Life Science - FDA - Medical Grade USP Class VI - Metal Detectable NSF61 Drinking Water - USDA 3A


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.

Popular Products:

  • O-rings, Micro and Giant
  • Tri-Clamp Gaskets or Sanitary gaskets
  • PTFE encapsulated O-rings
  • X-rings and washers
  • Custom Molded

Popular Materials:

  • FDA Compliant per CFR 21.177.2600
  • USP Class VI Approved
  • 3A Dairy Compliance
  • NSF61, KTW and WRAS Approved
  • Metal Detectable Materials
  • ADI Free Materials
  • LIM silicone per customer specification
  • Clean Room Manufacturing and Packaging

Popular Compounds

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

P/N Material Durometer (Shore A) Color Temp Low F Temp High F FDA* USP Class VI** NSF61 USDA 3A Metal Detectable
E1000 View Datasheet EPDM 70 Black -65 300      
  Peroxide cured EPDM, Different Durometer , KTW, WRAS standards available
E1074 View Datasheet EPDM 70 White -65 300    
  Wide range of compliance
E1080 View Datasheet EPDM 70 Black -40 250    
  Wide range of compliance
E1097 View Datasheet EPDM 70 Black -65 300    
  Formulated for Chloramine Resistance. Can be manufactured in custom shapes with minimal setup charge.
B1002 View Datasheet NBR 70 Black -30 250        
  Available in many durometers and colors
B1039 View Datasheet NBR 70 White -30 250        
  Available in many durometers and colors
B1058 View Datasheet NBR 70 Black -30 250      
  KTW, WRAS and other standards available.
B1105 View Datasheet NBR 70 Black -30 250      
  Metal detectable for contamination detection sensors(additional colors available)
P/N Material Durometer (Shore A) Color Temp Low F Temp High F FDA* USP Class VI** NSF61 USDA 3A Metal Detectable
S1000 View Datasheet VMQ 70 Orange -75 400        
  Available in many durometers and colors
S1020 View Datasheet VMQ 70 Clear Translucent -75 400        
  Clear Translucent, available in many durometer and color choices.
S1037 View Datasheet VMQ 70 Clear Translucent -75 400      
  Clean room manufactured, platinum cured (specific base materials and cleanroom packaging options available)
S1083 View Datasheet VMQ 70 Clear Translucent -65 400      
  Commercial manufactured, platinum cured (cleanroom manufacturing and packaging options available)
S1146 View Datasheet VMQ 70 White -75 480      
  Cleanroom manufactured, Lower cost than clear
V1039 View Datasheet FKM 75 White -15 437      
  Cleanroom manufacturing and packaging options available
V1118 View Datasheet FKM 70 White -15 437    
  Steam Resistant Terpolymer, Also available in black
V1148 View Datasheet FKM 70 Black -15 392      
  Metal detectable for contamination detection(additional colors available)
Z1204 View Datasheet FFKM 75 Black 20 450      
  Least expensive for standard sizes  Alternative to Kalrez® 6230
Z1409 View Datasheet FFKM 75 Black -4 500        
  Greater temperate resistance range, Alternative to Kalrez® 6230
Z1318 View Datasheet FFKM 75 White 5 500    
  Least expensive for standard sizes Alternative to Kalrez® 6221
Z1305 View Datasheet FFKM 80 White 5 590    
  Greater temperate resistance range,  Alternative to Kalrez® 6221
P/N Material Durometer (Shore A) Color Temp Low F Temp High F FDA* USP Class VI** NSF61 USDA 3A Metal Detectable

*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.


Metal Detectable O-rings and X-Ray Inspectable Materials

Over time and repeated CIP, sterilization, and processing equipment components in food, beverage, and pharmaceutical processing equipment can degrade.  As elastomer seals degrade, there is a high risk of rubber fragment contamination.  Metal detectable O-rings and Seals are designed to work with Inline X-ray detection, Metal detection and Magnetic separator equipment for immediate contamination alert.  Different base materials like FKM, Silicone, EPDM and Buna-N are filled with a unique combination of magnetic metallic fillers so easily detectable allowing systems to quickly reject contaminated product and trigger equipment PM to drastically reduce the potential of contamination of the final product.

We have found the metal detectable O-Ring and Seal market is NOT one material fits all detection equipment and requirements.  If the more popular materials do not work, Marco Rubber is equipped to offer fast prototype runs of custom formulated materials to confirm performance.Metal detectable seals are offered in O-rings, X-rings, Sanitary and clamp gaskets and any custom shape desired.

US Pharmacopeia (USP NF) Class VI

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 extractables, 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.

Marco Rubber manufacturers USP Class VI compliant O-rings and seals in various elastomer types, including EPDM, silicone, FKM (Viton) and Markez ®FFKM.  Manufacturing and packaging in Clean Rooms is available with some compounds for the most critical applications.

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

Food and Drug Administration (FDA CFR 21) - FDA O-Rings

The Food and Drug Administration is the US Federal Agency responsible for ensuring that food safety, wholesome and sanitary; human and veterinary drugs, biological products and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe.

Although the jurisdiction of the FDA is restricted to the United States, FDA regulations are commonly adopted as international control standards. Through its Codes of Federal Regulations the FDA manages a list of materials and chemicals that are approved for contact with foods. FDA CFR 21.177.2600 paragraphs A through D describe the relevant regulations for ‘Rubber articles intended for repeated use’. This lists the ingredients, and any quantitative limits, that may be used in a rubber compounds for molded products intended for repeated use in all stages of food manufacture, preparation and transportation.

FDA CFR 21.177.2600 paragraphs E and F also specify limits on extractible products if the FDA rubber seal is to be used in contact with aqueous or fatty foods. The regulation specifies extraction test limits in water and n-hexane. It is important to note that for an FDA rubber material to be compliant to these requirements, and then this claim must be supported with appropriate documentation such as a manufacturer’s FDA Compliance Certificate.

FDA does not ‘approve’ products to CFR 21.177.2600. It is for the manufacturer of the finished FDA rubber product to demonstrate compliance by issuing a FDA certificate. It is also important to note that whilst a component may be made from a FDA rubber material that is suitable for food contact; this does not mean that the part is technically suitable for its intended application.

Marco Rubber manufactures O-rings, hygienic gaskets and custom-designed components from a range of FDA-compliant rubber materials, including NBR, EPDM, Silicone, HNBR, FKM (Viton), and Markez ®FFKM.

Class of use for rubber articles


FDA requirementFDA requirement

Limit for extractives

Dry foods

Must be formulated and cured under
conditions of good manufacturing
practice as to be suitable for repeated use.

No specified test

Aqueous foods

Must meet extraction test criteria
(distilled water at reflux temperature).

First 7 hours: Not exceeding 20mg per square inch.
Next 2 hours: Not exceeding 20mg per square inch.

Fatty foods

Must meet extraction test criteria
(n-hexane at reflux temperature).

>First 7 hours: Not exceeding 175mg per square inch.
Next 2 hours: Not exceeding 4mg per square inch.

More information:

Potable Water Standards

NSF/ANSI Standard 61 is an US Standard issued by the National Sanitation Foundation which defines the acceptable levels of contaminating substances and impurities that may leach or migrate from components and devices into drinking water systems. Marco Rubber stocks NSF61 compliant O-rings but also supplies a variety of NSF 61 compliant materials in standard and non-standard configurations, please contact our sales and engineering.

WRAS - Water Regulations Advisory Scheme
Materials approved for British drinking water applications in the United Kingdom must satisfy the requirement of BS6920 for the Water Regulations Advisory Scheme. The testing regime for WRAS approval is different to FDA testing, in that it requires that elastomer products must also be tested to ensure that they do not promote the propagation of bacteria.

In Germany, KTW specifies the requirements of elastomers in potable water as set out by the German Technical and Scientific Association for Gas and Water (DVGW) in the regulation "Arbeitsblatt W270".  Drinking water approvals vary from country to country, although it is common for one country to use a material that has been approved under the standard of another country. Our Technical Team can advise on which products are suitable for drinking water applications against a number of national standards.

ACS XP P 41-250

Attestation de conformité sanitaire ACS XP P 41-250 is a system developed by the French health authorities to evaluate and certify the sanitary conformity and suitability of products which come into contact with drinking water destined for human consumption

3-A Sanitary Standard (Dairy)

Marco Rubber manufactures O-rings, Clamp gaskets/Hygienic gaskets and custom components in accordance with 3-A Standard 18-03 “3-A Sanitary Standards for multiple-use rubber and rubber-like materials used as product contact surfaces in dairy equipment”, defining requirements for food quality materials that must also be suitable for cleaning and sanitizing solutions.

Formed by the US food and Dairy industry, 3-A Sanitary Standards Inc. defines specifications and best practice for the design, manufacture, installation and use of hygienic equipment. As with FDA, the 3-A standards are adopted on a worldwide basis.

Marco Rubber elastomers meeting the 3-A standard include EPDM, silicone, FKM (Viton) and Markez® allowing equipment manufacturers/users to select the most appropriate elastomer to temperature, chemical and physical performance criteria.

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