Transitioning to a continuous processing approach requires the implementation of an effective virus clearance strategy, which is intended to prevent various virus contaminations that could threaten patient safety.
Warm temperatures can denature some hormones and proteins thus causing cleaning problems. A critical cleaning company gives insight on how temperature can effect enzymatic and emulsifying activity in cleaning mechanisms.
The 2020 release of the EU GMP Annex 1 draft includes a new chapter on viable and non-viable environmental and process monitoring. Trend analysis and its impact on the contamination control strategy is now an essential activity referenced multiple times. There is also clear differentiation between qualification and monitoring, and quality risk management concepts are interwoven into each section.
It goes without saying that upgrades during a manufacturing shutdown pose less risk as there are no products being produced, but there are instances when it is critical to expand capacity or modify functionality while maintaining some processing. Following are a steps to help maintain control of production and changes—and demonstrate proof of control—while keeping the involved workers and the products safe.
The goal of cleanroom monitoring is to assess the potential contamination risk of the product. The latest Annex 1 draft has some new definitions and guidance regarding cleanroom classification, qualification, and monitoring.