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Medical & Pharmaceutical Grade O-ring Materials
In the fields of medicine and pharmaceuticals, the quality and safety of materials used are of paramount importance. Medical and pharmaceutical grade materials are designed and manufactured to meet rigorous standards, ensuring that they do not compromise patient health. In this web page, we will delve into the significance of medical and pharmaceutical grade materials, common application considerations, and discuss the USP Class VI 87 & 88 standards that govern these materials.
Check with one of Canyon’s helpful product engineers for an expert material and manufacturing recommendation.
With Canyon Components, you can be sure that high quality materials that meet you needs are always readily available. Custom & standard Medical & Pharmaceutical Grade Materials available now!
Medical & Pharmaceutical Materials Available
Thousands of Medical & Pharmaceutical Grade Materials are available now with Canyon Components! Some common Medical & Pharmaceutical Grade Materials include the following.
What are Medical & Pharmaceutical Grade Materials?
- Medical and pharmaceutical grade materials are substances, components, or equipment specifically engineered to meet the stringent requirements of the healthcare and pharmaceutical industries. These materials must be biocompatible, non-toxic, and free from contaminants to ensure patient safety and the efficacy of pharmaceutical products.
Common Conciderations
- 1. Biocompatibility
Materials must be biocompatible, meaning they do not cause adverse reactions when in contact with living tissues, blood, or bodily fluids.
2. Purity and Sterility
Materials should be pure and sterile to prevent contamination of pharmaceutical products and minimize the risk of infections or adverse reactions in medical applications.
3. Chemical Compatibility
Materials must be chemically compatible with the drugs, chemicals, and processes they come into contact with, ensuring product stability and efficacy.
4. Traceability
Materials should be traceable to ensure quality control, batch tracking, and recall procedures in case of issues.
5. Regulatory Compliance
Compliance with regulatory standards, such as the USP Class VI 87 & 88, is essential to meet the strict requirements of the healthcare and pharmaceutical industries.
Key Standards
- 1. USP Class VI: USP Class VI materials undergo an array of cytotoxicity tests that aim to certify that a material is biocompatible by proving that it doesn't leach any chemicals that have harmful reactions or long term bodily effects. These tests are designed to assess systemic biological reactivity when the material in question makes contact with mammalian cells. It's commonly used for O-rings, gaskets, & custom molded parts.
2. USP Class VI <87>: USP Class VI <87> is a set of in-vitro cytotoxicity tests involving agar diffusion, elution assays, and direct contact. It's commonly used for O-rings, gaskets, & custom molded parts.
3. USP Class VI <88>: USP Class VI <88> is a set of in-vivo cytotoxicity tests involving direct implantation, intracutaneous injection, and systemic injection studies. It's commonly used for O-rings, gaskets, & custom molded parts.
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Common Usage
Comparable Materials
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Common Usage
EP70BK03
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
FDA Compliant, NSF 61 Certified, Peroxide Cured EPDM
Drinking Water Use, Food & Drug Manufacturing
EP70BK36
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
FDA Compliant, USP VI <87> & <88>, 3A, NSF 61 Certified, KTW, WRAS, UL 778, Peroxide Cured EPDM
Drinking Water Use, Medical Devices, Dairy, Food & Drug Manufacturing
EP70BK58
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
FDA Compliant, WRC, ACS, W270, NSF 61 Certified, KTW, UL 157, Peroxide Cured EPDM
Drinking Water Use, Food & Drug Manufacturing
EP70BK60
EPDM
70
-55°C to +130°C
(-67°F to +266°F)
FDA Compliant, NSF 61 Certified, UL 157, Sulfur Cured EPDM
Drinking Water Use, Food & Drug Manufacturing
EP70OW05
EPDM
70
-55°C to +130°C
(-67°F to +266°F)
NSF 61 Certified, Off White, Sulfur Cured EPDM
Drinking Water Use
NB70BK03
NBR (Buna-N)
70
-35°C to +125°C
(-31°F to +257°F)
FDA Compliant, NSF 61 Certified, NBR
Drinking Water Use, Food & Drug Manufacturing
NB70BK09
NBR (Buna-N)
70
-35°C to +125°C
(-31°F to +257°F)
NSF 61 Certified, NBR
Drinking Water Use
SHIELDING PERFORMANCE
COMPOUND
BASIC FEATURES
DETAILS
CanGuard™
Material
Temp (°C)
Filler
Volume Resistivity (Ω/cm)
Shielding (dB)
Color
Shore A
Additional Specifications
Comparable Materials
SI70BK14
Silicone (VMQ)
Black
-55 to +200
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® S6600
70
Carbon
2.5 to 10
30 to 80
SI65GD18
Silicone (VMQ)
Gray
-55 to +150
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® S6305, 6370, 6371, 6308, 6330
65
Nickel Plated
Graphite
0.1
85 to 110
SI65TN16
Silicone (VMQ)
Tan
-55 to +150
MIL-DTL-83528 Type M
Parker® Chomerics CHO-SEAL® 1350, 1310
65
Silver Plated
Glass
0.006
90 to 100
SI65TN17
Silicone (VMQ)
Tan
-55 to +160
MIL-DTL-83528 Type B
Parker® Chomerics CHO-SEAL® 1285
65
Silver Plated
Aluminum
0.008
100 to 120
SI65TN11
Silicone (VMQ)
Tan
-45 to +125
MIL-DTL-83528 Type A
Parker® Chomerics CHO-SEAL® 1215, 1273, 1270
65
Silver Plated
Copper
0.004
50 to 120
SI60BK15
Silicone (VMQ)
Black
-55 to 160
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® S6600
60
Carbon
2.5 to 10
50 to 75
SI65BU57
Silicone (VMQ)
Blue
-55 to 160
MIL-DTL-83528 Type B
Parker® Chomerics CHO-SEAL® 1285
65
Silver Plated
Aluminum
0.008
100 to 120
FS65GD15
Fluorosilicone
Gray
-55 to +150
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® L6303
65
Nickel Plated
Graphite
0.1
100 to 130
FS70TN13
Fluorosilicone
Tan
-55 to +160
MIL-DTL-83528 Type D
Parker® Chomerics CHO-SEAL® 1287
70
Silver Plated
Aluminum
0.012
100 to 125
FS70TN20
Fluorosilicone
Tan
-55 to +160
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® 1287
70
Silver Plated
Aluminum (Passivated)
0.012
115 to 120
FS75BU51
Fluorosilicone
Blue
-55 to 160
MIL-DTL-83528 Type D
Parker® Chomerics CHO-SEAL® 1287
75
Silver Plated
Aluminum
0.012
100 to 125
FS75TN50
Fluorosilicone
Tan
-55 to 125
MIL-DTL-83528 Type C
Parker® Chomerics CHO-SEAL® 1217
75
Silver Plated
Copper
0.01
110 to 120
FS75TN60
Fluorosilicone
Tan
-50 to 160
MIL-DTL-83528 Type C
75
Silver Plated
Nickel
0.008
75 to 110
EP75BK15
EPDM
Black
-30 to 100
MIL-DTL-83528
Parker® Chomerics CHO-SEAL® 6307, 6452
75
Nickel Plated
Graphite
0.1
110 to 130
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Specifications
Medical & Pharmaceutical Materials Available
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Each of these materials has its own advantages, limitations, and cost implications. The choice of material usually depends on factors like chemical compatibility, temperature, pressure, dynamic or static use, and specification requirements.
Canyon Components strives to meet all customer service requests. Feel free to contact Canyon Components engineering and let our knowledgeable staff help you design the perfect part for your needs.
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Specifications
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
H₂S Resistance
Steam up to 300°F
Steam up to 400°F
VT75BK60
FKM (Viton®)
75
-21°C to +225°C
(-6°F to +437°F)
Extreme Chemical Resistance FKM Type ETP.
2
3
20 % Max
VT90BK31
FKM (Viton®)
90
-40°C to +225°C
(-40°F to +437°F)
90 Shore A, AED, Low Temp FKM GLT tested to Norsok M-710 & NACE TM0297.
2
4
5 % Max
VT90BK15
FKM (Viton®)
90
-28°C to +225°C
(-18°F to +437°F)
90 Shore A, AED, Low Temp FKM B tested to Norsok M-710.
3
4
5 % Max
VT90BK51
FKM (Viton®)
90
-51°C to +225°C
(-60°F to +437°F)
90 Shore A, AED, Extreme Low Temp FKM ULT tested to Norsok M-710 & NACE TM0297.
1
3
5 % Max
VT90BK59
FKM (Viton®)
90
-61°C to +225°C
(-78°F to +437°F)
90 Shore A, AED, Ultra Low Temp FKM ULT tested to Norsok M-710, API 6A & NACE TM0297.
1
3
5 % Max
EP90BK41
EPDM
90
-50°C to +288°C
(-58°F to +550°F)
90 Shore A, AED, High Temp Steam, L'Garde Cured EPDM tested to NACE TM0297.
1
1
30 % Max
HN90BK01
HNBR
90
-55°C to +163°C
(-67°F to +325°F)
90 Shore A, AED, Low Temp HNBR tested to Norsok M-710 & API 6A.
2
4
5 % Max
HN90BK11
HNBR
90
-26°C to +177°C
(-15°F to +350°F)
90 Shore A, AED, High Temp HNBR tested to Norsok M-710 & NACE TM0297.
2
4
5 % Max
HN90BK10
HNBR
90
-55°C to +165°C
(-67°F to +329°F)
90 Shore A, AED, Low Temp HNBR tested to Norsok M-710.
2
4
5 % Max
HN95BK15
HNBR
95
-55°C to +165°C
(-67°F to +329°F)
90 Shore A, AED, Low Temp HNBR.
2
4
5 % Max
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Specifications
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Specifications
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Temp (°C)
Description
Specifications
VT75BK55
FKM (Viton®)
75
-34°C to +225°C
(-29°F to +437°F)
FKM Type GFLT, UL 157 B, C (Ethanol), D, G
Low Temp Gasoline, Kerosene, Diesel Applications
VT75BK92
FKM (Viton®)
75
-34°C to +225°C
(-29°F to +437°F)
FKM Type GFLT, UL 157 B, C(Ethanol), D, F, G, J
Low Temp Gasoline, Diesel, Kerosene, NG, LPG Applications
VT75BK93
FKM (Viton®)
75
-26°C to +225°C
(-15°F to +437°F)
FKM, UL 157 B, C(Ethanol), D, F, G, H, J
Gasoline, Diesel, Kerosene, NG, LPG, Heated Fuel Oil Applications
VT75BK95
FKM (Viton®)
75
-28°C to +225°C
(-18°F to +437°F)
FKM Type B, UL 157 B, C(Ethanol), D, F, G, J
Gasoline, Diesel, Kerosene, NG, LPG Applications
VT75BK98
FKM (Viton®)
75
-40°C to +225°C
(-40°F to +437°F)
FKM Type GLT, UL 157 B, C(Ethanol), D, F, G, J
Extreme Low Temp Gasoline, Diesel, Kerosene, NG, LPG Applications
VT80BK94
FKM (Viton®)
80
-26°C to +225°C
(-15°F to +437°F)
FKM, UL 157 B, D, F, J
Gasoline, Kerosene, NG, LPG Applications
FS70BU01
Fluorosilicone
70
-75°C to +175°C
(-103°F to +347°F)
Fluorosilicone, UL 157 B, C(Ethanol), D, G, MIL-DTL-25988, AMS-R-25988, MIL-R- 25988 Class 1, Type 1 & 2
Gasoline, Kerosene, Diesel Applications
EP70BK36
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
Peroxide Cured EPDM, UL 778, FDA Compliant, USP VI, 87, 88, 3A, NSF 61, KTW, WRAS
Drinking Water Applications
EP70BK55
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
Peroxide Cured EPDM, UL JOHX2
Water, Steam, Inert Gas Applications
EP70BK58
EPDM
70
-55°C to +150°C
(-67°F to +302°F)
Peroxide Cured EPDM, UL 157 A(Water, Dry Chemical, Carbon Dioxide), L, M, N, O, 1, 2, WRC, ACS, W270, FDA, NSF 61, KTW
Extinguishing Agents, Detergents, Ozone Applications
EP70BK60
EPDM
70
-55°C to +130°C
(-67°F to +266°F)
Sulfur Cured EPDM, UL 157 A, FDA, NSF 61
Extinguishing Agents, Motor Operated Pumps
NB50BK40
NBR (Buna-N)
50
-40°C to +60°C
(-40°F to +140°F)
NBR, UL 157 F, G, J
Natural Gas, Diesel Fuel, LPG Applications
NB70BK16
NBR (Buna-N)
70
-40°C to +125°C
(-40°F to +257°F)
NBR, UL 157 A(Water, Dry Chemical), B, C(Ethanol), D, F, G, J
Extinguishing Agents, Gasoline, Diesel, Kerosene, NG, LPG Applications
NB70BK40
NBR (Buna-N)
70
-40°C to +125°C
(-40°F to +257°F)
NBR, UL 157
Gasoline, Kerosene, Fuel Oils, LPG Applications
NB70BK41
NBR (Buna-N)
70
-40°C to +125°C
(-40°F to +257°F)
NBR, UL 94 HB Compliant
High Temp, UL 94 Flame Applications
DETAILS
COMPOUND
FEATURES
Canyon™
Material
Shore A
Color
Temp (°C)
Description
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