M-Cor Inc. Compliances:

FDA and USP

Encapsulation :(PFA and FEP)

The FEP or PFA resins of which the clear encapsulation of the Encap-O-Seal o-ring is manufactured are 100% virgin resins. The FEP and PFA resins of which the FEP and PFA encapsulation of the Encap-O-Seal is produced consist of ingredients which are allowable under part 177 of Title 21 of the Food and Drug Administration’s regulations for safe use as articles or components of articles for producing, manufacturing, processing, preparing, treating, packing, transporting or holding food in accordance with regulation 177.1550.

The FEP and PFA resins of which the FEP and PFA encapsulation of the Encap-O-Seal o-ring is manufactured consist of 100% virgin FEP or PFA resins which are allowable ingredients under USP Class VI.

Elastomeric Energizers (Core Materials of the Encap-O-Seal O-ring)

The core material of the Encap-O-Seal o-ring is composed either of silicone (VMQ, MVQ), EPDM (see below), or FKM/FPM (Viton® or Viton®-equivalent) elastomers.

Core Material: FKM/FPM (~Viton®, 3M Dyneon)

  • Standard. The FKM/FPM (~Viton® grade A) core material of the standard Encap-O-Seal o-ring is manufactured of M-COR FKM compound MCOR7228-75KV. Where applicable, the FKM (~Viton® grade A) core material meets or exceeds AMS3216F, AMS D-2000 (SAE J-200), AMS 7280, AMS 7276 and the former MILR83248 specifications. The standard FKM (~Viton® grade A) core material is not manufactured of FDA or USP class VI allowable ingredients.
  • Special-Order FDA. Encap-O-Seal o-rings with FKM/FPM core material manufactured from compounds using ingredients that are allowable under FDA Title 21 CFR 177.2600 are available as special order items. Please enquire as necessary. Minimum orders apply.
  • Special-Order USP Class VI. Encap-O-Seal o-rings with FKM/FPM core material manufactured from compounds using ingredients that are allowable USP Class VI are available as special-order items. Please enquire as necessary. Minimum orders apply.
  • Special-Order FDA and USP Class VI. Encap-O-Seal o-rings with FKM/FPM core material manufactured from compounds using ingredients that are allowable under both FDA Title 21 CFR 177.2600 and USP Class VI are available as special-order items. Please enquire as necessary. Minimum orders apply.

Core Material: VMQ/MVQ (silicone)

The silicone (VMQ/MVQ) core material of the Encap-O-Seal o-ring is manufactured of silicone compound FPLTRD70-7B red 70 durometer rubber (white silicone is also available). This compound is manufactured of ingredients that are allowable under FDA Title 21 CFR 177.2600: “Rubber articles intended for repeated use may be safely used in producing, manufacturing, processing, preparing, treating, packaging, transporting, or holding food, subject to the provisions of this section. The standard silicone (VMQ/MVQ) core material of the Encap-O-Seal has not been tested for compliance with USP Class VI protocols.

Core Material: EPDM

The EPDM core material of the Encap-O-Seal o-ring is manufactured of EPDM compound 75-81385 75 durometer rubber. This compound is manufactured of ingredients which are allowable under FDA par 177 title 21 regulation 177.2600. The standard EPDM core material of the Encap-O-Seal has not been tested for compliance with USP Class VI protocols.

All M-COR parts and material conform to directives 2002/95/EG; 2005/717 (RoHS); 2003/11/EG; 94/4EG (ATEX). In addition all the materials used as intentional ingredients in the compounds and finished products used in M-COR’s Encap-O-Seal encapsulated o-rings, i.e., PFA, FEP, FKM/FPM, EPDM, and VMQ/MVQ conform to REACH Directive regulation (EC) 1907/2006. None of these materials contains the SoVHC banned or regulated under REACH.

Neither M-COR’s FEP/PFA Encapsulated FKM/FPM, VMQ or EPDM o-rings nor the material used in their manufacture contain any raw materials produced from animal derived origin (ADE-free/ADCF). Additionally, neither the Encap-O-Seal nor its components are derived from specific-risk materials as defined in European Commission Decision 97/534/EC (TSE-BSE). The manufacturing process does not use any ingredient of animal origin nor does our product come in contact with animal products during storage. We further declare that M-COR’s FEP and PFA encapsulated o-rings are Dioxine free.

DISCLAIMER: The information contained on this site is provided for informational purposes only and should not be construed as a recommendation by M-COR for use of our products in any particular application. The purchaser and/or end-user must thoroughly and independently test the Encap-O-Seal under actual end-use conditions and independently verify satisfactory performance of the product for its intended use before specifying it in any application.