Applied Cleaning Validation Practices: A STERIS Master Class process

This two-day intensive course presented by invited industry experts will cover industry
practices, regulatory expectations, and trends in cleaning and cleaning validation. It is
designed for biopharmaceutical manufacturers who are concerned about developing or
maintaining a high-quality, efficient, and most importantly, compliant cleaning process.
The training will address several current challenges to cleaning and validation in the
biopharmaceutical industry and include case studies, best practices, and hands-on
exercises using state-of-the-art bioprocessing equipment located in the BTEC facility. The
course will cover numerous topics, including the following:

• Lifecycle approach to cleaning validation
• Cleaning chemistries and application parameters
• Laboratory studies and scale-up
• CIP, COP, manual cleaning methods
• Process and engineering issues
• Cleaning process equipment—bioreactors, rings, membranes
• Cycle development
• Process design and qualification
• Setting acceptance criteria
• Rinse and swab sampling
• Analytical methods and validation
• Protocols, grouping strategies
• Dedicated equipment and campaigns
• Continuous improvement
• Stainless steel maintenance
• Bioburden and biofilms
• Global regulatory documents and citations