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Canyon Components CanRez Kalrez Viton O-rings and custom parts gaskets

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.

Medical & Pharmaceutical Grade O-ring  Materials

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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

EP70BK03

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

EP70BK36

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

EP70BK58

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

EP70BK60

EP70OW05

EPDM

70

-55°C to +130°C
(-67°F to +266°F)

NSF 61 Certified, Off White, Sulfur Cured EPDM

Drinking Water Use

EP70OW05

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

NB70BK03

NB70BK09

NBR (Buna-N)

70

-35°C to +125°C
(-31°F to +257°F)

NSF 61 Certified, NBR

Drinking Water Use

NB70BK09

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

SI70BK14

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

SI65GD18

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

SI65TN16

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

SI65TN17

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

SI65TN11

65

Silver Plated
Copper

0.004

50 to 120

SI60BK15

Silicone (VMQ)

Black

-55 to 160

MI