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- W4286610729 abstract "During manufacturing, process streams are chemically and physically altered to produce the finished drug product. Drug product production operations typically put the process stream into contact with polymeric manufacturing components such as filters, tubing, connectors, reactors, storage containers, and related items. During contact, chemicals may leach from the production equipment and into the process stream. If such leached substances persist in the process stream to the end of the manufacturing process, they are present in the drug product as process equipment-related leachables ( PERLs ). PERLs have the same potential of affecting drug product quality and safe use as do packaging-derived leachables and can additionally affect the success of the manufacturing process. Industry groups and the USP have developed aligned approaches to the chemical characterization of manufacturing components involving assessment of the leachables risk and the assignment of testing based on risk. These risk evaluation processes are described in this chapter, which also provides examples of their application. Risk-based testing strategies for the qualification of manufacturing components are discussed and case studies involving manufacturing extractables/leachables are provided, specifically addressing the circumstance of reactive PERLs." @default.
- W4286610729 created "2022-07-22" @default.
- W4286610729 date "2022-07-22" @default.
- W4286610729 modified "2023-10-16" @default.
- W4286610729 title "Applications – Pharmaceutical Drug Products – Manufacturing Components and Systems" @default.
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- W4286610729 doi "https://doi.org/10.1002/9781119605096.ch8" @default.
- W4286610729 hasPublicationYear "2022" @default.
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