USP Class VI O-Rings Pharmaceutical Grade Medical O-Rings

USP Class VI O-Rings Pharmaceutical Grade Medical O-Rings

USP Class VI O-Rings - United States Pharmacopeia

Marco Rubber manufacturers USP Class VI medical O-rings and medical grade seals in various rubber elastomers, including EPDM, silicone, Viton® and Markez® FFKM. Manufacturing and packaging in Clean Rooms is available with some compounds for the most critical applications.

The United States Pharmacopeia (USP) is a non-government organization that promotes public health by establishing state-of-the-art standards to ensure the quality of medicines and other health care technologies. While this organization is concerned with the pharmaceutical and bio-technology industries, many manufacturers of hygienic equipment will be designing multipurpose designs that may be used in a range of different industry sectors. Standards are published in the US Pharmacopeias and the National Formulary (USP NF). Compliance to USP Class VI is often requested by end users. Testing for compliance involves an assessment of the effects of the material, and extractable, on tissue.

United States Pharmacopeia USP 26, NF21, 2003 Class VI Two types of biological reactivity test are applicable to elastomers, plastics and polymeric materials; Chapter <87> involves in vitro testing and Chapter <88> involves in vivo testing.

An additional requirement some of our O-Rings and materials meet is free from animal derived ingredients (ADI-free).

Pharmaceutical, food and water processing industries present many demanding sealing applications. Unlike other industries where chemical or temperature resistance is the key seal selection criteria, food and pharmaceutical applications can add the requirement of cleanliness and regulatory challenges. Elastomer seals used in process equipment, pumps, valves, pipe work, couplings, reaction vessels and bulk containers must be able to cope with a wide range of process media, potent active pharmaceutical ingredients (APIs) and aggressive cleaning and sterilizing processes. In addition, seals must be compliant with a growing range of legislative manufacturing regulations and hygiene standards. Marco Rubber offers a comprehensive range of sealing solutions compliant with the requirements of the Food and Drug Administration (FDA), United States Pharmacopeia - Class VI (USP Class VI) and 3-A Sanitary standards, as well as Good Manufacturing Practice (GMP) quality criteria. In addition to industry-standard Elastomers such as EPDM and silicone, Marco offers Markez® Perfluoroelastomers for extreme operating conditions, we also offer a range of FKM materials that are compliant or approved to different regulatory standards.

O-rings and Gaskets

Popular Compounds

Contact us for help selecting from these and the many more available.

CPD# MATERIAL DUROMETER (SHORE A) COLOR LOW TEMP (F) HIGH TEMP (F) FDA* USP CLASS VI** NSF61 USDA 3A METAL DETECTABLE
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E1000 EPDM 70 Black -65 300 checkmark checkmark
Peroxide cured EPDM, Different Durometer , KTW, WRAS standards available
E1074 EPDM 70 White -65 300 checkmark checkmark checkmark
Wide range of compliance
E1080 EPDM 70 Black -40 250 checkmark checkmark checkmark
Wide range of compliance
E1097 EPDM 70 Black -65 300 checkmark checkmark checkmark
Formulated for Chloramine Resistance. Can be manufactured in custom shapes with minimal setup charge.
B1002 NBR 70 Black -30 250 checkmark
Available in many durometers and colors
B1039 NBR 70 White -30 250 checkmark
Available in many durometers and colors
B1058 NBR 70 Black -30 250 checkmark checkmark
KTW, WRAS and other standards available.
B1105 NBR 70 Black -30 250 checkmark checkmark
Metal detectable for contamination detection sensors(additional colors available)
S1000 VMQ 70 Orange -75 400 checkmark
Available in many durometers and colors
S1020 VMQ 70 Clear Translucent -75 400 checkmark
Clear Translucent, available in many durometer and color choices.
S1037 VMQ 70 Clear Translucent -75 400 checkmark checkmark
Clean room manufactured, platinum cured (specific base materials and cleanroom packaging options available)
S1083 VMQ 70 Clear Translucent -65 400 checkmark checkmark
Commercial manufactured, platinum cured (cleanroom manufacturing and packaging options available)
S1146 VMQ 70 White -75 480 checkmark checkmark
Cleanroom manufactured, Lower cost than clear
V1039 FKM 75 White -15 437 checkmark checkmark
Cleanroom manufacturing and packaging options available
V1118 FKM 70 White -15 437 checkmark checkmark checkmark
Steam Resistant Terpolymer, Also available in black
V1148 FKM 70 Black -15 392 checkmark checkmark
Metal detectable for contamination detection(additional colors available)
Z2001 FFKM 80 Black 1 610 checkmark checkmark
Ultimate nearly univeral chemical compatibility FDA and USP medical grade FFKM, Higher temperature steam resistance, acid, amines, solvents, compresion set resistance, high pressure AED rapid decompression. Compare to Kalrez® 6230, Kalrez® LS222
Z2004 FFKM 75 Black 5 430 checkmark checkmark
Low cost performance value, nearly universal chemical compatibility, acid, amines, solvents, compression set resistance, FDA compliant and USP Class VI medical grade. Compare to Kalrez® 6230, Kalrez® LS222
Z2000 FFKM 75 Black 5 635 checkmark
 Highest temperature FFKM with best long term compression set resistance up to 335ºC, short exposures up to 350ºC, Low sticking force, semicon metallic clean, low outgassing, wide range of chemical acid, solvent resistance, FDA compliant. Compare to Kalrez® 7075, Kalrez® 4079, Kalrez® 8900
Z1318 FFKM 75 White 5 500 checkmark checkmark
USP Class VI and FDA compliant white FFKM with wide range compatibility. Compare to Kalrez® 6221, Kalrez® LS205, Chemraz® 625

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*FDA compliance per 21 CFR 177.2600 parts A-D, E&F approved compounds available upon request. **USP <87> and USP <88> approved compounds available upon request.
The temperature ranges presented above are approximations for dry air service only and should not be used to determine design specifications or end-use temperature limits. Actual temperature range of a compound in an end-use application is highly dependent on part type, hardware configuration, applied forces, chemical media, pressure and thermal cycling effects, and other factors. The most practical way of determining an end-use temperature range is testing in the actual application conditions. Consult a Marco Engineer for more details.

New Customer Hotline: 800-775-6525

Existing Customer Specialist: 800-775-6525 or repeat customers

Marco Rubber & Plastics
PO Box 1150
Seabrook, NH 03874

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