USP <665> & <1665>

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.

What Is USP <665>?

USP <665> outlines considerations for characterizing and qualifying plastic components — extractables or process equipment-related leachables (PERLs) — in pharmaceutical manufacturing equipment. Under USP <665>, potential extractables must be identified and characterized through testing. Once extractables have been identified, the risk of leaching must then be assessed to determine suitability and conditions for use.

Risk assessment, per the USP, entails assessing individual risk contributors as well as total risk as a combination of individual factors. For USP <665>, the assessment should gauge the propensity for leaching, leaching power, and any downstream processes that may dilute the presence of contaminants and mitigate risk.

USP <665> testing should generally involve exposure to extreme high and low temperatures as well as solvents.

What Is USP <1665>?

USP chapter <1665> is defined as the Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products. This USP chapter includes information about the correct use of USP <665>, as well as rationale for these relatively recent additions to the USP.

BA Sciences offers a full range of testing, qualification, and validation services for laboratory facilities and can help you meet the requirements of USP <665> and USP <1665>. We feature state-of-the art processes and equipment with expertise in testing and analysis. We also offer BPOG protocol testing, a collaborative industry protocol with proven processes to meet the requirements of USP <665> and <1665>. To learn more, contact us today.

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