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.