West Pharmaceutical Services : USP Particle Workshop – Addressing Issues and Improving Clarity
July 18, 2017 at 01:18 pm EDT
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USP Particle Workshop - Addressing Issues and Improving Clarity
United States Pharmacopeia (USP) held a two-day workshop, Control and Determination of Visible and Sub-Visible Particulate Matter in Biologics, June 26 & 27 at their Rockville (MD) site. This was the first USP particle workshop in several years; the robust attendance demonstrated that control of particles continues to be a major focus of the pharmaceutical industry.
A range of topics were covered:
Day-1
Inherent particle challenges with biologic drugs and cell therapy products
Safety impact of particles
Regulatory perspectives
Testing perspectives for biologic drugs
Day-2
Mitigation of particles during manufacturing
Control measures for packaging components
Particle formation during fill/finish
Risk-based approaches to visible particle inspection
Key take-aways were noted:
USP is planning to create a Chapter specific to a standard for particles in packaging components and administration systems.
NIST has completed the next generation of standards for protein particle testing (based upon abraded ETFE) - scheduled to be available in Fall-2017.
Upstream controls are extremely important - explaining why there is such a focus on mitigating particles on packaging components and other upstream processes that lead to the completed filled biologic drug (which is visually inspected at 100%).
Silicone oil use continues to be an area requiring better understanding, investigation, and control.
In respect to the biologic drug itself, 2-10 micron particles are important to understand, however the technology is still not strong in being able to accurately quantify particles at this size.
The issue of particles is challenging; clearly needed is a cross-industry approach, comprising industry, academia, regulators, and suppliers, to consider life-cycle management and improve clarity. West remains at the forefront of particle technology - active in organizations addressing them, and developing new methods to measure them - always with the focus of patient safety. To read more on particle technology visit West's Knowledge Center on our website.
West Pharmaceutical Services Inc. published this content on 18 July 2017 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 18 July 2017 17:33:12 UTC.
Original documenthttp://westpharma.com/en/blog/2017/July/usp-particle-workshop--addressing-issues-and-improving-clarity
Public permalinkhttp://www.publicnow.com/view/C411C4695868849CAD4F8AB2A79C1DE7FFD783D1
West Pharmaceutical Services, Inc. specializes in the design, manufacture and marketing of components and systems for the containment and delivery of injectable drugs. The group offers packaging, components for syringes, cartridge systems, auto-injection devices, accessories for vials, specialty components, etc. Net sales break down by family of products as follows:
- own manufactured products (81.8%);
- products manufactured under contract (18.2%).
Net sales are distributed geographically as follows: the United States (42.3%), Germany (16.8%), Ireland (8.7%), France (7.5%), Europe (12.1%) and other (12.6%).
WEST PHARMACEUTICAL SERVICES, INC. 
