FCN No. 325

Sartorius Stedim Chromatography Resins SAS

According to Section 409(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act, food contact substance notifications (FCNs) are effective only for the listed manufacturer and its customers. Other manufacturers must submit their own FCN for the same food contact substance and intended use.

• Food Contact Substance: 1-Propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-, monosodium salt, polymer with N,N'-methylene bis[2-propenamide], peroxydisulfuric acid ([(OH)S(O)₂]2O₂) diammonium salt-initiated (CAS Reg. No. 388567-01-9).
• Notifier: Biosepra SA, Division of Ciphergen Biosystems Inc.
• Manufacturer/Supplier: Sartorius Stedim Chromatography Resins SAS
• Intended Use: For repeated use as an ion exchange resin to absorb and purify enzymes and other proteins from sweet whey, nonfat milk, and milk at temperatures of 15°C or less.
• Limitations/Specifications: I. The temperature of the sweet whey or milk passing through the FCS must be maintained at 15°C or less. The flow of the whey or milk passing through the FCS for each cycle must not be less than 100 volumes per volume of resin, and the contact time must be less than 8 hours. II. The FCS must be washed and preconditioned prior to use and after each cycle as described in detail in the notification.
• Effective Date: Aug 2, 2003
• National Environmental Policy Act (NEPA)** Submission: Categorical Exclusion 25.32(j)
• FDA Decision: Categorical Exclusion Memo

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*See Food Types and Conditions of Use for Food Contact Substances (Tables 1 and 2).

**More about Environmental Decisions and Definitions of Environmental Terms.
See also Inventory of Environmental Impact Decisions for Food Contact Substance Notifications.

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