Compliance

Compliance

For pharmaceutical, medical devices, and hygienic fluid handling customers, Greene Tweed’s specialty compounds with their low leachable profile maintain their inert nature and chemical resistance, satisfying regulatory compliance under the most demanding conditions. Greene Tweed’s in-house prototype and testing capabilities enable a close collaboration with customers and ensure the industry’s rigorous quality standards are met or exceeded.

Several of Greene Tweed’s elastomers, including various grades of Chemraz® (FFKM), Fusion™ (FKM), and Fluoraz® (FEPM), are FDA 21 CFR, USP Class VI, 3-A Sanitary compliant, and ADI free, and have been subjected to extensive third-party testing.

Greene Tweed’s expansion in the Life Sciences market ensures continued innovation in research and design, enabling the company to engineer the industry’s next-generation sealing, thermoplastic, and composite technology.

Note: Please contact Greene Tweed for specific compliance questions, third-party testing, or supplier certifications.

 

  FDA USP Class VI

Material Family
Tradename Compound Description Color Compliant Reg. 21 CFR In-Vivo <88> In-Vitro <87>
FKM Fusion™ 716 70 Shore A Black 177.2600
FEPM Fluoraz® 890 80 Shore A Black 177.2400
(FCN 000246)
FFKM Chemraz® SD517 80 Shore A White 177.2400
(FCN 000247)
SD585 80 Shore A Cream 177.2400
(FCN 000247)
SD625 80 Shore A Black 177.2400
(FCN 000245)

 

  FDA USP Class VI

Material Family
Tradename Compound Description Color Compliant Reg. 21 CFR In-Vivo <88> In-Vitro <87>
PTFE Avalon® 01 Virgin PTFE White * 177.1550 * *
87WS 5% glass-modified PTFE White 177.1550 & GRAS
56 Virgin-modified PTFE White * 177.1550 * *
PEEK Arlon® 1000 Virgin PEEK Tan * 177.2415 * *
1330 PEEK Tan * 177.1550
177.2415
* *

 

* Please contact Greene Tweed for specific compliance questions, third-party testing, or supplier certifications.



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