Particulate Control in Parenteral Drug Delivery Devices

Particulate contamination in parenteral drug delivery devices poses significant risks to patient safety, including embolism, phlebitis, and granuloma formation. Multiple regulatory standards establish requirements for particulate matter control across different device types and administration routes. ISO 11040 series address prefilled syringes for pharmaceutical use with specific requirements for container closure integrity, extractables and leachables, and particulate contamination limits aligned with pharmacopeial requirements. ISO 11608 series cover pen injectors and autoinjectors for self-administration with general requirements including particulate control during device operation, including design features to minimize particle generation from device components and during activation. ISO 8536-4 addresses infusion sets for single use with requirement for particles. This framework ensures comprehensive particulate control across various drug delivery platforms, protecting patient safety while maintaining product quality throughout the supply chain.

Presented by Rong Guo, Senior Reviewer at CDRH/FDA

Rong Guo is a senior reviewer focusing on device constituents in combination products and standalone injection/infusion and general hospital devices at CDRH/FDA. She is an US expert on several ISO standards committees including syringes, needles, and needle-based injection systems. Prior to joining CDRH, she is FDA/NCI Interagency Oncology Taskforce Fellowship recipient and worked as a CMC reviewer at CDER/FDA. She received her PhD from University of Maryland College Park in molecular virology.

Followed by a live question and answers session