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 in place with your company.
Precision Associates is a supply of Gallagher Fluid Seals.
Precision Associates was recently informed by one of their suppliers that it was discontinuing the supply of a polymer used in several of its FKM compounds as of June of 2022. Upon notification, Precision began procuring as much of the material as possible and began identifying suitable alternatives. Their evaluation is complete, and they were able to identify a suitable replacement and reformulated their 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.
They'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. They do not anticipate issues with 3A, or any of the other material standards but there will be an announcement if that changes.
Compound 9744 is the most widely-used compound impacted and was the first one to be reformulated.
Precision Associates 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 |
Precision's internal qualification for all reformulations will include:
- Internal testing of physical and processing characteristics to match as closely as possible to the original.
- Recertifying all reformulations to the same material standards as the original.
PAI is able to quote any additional qualification requirements you may have. As has always been the case, Precision and Gallagher Fluid Seals provide no assurance to you that the 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. Customers with open PO lines will need to update the POs to reference the replacement product prior to shipment.
Gallagher understands that changes in compound formulations can be a significant change and present some level of risk to your application.
Please feel free to contact us with any questions, or to discuss any additional qualification activity you may require.