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Category: Batchproductionrecords

Filling parts and accessories approved by the FDA

December 10, 2014 by Kristen Cifranic

The FDA requires certain filling parts and accessories to be approved for safety and identity. Do you know which filling parts and accessories must be FDA approved? See our list below: * Lot stickers are required by the FDA in order to identify the drug product in the event of a recall. The lack of the lot number causes the drug product to be misbranded. * FDA and NIOSH report that reusing single use washers, like nylon or plastic, can contribute to oxygen fires. Applied recommends using brass and Viton multiple use washers because they create a higher level of durability and safety when used in oxygen atmospheres. * Batch Production Records are one of the three types of written documents that a transfiller needs to keep. These records need to be kept on file for one year after the expiration of a batch (if an expiration date is used) or 3 years after the distribution of the batch if no expiration date is used.

Posted in Brassandvitonwashers, Fillingparts, Fillingaccessories, Lotstickers, Batchproductionrecords

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