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 ...
The authors present a simple way to qualify a swab-sampling procedure for its ability to recover residues of a small-molecule API from cleaned equipment surfaces. Spiking studies were specifically ...
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 ...
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