nontoxic elements are used as alloying
elements in biomedical alloys
� Principal metals used: Stainless Steels, Pure
titanium and titanium alloys, and Cobalt-base
alloys
- Ability to bear significant loads, withstand fatigue loading, and undergo plastic deformation prior to failure
� Orthopedic surgeries commonly involve metallic
implantation
� Metallic implants are used in maxillofacial surgery,
cardiovascular surgery and dental materials
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Types of Biomaterials
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• Polymers� Used for: facial prostheses, tracheal tubes, heart
components, kidney components, liver components, dentures, hip and knees joints
� Medical adhesives
� Coatings and sealants
Application Polymer Used
Knee, Hip, & Shoulder
Joints
Ultrahigh molecular weight
polyethylene (UHMWPE)
Finger Joints Silicone
Sutures Polylactic and Polyglycolic
acid, Nylon
Tracheal Tubes Silicone, Acrylic, Nylon
Heart Pacemaker Acetal, Polyethylene,
Polyurethane
Blood Vessels Polyester,
Polytetrafluoroethlene, PVC
Gastrointenstinal Segments Nylon, PVC, Silicones
Facial Prostheses Polydimethyl siloxane,
Polyurethane, PVC
Bone Cement Polymethyl methacrylate
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Biopolymers
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Polymer Typical Use
Polyethylene Tubing, Connectors and Bottles, Plastic Surgery Implants
Polypropylene Disposable Syringes, Connectors, Finger-joint Prostheses, Nonabsorbable Sutures
Polytetrafluoroethylene, Polydifluoromethylene
Vascular Graft Prostheses, Heart Patches, Retinal Detachment Treatment
Polystyrene Disposable Laboratory Items
Polymethyl methacrylate Bone Cement, Artificial and Implanted Teeth, Denture Materials and Fillings, Intraocular Lens
Polyvinyl chloride Disposable Medical Items, Blood Tubing Line, Cardiac Catheters, Artificial Limb Materials
Polydimethylsiloxanes (Silicone rubber)
Plastic Surgery Implants, Artificial heart and Heart-assist Pump Materials, Atrioventricular Shunts, Finger-joint Repair
Polyacrylonitrile Membrane for dialysis
Polyurethane Balloon for Intra-aortic Pump, Heart Valve Prostheses, Tubing
Polyvinyl alcohol Drug-delivery System
Polyamides (nylons) Nonabsorbable sutures, Tendon prosthesis, Drug-delivery System, Tracheal Tubes
Polyethylene terephthalate Tendon and Ligament Reconstruction, Tracheal Replacement, Surgical Mesh Fabric
Hydrogels Contact Lenses, Wound Dressings, Ophthalmic Implants, Drug-delivery System
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Types of Biomaterials
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• Ceramics
� Ideal as biological implants; bone bonds well to them and they exhibit inertness within the body, high stiffness, and low friction and wear
� Main drawback is
their brittle nature, low
impact resistance
� Used for restorative materials in dentistry
• Composites � Combination of low
density/weight and high strength make them ideal for prosthetic limbs
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Adhesives
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• Adhesive biomaterials typically fall into three categories
� Medical device assembly
� Manufacturing of life-support equipment, sterile disposable
items, sterile reusable items, and devices used for sensing,
monitoring, and reporting
� Hard tissue attachments
� Orthopedics and dentistry
� Soft tissue attachments
� Wound closure
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Hydrogels
• Hydrogels are flexible polymers used in a wide variety of applications including tissue engineering, drug delivery, contact lenses and superabsorbent materials.
• When a hydrogel is heated, the structure dissociates and the gel “melts” or collapses. Understanding and quantifying the chemistry of gelation on cooling and collapse on heating is important for consistent hydrogel formation.
• Hydrogels sense changes of pH, temperature, and concentrations of metabolite and these properties are used in their applications.
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TA Instruments – Thermal Analysis, Calorimetry, Rheology, Mechanical Testing
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• Heat of Reactions
• Phase Changes
• Transition Temperatures
• Reaction Kinetics
• Thermal, Oxidative Stability
Calorimetry
• Residual Solvent Content
• Sorption/Desorption Profiles
• Thermal, Oxidative Stability
• Decomposition Kinetics, Lifetime Plots
Thermogravimetric Analysis
• Dimensional Changes
• Coefficient of Thermal Expansion
• Softening Point
• Annealing Characteristics
Dilatometry/Thermo-Mechanical Analysis (TMA)
• Visco-Elastic Properties
• Structure-Property Relationship
• Process Conditions
• End Product Performance
Rheology/Rubber Testing Products
• Fatigue Life
• Failure Analysis
• Viscoelastic Properties
• Physiologic Simulation
Mechanical Testing
• Thermal Diffusivity
• Thermal Conductivity
• Specific Heat Capacity
• Thermal Resistivity
Thermal Conductivity
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What is Thermogravimetric Analysis (TGA)?
• Thermogravimetric Analysis (TGA)
measures weight/mass change
(loss or gain) and the rate of weight
change as a function of
temperature, time and atmosphere.
• Measurements are used primarily to
determine the composition of
materials and to predict their
thermal stability. The technique can
characterize materials that exhibit
weight loss or gain due to
sorption/desorption of volatiles,
decomposition, oxidation and
reduction.
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Thermogravimetric Analyzers
• A TGA must accurately:
� control heating rate (furnace)
� measure the change in temperature (thermocouple)
� measure the mass of a sample and the change in mass as it is
heated or held at an isothermal temperature (balance)
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TGA Applications
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• Thermal stability of materials
• Oxidative stability of materials
• Composition of multi-component systems
• Decomposition mechanism when coupled with evolve gas
analysis techniques (FTIR, MS)
• The effect of reactive or corrosive atmospheres
on materials
• Moisture and volatiles content of materials
• Estimated lifetime of a product
• Decomposition kinetics of materials
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Thermal Stability of Polymers
1: Gas 1 (N2)
2: Ramp 20ºC/min to 650ºC
3: Gas 2 (air)
4: Ramp 20ºC/min to 1000ºC
Gas Switch
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Thermal Decomposition and Degradation
• Solid polymeric materials undergo both physical andchemical changes when heat is applied. This usuallyresults in undesirable changes to the properties of thematerial.
• ASTM provides a distinction to the terms thermaldecomposition and thermal degradation:
�Thermal decomposition: the process of extensive chemicalspecies change caused by heat
�Thermal degradation: a process whereby the action of heator elevated temperature on a material, product or assemblycauses a loss of physical, mechanical or electricalproperties.
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Thermal Stability of Polymers
Upon degradation,
typical property
changes include:
• Reduced ductility
and embrittlement
• Chalking
• Color changes
• Cracking
• General reduction
in most other
desirable physical
properties
Thermal degradation generally involves changes to the molecular weight (and molecular weight distribution) of the polymer.
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Heat Flow (Normalized) (W/g)
DSC of PLA
Exo Up
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CONDITIONSDiscovery 5500 TGARamp 10 °C/min to 700 °CNitrogen Purge80 µL / 80 mg Sample
Triplicate TGA of 0.1 wt% AqueousPolyvinylpyrrolidone
-20
0
20
40
60
80
100
120
We
igh
t (%
)
0 100 200 300 400 500 600 700
Temperature (°C)
0.1% PVP.UA––––––– 0.1% PVP(1).UA– – – – 0.1% PVP(2).UA––––– ·
Universal V4.5A TA Instruments
TGA of Polyvinylpyrrolidone (PVP) - Residual Content (Aqueous Polymer Solution)
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CONDITIONSDiscovery 5500 TGARamp 10 °C/min to 700 °CNitrogen Purge80 µL / 80 mg Sample
100 Fold Magnification
-0.2
0.0
0.2
0.4
0.6
0.8
1.0
1.2
We
ight
(%)
0 100 200 300 400 500 600 700
Temperature (°C)
0.1% PVP.UA––––––– 0.1% PVP(1).UA– – – – 0.1% PVP(2).UA––––– ·
Universal V4.5A TA Instruments
100-Fold Magnification
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0.0910%(0.0715mg)
0.0901%(0.0716mg)
CONDITIONSDiscovery 5500 TGARamp 10 °C/min to 700 °CNitrogen Purge80 µL / 80 mg Sample
1,000 Fold Magnification
0.0934%(0.0748mg)
-0.02
0.00
0.02
0.04
0.06
0.08
0.10
0.12
We
ight
(%)
100 200 300 400 500 600 700 800
Temperature (°C)
0.1% PVP.UA––––––– 0.1% PVP(1).UA– – – – 0.1% PVP(2).UA––––– ·
Universal V4.5A TA Instruments
1,000-Fold Magnification
Accurate analysis in the microgram range
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Kinetics by TGA
����������: � = �� − �
�� − �
21
0
T
Co
nve
rsio
n, %
Initial weight:
win100
Weight at T:
wT
Final weight:
wf
We
igh
t, %
α�
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Polylactic Acid (PLA) Decomposition ASTM E1641 (Nitrogen Atmosphere)
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|Weight (%)|
TGA Analysis of PLA in Nitrogen
2, 4, 6, 8 and 10 °C/min
Determine the temperature at which there is1, 2, 5 and 10% weight loss due to decomposition.
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PLA Decomposition by ASTM E1641Lifetime Plot Using a 2% Conversion
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If processing is performed at 200°C (above the melting temperature, undera nitrogen blanket), PLA is predicted to lose 2% weight due todecomposition if held for 66 hours at that elevated temperature.
0.1
1.
10.
100.
1000.
10000.
1E5
1E6
1E7
Life
tim
e
(hr)
1.8 2.0 2.2 2.4 2.6 2.8
(1000/K)Exo up TAInstruments
E: 138.6 kJ/MoleLog Z: 10.03 1/min60 min half-life: 331.5°CConversion: 2.0 %
2.11 1000/K66.2 hr
100.150.200.250.Temperature (°C)
hour
day
week
month
year
decade
century
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Simple Heat Flux DSC Cell Schematic
Reference Sensor
An empty pan on the
reference sensor should
react similarly to the pan
on the sample sensor, thus
canceling out any pan
contribution
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Sample Sensor
Heat absorbed by the
sample gives an
endothermic response
Heat released by the
sample gives an
exothermic response
Sample
# = ∆%/'
∆# = #�()*+� − #��,����-�
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DSC Heat Flow
t)(T,dt
dT Cp
dt
dHf+=
Heat Capacity
Glass Transition
Specific Heat Capacity
Kinetic
Crystallization
Cure reactions
Volatilization
Decomposition
Denaturation
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Heat Flow (Normalized) (W/g)
Exo Up
Endothermic Heat Flow Heat Absorbed by Substance
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Endothermic Events
• Glass transition
• Melting
• Evaporation/
volatilization
• Enthalpic recovery
• Polymorphic
transitions
• Some
decompositions
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Exothermic Heat FlowHeat Released by Substance
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Exothermic Events
• Crystallization
• Cure reactions
• Polymorphic transitions
• Oxidation
• Decomposition
Heat Flow (Normalized) (W/g)
Exo Up
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Morphology of Polymers: Amorphous and Semi-Crystalline
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Heat Flow (Normalized) (W/g)
Exo Up
Solid, rigid amorphous
Rubbery, amorphous
Glass Transition
Crystallization
Solid, crystalline
Melting
Liquid, amorphous
A modest cooling rate of 10C/min quenches PLA into its' amorphous phase
DSC of Polylactic Acid (PLA)
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Determining the Glass Transition Temperature, Tg
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• ASTM Standards
� E3418 Standard test method for transition temperaturesand enthalpies of fusion and crystallization of polymers bydifferential scanning calorimetry
� E1356 Standard test method for assignment of the glasstransition temperatures by differential scanning calorimetry
• ISO Standard
� ISO11357-2 Determination of glass transitiontemperature and glass transition step height
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The Glass Transition (Tg)
• The glass transition is a change in the free volume and molecular
mobility in the amorphous phase of a material that results in a step
change in heat capacity.
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Below Tg
• Rigid, Glassy
• Immobile, no long range molecular movement
• Disordered Solid
Tg Transition
2nd Order Transition
Above Tg
• Rubbery Flow
• Increased Mobility
• Disordered Solid
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Reporting the Glass Transition Temperature
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Miscibility of Polymer Blends – Impact on Tg
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• Miscible polymer blends (homogeneous polymer blend): Polymer blend that is asingle-phase structure. In this case, one glass transition temperature will be observed(Fox equation).
* Newman et al. J Pharm Sci. 2008, 97, 4840-4856
Compound * Tg (°C) - Measured Tg (°C) – Fox Calculated
Trehalose 120
70% Trehalose/30% Dextran 140 140
30% Trehalose/70% Dextran 182 178
Dextran 225
1
%.
= /(
%., (
+ 2
%., 2
Fox Equation
• Tg,a : glass transition of component a• Tg,b : glass transition of component b• wa : weight fraction of component a• wb: weight fraction of component b
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What Affects the Glass Transition?
• Heating Rate
• Heating & Cooling
• Aging
• Molecular Weight
• Plasticizer (compatibility)
• Filler
• Crystalline Content
• Copolymers
• Side Chains
• Polymer Backbone
• Hydrogen Bonding
Anything that effects the mobility of the molecules,
affects the Heat Capacity and, in turn, the Glass Transition
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Study of melting/crystallization using a DSC
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• Melting is the process of converting solid, crystalline structure (lowerenergy) to a liquid amorphous structure (higher energy).
• Crystallization – The process of converting either solid amorphousstructure (cold crystallization on heating) or liquid amorphous structure(cooling) to a more organized solid crystalline structure
• Melting:� low energy state → high energy state; requires input of energy;
Endothermic peak
• Crystallization:� high energy state → low energy state; releases energy; Exothermic peak
• We integrate these peaks, on a time basis to determine the Heat ofFusion (melting) and Heat of crystallization
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Experimental Method
A Heat Cool Ramp Method
1) Ramp 10°C/min to -90°C or Equilibrate to -90°C*
2) Ramp 10°C/min to 200°C
3) Ramp 10°C/min to -90°C or Equilibrate to -90°C*
4) Ramp 10°C/min to 200°C
• Start test at least 30°C below the expected Tg
• End test at least 50°C above the expected Tg foramorphous solids; stay below the decompositiontemperature
• Increase heating rate and/or mass if Tg is barelydetectable; this increases sensitivity
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Basis of Multiple Heat Cool Heat Cycles
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• 1st heating scan: Called the initial run. It reveals informationabout the current condition of the specimen; i.e., the thermaland mechanical history as influenced by processing conditions,crystallinity and curing, service temperatures etc.
• Cooling scan: Subsequent controlled cooling rates create anew, known specimen history
• 2nd and 3rd heating scans: Used for determining thecharacteristic properties of the material. In the case of reactiveresins, a third heat cycle may be performed to validate thecompletion of the reaction.
* Reference: Thermal Analysis of Plastics: Theory and Practice by G.W. Ehrenstein, G. Riedel, P. Trawiel 2004
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Polylactic Acid (PLA): Crystallinity After a Controlled
Cooling Rate From the Melt
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Polylactic Acid (PLA): Crystallinity After an
Uncontrolled Cooling Rate From the Melt
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Dynamic Mechanical Analysis (DMA) of PLAGlass Transition and Cold Crystallization
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Sample: PLASingle Cantilever1Hz Frequency10um AmplitudeRamp 3.00 °C/min to 150.00 °C
0.5
1.0
1.5
Ta
n D
elta
0.1
1
10
100
1000
Loss M
odu
lus (
MP
a)
1
10
100
1000
10000S
tora
ge M
od
ulu
s (
MP
a)
40 60 80 100 120 140
Temperature (°C)
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An Overlay of the Storage Modulus and Heat Flow of Polylactic Acid
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-12
-10
-8
-6
-4
-2
0
2
Hea
t F
low
(m
W)
1
10
100
1000
10000
Sto
rage
Mo
dulu
s (
MP
a)
0 50 100 150 200
Temperature (°C)
PLA : DMA Temperature RampPLA: DSC Temperature Ramp
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Crosslinking reactions – Cure of elastomers, adhesives and epoxies
• A “thermoset” is a cross-linked polymer formed by an irreversible
exothermic chemical reaction.
• Crosslinking reactions are generally exothermic. As the chemical
reaction takes place, it is almost always accompanied by a release of
heat.
• The reactions can be easily monitored using a DSC
� Heat of reaction
� Residual cure
� Glass transition
� Heat capacity
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Cure Reaction of Liquid Silicone ElastomerRunning Integral Analysis
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Cure Reaction of an Implantable ElastomerKinetics Analysis
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-0.30
-0.25
-0.20
-0.15
-0.10
-0.05
-0.00
He
at
Flo
w (
W/g
)
80 100 120 140 160
Temperature (°C)Exo up TAInstruments
Reaction Order: 1.00Activation Energy: 395.0 kJ/molLog[pre-exp factor]: 53.22 log[1/min]Heat of Reaction: 12.4 J/gStandard Error: 0.0503 1/sec
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Cure Reaction of an Implantable ElastomerKinetics Analysis – Half Life Prediction
44
-2000
0
2000
4000
6000
8000
Ha
lf-L
ife
(m
in)
80 100 120 140 160
Temperature (°C)Exo up TAInstruments
Temp Temp 1/Temp Half-Life
°C K 1000/K min
95.00 368.15 2.72 450.0
101.00 374.15 2.67 56.8
107.00 380.15 2.63 7.65
113.00 386.15 2.59 1.10
119.00 392.15 2.55 0.167
125.00 398.15 2.51 0.0269
131.00 404.15 2.47 0.00458
137.00 410.15 2.44 0.000820
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Cure Reaction on a Rubber Process Analyzer (RPA)
• Measures material response to shear deformationor force as a function of time, temperature,frequency, or deformation
� Typically reports viscoelastic properties of storagemodulus (G’), loss modulus (G”), and tan delta
• Common Uses:
� Complete pre and post cure viscoelasticcharacterization
� Measure cure profile of materials during isothermal or anisothermal tests
� Effects of filler/vulcanization network
� Payne Effect
� Identifying differences in viscoelastic materialproperties
� Frequency dependence
� Strain dependence
� Stress relaxation
Stress, σ*
Phase angle, δ
Amplitudestrain, stress(Normalized)
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Cure Reaction of an Implantable Silicone Elastomer
Physical Property Measurement – Anisothermal
46
Str
ess
or
Str
ain
Time
Data Acquisition Interval
m = ramp
rate
Tem
pe
ratu
re
Applying customized temperature/heating profiles can
affect curing kinetics and final elastomer properties
cure initiation
cure completion
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Cure Reaction of an Implantable Silicone Elastomer
Physical Property Measurement – Isothermal
47
Time
Str
ess o
r str
ain T
em
pe
ratu
re
Storage (elastic) modulus can be monitored in real time by applying sinusoidal deformation.
Increase in G’ over time indicates curing reaction progressing.
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Thermal Analysis Review
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• Thermogravimetric Analysis
� Stability
� Volatile content
� Decomposition kinetics
• Differential Scanning Calorimetry
� Transition temperatures
� Crystallinity
� Heat of reactions
� Reaction kinetics
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Agenda
49
• 9 - 10:15am: Thermal analysis and stability of biomaterials
• 10:15-10:30am: Break
• 10:30-noon: Using rheology to characterize flow and
viscoelastic properties of hydrogels, adhesives and biopolymers
• 12-1pm: Lunch
• 1-2:15pm: Mechanical testing of medical devices
• 2:15-2:30 - break
• 2:30-3:15pm: Mechanical testing of engineered tissues and
biomaterials
• 3:15-4pm – Q&A with TA Instruments Applications Engineers
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Thank You
The World Leader in Thermal Analysis, Rheology, and Microcalorimetry
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