PTI - international

Agenda: Day Two

V. Establish Effective Cleaning Methods

• Understand the theory of how residues are removed from equipment surfaces
  • determine when acidic and basic cleaning is appropriate and useful
  • understand the role of surfactants and detergents in cleaning
  • determine the quality of water to be used
  • learn when to utilize nonaqueous cleaning solvents
• Determine the types of cleaning techniques available (Manual, COP, CIP)
• Manual cleaning:
  • cleaning aids and devices available
  • identify critical cleaning parameters for manual cleaning
  • importance of training for achieving reproducible manual cleaning
• Semi-automated cleaning (COP):
  • develop familiarity with available washing machines and how used
  • importance of the loading pattern
• Automated cleaning (CIP):
  • different types of sprayballs
  • principle of sprayball pattern analysis
• Establish your cleaning method based on key factors:
  • nature of residues to be removed
  • available and permitted cleaning agents
  • type of equipment to be cleaned
  • nature of manufacturing process
• Identify the types of acceptable cleaning agents
• Write sufficiently detailed cleaning procedures

Exercise: Design Cleaning Methods Based on a Test Case

VI. Apply Risk Analysis to Cleaning Validation

• Understand the basic concepts of applying risk analysis to cleaning validation
• Apply risk management principles when selecting validation targets
• Simplify validation based on equipment grouping and residue grouping
• Evaluate maximum hold times before cleanings ("dirty" hold times)
• Evaluate maximum hold times between cleanings ("clean" hold times)

Exercise: Evaluate a Test Case Study

VII. Develop and Maintain Adequate Documentation Systems

• Analyze documentation requirements for cleaning validation projects
• Examine critical cleaning validation documentation:
  • validation master plan
  • protocols and final reports
  • cleaning SOPs
  • analytical methods validation documents
• Outline the parameters and criteria for cleaning validation protocols
• Set appropriate limits and other acceptance criteria
• Become familiar with the basic concepts and purposes of the Final or Summary Reports

Exercise: Prepare the Skeleton of a Cleaning Validation Master Plan

VIII. Monitor and Control Validated Cleaning Procedures

• Decide what parameters should be monitored for manual cleaning versus automated processes
• Determine the difference between "monitoring" and "revalidation"
• Determine the impact of change control upon cleaning
• Characterize changes as major, minor or critical