Why It Is Important:
Companies that perform manual, automated or CIP cleaning of their production equipment are required to demonstrate compliance with regulatory requirements for effective removal of residues. Still many of these companies use historical limits and complex test methods.
Testing rinse water or swab samples is a common technique in bio-pharmaceutical manufacturing to ensure the cleaning process removes residues to a safe limit. The quality of these is mandated by global regulatory bodies to define limits based on toxicological evaluations and specified testing requirements. This talk is designed to help companies understand that cleaning needs to be looked at as an ongoing process, including continuous monitoring to ensure removal of all product and cleaning residues and removal of any potential contaminants. Testing for TOC and Conductivity in the laboratory, at-line or online can be acceptable methods to achieve compliance to the current guidelines and enhance the turnaround time of production equipment.
Who should attend:
- QA/QC Manager
- Validation Manager
- Lab Manager
- Production Manager
- Validation Engineer
- Automation Engineer
- Facilities Manager
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