USP788 Requirements & Solutions
Release of parental drugs for injection requires the test apparatus to be accurate, precise, reliable, and compliant with the latest international regulations, including
USP788.
Learning how to keep a light obscuration particle counter under continuous control, guaranteeing steady performance, is the key to commercializing quality products and ensuring patient safety.
The on-demand webinar below will cover the key international controls, specifically USP 788, to properly perform particle count testing in injectable liquids; including instruction and best practices to run meaningful and frequent suitability tests.
Skip to the end for a demo of the APSS 2000 particle counter.
Daniele Pandolfi is the Global Product Line Manager, Aerosol in Particle Measuring Systems’ Life Science Division. He has over eleven years’ experience in particle counter instrumentation and cleanroom contamination control, focusing on strong customer relationships. He has helped many cleanroom users solve their cGMP issues. Mr. Pandolfi has been responsible for the EMEA Service Department, and a member of the Global Life Science organization since 2015.
Heather Mason is a Microbial Specialist working with the America’s Sales Managers at Particle Measuring Systems, providing insight and customer assistance with microbial monitoring process and products. Before joining PMS, Heather worked over 10 years as a pharmaceutical Quality Control Manager for a vaccine company and as Quality Manager for a solid oral dose pharmaceutical manufacturing company.
