This webinar will cover the following topics:
Regulatory Requirements: Contamination Control Strategy & Cross Contamination
• The view of EU GMP Annex 1
• The view of US-FDA: Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice
• ASTM – Clean by Design
• Shared facilities regulations
• Contamination and sterile products
Sources of Contamination – Modes of Cross Contamination – Segregation
• Do different sources mean different impact?
• Where cross contamination could occur and different likelihoods
• Is segregation a no brainer?
• Cross contamination in issues
Cross Contamination through poor Equipment Design
• Cleanability of equipment as the key to avoiding cross contamination
• In-line cleanability? – Cleanability for parts that are disassembled?
• Importance of drainability (cross-contamination by product and detergent residues)
• Gap-free and dead-space-free design of system components
• Components (connections, valves, pumps, sensors)
• Mixing and preparation vessels, bioreactors
• Cross-contamination due to lack of technical support
• Deterioration of surface Quality
• Wear of static and dynamic seals
Cross Contamination through poor Organization
• Organizational points to consider.
• The human factor
• The importance of training and motivation
Cleaning & Cleaning Validation
• Risk Assessment
• Poor Cleaning – main reason for cross contamination
• Dealing with multipurpose strategies in cross contamination Control
• Cross Contamination – main focus of cleaning validation
• Selection of Cleaning Agents – Worst Case Soiling
• Developing Disinfectant Efficacy Studies
Documentation: CCS, HBEL assessment, QRM
• Cross contamination control and CCS
• Cleaning validation
• Cross contamination control – it is all about QRM
