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As regulatory standards evolve, the implementation of select technologies becomes vital to meet the requirements of cleanroom environments. In the latest update to the EU GMP Annex 1 in 2022, isolators have emerged as the preferred technology in aseptic fill finish processes to ensure ideal cleanroom conditions and minimize microbial contamination associated with human interventions.

In the ever-evolving pharmaceutical industry, ensuring the quality of products through rigorous aseptic process validation is paramount. This article, inspired by the insights from the “Aseptic Process Validation – A Risk-Based Approach” webinar featuring Shanshan Liu and Laura Noone of No deviation, dives into the critical aspects of Aseptic Process Validation. With a focus on

In this blog series, we’ll be exploring the concept of a Unified Knowledge Space, how it fits into Pharmaceutical Manufacturing, how you can implement it, and uncover its remarkable benefits. Part 1 – What is a Unified Knowledge Space (UKS)? Introduction You may or may not be familiar with the concept known as Unified Namespace