advanced materials a review of what is applicable in sut
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Advanced MaterialsA Review of What is Applicable in SUT
Amy Plancon, Jayanthi Grebin, and James Hicks
Panel Organizer: Eva Heintz, Ph.D.
LDPE & PP
• Offer a range of properties, and may be suitable for a wide range of applications
• Versatile materials
• Depends on polymer type and additives
• Some materials such as LDPE can be made “additive-free,” depending on polymerization process
• Can meet pharmacopoeia standards (EP, USP, DMF)
POLYCARBONATE
• High impact strength
• Inherent ‘water-clear’ transparency
• High heat resistance
• Unlimited colors – transparent, translucent, opaque
• FDA & Biocompatibility
• Very good processability and design versatility
• Multiple sterilization options
CHEMICAL PROPERTIES: TYPES OF ADDITIVES
Additives are used to improve processing of polymers and to
enhance their properties
Modifiers
• Impact modifiers
• Nucleating agents/clarifiers
• Organic peroxides
• Plasticizers
Property Extenders
• Antioxidants
• Antistatic agents
• Heat stabilizers
• Light stabilizers
Processing Aids
• Anti-blocking agents
• Lubricants/mold release
• Slip agents
• Improves film toughness
• Inhibits gels
• Increases gamma
stability
• Facilitates bag opening
• Minimizes blocking
SUMMARY
Input
• LDPE
• HDPE
• PP
• PC
• Additives
Process
• Injection molding
• Extrusion
• Film (blown, cast)
• Printing
• Filling
• Sterilization
Output (SUT)
• Mechanical
• Modulus
• Impact
• Rupture
• Chemical
• Extractables & leachables
Sin
gle
Use T
ech
no
log
y
Influencing Single Use Technology
Fluoropolymer Applications
•Consumer Electronics
•Food Processing
•Industrial Coatings
•Semiconductor Manufacturing
Source: ASME-BPE 2016
Polytetrafluoroethylene or PTFE (1938)
•PTFE, later trademarked as Teflon®, was discovered by Dr. Roy Plunkett in 1938.
•The fluorine atoms prefer their own kind, drawing to each other while repelling other kinds of molecules.
•C-C and C-F bonds are among the strongest in single bond organic chemistry, accounting for many of its unique properties.
Source: https://www.chemours.com/Teflon/en_US/products/history.html
Teflon® is a trademark of The Chemours Company.
F
C
F
F
C
Fn
Carbon
Fluorine
Fluorine
Fluoropolymers
• Nonstick
• Low coefficient of friction
• Wide Temperature resistance
• Unique electrical properties
• Cryogenic stability
• Universal chemical resistance
Chemical Resistance
Fluoropolymers’ unmatched chemical resistance is suitable for just about any pharmaceutical or bioprocessing application
•Strong mineral acids
•Inorganic bases
•Salt solutions
•Organic acids
•Alcohols
•Esters
•Aldehydes
Source: Compass Publications Chemical Resistance Guide for Plastics, ©2000
260
120
80
70
45
-240
-60
-60
-70
-18
-300 -200 -100 0 100 200 300
Fluoropolymer
PVDF
EVA
HDPE
PP
Temperature Use Range (°C)
Polymer Compounds
•Polymer additives• Antioxidants• Photostabilizers• Plasticizers• Lubricants• Acid scavengers• Pigments/colorants• Cross linking agents
•Adhesives (i.e. tie layer)
•Catalysts
Potential sources of E&L in many polyolefins
Polyester (PET) Layer
Tie Layer
EVOH Layer
Tie Layer
ULDPE Contact Layer
Polymer Compounds
•Polymer additives• Antioxidants• Photostabilizers• Plasticizers• Lubricants• Acid scavengers• Pigments/colorants• Cross linking agents
•Adhesives
•Catalysts
Potential sources of E&L in fluoropolymers
Fluoropolymer Contact Layer
Summary
Compatibility
◦ Outperforms other polymers as very few chemicals have an effect on fluoropolymers
Strength
◦ Maintains mechanical properties across a wide range of process temperatures
Extractables
◦ No additives to base resin result in extremely low extractable profile
James Hicks
Solvay Specialty Polymers
July 14, 2017
Thermoplastics: High Performance Aromatic Based Polymers and
High Barrier PVDC
• Commodity Polymers
• PE, PP, PVC, PS
• >75% of manufactured polymers are in this category.
• Engineered Polymers
• PC, ABS, PA, PEX, PET
• High structural properties and/or other unique properties not available with commodity polymers.
• High Performance Polymers
• PSU, PES, PPSU, PARA, PPA
• Engineered polymers taken to the next level.
• Ultra Polymers
• PEEK, PAI
• Specially design polymers capable of meeting multiple demanding criteria.
A Review of the Categories of Thermoplastics
Sulfone polymer base
PEEK polymer base
PVC polymer base
Nylon (PA) polymer base
Conversion to High Performance Plastics
METALS
COMMODINITY AND
ENGINEERING
PLASTICS
• Increase Chemical
Resistance – Acidic or
Alkaline conditions
• Lower Costs to
manufacture
• Weight Reduction
• Consolidation of parts
• Increase Chemical
Resistance
• Increase Mechanical
Performance
• Increased Thermal
Performance
ULTRA AND HIGH
PERFORMANCE
PLASTICS
Drivers for Thermoplastics to Metal Conversions
• Weight / Ergonomics
• Colorability / Transparency
• Design flexibility
• Part consolidation
• Lower cost manufacturing
Sterilization Methods
Not all Plastics can Withstand a wide range of Sterilization Methods
Steam (up to 134°C for 18 minutes)
Ethylene Oxide
Hydrogen Peroxide
Gamma Radiation
10 cycles
500 cycles
1,000 cycles
100 cycles
200 cycles
40-50 kGy
PC - Polycarbonate ✓ ✓ ✓ ✓
PARA – Aromatic Nylon ✓ ✓ ✓
PSU - Polysulfone ✓ ✓ ✓ ✓ ✓
PPSU - Polyphenylsulfone ✓ ✓ ✓ ✓ ✓ ✓
PEEK - Polyetheretherketone ✓ ✓ ✓ ✓ ✓ ✓
Sulfone and PEEK based polymers - Compliance Profile
• EU Regulation No 10/2011 on plastic materials and articles intended to come into contact to foodstuffs(2)
• U.S.: approvals for Food and Drug Administration (FDA) 21 CFR Part 176.170(1)
• USP VI Compliance
• ISO 10993 Complaince(2)
• NSF Std 51 and 61
• Low extractables and leachables
1) Information on current listings for specific grades is available from your Solvay representative
2) Sectional complaince varies with product and grades
Most base grades have:
Polyvinylidene Chloride - PVDC: Strong Properties by Chemistry
Flame Resistance: High LOI
Copolymer: Tailor-made
Functionality:
Steric hindrance:
Crystallinity:H2O Vapor Barrier
O2 BarrierHF Sealability
Polarity:
Low melt T:
Low Tg: ThermoformingShrink
Flexibility
( ) X( )
VDC-Monomer
H
C
H
Cl
C
Cl
H
C
H
Cl
C
Cl
XComonomer(s)
Polymerization
Source: Statoil
Source: brasilien.de
Printability Adhesion
Heat Sealability
Salt
Optional: Ethylene via
Biomass
Oil
Oxygen and Water Vapor Comparison
PVDC provides both outstanding water vapor and oxygen barrier
Water Vapor38 ºC / 90% rel. humidity
g · µm / (m²·d)1)
Oxygen Dry: 25 ºC/ 0% rel. humidity
LDPE
HDPE
OPP
R-PVC
PA 6-6
PETP
PAN
EVOH (EVAL)
Cellophane
PVOH (PVAL)
ca. 200000
ca. 60000
ca. 50000
2500 - 3000
1500 - 2500
ca. 1500
100 - 300
5 -80
300 - 500
3 - 4 > 500000
ca. 100000
1500 - 3500
1500 - 2000
ca. 800
1000 - 2000
600 - 900
100 - 200
ca. 150
300 - 500
PVDC 10 - 230 7 - 80
cm3 · µm/ (m²·d·bar)1)
1) Film thickness: 1 µm (= intrinsic permeability)
PVDC - Compliance Profile
• U.S.: PVDC approvals for Foodand Drug Administration (FDA) 21 CFR Part 170-199(1)
• European Pharmacopeia
• EU Regulation No 10/2011 on plastic materials and articlesintended to come into contactto foodstuffs(2)
1) Information on current listings for specific grades is available from your Solvay representative
2) Including EU Regulation No 1282/2011
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