Silicone Solutions for Medical Device Applications

Silicone Solutions for Medical Device Applications
Proven Performance.
Trusted Expertise.
Explore new frontiers
in healthcare
Medical care has made unprecedented advances in the last
30 years, and the new technology you are developing continues
to transform healthcare. Innovation in material science is a key
part of that transformation, and Dow Corning continues to be
a source of innovative materials that help you discover new
directions in medical device design. We offer a versatile portfolio
of high-performance medical-grade silicone elastomers, adhesives
and fluids — and the trusted, technical, process and regulatory
expertise to help you select the right material for your application.
Elastomers
■
High consistency rubbers
■
Liquid silicone rubbers
Adhesives
■
Pressure sensitive adhesives
■
Soft skin adhesives
■
Curable adhesives for device bonding
Coatings
■
Fluids and emulsions for coating
and siliconization
High Consistency
Rubber (HCR)
HCRs are millable thermoset silicone
elastomers that can be extruded
continuously to form a desired size
and shape before curing. Silicone
tubing is an example.
Benefits
Innovation Meets Expertise
You want to explore new directions and create the next
generation of medical device technology. You have a
powerful ally with Dow Corning. When we are part of your
team, you’re backed by our expertise and our culture
of discovery and innovation, which has been nurtured
by six decades of proven performance. You’ll find a
depth of knowledge not just in silicone chemistry, but
in the medical device industry, process technology and
regulatory compliance.
Product Description
Typical Applications
Two-part (1:1 by weight),
platinum-catalyzed, enhanced
tear-resistance silicone elastomers
•Fabrication of molded medical/surgical/
diagnostic devices and components
HCR
Silastic® BioMedical
Grade Elastomers
•DMF (drug master file)
access available
upon request
•Excellent batch-to-batch reproducibility for
critical applications
• Manufactured in a dedicated healthcare facility
•Fabrication of extruded parts
®
Silastic BioMedical
Grade Bases
•DMF (drug master file)
access available
upon request
•Must add peroxide
Two-part (1:1 by weight),
platinum-catalyzed, enhanced
tear-resistance silicone elastomers
Dow Corning®
C6 Series Elastomers
•Highly reproducible and stable materials
•Fabrication of extruded parts
• Manufactured in a dedicated healthcare facility
•Fabrication of molded medical/surgical/
diagnostic devices and components
• Improved cost efficiency
Dow Corning®
C6 Series Elastomers
One-part, high-consistency rubber base
•Must add peroxide
Dow Corning®
QP1 Elastomers
•Choice of cure systems (peroxide/platinum)
• Manufactured under ISO quality system requirements
•Fabrication of extruded parts
One-part, high-consistency rubber base
•Base, must add curatives
Dow Corning®
C6 Series Elastomers
•Low hysteresis
•Lower hysteresis for demanding applications
(i.e. peristaltic pump tubing)
Two-part (1:1 by weight),
platinum-catalyzed, enhanced
tear-resistance silicone elastomers
•Fabrication of molded medical/surgical/
diagnostic devices and components
•Fabrication of extruded parts
•Fabrication of molded medical/surgical/
diagnostic devices and components
Select European
Pharmacopeia
3.1.9
Cytotoxicity
Mutagenicity/Genotoxicity
Hemolysis
Skin Sensitization
Pyrogenicity (USP)
90-Day Implant
30-Day Implant
7-Day Implant
USP Class V and VI
Substance Soluble
in Hexane
Volatile Matter
Food Grade Compliance*
Hardness, Shore A
Tensile Strength
(MPa/psi)
Elongation at Break (%)
Tear Strength,
Die B (kN/m/ppi)
Relative Density
Biocompatibility Testing
Silastic® Q7-4720 BioMedical Grade ETR Elastomer1
•
•
•
•
•
•
•
•
•
•
•
•
23
8.9/1300
1310
31.6/180
1.11
Silastic® Q7-4735 BioMedical Grade ETR Elastomer1
•
•
•
•
•
•
•
•
•
•
•
•
36
9.3/1350
1180
36.8/210
1.12
Silastic® Q7-4750 BioMedical Grade ETR Elastomer1
•
•
•
•
•
•
•
•
•
•
•
•
50
10.0/1450
930
45.6/260
1.16
Silastic® Q7-4765 BioMedical Grade ETR Elastomer1
•
•
•
•
•
•
•
•
•
•
•
•
65
8.0/1160
900
45.6/260
1.20
Silastic® Q7-4780 BioMedical Grade ETR Elastomer1
•
•
•
•
•
•
•
•
•
•
•
•
77
7.8/1130
660
42.1/240
1.20
Silastic® Q7-4535 BioMedical Grade ETR Elastomer1, 2
•
•
•
•
•
•
•
•
•
•
•
•
36
8.1/1180
830
24.6/140
1.12
Silastic® Q7-4550 BioMedical Grade ETR Elastomer1, 2
•
•
•
•
•
•
•
•
•
•
•
•
48
9.3/1360
680
31.6/180
1.16
Silastic® Q7-4565 BioMedical Grade ETR Elastomer1, 2
•
•
•
•
•
•
•
•
•
•
•
•
67
7.9/1150
620
38.6/220
1.20
Dow Corning® C6-135 Elastomer
•
•
•
•
•
•
•
•
36
8.2/1200
1120
35.1/200
1.12
Dow Corning® C6-150 Elastomer
•
•
•
•
•
•
•
•
50
10.6/1540
980
42.1/240
1.16
Dow Corning® C6-165 Elastomer
•
•
•
•
•
•
•
•
61
8.0/1170
940
42.1/240
1.21
Dow Corning® C6-180 Elastomer
•
•
•
•
•
•
•
•
77
7.2/1050
610
38.6/220
1.21
Dow Corning® C6-235 Elastomer2
•
•
•
•
•
•
•
•
37
7.5/1100
810
21.1/120
1.12
Dow Corning® C6-250 Elastomer2
•
•
•
•
•
•
•
•
49
8.2/1200
530
26.3/150
1.16
Dow Corning® C6-265 Elastomer2
•
•
•
•
•
•
•
•
66
8.2/1200
560
35.1/200
1.20
Dow Corning® QP1-30 Silicone Elastomer3
•
•
•
•
28
9.5/1390
790
12.3/70
1.09
Dow Corning® QP1-50 Silicone Elastomer3
•
•
•
•
48
11.8/1720
545
15.8/90
1.13
Dow Corning® QP1-60 Silicone Elastomer3
•
•
•
•
57
13.0/1890
535
21.1/120
1.16
Dow Corning® QP1-70 Silicone Elastomer3
•
•
•
•
68
12.6/1835
470
24.6/140
1.20
Dow Corning® C6-350 LH Elastomer
•
•
•
•
49
8.5/1240
730
38.6/220
1.15
Products
•
•
•
•
*Contact your Dow Corning representative for area-specific information
Use of this material for implantation ≥ 30 days requires indemnification
1.0 parts Di(2,4-Dichlorobenzoil) peroxide compounded with 100 parts base molded 5 min at 115 °C (240 °F)
3
1.2 parts Di(2,4-Dichlorobenzoil) peroxide compounded with 100 parts base molded 5 min at 115 °C (240 °F)
1
2
Liquid Silicone
Rubber (LSR)
Innovation Meets Expertise
You want to explore new directions and create the next
generation of medical device technology. You have a
powerful ally with Dow Corning. When we are part of your
LSRs are pumpable thermoset
team, you’re backed by our expertise and our culture
silicone elastomers that can be
of discovery and innovation, nurtured by six decades of
processed by molding equipment.
proven performance. You’ll find a depth of knowledge not
They are ideal for intricate designs
just in silicone chemistry, but in the medical device industry,
and close-tolerance parts.
process technology and regulatory compliance.
Benefits
Product Description
Typical Applications
LSR
Silastic® BioMedical
Grade Liquid
Silicone Rubber
• High-quality, consistent materials for critical applications
• Manufactured in a dedicated healthcare facility
Two-part (1:1 by weight),
platinum-catalyzed, liquid silicone
rubber materials
•DMF (drug master file)
access available
upon request
• Injection molding of precision and
intricate parts of medical devices
(O-rings, stoppers and closures)
•Mesh or fabric coating
• Improved molding performance
• Formulated to significantly reduce mold fouling
• Enhance throughput and limit cleaning and change-outs over time
• Improved mechanical properties like tear strength and compression set
• Highly reproducible and stable materials
• Manufactured in a dedicated healthcare facility
Two-part (1:1 by weight),
platinum-catalyzed, liquid silicone
rubber materials
Dow Corning®
C6 Series LSR
• Improved molding performance
• Injection molding of precision and
intricate parts of medical devices
(O-rings, stoppers and closures)
•Mesh or fabric coating
•Implantation applications ≤ 29 days
• Formulated to significantly reduce mold fouling
• Enhance throughput and limit cleaning and change-outs over time
• Improved mechanical properties like tear strength and compression set
• No need for post cure to stabilize physical properties
• Manufactured in a dedicated healthcare facility
• Formulated to reduce mold fouling, resulting in longer run times
before cleaning
•Less downtime and greater cost efficiency
•Improved mold release
•No need for post cure
• No need for post cure to stabilize physical properties
Two-part (1:1 by weight),
platinum-catalyzed, liquid silicone
rubber materials
®
Dow Corning
QP1 LSR
• Injection molding of precision and
intricate parts of medical devices
(O-rings, stoppers and closures)
•Mesh or fabric coating
•Implantation applications ≤ 29 days
• High batch-to-batch consistency means fewer adjustments
• Low viscosity material flows into intricate molds at lower pressures
• Wider process window
• Shortens process cycle time
• Formulated to significantly reduce mold fouling
• Enhance throughput and limit cleaning and change-outs over time
• Greater molding consistency
Select European
Pharmacopeia
3.1.9
Cytotoxicity
Mutagenicity/Genotoxicity
Hemolysis
Skin Sensitization
Pyrogenicity (USP)
90-Day Implant
30-Day Implant
7-Day Implant
USP Class V and VI
Substance Soluble
in Hexane
Volatile Matter
Food Grade Compliance*
Hardness, Shore A
Tensile Strength
(MPa/psi)
Elongation at Break (%)
Tear Strength,
Die B (kN/m/ppi)
Relative Density
Biocompatibility Testing
Silastic® 7-6830 BioMedical Grade Liquid Silicone Rubber1
•
•
•
•
•
•
•
•
•
•
•
•
30
8.8/1280
790
24.1/140
1.13
1
Products
•
•
•
•
•
•
•
•
•
•
•
•
40
9.8/1430
700
36.8/210
1.13
Silastic® Q7-4840 BioMedical Grade Liquid Silicone Rubber1
•
•
•
•
•
•
•
•
•
•
•
•
44
9.4/1370
540
36.8/210
1.12
1
Silastic Q7-4850 BioMedical Grade Liquid Silicone Rubber
•
•
•
•
•
•
•
•
•
•
•
•
50
10.1/1470
630
45.1/260
1.15
1
•
•
•
•
•
•
•
•
•
•
•
•
60
8.8/1280
540
50.9/290
1.10
Silastic® 7-4870 BioMedical Grade Liquid Silicone Rubber1
•
•
•
•
•
•
•
•
•
•
•
•
66
9.5/1380
420
47.4/270
1.15
Silastic® Q7-7840 BioMedical Grade Liquid Silicone Rubber1
•
•
•
•
•
•
•
•
•
•
•
•
40
9.3/1360
750
30.7/175
1.14
®
1
•
•
•
•
•
•
•
•
•
•
•
•
50
9.0/1310
660
48.2/275
1.13
®
1
Silastic Q7-7870 BioMedical Grade Liquid Silicone Rubber
•
•
•
•
•
•
•
•
•
•
•
•
67
9.4/1370
415
45.6/260
1.14
Dow Corning® C6-530 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
30
8.2/1190
830
26.3/150
1.13
Dow Corning® C6-540 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
40
8.9/1290
740
42.1/240
1.13
Dow Corning® C6-550 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
50
10.4/1520
660
44.7/255
1.14
Dow Corning C6-560 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
60
8.8/1280
540
50.9/290
1.10
Dow Corning® C6-570 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
65
9.1/1320
440
54.4/310
1.15
Dow Corning® C6-740 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
•
40
8.6/1250
680
30.7/175
1.14
Dow Corning® C6-750 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
•
50
8.8/1280
610
42.1/240
1.13
Dow Corning® C6-770 Liquid Silicone Rubber
•
•
•
•
•
•
•
•
•
67
9.3/1360
450
42.1/240
1.14
Dow Corning® QP1-20 Liquid Silicone Rubber
•
•
•
•
•
20
5.6/810
650
18.4/105
1.12
Dow Corning QP1-30 Liquid Silicone Rubber
•
▲
•
•
•
30
5.7/830
625
18.4/105
1.13
Dow Corning® QP1-40 Liquid Silicone Rubber
•
▲
•
•
•
40
7.5/1090
580
31.6/180
1.14
Dow Corning® QP1-45 Liquid Silicone Rubber
•
▲
•
•
•
45
7.8/1140
485
38.6/220
1.13
Dow Corning® QP1-50 Liquid Silicone Rubber
•
▲
•
•
•
50
8.6/1260
510
41.2/235
1.13
Dow Corning® QP1-60 Liquid Silicone Rubber
•
▲
•
•
•
60
9.6/1400
460
50.9/290
1.14
®
•
▲
•
•
•
68
9.7/1420
405
44.7/255
1.14
®
Dow Corning QP1-75 Liquid Silicone Rubber
•
•
•
•
•
73
8.9/1300
400
15.8/90
1.16
Dow Corning® QP1-230 Liquid Silicone Rubber
•
•
•
•
•
30
6.8/990
630
15.8/90
1.12
®
Silastic 7-6840 BioMedical Grade Liquid Silicone Rubber
®
®
Silastic 7-4860 BioMedical Grade Liquid Silicone Rubber
Silastic Q7-7850 BioMedical Grade Liquid Silicone Rubber
®
®
Dow Corning QP1-70 Liquid Silicone Rubber
Dow Corning QP1-240 Liquid Silicone Rubber
•
▲
•
•
•
40
8.0/1160
540
36.8/210
1.11
Dow Corning® QP1-250 Liquid Silicone Rubber
•
▲
•
•
•
50
8.2/1200
495
47.4/270
1.12
Dow Corning® QP1-260 Liquid Silicone Rubber
•
▲
•
•
•
60
8.6/1400
390
50.1/290
1.12
•
•
•
•
•
68
9.5/1390
325
54.4/310
1.14
®
®
Dow Corning QP1-270 Liquid Silicone Rubber
1
Use of this material for implantation ≥ 30 days requires indemnification
* Contact your Dow Corning representative for area-specific information
▲
Biocompatibility potential based on test data from analogous materials
Adhesives
Pressure sensitive adhesives (PSAs)
and soft skin adhesives (SSAs) can
be used for wearable monitoring
devices, wound care products,
medical device attachments,
external prosthetic devices and
specialty cosmetic applications.
Benefits
Innovation Meets Expertise
You want to explore new directions and create the next
generation of medical device technology. You have a
powerful ally with Dow Corning. When we are part of your
team, you’re backed by our expertise and our culture
of discovery and innovation, nurtured by six decades of
proven performance. You’ll find a depth of knowledge
not just in silicone chemistry, but in the medical device
industry and process technology.
Product Description
Typical Applications
Processing Methods
PSA
• Biocompatibility (non-irritating
and non-sensitizing)
Dow Corning®
MG Series Pressure
Sensitive Adhesives
for Medical Devices
• High adhesion and
conformity to skin
One-part, polycondensed
polydimethylsiloxane/silicate
resin adhesives
• Adhesion for extended
wear time
Volatile solvent-based
silicone adhesives
• High gas and moisture
permeability
• Available in a range of tack
options, solvent types and
solid contents to help meet
application needs and
processing constraints
Uses conventional tape
coating equipment
• Non-sensitizing adherence
of medical devices/appliances
(colostomy, ileostomy,
surgical dressings/pads,
external prosthetic devices
and patient monitoring)
One-part, polycondensed
polydimethylsiloxane/silicate
resin adhesive
• Transfer coating
• Brushing process
Can be applied using
conventional hot melt
coating equipment
Hot melt silicone adhesive
Elastomer
Dow Corning®
Soft Filling Elastomer
• Transparent
• Low viscosity
Two-part (1:1 by weight),
platinum-catalyzed, soft
fillerless elastomer
• Filling material for external
foam prostheses and
pressure cushions
Two-part (1:1 by weight),
platinum-catalyzed, soft
fillerless elastomeric adhesive
• Non-sensitizing, gentle
adhesion to skin (wound care
and scar therapies)
SSA
Dow Corning®
MG Series Soft Skin
Adhesives
• Transparent
• Low viscosity
Knife over roll coating process
is recommended
• Specification writers: These values are not intended for use in preparing specifications. Please contact a Dow Corning representative prior to writing specifications on these products.
• Adhesion promoters are available. Please contact your Dow Corning representative for details.
•
•
•
•
•
•
•
•
•
2000
Not
Applicable
100
Not
Applicable
Melt Viscosity at 185 °C (cP)
Solvent Type
FDA Drug Master File
System Toxicity
Pyrogenicity (USP)
59
Not
Applicable
30300
21
Medium
700
21
High
670
16
590
9
Very
High
245-275
0.1
500
320
90
0.6
0.11
•
500
320
90
0.6
0.11
▲
•
2900
2900
135
1.1
0.03
▲
•
5100
5100
140
1.9
0.05
•
•
•
Dow Corning® MG7-9800 Soft Skin Adhesive
•
•
•
Dow Corning® MG7-9850 Soft Skin Adhesive
▲
▲
Dow Corning® MG7-9900 Soft Skin Adhesive
▲
▲
Based on test results on adhesive solids
on biocompatibility test data from analogous materials
Ethyl
Acetate
Not
Applicable
700
470
Dow Corning® MG7-9700 Soft Skin Adhesive
▲ Based
2500
Medium
470
•
•
Ethyl
Acetate
Shear (kg)
•
Peel Adhesion (g/cm)
•
Dow Corning® 7-9600 Soft Filling Elastomer
1
64
siloxane
Not
Applicable
Nominal Tack Value
Sensitive Adhesive1
90
•
•
•
Release (N/2.5cm)
Dow Corning® MG-2410 Silicone Pressure
32
Adhesion (N/2.5cm)
Sensitive Adhesive1
Viscosity at 25 °C (cP)
Dow Corning® MG-2502 Silicone Pressure
methyldi-
Penetration After Cure
(mm/10)
Sensitive Adhesive1
Solid Content (%)
Dow Corning® MG-2402 Silicone Pressure
•
Viscosity Part B (mPa·s)
Sensitive Adhesive
•
Hexa•
Viscosity Part A (mPa·s)
1
Skin Sensitization
Dow Corning® MG-2401 Silicone Pressure
Skin Irritation
Products
Mutagenicity/Genotoxicity
Cytotoxicity
Biocompatibility Testing
Not
Applicable
Contact Dow Corning
Every day, you face complex challenges. Our global team
of experts is ready to help with material, processing or
regulatory issues. Let us know how we can help you at
dowcorning.com/healthcare.
Your Global Connection
Dow Corning has sales offices and manufacturing facilities
worldwide, as well as full-service, global technical support.
Contact us today by visiting dowcorning.com/ContactUs.
Images: AV22941, AV06729, AV20294, AV18539, AV13681, AV18540, AV12392, AV19192, AV02278,
AV06484, AV06727, AV24799
LIMITED WARRANTY INFORMATION – PLEASE READ CAREFULLY
The information contained herein is offered in good faith and is believed to be accurate. However, because
conditions and methods of use of our products are beyond our control, this information should not be used in
substitution for customer’s tests to ensure that our products are safe, effective and fully satisfactory for the
intended end use. Suggestions of use shall not be taken as inducements to infringe any patent.
Dow Corning’s sole warranty is that our products will meet the sales specifications in effect at the time of shipment.
Your exclusive remedy for breach of such warranty is limited to refund of purchase price or replacement of any
product shown to be other than as warranted.
TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, DOW CORNING SPECIFICALLY
DISCLAIMS ANY OTHER EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE OR MERCHANTABILITY.
DOW CORNING DISCLAIMS LIABILITY FOR ANY INCIDENTAL OR CONSEQUENTIAL DAMAGES.
Dow Corning and Silastic are registered trademarks of Dow Corning Corporation.
We help you invent the future is a trademark of Dow Corning Corporation.
©2016 Dow Corning Corporation. All rights reserved.
AMPM390-15
Form No. 52-1225-01