FAQ Directory
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2008 WEBCAST-UNDERSTANDING THE NUANCES OF ISO 11607
- GENERAL INTEREST
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MATERIAL AND STERILE BARRIER SYSTEMS
- Adhesives for Rapid ETO Cycles
- Choosing Sterilizable Materials
- Delamination and Breach of Sterile Barrier
- Double Barrier Packaging
- Establishing Minimum Seal Strength
- Explaining Sheet Separation
- Incoming Inspection of Packaging Materials
- Obtaining the Max T and RH from Environmental Challenging Tests
- Porous Area Needed for EtO Sterilization
- Storage of Preformed Sterile Barrier Systems
- Use of Water-Based Coatings in ETO Sterilization
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TEST METHOD VALIDATION
- Creation of Channels for Dye Test Validation
- Frequency of Test Method Validation
- Hiring Someone to Validate Test Methods
- Interpreting Test Method Validation Results
- Test Method Validation in a One Person Lab
- Validating Standard Test Methods
- Validation of Visual Test Method
- Which Standards to Validate
- VALIDATION
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WORST CASE
- Examples of Worst Case Sterile Barrier Systems
- Performance Testing of Worst Case Sterile Barrier System
- Process Windows and Specifications
- Requirements for Exposing a Packaging System to a "Worst Case" Sterilization Dose
- Using Sterile Barrier Systems Produced in Validated Processes
- Using Sterile Barrier Systems Produced in Validated Processes for Performance Testing
- GENERAL INTEREST
- MATERIALS
- OUTSOURCE
- PACKAGE DEVELOPMENT
- STERILIZATION
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TESTING
- Improving Test Methods
- INFLATION BURST
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INTEGRITY TESTING
- Bubble Emission Testing of Packages to Evaluate Package Integrity
- Channels in the Seal Area
- Dye Penetration with Non-Porous Pouches
- Dye Testing of Packages to Evaluate Seal Integrity
- Non-Destructive Integrity Test Methods
- Post Distribution Testing
- Sensitivity of Integrity Test Methods
- Strength and Integrity Testing Difference
- Using Dye Penetration for Double Package Testing
- Using Dye Penetration for Whole Package Testing
- SEAL INTEGRITY
- SEAL STRENGTH
- TEST METHOD VALIDATION
- VALIDATION