USP <665> and USP <1665> have been created to address the risk of extractables and leachables (E&L) in plastic components and systems used in the manufacture of pharmaceutical products. These chapters of the USP especially focus on single use systems (SUS), which are increasingly in use in pharmaceutical drug manufacturing and pose a risk of contaminants and other materials leaching from the equipment.
Pharmaceutical drug manufacturing products that USP <665> and USP <1665> may include are polymeric plastic bioprocessing bags, tubing, valves, connectors, sampling equipment, filtration cassettes, and more. The single-use plastic variants of these products are increasingly in demand due to efficiency and cost benefits but must be tested to ensure that components of the plastic do not leach, which can pose a danger to end users.
