Created by: John O’Neill, Editor, StabilityHub.com Stability excursions are unintended lapses in the control parameters (such as temperature, relative humidity, and light) which are designed to preserve a product at experimental, manufacturing, shipping, and patient environment conditions. Significant excursions bring into doubt the validity of data generated in stability studies and the integrity of product […]

Created by: Matthew Jackson, Validation Manager, Torbay Pharmaceuticals This article was based on my session, Cleaning Validation Program Design: Risk-based Lifecycle Approach, delivered at the KENX’s Cleanroom Validation, Disinfection & Environmental Monitoring Conference April 27-29, 2022 Virtually and in person in Philadelphia, PA. KENX’s hybrid conferences highlight those paving the way in best practices in […]

Created by: Fred Ohsiek, Senior Global Technical Manager, Life Science (Cleaning Validation) for Ecolab in North America Developing an automated clean-in-place (CIP) recipe is a challenging activity for project such as a new facility, equipment or wing addition to an existing facility, a new product, or optimizing a legacy cleaning process. This article will focus […]