material selection in flexible packaging - aimcal...– packaging for terminally sterilized medical...
TRANSCRIPT
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Material Selectionin Flexible PackagingDR. HENK P. BLOM
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Science Driven Vertically-Integrated Flexible Packaging
Manufacturer
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Primary requirementsISO 11607 – Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems◦ The goal of a terminally sterilized medical device packaging system is to
allow sterilization, provide physical protection, maintain sterility up to the point of use and allow aseptic presentation. The specific nature of the medical device, the intended sterilization methods(s), the intended use, expiry date, transport and storage all influence the packaging system design and choice of materials.
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The heat-stable layer
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Main RequirementsProvides thermal and dimensional stability
Enables the film to be heat-sealed without sticking or stretching
Can provide scuff or abrasion resistance
Provides film stiffness / toughness
Printing substrate (reverse or surface)
oPAoPET
oPP Cast PA
HDPETyvek
+ Paper
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Oriented Polyester (oPET)• Outstanding dimensional / thermal
stability
• Excellent tensile strength
• Outstanding abrasion resistance
• Poor stress-flex resistance
• Prone to dart tearing
Oriented Nylon (oPA)• Outstanding cut resistance• Excellent puncture resistance• Good stress-flex and pinhole resistance• May cross-link and embrittle when
irradiated (high doses of γ or e-beam)
Cast Nylon• Outstanding durability• Outstanding stress-flex / pinhole
resistance• Outstanding blunt puncture resistance• Difficult to cut• May cross-link and embrittle when
irradiated (high doses of γ or e-beam)
Oriented Polypropylene• Good dimensional and thermal stability
(less than oPET and nylons)• Not suitable for gamma or e-beam
irradiation (severe degradation and embrittlement)
• Excessive shrinkage in retort applications (compared to oPET)
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Tyvek®• Breathable, uncoated or with appropriate
coatings• Outstanding strength• Outstanding durability• Outstanding tear resistance• Fair thermal stability• Fair dimensional stability
Paper• Breathable, uncoated or with
appropriate coatings• Thermally stable• Add bulk• Excellent printing surface• Particulate can be a concern
HDPE• Fill this one in…
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The barrier layer
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Main requirementsProvide barrier (either in or out) to:◦ Oxygen◦ Water Vapor◦ Aroma◦ Chemical◦ UV◦ Microbial◦ Others
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A barrier taxonomyBarrier films◦ Barrier proportional to film thickness
Barrier coatings◦ Barrier proportional to coating thickness
Combination of films/coatings
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The Historical SolutionAluminum Foil◦ Virtually impervious to moisture and gas (> 1 mil / 25 µm thickness)◦ Well understood with long history◦ Opaque◦ Limited formability Foil Gauge
(in / µm)Typical Count
(per ft2)Typical Maximum
Count (per ft2)
0.00025 / 6.4 41 320
0.00030 / 7.6 20 60
0.00035 / 9.0 12 40
0.00050 / 13 6 20
0.00070 / 18 1 10
0.0010 / 25 0 0
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Seal ingressWhen the film barrier is that good, ingress through the seals can impact the overall package barrier performance
LDPE
FoilPET
PETFoil
LDPE
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EVOHExcellent Oxygen Barrier◦ 0.006 - 0.12 cc·mil/100 in2·day
Excellent odor/aroma barrier
Thermoformable
LLDPE
EVOH
LLDPETie layer
Tie layer
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COCGood moisture barrier ◦ 0.2 g·mil/100 in2·day
Enhances stiffness
Excellent clarity
Thermoformable
Heat resistant grades available
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PCTFEExcellent moisture barrier◦ Aclar 22A: 0.038 g·mil/100 in2·day ◦ Aclar UltRx, SupRx: 0.016 g·mil/100 in2·day◦ Aclar Flex: 0.010 g·mil/100 in2·day
Inert
Excellent clarity
Thermoformable
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NanocompositesPolymer structures containing fillers (e.g. clays)◦ Generally blended into nylons and polyolefins◦ Can also be blended into coatings
Filler separates into tiny high aspect ratio plateletsImproved mechanical propertiesIncreased oxygen and gas barrier
Essentially increases the “apparent thickness” of the film
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MetallizationAluminum metallization◦ Good oxygen and moisture barrier
Material O2TR(cc/100 in2·day)
WVTR(g/100 in2·day)
Metallized PET (standard) 0.1 0.05
Metallized PET (high optical density) 0.04 0.03
Metallized PET (high barrier) <0.02 <0.02
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PVdCGood oxygen and moisture barrier
Good aroma/flavor barrier
Widely used and well understood
Contains chlorine◦ Specialized equipment to apply◦ Extra diligence required during
incineration
Material O2TR(cc/100 in2·day)
WVTR(g/100 in2·day)
PVdC-coated PET 0.5 0.5
PVdC-coated OPP 1.3 0.3
PVdC-coated Nylon 6 0.5 0.65
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PVOHPolyvinyl alcohol
Excellent oxygen barrier◦ PVOH-coated PET
◦ 0.2 cc/100 in2·day
◦ PVOH-acrylic-coated OPP◦ 0.02 cc/100 in2·day
Barrier dependent upon coating thickness
Moisture sensitive
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ClearFoil® - SiOx and Al2O3barrier coatings
* Suitability for retort and gamma sterilization is dependent on sealant chemistryOxygen barrier was tested at 0% relative humidity and 73°F. Moisture vapor was tested at 100% humidity and 100°F. Barrier numbers represent typical values and are not limiting specifications.ClearFoil is a registered trademark of Rollprint Packaging Products, Inc.
14 05/17
Product Name
Barrier Coating
Sterilization Method* BarrierRelative
Cost($-$$$)
Retort/Autoclave
Hot-fill/Low Temp. Pasteurizat
ion
Gamma EtOMV Barrier(g/100in2/
24 hrs)
O2 Barrier(cc/100in2/
24 hrs)
MV Barrier(g/m2/24
hrs)
O2 Barrier(cc/m2/24
hrs)
ClearFoil® Z Al2O3 • • 0.0008 0.0008 0.012 0.012 $$$
ClearFoil® X Al2O3 • • 0.003 0.004 0.047 0.06 $$
ClearFoil® M Al2O3 • • • 0.02 0.02 0.31 0.31 $$
ClearFoil® V Al2O3 • • 0.02 0.05 0.31 0.78 $
ClearFoil® V2 Al2O3 • • • • 0.05 0.002 0.85 0.037 $$
ClearFoil® A SiOx • • • • 0.04 0.04 0.62 0.62 $$$
ClearFoil® E Al2O3 • • 0.06 0.02 1.0 0.3 $
ClearFoil® D Al2O3 • • 0.06 0.06 0.93 0.93 $
ClearFoil® H Al2O3 • • 0.13 0.13 2.0 2.0 $
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ClearFoil® - SiOx and Al2O3barrier coatings
0.001250.003
0.0525
0.0111
0
0.01
0.02
0.03
0.04
0.05
0.06
0.07
1 & 2 mil Foil ClearFoil® X
g/10
0in2
•day
0 cycles 20 cycles
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The sealant layer
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Sealants overviewWeld (or lock-up) seals – seals like materials together◦ Films
Peelable seals – controlled material incompatibilities◦ Adhesive peel◦ Cohesive peel◦ Films◦ Heat seal coatings
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PolyethylenePolyethylenes:
PE type Density (g/cm3)
Very Low Density Polyethylene (VLDPE) 0.890 - 0.915
Low Density Polyethylene (LDPE) 0.915 - 0.925
Medium Density Polyethylene (MDPE) 0.926 - 0.940
High Density Polyethylene (HDPE) 0.941 - up
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PolyethyleneLinear (e.g. LLDPE, LMDPE)◦ Higher melt points (15 - 25oF higher)◦ Better chemical resistance◦ Better durability
◦ Impact strength◦ Puncture resistance
◦ Stronger seals (to itself)
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PolyethyleneMetallocenes (e.g. mLLDPE, mPE)◦ Single-site metallocene catalyst yields lower molecular weight distribution
than traditional multi-site catalyst◦ Low extractables◦ Lower seal initiation temperature◦ Better hot tack◦ Superior tensile strength◦ Higher elongation◦ Better durability
◦ Puncture◦ Impact
A
A
A
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Polyethylene CopolymersEthylene vinyl acetate (EVA)◦ Most range from 2% - 24% vinyl acetate◦ As VA content increases:
◦ Sealing and softening temperature decrease◦ Impact strength increases◦ Flexibility increases◦ Stress-flex properties increase
◦ Less crystalline than equivalent LDPE◦ Less chemical resistance than LDPE
Ethylene-Methyl Acrylate (EMA)
Ethylene-Ethyl Acrylate (EEA)
Ethylene Acrylic Acid (EAA)
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PolypropyleneHomopolymer grades◦ High melt point (Approx. 330oF)◦ Excellent temperature resistance◦ Used for autoclave sterilization◦ Good chemical resistance◦ More stiff and brittle than PE◦ Less crystalline than PE
Random copolymer grades◦ Contain 1 - 5% ethylene molecules
randomly inserted into the polymer backbone
◦ Lower melting point◦ More flexible◦ Better impact resistance◦ Easier to heat seal than
homopolymer PP◦ Better performance at cold
temperatures
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Ionomers (Surlyn)Derived from ethylene-methacrylicacid copolymers◦ Zinc cation
◦ Best for product high in alcohol or water content
◦ Provide adhesion to foil
◦ Sodium cation◦ Better hot tack◦ Better resistance to oil and grease
Low sealing temperature
High seal strength
Good hot tack
Ability to seal through contaminants
Good oil and grease resistance
Good impact strength
Good puncture resistance
Excellent formability
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Amorphous Polyester (APET)Excellent chemical resistance
Chemically “clean”
High temperature resistance◦ Dry heat sterilization
Seals to polar materials
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Peelable seals - backgroundAdhesive Peel◦ Poor Seal Indicator◦ Sensitive to Operating Variation
Outer film surface
Sealant
SealedSealed
andpeeled
UnsealedUnsealed
Substrate
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Peelable seals - backgroundCohesive Peel◦ Seal Indicator◦ Wider Operating Window◦ Stringing
SealedSealed
andpeeled
UnsealedUnsealed
Outer film surface
Sealant
Substrate
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Peelable seals - backgroundDelamination (Interlaminar)◦ Webbing/Stringing◦ Variable Seal Strength
SealedSealed
andpeeled
UnsealedUnsealed
Substrate
Outer film surface
Sealant
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Heat Seal CoatingsVinyl acetate (VA)
Ethylene inter-polymers
Polypropylene (PP)
Polyester (APET)
Ionomer (Surlyn)
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PolybutyleneCohesive peel
Control seal strength with chemistry
Can be films or extrusion coatings
Polybutylene Concentration100 0
Seal
Str
engt
h
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0
200
400
600
800
1000
1200
1400
1600
1800
2000
0.75 1.25 2.00
Seal
stre
ngth
(g/i
n)
Polybutylene sealant thickness (mil)
Variation of seal strength with polybutylene sealant thickness
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PolybutyleneSeal initiation temperature of non-aged film lower than aged film
Aged seal strength lower than non-aged seal strength
0
500
1000
1500
2000
2500
0 2 4 6 8
Seal
stre
ngth
(g/in
)
Aging time (days)
Effect of aging on polybutylene seal strength
Film aged before sealing
Effect of seal aging
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Alternate peelable chemistriesSeal strength largely independent of temperature, pressure, and dwell
WYSIWYG (What You See Is What You Get)
Bright white seal indicator without stringing
Seal strength controlled by chemistry
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0
500
1000
1500
2000
250 275 300 325 350 375
Seal
stre
ngth
(g/in
)
Temperature (oF)
PB BlendAllegro B 1 sec 80 psiAllegro B 1 sec 60 psiAllegro B 1.5 sec 60 psi
Much flatter seal strength profile as a function of temperature, compared to polybutylene-based peelable sealants
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0
500
1000
1500
2000
250 275 300 325 350 375
Seal
stre
ngth
(g/in
)
Temperature (oF)
Allegro® C
Allegro® B
Allegro® T
Sealed to LDPE
Seal strength can be tailored by adjusting the sealant chemistry
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Making the Best ChoiceProduct to be packaged
Type of sterile barrier system
Packaging equipment
Sterilization method
Width “sweet spot”
Volume
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