The Medical Device Market - Blow Molding · PDF fileWorldwide Medical Device Industry...
Transcript of The Medical Device Market - Blow Molding · PDF fileWorldwide Medical Device Industry...
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Medical Device Design
and the Materials Used
(both Legacy & Next Gen Specialty Polymers)
in Device Construction
Len Czuba Czuba Enterprises, Inc. www.czubaenterprises.com
Materials And Design 101
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 1
Introduction and Overview
1. Size of market
2. FDA classification
3. Durables
4. Disposables
5. Implantables
6. Diagnostics
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Market overview
Worldwide Medical Device Industry revenues - $350 B 1
U.S. Medical Device Market (2010) - $95 B 2
Healthcare’s percentage of U.S. GDP – 17.7% 3
US exports - $37 B with growth rate of 5 - 8%
1 – WTP Advisors 2 – Espicom Business Intelligence 3 – CMS Office of the Actuary
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Market overview
• Plastics Annual Volume Usage in Pounds
– Globally - 500 Billion
– Medical Industry - 5 to 7 Billion
– US Medical Consumption - 2.5 to 3 Billion
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Market overview
Rate of new materials being developed is accelerating
• Medical Plastics US Patents
– During 1980’s - 60 patents
– During 1990’s - 209 patents
– 1st 4 years of 2000’s - 218 patents
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• Class I
– Peripheral devices, non-contact
• Class II
– Short term tissue contact (<30 days)
• Class III
– Long term tissue contact (30 days +)
Medical Devices As defined by the FDA in 21 CFR
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Definitions
• Device Classification
CLASS I
Medical devices listed under General Controls section
CLASS II
Medical devices listed under Special Controls section
CLASS III
Medical devices requiring Premarket Approval
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• Class I
– Peripheral devices, non-contact
• Elastic bandage
• Syringe
• Nasal cannula
• Tissue cassette
• Urine collection bag
• Irrigation catheter
• Bedpan
• Otoscope
Medical Devices As defined by the FDA in 21 CFR
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• Class II
– Short term tissue contact (<30 days)
• Blood transfusion set
• Endoscope
• Endoscopic obturator
• Blood pressure cuff
• Urinary (urethral) catheter
• Biopsy needle
• Angioscope
• Insufflator
• Anesthesia kit
• Angioscope
Medical Devices As defined by the FDA in 21 CFR
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• Class III
– Long term tissue contact (30 days +) • Pacemaker
• Heart valve
• AV shunt
• Surgical mesh
• Implantable infusion pump
• Absorbable and cardiovascular sutures
• Vascular stent
• Intra-ocular lenses (IOLs)
• Intravenous bag
• Dental laser
• Synthetic tendons and ligaments
• Blood storage container
Medical Devices As defined by the FDA in 21 CFR
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• Class III
– Long term tissue contact (30 days +)
Medical Devices As defined by the FDA in 21 CFR
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Definitions
• Types of Medical Devices / Products
Durables – Instruments, Hardware, Scopes, Monitors
Housings, Furniture, Trays, Cabinets
Disposables – Single use products
Medical devices, IV containers, Tubing, Catheters
Implantables– Designed to be in place 30 days or more
Orthopedic implants, Stents, Resorbable Anchors
Diagnostics – Trays, Containers, Slides, Dishes
Plastics used in treating patients, diagnosing disease
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Definitions
• Implant
– Any foreign material that is positioned in the body,
or under or through the skin
• Long-term Implant
– Any implant that is in place for longer than 29 days
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PEEK* polymer implantables
Info from C. Valentine presentation Sep 4, 2008 EMP08, Belfast
*PEEK is supplied by Invibio Ltd.
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 2
Materials used
1. Commodity
2. Engineering
3. Specialty
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• Polyolefins • Polycarbonate • Fluoroplastics • Epoxy resins
• Styrenics • Polyesters • Silicones • Phenolics
• Vinyls • Polyethers • Barrier resins • Aminoplastics
• Acrylics • Polyamides • Alkyds
• Sulfones • Vinyl esters
• Polyimides • Unsat. Polyesters
• Thermoplastic • Polyurethanes
Polyurethanes
Thermosets (15%)*
Commodity Plastics
(89%)
Engineering Plastics (10%)
Performance Plastics
(1%)
Thermoplastics (85%)*
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Market overview
• Commodity Plastics – 70 to 75%
• Engineering Plastics – 10 to 15%
• Thermosets – 5 to 10%
• Elastomers – 5 to 7%
• Implantables – 1 to 2 %
Consumption by type of material / device
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Polymer usage
Comparison
• PVC >35%
• PP ~20%
• PS ~15%
• PE ~10%
• others ~20%
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Len Czuba
Feb 2005
Morphology of Commodity Polymers
Is the presence of 3D order in solid plastic
• LDPE - semi-crystalline (3D order)
• HDPE - semi-crystalline
• PP - semi-crystalline
• PVC - amorphous (NO 3D order)
• PS - amorphous
• ABS - amorphous (not transparent)
Naturally
translucent
Naturally transparent
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PVC PP
PE PS
The BIG 4
A Multitude of Choices
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• IV Solution Containers
• Blood Collection and Storage Bags
• Renal Dialysis Solution Containers
• Fluid Delivery Tubing
PVC in
Medical Disposables
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Thermoplastic Properties
Property Amorphous Crystalline
Optical Transparent Translucent/opaque
Volumetric Shrinkage
Low High
Chemical Resistance
Poor Excellent
Melt Viscosity High Low
Heat Content Lower Higher
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Tests to evaluate properties
• Mechanical: brittle failure, cracking, ductile
failure resulting in a reduction in properties
• Aesthetic: color, crazing, hazing, etc.
• Thermal: warpage, twisting, melting, burning,
etc.
• Chemical: environmental stress cracking,
absorption, leaching, dissolution, irradiation, etc.
• Environmental: weathering, UV degradation,
ozone, pollution, etc.
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Important considerations in product design & material selection
• Material Selection
• Design • Sharp corners
• Thick-thin transitions
• Processing • Material degradation
• Residual stresses
• Voids
• Weld Lines
• Service Conditions • Over stressed
• Elevated temperatures
• Used beyond lifetime
• Fatigue failure
• Environmental stress cracking
• UV, ozone, chemical degradation
• Secondary operations
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Medical Plastics
The emergence of medical devices
Original materials – natural products
Glass containers / metal blades needles
Rubber tubing _ .
Plasticized PVC
Olefin polymers
Styrenics
etc.
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Medical Plastics
Biomaterials – historical overview
PVC Blood bags replaced glass storage bottles
(Thrombo-resistant surfaces a benefit!)
Catheters, Tubing, Filters, Membranes
Blood circuits and Blood dialyzer systems
Heart valves, LVAD, Total artificial hearts
Vascular grafts, Pacemaker lead wire coatings
Hip and joint replacements
Breast implants
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Medical Plastics
Biomaterials – historical overview
Sutures
Tissue adhesives
Anti-adhesion sheeting, sprays, gels
IV bags and accessories
Chemotherapy ports and catheters
Central catheters, Balloon catheters
Cardiac catheters, Stents
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Advanced Materials
1. Engineering polymers
• Polyesters
• Urethane Polymers
• LSR and TPE Elastomers
• Fluoropolymers
2. Implantable engineering polymers
• PEEK
• Polysulfone
3. “Bio”polymers
4. Bioresorbable polymers
5. Sustainable polymers
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• Silicone – Elastomer sheeting and tubing
– Knuckles, scaffolding, gel bladders
• Polyester
• Graphite heart valve
• PMMA - polymethyl methacrylate
• Polyurethane – sheeting, tubing & wire coating
Medical Plastics
in Device Evolution Product examples
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Medical Thermoplastic
Polyurethanes
Hard Segment/Domain
Diisocyanate
Short chain diol
Soft Segment/Domain
Macrodiol
Softens
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• PTFE – PolyTetra-Fluoro Ethylene
– Membrane, grafts, plodgets, plugs
• Polyamide, Polyester and Polypropylene – Mesh / screening / cuffs
• Polysulfone
• PEEK polymer – PolyEther Ether Ketone and Polyaryletherketone
Medical Plastics Product examples
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• Acetal – POM - Polyoxymethylene aka Delrin, Celcon
• Resorbable bone grafts
– PLA, PLGLA
• Hydrogels
• Others
Medical Plastics Product examples
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Bioresorbable
polylactide implants
[Inion Ltd, Guildford (UK)]
Info from D. Obeloer presentation Sep 4, 2008 EMP08, Belfast
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• Ocular Lens Implant
• Resorbable Sutures
• Bone Repair / Replacement
• Joint Replacements
Medical Plastics Product examples
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• Heart valve replacement
• Artificial heart
• Vascular grafts
• Tissue adhesives
Medical Plastics Product examples
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• Tissue implants
• Breast enhancement
• Hernia repair / reinforcement
– mesh / screening / cuffs
• Anti-adhesion film
Medical Plastics Product examples
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• Pacemaker leads
• Nerve stimulators
• Spinal implants
• Shunts
Medical Plastics Product examples
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• Drug eluting implants
– Osmopump, Norplant, NuvaRing
• Chemotherapy Ports
• Catheters
• Insulin pump housings
Medical Plastics Product examples
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• Stainless Steel – Plates, pins, screws, cages
• Titanium
• Ceramics
• Acrylic – PMMA - polymethyl methacrylate
• UltraHigh Molecular Weight PE – UHMWPE
• Biological tissue for sutures – “Catgut” – collagen
Medical Plastics Product examples
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Biodegradable polymer implant
Ring snap-in joint
Guide wire
Prototype of the implant in the half folded
position
Prototype of the implant in the fully deployed
position
CAD-Model
CAD-Model
Info from I. Michaelis presentation Sep 4, 2008 EMP08, Belfast
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 3
Testing requirements
1. Physical / Functional
2. Chemical
3. Biological
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• Physical / Functional
• Chemical compatibility
• Biological compatibility
Testing Requirements
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• Physical / Functional
– Materials of construction
• Tensile
• Elongation
• Hardness
• Clarity
– Finished device (as it is to be used)
• Safe
• Effective
• Robust
Testing Requirements
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• Chemical compatibility
– IR fingerprinting (FTIR)
– MWD
– Rheology (ASTM)
– Thermal (DSC, TGA)
– Aqueous extraction (LC)
– Identification of extractibles (GC MS)
– Heavy metals
Testing Requirements
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• Biological compatibility
– Cytotoxicity
– Eluates
– Intracutaneous
– Implant
– Genotoxicity
– Carcinogenicity
– Reproductive
– Biodegradation
Testing Requirements
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Implantation of bioresorbable to
close cardiac septum defect
Info from I. Michaelis presentation Sep 4, 2008 EMP08, Belfast
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 4
Processing considerations
1. Injection molding
2. Extrusion
3. Blow Molding
4. Assembly
5. Packaging
6. Sterilization
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Injection Molding
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Injection Molding
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Injection Molding
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Injection Molding
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Residual Stresses in Injection Molding
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Residual Stresses
• Residual stresses can also result from – Thermoforming
– Blow molding
– Ultrasonic welding
– Machining (sawing, cutting, etc.)
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DIE
3-ROLL STACK
SHEET
TAKE-UP
PULL
ROLLS
Sheet and Cast film
Extrusion
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Cast Film Process
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MELT
CHOKER BAR
ADJUSTABLE
BOLT
FLEXIBLE LIP SHEET DIE
Cast film and sheet dies now use coat-hanger designs and are equipped
with a restrictor bar and adjustable flex-lip die opening.
Sheet Extrusion Die
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Coathanger Die
for Sheet Extrusion
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Cast Sheet Calendaring
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Chill Roll Stack
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Cast Sheet Calendaring
Single Polishing
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Double Polishing
Cast Sheet Calendaring
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Blown Film Extrusion
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Blown Film Extrusion
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Blown Film Extrusion
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Coextrusion
The conversion of multiple thermoplastics, flowing
through separate channels in a multilayer die or
feed block system that are combined
into a common primary channel and then
shaped by a die.
Multiple layers provide properties that cannot
be provided by a single material for high barrier
co-extrusion processing.
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•3 Materials in 3 Separate Extrusion Systems
•Can be 3, 4 or 5 layered film or sheeting
•Variety of applications from trays to panels
to housings
Co-extrusion
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Feedblocks
Feedblocks allow users to handle a wide range of
polymers, rates and structures without sacrificing
performance.
To meet performance requirements for versatility,
economics and reliability, several different types of
feedblocks are now available:
Selector Fixed Top Hat Variable
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Since many polymers are
incompatible, an adhesive layer (tie
layer) is needed to obtain sufficient
interlayer adhesion in order to
prevent subsequent delamination of
the product.
Multilayer structures
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Thermoforming
1.Cut sheet
2.Continuous roll fed
3.Plug assist/deep draw
4.Heavy gauge
5.Form/fill/seal
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A variety of trays showing colors,
material options and designs
Trays provided by Nelipack Custom
Thermoformed Products, Div. of Sealed Air
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Thermoforming
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Thermoforming
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Trays numbered to show procedural steps
PETG tray with heat seal lip
and tan styrene insert tray
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White styrene tray has heat seal lip
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White styrene clamshell with security
“Tamper-evident” rivet feature
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Detail of security “Tamper-evident” rivet feature
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Detail of security “Tamper-evident” rivet feature
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Post Processing Assembly
1.Ultrasonic sealing
2.Heat sealing of welding
3.Solvent bonding
4.Printing & decorating
5.Annealing
6.Film & sheet slitting
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 5
Sterilization options
1. Steam autoclaving
2. Ethylene oxide gas
3. High energy radiation
A. Gamma
B. Electron beam
4. Other
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• Sterilization
– Heat • Dry heat
• Steam autoclave
– Gas • Ethylene oxide
– High energy radiation • Gamma
• Electron beam
– Other
Sterilization “An important but tricky step”
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Sterilization
Tolerance of Commodity Plastics to Sterilization Methods
Ethylene Oxide High Pressure
Steam Radiation
Polyvinyl chloride Excellent Excellent
Excellent phys-
cal, poor color
except color bal-
anced formulation
Polypropylene Excellent Good
Good physical,
excellent color
(special
formulations)
High density
polyethylene Excellent Fair Excellent
Low density
polyethylene Excellent Poor Excellent
Polystyrene Fair Poor Excellent
Polyester Excellent Poor Excellent
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Sterilization
Heat, High Pressure Steam
Mode of Action
Physical and chemical: denaturation and or decomposition of
proteins, nucleic acids, polysaccharides, etc. by hydrolysis,
oxidation, and other reactions. This can either kill the organism
or prevent it from reproducing
Site of Application Device manufacturer, contract sterilizer, OEM, kit packager, or
medical treatment site
Applicable Products All devices, drugs and their packages including large volumes of
medical solutions
Advantages
• Applicable to small and large jobs
• Only viable method at site of medical service
• Rapid turnaround
• Safety
• Simplicity of installation
• Most established of all methods
Disadvantages • Damage to devices, drugs, and packaging material
• High energy consumption
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Sterilization
Tolerance of Specialty Polymers to Sterilization Methods
Polymer Ethylene Oxide High Pressure Steam Radiation
ABS OK Poor Very good
Acetal OK Good Poor
Acrylic OK Good Fair
Cellulosics OK Good Good
K-Resin OK Poor Very good
Nylon (aliphatic) OK Excellent Good
Nylon (aromatic) OK Excellent Excellent
Polycarbonate OK Excellent Fair
Polymethylpentene OK Good Good
Polysulfone OK Excellent Excellent
Butyl rubber OK Excellent Fair
Natural rubber OK Excellent Very good
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Sterilization
Ethylene Oxide Gas
Mode of Action Chemical: ethoxylation (alkylation) and deactivation of nucleophilic sites on nucleic acids and proteins. This can either kill the organism or prevent it from reproducing
Site of Application Device manufacturer or contract sterilizer
Applicable Products
Flat devices and empty, permeable or open containers packed in permeable materials. No packaged liquids or
solids in impermeable containers
Advantages
• Cost, scale • Proven effectiveness
• Broad applicability in wide range of polymers • Good for mixed material devices
Disadvantages
• Toxicity of EtO • Primary and secondary outgassing requirements
• Temperature of process, possible material damage • Poor migration of EtO down long tubes
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Chemical resistance plaques
• Plaque submerged in Virex®
Tb
• External stress applied
• Eastman Tritan™ copolyester
retains clarity and integrity
• Tritan demonstrates
excellent environmental
stress crack (ESC)
resistance
Tritan
Copolyester
Lipid
Resistant PC
General PC General Acrylic
Industry Trend:
Patient Safety and
Comfort / Cost
Containment
Industry Need:
Lower Infection Rates /
No materials of concern
Material Requirement:
Chemical Resistance to
disinfectants
Polyesters Chemical Resistance
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Improved appearance due to less color shift during
sterilization
Less color shift – better aesthetics & patient comfort and product
can be shipped much faster
Industry Trend:
Safety and Comfort
Cost Containment
Industry Need:
Accuracy and Reliability
No materials of concern
Material Requirement:
High Clarity
Polyesters – Color Stability
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Sterilization High Energy Radiation
Mode of Action
Physical/chemical. Collisions of rays with biological
materials produces radicals which lead to crosslinking,
oxidation, and/or scission in the genetic molecules. Viable
reproduction is prevented
Site of Application Device manufacturer or contract sterilizer
Applicable
Products
Plastic medical devices including up to small amounts of
metal and medical packaging. No drugs, parenteral
solutions, or other liquid filled products or other dense
species
Advantages
- Cost, scale
- Safety
- Speed
- Proven effectiveness
Disadvantages
- Investment; capital facility required
- Radiation safety management
- Damaging to many plastics
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Side View of
E-Beam/X-Ray Operation
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Electron Beam Rhodotron
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Product Passes Under Scan
Horn
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 6
Hot topics and trends
1. Anti-microbials
2. Non-PVC
(eliminate phthalates/PVC?)
3. Implantables
4. Bioresorbables
5. APIs
(Active pharmaceutical ingredients)
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• Hospital acquired infections (HAIs) are a leading cause of death in the
US
– In 2002, more than 98,000 people died from HAIs in US hospitals alone
– Nearly 2 million nosocomial infections per year
• Hospitals spend upwards of $30B/year treating HAIs (Center for Disease
Control Estimates)
– Costs are increasing due to longer life expectancies and an aging
population
– Antibiotic resistant infections (e.g. MRSA, VRE, & VRSA), accounting for
>70% of nosocomial infections, are significant contributors due to less
effective and more expensive treatments.
• Hospitals are no longer reimbursed for costs of treating many HAIs due
to recent CMS Medicare/Medicaid changes
Hospital acquired infections are a
growing problem
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• Urinary tract infections
• Surgical site infections
• Respiratory tract infections
• Skin infections
• Blood stream infections
• Gastrointestinal tract infections
• Central nervous system
infections
Polymicrobial biofilm on the surface of a steel medical device.4
Types of HAIs
(Hospital Acquired Infections)
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How Ionic Silver Works
Interrupt cell multiplication
Inhibit cell metabolism
Disrupt cell wall
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• CAUTIs are the most common nosocomial infection5,6,7
– 561,667 cases reported annually in 2002, down from 900,000 – 1 million in the 1990s
– 32% - 40% of all nursing home/hospital infections
– 80% of all nosocomial UTIs
• Bacteremia and Mortality
– 13,088 attributable deaths due to CAUTIs in 2002 (mortality rate of 2.3%)8
– 17.4% of hospital-acquired bacteremia from a urinary source9
• 10.8% mortality
Catheter Associated Urinary Tract
Infections (CAUTIs)
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Chemical resistance plaques
• Plaque submerged in Virex®
Tb
• External stress applied
• Eastman Tritan™ copolyester
retains clarity and integrity
• Tritan demonstrates
excellent environmental
stress crack (ESC)
resistance
Tritan
Copolyester
Lipid
Resistant PC
General PC General Acrylic
Industry Trend:
Patient Safety and
Comfort / Cost
Containment
Industry Need:
Lower Infection Rates /
No materials of concern
Material Requirement:
Chemical Resistance to
disinfectants
Polyesters Chemical Resistance
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• Class III
– Long term tissue contact (30 days +) • Pacemaker
• Heart valve
• AV shunt
• Surgical mesh
• Implantable infusion pump
• Absorbable and cardiovascular sutures
• Vascular stent
• Intra-ocular lenses (IOLs)
• Intravenous bag
• Dental laser
• Synthetic tendons and ligaments
• Blood storage container
Medical Devices As defined by the FDA in 21 CFR
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• Non-PVC containers and accessories
Internet source: www.achillesusa.com/plastic-health.php
Eastman Chemical Company
Ecdel thermoplastic elastomers and
Eastar copolyester plastics.
Internet source: www.eastman.com/medical
Achilles USA
EVA and Olefin film laminates
Several Case Studies
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• Class II
– Short term tissue contact (<30 days)
• Blood transfusion set
• Endoscope
• Endoscopic obturator
• Blood pressure cuff
• Urinary (urethral) catheter
• Biopsy needle
• Angioscope
• Insufflator
• Anesthesia kit
• Angioscope
Medical Devices As defined by the FDA in 21 CFR
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• Class III
– Long term tissue contact (30 days +)
Medical Devices As defined by the FDA in 21 CFR
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PEEK* polymer implantables
Info from C. Valentine presentation Sep 4, 2008 EMP08, Belfast
*PEEK is supplied by Invibio Ltd.
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• Bone screw Material: PEEK
Biomet Sports Medicine / PMC Smart Solutions (injection molding)
suture anchor
insertion instrument
Several Case Studies
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Definitions
• Implant
– Any foreign material that is positioned in the body,
or under or through the skin
• Long-term Implant
– Any implant that is in place for longer than 29 days
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Bioresorbable
polylactide implants
[Inion Ltd, Guildford (UK)]
Info from D. Obeloer presentation Sep 4, 2008 EMP08, Belfast
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• Compatibility – Resorbability
• Sutures
• Tissue anchors / Bone screws
• Reinforcement mesh and Stents
[Inion Ltd, Guildford (UK)]
Trends Leading to New
Material Requirements
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Drug Delivery Example
• Excellent
compliance /
conformity
properties (Good
Wiper)
• .Exhibited ability to
pull 023” / side
undercut resulting
in no P/L on the
wiper surface
Low Extractables Excellent Barrier
• Glass Replacement • Extremely Hydrophobic • Excellent light stability
lowest refractive indexes • Excellent low temperature
performance
Low Adhesion Low stick / slip
Excellent Biodegradation Resistance Inert
Corrosion Resistance
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• Fluoropolymers are compatibility with most
organic compounds
– Naturally inert with excellent chemical
resistance, temperature range, friction and
barrier properties
– Non-stick properties make secondary coatings
like silicone unnecessary
• Offers performance advantages for liquids, sprays
and powders during manufacturing, testing,
storage, packaging and delivery
Fluoropolymer Advantages
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Fluoropolymers
produces highly toxic
HF and COF2 gases
during processing
Requires critical safety
measures
Requires specialized tool steels
due to corrosion
Requires custom hot runner
system design and components
Corrosion
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Injection Molding
Traditional vs Direct Gating
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Drug Delivery Example
• Excellent
compliance /
conformity
properties (Good
Wiper)
• .Exhibited ability to
pull 023” / side
undercut resulting
in no P/L on the
wiper surface
Low Extractables Excellent Barrier
• Glass Replacement • Extremely Hydrophobic • Excellent light stability
lowest refractive indexes • Excellent low temperature
performance
Low Adhesion Low stick / slip
Excellent Biodegradation Resistance Inert
Corrosion Resistance
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Complexity and Tolerances
Example of
intricate
geometries
and thin
walls
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The US EPA has calculated the maximum acceptable or "reference" dose
(RfD) of BPA to be 0.05 milligrams per kilogram of body weight per day (US
EPA, 1993). The EPA RfD is set for a lifelong daily intake of a substance
(without adverse effects) and includes a considerable safety margin for
sensitive stages of life such as childhood. The US EPA calculated the RfD by
dividing the Lowest-Observed-Adverse-Effect-Level (LOAEL, 50 milligrams per
kilogram body weight per day) from an earlier chronic toxicity study by an UF
of 1000. [http://www.epa.gov/iris/subst/0356.htm]
CONCLUSION: EPA RfD for BPA = 50 µg/kg BW/day = 50 ppb/day [no update]
EPA Position on BPA (since 1993)
Approximate Lethal Dose
Nicotine = 1 mg/kg
Tetrodotoxin (puffer fish) = 10 µg/kg
Saxitoxin (shellfish) = 10 µg/kg
Botulin toxin = 1 ng/kg
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Willhite and McLellan report that is the systemic toxicity of ingested BPA that
represents the most important point-of-departure for human health risk
assessment. Application of a 10-fold inter- and intraspecies uncertainty factors
(UF) and a 3-fold database UF (to account for lack of comprehensive
neurobehavioral and immunologic evaluations) to the 5 mg/kg NOAEL results
in an oral RfD of 0.016 mg/kg-day (16 ppb). Based on the total urinary
exposures (Germany, US, Japan) minimum margins of exposure range from
260 – 2200.
CONCLUSION: RfD 16 ppb?
New RfD for BPA (JAN/FEB 2010)?
Willhite CC, McLellan CJ (2010) Bisphenol A: Ghost
of Villain? International J. Toxicology 29(1): 127
(XIII)
Botulinum toxin: LD50 ~ 1 ng/kg
(ppt)
BOTOX (s.c)
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NTP Technical Report on the Carcinogenesis Bioassay of Bisphenol A.
National Toxicology Program. 1982. Technical Report Series No. 215.
Summary and full report available at:
http://ntp.niehs.nih.gov/index.cfm?objectid=0706194F-FF39-0F1B-
74A83661261ABA96
An Evaluation of the Possible Carcinogenicity of Bisphenol A to Humans.
Haighton, L.A., et al. 2002. J. Reg. Toxicol. Pharmacol. 35: 238-254.
CONCLUSION: Not likely to be a human carcinogen
Carcinogenicity
Animal testing is a bridge to human
effects
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Endocrine Activity
Normal Reproductive Organ Development in CF-1 Mice Following Prenatal
Exposure to Bisphenol A. Cagen, S.Z. et al. 1999. Toxicol. Sci. 50:36-44.
http://www.bisphenol-a.org/pdf/ToxicologyCagen3.pdf
Normal Reproductive Organ Development in Wistar Rats Exposed to Bisphenol
A in Drinking Water. Cagen, S.Z. et al. 1999. Regul. Toxicol. Pharmacol. 30(2 Pt
1):130-9.
CONCLUSION: No endocrine effects observed
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Course agenda
1. Introduction and Overview
2. Materials used
3. Testing Requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
7. Summary and Conclusion
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Chapter 7
Summary and Conclusion
1. Introduction and Overview
2. Materials used
3. Testing requirements
4. Processing considerations
5. Sterilization options
6. Hot topics and trends
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Any other questions?
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• Accumedix
• Cadent Resources
• River North Solutions
• MedCatalyst Consulting
• Foresight Business Consulting
MedSource
Coalition
A proud member of
• Blair Consulting Group
• Design Integrity, Inc.
• SpectraMedEx, LLC
• Czuba Enterprises
• RTEmd
Collaborating to develop new products, services, and management
systems in the medical, pharmaceutical, and biotech fields.
www.medsourcecoalition.com
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MedSource
Coalition Collaborating to develop new products, services, and management
systems in the medical, pharmaceutical, and biotech fields.
www.medsourcecoalition.com
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Medical Device Design
and the Materials Used
(both Legacy & Next Gen Specialty Polymers)
in Device Construction
Len Czuba Czuba Enterprises, Inc. www.czubaenterprises.com
Materials And Design 101
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Len Czuba
October 2011
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