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.
FDA and NIOSH report that reusing single use washers, like nylon or plastic, can contribute to fires.Applied recommends using Brass and Vitonwashers when reusing washers. When used more than once, the Nylon crush gaskets require higher torque than the elastomeric sealing washers in order to seal the cylinder valve / regulator interface, and if they are used again, they require more torque with each successive use. The cylinder valve / regulator connection is designed to be hand-tightened. If the crush gaskets are re-used, the need for increased torque may require using a wrench or other hand tool, which can deform the crush gasket and damage the cylinder valve and regulator. This can result in leakage of oxygen past the cylinder valve seat and across the nylon crush gasket. According to a forensic analysis supported by FDA and NIOSH, flow friction caused by this leakage of compressed oxygen across the surface of the crush gasket may produce enough thermal energy to spontaneously ignite