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.

Industry View on Particulate Control in Parenteral Drug Delivery Devices

Following the regulatory perspective, West will provide an industry view on particulate control from the standpoint of primary packaging components and syringe-based drug delivery systems. This part of the webinar will explore how particulate matter can be introduced, controlled, and assessed across the lifecycle of parenteral drug delivery systems: from component and material selection through manufacturing, assembly, testing, and final use.

The presentation will also provide further insight into PDA TR 85 on visible particles, which includes approaches for extracting particles from components and evaluating them using appropriate test methods, statistical tools that can be used to demonstrate consistency between operators, as well as considerations for inspecting glass components prior to filling. In addition, the session will discuss the advantages and limitations of commonly used particulate test methods, such as light obscuration and other analytical techniques. The presentation will also review relevant standards and guidance used for product and component evaluation, including ISO 8871-3 for particle testing of elastomeric closures, USP <382>, ISO 11040 for prefilled syringes, and ISO 11608 for needle-based injection systems. Special attention will be given to silicone oil-related particles and the challenges of particle differentiation when transitioning from vial-based formats to prefilled syringe systems. The session will include discussion of fluid imaging and emerging software-enabled tools that may support improved particle characterization.

The presentation will conclude with a risk-based view of particulate control, connecting component design, material selection, manufacturing controls, product verification, and system-level performance.

Dr. Bettine Boltres, Director Scientific Affairs, Integrated Systems at West Pharmaceutical Services, Inc

As Director Scientific Affairs, Integrated Systems, Dr. Bettine Boltres is supporting the scientific exchange between West and the pharmaceutical industry. This is complementing her work as Product Manager for Schott Pharmaceutical Tubing, where she provided scientific consulting for glass primary packaging. Bettine is anactive member of the USP Packaging and Distribution Expert Committee, the European Pharmacopoeia Commission Group of Experts 16 (elastomers and plastics) and the GLS Working Party (glass). She is member of the ISO Working Group 4 (Elastomers) and Working Group 2 (glass). Additionally, Bettine is on the PDA Board of Directors and in 2015 she published the book “When Glass Meets Pharma”, which builds the bridge between glass for pharmaceutical primary packaging and drug substances. Dr. Boltres is a (bio)chemist by training, receiving a diploma in chemistry from the university of Frankfurt, Germany and a PhD in biochemistry from the university of Cologne, Germany.

John Rech, Technology Manager – Particle – Analytical Services at West Pharmaceutical Services, Inc

John Rech is a Technology Manager at West Pharmaceutical Services, Inc. John’s role as a technology manager involves managing scientific projects, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams to develop and drive scientific strategies. Additionally the role requires engaging with external stakeholders including regulatory agencies, business partners and standard setting organizations. To that end, John is participating in a number of standard setting organizations such as ASTM, AAMI, ISO, ISPE and the PDA. Additionally, the role involves attending and occasionally presenting at relevant conferences to ensure that West is ahead of industry trends and evolving cGMP requirements. Prior to working at West, John has 12 years of experience working in the pharmaceutical industry and has experience with experience in chromatography method development and validation, physical testing, metrology, and packaging validation. John Rech has a Bachelor of Science degree in Biology from Kutztown University

Followed by a live question and answers session

Sponsored by West Pharmaceutical Services, Inc

About West
West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With over 10,000 team members across 50 sites including 25 manufacturing facilities worldwide, West helps support our customers by delivering over 41 billion components and devices each year. Headquartered in Exton, Pennsylvania, West in its fiscal year 2025 generated $3.07 billion in net sales. West is traded on the New York Stock Exchange (NYSE: WST) and is included in the Standard & Poor’s 500 index. For more information, visit www.westpharma.com.