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Sterility Testing Using an Isolator

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Product Sterility Testing: Basic testing requirements and methods. This presentation will cover:
• Isolator use
• Isolator package validation requirements
• Bacteriostasis and Fungistasis (B/F) requirements
• Packaging constraints/issues
• Failure investigations
• Isolator use
• Isolator package validation requirements
• Bacteriostasis and Fungistasis (B/F) requirements
• Packaging constraints/issues
• Failure investigations