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Aseptic Processing Volume III

Price: $199.00
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Item Number: PASZ102
Automation
  • The Impact of Automation on Aseptic Processing
Cleaning & Cleaning Validation
  • Equipment-Hold Time for Cleaning Validation
  • Setting Cleaning Validation Acceptance Limits for Topical Formulation
  • Ruggedness of Visible Residue Limits for Cleaning Validation
Cleanroom Design & Technology
  • Donning by Design: Sterile Cleanrom Gowning Evolves to Help Minimize Contamination Risk
Disposables
  • Disposable Components in Aseptic Processing
Filtration
  • Considerations on Re-Use of Sterilizing-Grade Filters
  • Guidelines for Selecting Normal Flow Filters
Integrity Testing
  • Improving the Integrity Test Assurance of Multiround Housings Assessments
Lyophilization & Alternatives
  • Freeze-Drying with Closed Vials
  • Deep Freeze: Innovations in Lyophilization
  • Evaluating Functional Equivalency as a Lyophilization-Cycle Transfer Tool
Risk Management
  • Risk Management for Aseptic Processing
  • Compliance Risk Management: Using a Top-Down Validation Approach
  • Applying Quality by Design to Sterile Manufacturing Processes
Sterilization
  • Establishing Material Compatibility, Process Conditions, and Bubble Points of Filters
  • The Rotation of Disinfectants Principle: True or False?
 

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