Because conventional cleaning methods can risk product loss, biopharmaceutical manufacturers are often reluctant to use PDE/ADE limits to validate cleaning processes. Cleaning validation for biologics ...

Developing a cleaning validation for a reusable medical device presents several challenges. How are you addressing them? "There have been many issues over the last 7 years, so there's increased ...

In applying a visually clean standard, any residue related to the cleaning process that is visible on the surface should constitute a failure. There are eight 'myths' surrounding cleaning validation ...

Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

This is a practical based course. We explore the issues and pitfalls you may experience when performing Cleaning Validation. Help, guidance and training is given on techniques to overcome the issues ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...

The pharmaceutical industry is undergoing a transformative era driven by increasingly stringent global regulatory requirements, significantly impacting operational processes, particularly those ...