Industries Served » Medical Rubber Components, USP Class VI & FDA Rubber » EPDM, Viton®, Silicone

Columbia Engineered Rubber Inc. offers a broad range of medical rubber components that are manufactured from FDA compliant and USP class six certified materials, for cleanliness and non-toxicity, for use in pharmaceutical manufacturing, diagnostic and surgical instruments and other non-implantable medical devices.


Common medical applications include extruded tubing, bellows and a wide range of different types of seals and sealing devices. Columbia has a range of medical grade and FDA compliant grade materials for medical and food grade medical applications including, EPDM, Viton®, and Silicone. For more information on USP and FDA requirements for medical rubber items, please refer to: www.usp.org or www.fda.gov
USP Class VI Applications

FDA Compliant and USP Class VI Compliant Elastomers

Ethylene-Propylene, EP, EPT, EPDM

Ethylene Propylene is a elastomer that demonstrates great weather aging and ozone resistance, excellent water and chemical resistance, great gas permeability and aging due to steam exposure. EPDM however, ranks poorly when exposed to oil and solvents but demonstrates average resistance to ketones and alcohols. click for EPDM
FDA Compliant Elastomers
FDA Compliant EPDM
FDA O-rings
Fluorocarbon, Viton®, Fluorel®, FKM

Fluorocarbon has a high resistance for heat, up to 400º F, as well as resistance to a wide range of oils and solvents, in particular; aromatic and halogenated hydrocarbons, acids and vegetable oils. Fluorocarbon is not recommended when ketones and nitro containing compound are used. click for Fluorocarbon
Silicone Medical Rubber Components
FDA Compliant Viton
Silicone, PVMQ

Silicone Rubber has the ability to meet any number of applications. Silicone can be compounded to have a Tensile area of 1500 PSI and tear up to 200lbs, low compression set and good resilience, moderate solvent resistance, excellent heat resistance, extreme low temperature properties and can be highly resistance to oxidation and ozone attack. click for Silicone

Medically Approved Material Selection Guide

EPDM
Very Good
Medical Rubber Rating, Very Good
Good
Medical Rubber Rating, Good
Average
Medical Rubber Rating, Average
Poor
Medical Rubber Rating, Poor
Not Recommended
Medical Rubber Rating, Not Recommended
EPDM - Chemical Resistance
Acids, Dilute
Medical Rubber Rating, Very Good
Fuel, Aliphatic Hydrocarbon Medical Rubber Rating, Poor
Acids, Concentrated
Medical Rubber Rating, Very Good
Fuel, Oxygenated Medical Rubber Rating, Poor
Acids, Organic
Medical Rubber Rating, Very Good
Halogenated Solvents Medical Rubber Rating, Poor
Acids, Inorganic
Medical Rubber Rating, Average
Hydrocarbon, Halogenated Medical Rubber Rating, Poor
Alcohol's
Medical Rubber Rating, Very Good
Ketones Medical Rubber Rating, Very Good
Aldehydes
Medical Rubber Rating, Average
Lacquer Solvents Medical Rubber Rating, Poor
Alkalies, Dilute
Medical Rubber Rating, Very Good
LP Gases and Fuel Oils Medical Rubber Rating, Poor
Alkalies, Concentrated
Medical Rubber Rating, Very Good
Mineral Oils Medical Rubber Rating, Poor
Amines
Medical Rubber Rating, Average
Oil Resistance Medical Rubber Rating, Poor
Animal and Vegetable Oils
Medical Rubber Rating, Good
Petroleum Aromatic Medical Rubber Rating, Poor
Brake Fluids,
Non-Petroleum Based
Medical Rubber Rating, Very Good
Petroleum Non-Aromatic Medical Rubber Rating, Poor
Diester Oils
Medical Rubber Rating, Not Recommended
Refrigerant Ammonia Medical Rubber Rating, Very Good
Esters, Alkyl Phosphate
Medical Rubber Rating, Good
Refrigerant Halofluorocarbons Medical Rubber Rating, Very Good
Esters, Aryl Phosphate
Medical Rubber Rating, Good
Refrigerant Halofluorocarbons with Oil Medical Rubber Rating, Very Good
Ethers
Medical Rubber Rating, Average
Solvent Resistance Medical Rubber Rating, Poor
EPDM - General Characteristics
Compression Set
Medical Rubber Rating, Very Good
Resilience - Rebound
Medical Rubber Rating, Good
Abrasion Resistance
Medical Rubber Rating, Good
Tear Resistance
Medical Rubber Rating, Good
Solvent Resistance
Medical Rubber Rating, Poor
Oil Resistance
Medical Rubber Rating, Poor
Aging Weather - Sunlight
Medical Rubber Rating, Good
Adhesion to Metals
Medical Rubber Rating, Good
Durometer Range (Shore A)
30 - 90
Tensile Range (P.S.I)
500 - 2500
Elongation (MAX %)
700
Low Temperature Usage (Fº)
to -60º
High Temperature Usage (Fº)
to 300º
Ethylene-propylene, EP, EPT, EPDM

Ethylene-propylene compounds are prepared from ethylene and propylene and usually a third monomer. These compounds are used frequently to seal phosphate ester fire resistant hydraulic fluids such as Skydrol. They are also very effective in brake systems, and for sealing hot water and steam. Ethylene-propylene compounds have good resistance to mild acids, alkalis, silicone oils and greases, ketones, and alcohols. They are not recommended for petroleum oils or diester lubricants. Ethylene-propylene has a temperature range of -67º F to 302º F (-555º C to 150º C). It is compatible with polar fluids that adversely affect other elastomers.

EPDM materials can be formulated for FDA food grade complaint level medical applications.

Advantages: Excellent weather resistance, Good low temperature flexibility, Excellent chemical resistance, Good heat resistance.

Disadvantages: Poor petroleum oil and solvent resistance.

Viton®
Very Good
Medical Rubber Rating, Very Good
Good
Medical Rubber Rating, Good
Average
Medical Rubber Rating, Average
Poor
Medical Rubber Rating, Poor
Not Recommended
Medical Rubber Rating, Not Recommended
Viton® - Chemical Resistance
Acids, Dilute Medical Rubber Rating, Very Good Fuel, Aliphatic Hydrocarbon Medical Rubber Rating, Very Good
Acids, Concentrated Medical Rubber Rating, Very Good Fuel, Oxygenated Medical Rubber Rating, Very Good
Acids, Organic Medical Rubber Rating, Average Halogenated Solvents Medical Rubber Rating, Good
Acids, Inorganic Medical Rubber Rating, Good Hydrocarbon, Halogenated Medical Rubber Rating, Good
Alcohol's Medical Rubber Rating, Good Ketones Medical Rubber Rating, Poor
Aldehydes Medical Rubber Rating, Poor Lacquer Solvents Medical Rubber Rating, Not Recommended
Alkalies, Dilute Medical Rubber Rating, Average LP Gases and Fuel Oils Medical Rubber Rating, Very Good
Alkalies, Concentrated Medical Rubber Rating, Poor Mineral Oils Medical Rubber Rating, Very Good
Amines Medical Rubber Rating, Poor Oil Resistance Medical Rubber Rating, Very Good
Animal and Vegetable Oils Medical Rubber Rating, Very Good Petroleum Aromatic Medical Rubber Rating, Very Good
Brake Fluids,
Non-Petroleum Based
Medical Rubber Rating, Poor Petroleum Non-Aromatic Medical Rubber Rating, Very Good
Diester Oils Medical Rubber Rating, Good Refrigerant Ammonia Medical Rubber Rating, Poor
Esters, Alkyl Phosphate Medical Rubber Rating, Poor Refrigerant Halofluorocarbons Medical Rubber Rating, Poor
Esters, Aryl Phosphate Medical Rubber Rating, Very Good Refrigerant Halofluorocarbons with Oil Medical Rubber Rating, Poor
Ethers Medical Rubber Rating, Poor Solvent Resistance Medical Rubber Rating, Very Good
Viton® - General Characteristics
Compression Set
Medical Rubber Rating, Very Good
Resilience - Rebound
Medical Rubber Rating, Good
Abrasion Resistance
Medical Rubber Rating, Average
Tear Resistance
Medical Rubber Rating, Good
Solvent Resistance
Medical Rubber Rating, Very Good
Oil Resistance
Medical Rubber Rating, Very Good
Aging Weather - Sunlight
Medical Rubber Rating, Very Good
Adhesion to Metals
Medical Rubber Rating, Good
Durometer Range (Shore A)
50 - 95
Tensile Range (P.S.I)
500 - 2000
Elongation (MAX %)
500
Low Temperature Usage (Fº)
to -30º
High Temperature Usage (Fº)
to 500º
Fluorocarbon, Viton®, Fluorel®, FKM

Fluorocarbon (Viton®) combines resistance to a broader range of chemicals than any of the other elastomers. It constitutes the closest available approach to the universal O-ring elastomer. Although most fluorocarbon compounds become quit hard at temperatures below -4º F (-20º C), they do not easily fracture, so they are serviceable at much lower temperatures. Fluorocarbon compounds provide a continuous 437º F (225º C), high temperature capability.

Viton materials can be formulated for FDA food grade complaint level medical applications.

Advantages: Excellent chemical resistance, Excellent heat resistance, Good mechanical properties, Good compression set resistance.

Disadvantages: Fair low temperature resistance

Silicone
Very Good
Medical Rubber Rating, Very Good
Good
Medical Rubber Rating, Good
Average
Medical Rubber Rating, Average
Poor
Medical Rubber Rating, Poor
Not Recommended
Medical Rubber Rating, Not Recommended
Silicone - Chemical Resistance
Acids, Dilute Medical Rubber Rating, Average Fuel, Aliphatic Hydrocarbon Medical Rubber Rating, Average
Acids, Concentrated Medical Rubber Rating, Average Fuel, Oxygenated Medical Rubber Rating, Poor
Acids, Organic Medical Rubber Rating, Good Halogenated Solvents Medical Rubber Rating, Poor
Acids, Inorganic Medical Rubber Rating, Average Hydrocarbon, Halogenated Medical Rubber Rating, Poor
Alcohol's Medical Rubber Rating, Average Ketones Medical Rubber Rating, Poor
Aldehydes Medical Rubber Rating, Good Lacquer Solvents Medical Rubber Rating, Poor
Alkalies, Dilute Medical Rubber Rating, Average LP Gases and Fuel Oils Medical Rubber Rating, Average
Alkalies, Concentrated Medical Rubber Rating, Very Good Mineral Oils Medical Rubber Rating, Poor
Amines Medical Rubber Rating, Good Oil Resistance Medical Rubber Rating, Average
Animal and Vegetable Oils Medical Rubber Rating, Very Good Petroleum Aromatic Medical Rubber Rating, Average
Brake Fluids,
Non-Petroleum Based
Medical Rubber Rating, Good Petroleum Non-Aromatic Medical Rubber Rating, Good
Diester Oils Medical Rubber Rating, Average Refrigerant Ammonia Medical Rubber Rating, Very Good
Esters, Alkyl Phosphate Medical Rubber Rating, Good Refrigerant Halofluorocarbons Medical Rubber Rating, Poor
Esters, Aryl Phosphate Medical Rubber Rating, Good Refrigerant Halofluorocarbons with Oil Medical Rubber Rating, Poor
Ethers Medical Rubber Rating, Not Recommended Solvent Resistance Medical Rubber Rating, Poor
Silicone - General Characteristics
Compression Set
Medical Rubber Rating, Good
Resilience - Rebound
Medical Rubber Rating, Good
Abrasion Resistance
Medical Rubber Rating, Poor
Tear Resistance
Medical Rubber Rating, Poor
Solvent Resistance
Medical Rubber Rating, Poor
Oil Resistance
Medical Rubber Rating, Average
Aging Weather - Sunlight
Medical Rubber Rating, Very Good
Adhesion to Metals
Medical Rubber Rating, Good
Durometer Range (Shore A)
30 - 90
Tensile Range (P.S.I)
200 - 1500
Elongation (MAX %)
700
Low Temperature Usage (Fº)
to -150º
High Temperature Usage (Fº)
to 482º
Silicone, PVMQ

Silicone is a semi-organic elastomer with outstanding resistance to extremes in temperature. Specially compounded, it can provide reliable service at temperatures as low as -175°F (-115°C) to as high as 482°F (250°C). Silicone also has a good resistance to compression set. Low physical strength and abrasion resistance combined with high friction, limits silicone to static seals. Silicone is used primarily for dry heat static seals. Although it swells considerably in petroleum lubricants, this is not detrimental in most static sealing applications.

Silicone materials are available with USP class VI certification for medical grade applications. Certifications are available upon request.

Advantages: Excellent at temperature extremes, Excellent compression set resistance

Biocompatibility
In extensive testing, silicone rubbers exhibited superior compatibility with human tissue and body fluids and an extremely low tissue response when implanted compared with other elastomers. Odorless and tasteless, silicones do not support bacteria growth and will not stain or corrode other materials.

Temperature Resistance
Silicones can withstand a wider range of temperature extremes than most other elastomers, remaining stable through temperature variations from -175°F to 482° F.

Chemical Resistance
Silicones will resist water and many chemicals, including some acids, oxidizing chemicals, ammonia, and isopropyl alcohol. Concentrated acids, alkalies, and solvents should not be used with Silicones.

Mechanical Properties
Silicone rubbers have high tear (to 250 PPI) and Tensile (to 1500 psi) strength, good elongation (to 1250%) and flexibility, low compression set and durometer range of 5 to 80 Shore A.

Electrical Properties
Silicones exceed all comparable material in their insulating properties as well as their versatility for electrical applications.

Clean Room Capabilities
Columbia manufactures and assembles components in a clean room for applications that require high cleanliness.
Molding Capabilities
Our Engineering staff and their vast experience in dealing with Silicone and producing custom Silicone products have enabled us to offer a comprehensive range of capabilities when fabricating a solution best suited for your product or application, some of these capabilities include:
Silicone Molding Capabilities - Liquid Injection, Transfer and Compression
Injection Molding
injection process the two part liquid silicone is injected into a mixer for homogenization and then directly into the mold cavity. Molding and vulcanization occur rapidly within the mold cavity at high temperatures shorting the overall time it takes to produce a part.
Injection molding offers many benefits in the fabrication of Silicone Rubber, including speed and cleanliness. In the
Injection Molding
Transfer Molding
Transfer Molding is a widely used practice in the Fabrication of Silicon rubber for use
in medical applications. Unlike Injection molding transfer molding is much more labor intensive and requires pre-mixing prior to being added to a mold cavity, and because this process takes place at lower temperatures than injection molding the operating cycles are longer.
Transfer Molding
Compression Molding
Compression Molding is similar to transfer molding, in that it is also a widely used practice in the fabrication of silicone rubber. Like transfer
molding compression molding is more labor intensive and requires pre-mixing of the rubber prior to being added to a mold cavity, and because this process also takes place at lower temperature than injection molding the operating cycles are again longer.
Compression Molding
Columbia's USP Class VI materials have been tested to the USP Class VI testing requirements which include: Toxicity Testing and Intracutaneous Toxicity. Columbia's products are sold as industrial grade products only, for use in non-implant devices. It is the customers responsibility to determine the suitability of Columbia's products for each specific application and to comply with all applicable statuary, regulatory and health care industry requirements and/or regulations.

Columbia's FDA "white list" materials are formulated entirely from ingredients listed in the Federal Regulation Title 21 "Food and Drugs," CFR 177.2600, "Rubber Articles Intended for Repeat Use," and have batch traceability. Please note that the FDA does not "approve" rubber compounds. It is the responsibility of the manufacturer to compound with food-grade materials from the FDA list of ingredients, as with all applications, customer(s) should test all components for the appropriateness for their specific application.

Viton ® is a registered trademarks of E. I. du Pont de Nemours and Company or affiliates
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