This is a notification of a planned reformulation of several of the Precision Associates, Inc. (PAI) FDA Fluorocarbon compounds. This notification is intended to meet the change notification requirements included in any quality or supply agreements we have in place with your company. If no agreement is in place, we are fulfilling our commitment to providing the highest levels of quality and service.

We were recently informed by one of our suppliers that it was discontinuing the supply of a polymer used in several of our FKM compounds as of June of 2022. Upon notification, we began procuring as much of the material as possible and began identifying suitable alternatives. Our evaluation is complete, and we were able to identify a suitable replacement and reformulated our compounds.

The various compounds we are reformulating are certified to a variety of material standards, most notably (FDA) 21 CFR 177.2600, and 3A sanitary standards.

We’ve determined that these new compounds will be (FDA) 21 CFR 177.2600 compliant and will certify them as such. Assuring 3A sanitary compliance is a lengthier process and is currently underway. We do not anticipate issues with 3A, or any of the other material standards but will inform you if that changes.

Compound 9744 is the most widely-used compound impacted and was the first one to be reformulated. Datasheets for it, and its replacement are found in the links below. Data sheets for other compounds will be provided as needed.

We will be replacing the existing list of compounds with new compound numbers, which will result in new PAI product numbers. A reference table showing the current compound number and the replacement is shown below.

FKM reformulation table

The table below identifies the compounds which are being reformulated. The table shows both the current PAI Compound number and the replacement.

Existing PAI Compound New Compound
9744 10744
9765 10765
9844 10844
9737 10737
9944 10944
9771 10771
9937 10937
9770 10770
9965 10965
9871 10871
609910 610910
9971 10971
9926 10926
9837 10837
609710 610710
609711 610711
9870 10870
9970 10970


Our internal qualification for all reformulations will include:

  1. Internal testing of physical and processing characteristics to match as closely as possible to the original.
  2. Recertifying all reformulations to the same material standards as the original.

PAI would be happy to quote any additional qualification requirements you may have. As has always been the case, we provide no assurance to you that our compounds are suitable for your application, or that they will meet your performance standards. You are responsible for those qualifications.

PAI intends to begin producing and shipping product produced from replacement polymers as early as 6/1/22. We will require customers with open PO lines to update them to reference our replacement product prior to shipment. Our customer service team will be in touch to request these changes in the coming weeks.

We understand that changes in compound formulations are not insignificant and present some level of risk to your application. We regret the decision made by our supplier to discontinue this critical polymer, and the position this has put your company and PAI in. We feel we have done everything in our power to bring you a solution to this problem as quickly and effectively as possible.

Please feel free to contact us with any questions, or to discuss any additional qualification activity you may require.

REFERENCE DOCUMENTS