Testing under USP <665> and USP <1665> focuses on understanding material behavior, identifying potential extractables, and evaluating leachables risk under defined conditions of use.
USP <665> & <1665> Testing
What Is USP <665>?
USP <665> outlines considerations for the characterization and qualification of plastic components and systems used in pharmaceutical manufacturing, including the identification of extractables and process equipment–related leachables (PERLs).
Testing under USP <665> is used to identify and characterize potential extractables through controlled studies. Once identified, extractables data supports a risk assessment to evaluate the likelihood of leaching under manufacturing conditions and to determine suitability for use.
Risk assessment under USP <665> considers individual risk contributors as well as cumulative risk, including factors such as leaching propensity, extraction conditions, and downstream process steps that may dilute or mitigate potential contaminants.
What Is USP <1665>?
USP <1665>, Characterization and Qualification of Plastic Components and Systems Used to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances and Products, provides scientific rationale and guidance for applying USP <665> in practice.
Testing under USP <1665> follows a risk-based approach, where the extent of characterization and qualification depends on factors such as material composition, contact conditions, duration of exposure, and the potential for purification steps to remove or reduce leachables. USP <1665> supports decision-making around study design, data interpretation, and overall qualification strategy.