1. Scope

Keywords

Rationale

Usually, the USP <788> test method and specifications for particulates in final parenteral drug products is "force fit" to the measurement and specification of levels of particulate matter in single-use systems used in biopharmaceutical manufacturing. The USP <788> does not describe how particles are extracted from the surfaces of single-use systems. In addition, application of the "large volume parenteral" (LVP) specifications in USP <788> may or may not be relevant for single-use systems. In addition, LVP specifications are per mL of drug product, and not per a specification (per device, per nominal volume, per surface area) applicable to a single-use system. Test methods for particulate count and sizes on the surfaces of single-use systems require specification and validation of (1) Liquid extraction of the surfaces of single-use assemblies which generates a test liquid (a suspension of particles in liquid), (2) Method for determination of the particle count and particle sizes in the test liquid, and (3) Requirements for reporting of test results. Out of scope is a detailed specification of the test method procedure (extraction procedure, count/size method), and specification of allowable particle level (counts/sizes) for single-use systems.