FAQ Directory

• 2008 Webcast-Understanding the Nuances of ISO 11607
  • General Interest
    • Using Webcast Presentations in Developing Rationale
    • Involving the Packaging Manufacturer in the Design Process
    • Sterile Fluid Pathway Products and ISO 11607
    • Global Use of ISO and ASTM Standards
  • Material and Sterile Barrier Systems
    • Use of Water-Based Coatings in ETO Sterilization
    • Adhesives for Rapid ETO Cycles
    • Incoming Inspection of Packaging Materials
    • Porous Area Needed for EtO Sterilization
    • Delamination and Breach of Sterile Barrier
    • Explaining Sheet Separation
    • Storage of Preformed Sterile Barrier Systems
    • Double Barrier Packaging
    • Establishing Minimum Seal Strength
    • Choosing Sterilizable Materials
    • Obtaining the Max T and RH from Environmental Challenging Tests
  • Test Method Validation
    • Test Method Validation in a One Person Lab
    • Hiring Someone to Validate Test Methods
    • Which Standards to Validate
    • Creation of Channels for Dye Test Validation
    • Validation of Visual Test Method
    • Interpreting Test Method Validation Results
    • Frequency of Test Method Validation
    • Validating Standard Test Methods
  • Validation
    • Validating Package Sealing Equipment
    • Validating Multiple Sealers
    • Selecting ISTA Conditioning Methods
    • Seal Area Validation
    • "Pre-Validated" Packages
  • Worst Case
    • Process Windows and Specifications
    • Performance Testing of Worst Case Sterile Barrier System
    • Examples of Worst Case Sterile Barrier Systems
    • Using Sterile Barrier Systems Produced in Validated Processes
    • Using Sterile Barrier Systems Produced in Validated Processes for Performance Testing
    • Requirements for Exposing a Packaging System to a "Worst Case" Sterilization Dose
• General Interest
  • Storage Conditions
  • Sustainability
    • Sustainability in Healthcare Packaging
• Materials
  • Packaging for a Disposable Bioburden Filter Apparatus That Will Be Gamma Sterilized
  • Barrier Properties
    • Pinholes and Microbial Barrier
  • Coatings
  • Extrusions
    • Gels in Extrusions
    • Gels and Barrier Integrity
    • Gels and Integrity in FFS
    • Effect of Gels: Visual and Integrity
    • Gel Size
  • Foil
    • Impact on Barrier of Pinholes in Foil Layer of a Lamination
    • Aluminum Foil Gauge/Thickness Specification
  • Material Properties
  • Printing
    • Printing on Sterilization Packaging
  • Sterilization
    • PVC Films and Gamma Radiation
    • SBS Paperboard and EtO Sterilization
• Outsource
  • Consultant
    • Consultant Recommendation
• Package Development
  • ISO 11607
    • ISO 11607 and Worst Case
    • ISO 11607 Section 6.4
  • Printing
    • Printing on Sterilization Packaging
  • Product Data Sheets
    • Data Sheet for Specification
  • Specifications
    • Writing a Preformed Sterile Barrier System Specification
  • Sustainability
    • Sustainability in Healthcare Packaging
• Sterilization
  • Packaging for a Disposable Bioburden Filter Apparatus That Will Be Gamma Sterilized
  • Whole Package Sterilization Qualification
  • ETO
    • Determining LDPE Suitability for ETO Sterilization
    • Using Multiple EO Cycles in Performance and Stability Validations
    • Targeting Package Air Permeability and Breathable Area in EtO
    • Moisture Sensitive Components in EtO Sterilization
  • Non-Traditional Methods
    • Packaging in Non-traditional Sterilization Methods
    • Novel Non-Traditional Sterilization Methods
  • Other Considerations in Sterilization
    • Packaging Expiration and Sterilization
    • Testing Integrity after Sterilization
  • Radiation
    • Penetration and Directional Exposure in E-beam and Gamma Radiation Sterilizations
    • References for Material Stability in Sterilization
    • E-Beam, Gamma and Product and Process Design
  • Retort/Autoclave
    • Visual Appearance After Retort/Autoclave
• Testing
  • Improving Test Methods
  • ISO 11067 and Test Method Validation
  • Inflation Burst
    • Calculating Burst Values
  • Integrity Testing
    • Bubble Emission Testing of Packages to Evaluate Package Integrity
    • Dye Testing of Packages to Evaluate Seal Integrity
    • Post Distribution Testing
    • Sensitivity of Integrity Test Methods
    • Strength and Integrity Testing Difference
    • Channels in the Seal Area
    • Dye Penetration with Non-Porous Pouches
    • Non-Destructive Integrity Test Methods
    • Using Dye Penetration for Whole Package Testing
    • Using Dye Penetration for Double Package Testing
    • F2096 and F1929: Redundant or Complimentary Tests?
    • Troubleshooting the Package Sealing Process
    • ISO 11067 and Test Method Validation
  • Leaks
    • Testing Fluid-filled Bags
  • Seal Integrity
    • Evaluating Seal Integrity of a Tyvek®/Tyvek® Pouch
    • F2096 and F1929: Redundant or Complimentary Tests?
  • Seal Strength
    • Round Robin Testing on F88 Seal Strength Testing
    • Bond Strength of Cold Seal Packages
  • Test Method Validation
    • Requirements for Test Method Validation
    • Test Equipment and ASTM Standards
• Validation
  • Troubleshooting the Package Sealing Process
  • Aging
    • Effect of Humidity on Accelerated Aging
  • Climatic Stressing
    • Developing Climatic Stressing Protocols
  • Developing Rationales
  • Equipment
    • Validation of Sealing Process
  • ISO 11607
    • ISO 11607 and Worst Case
  • Package
  • Post Initial Validation
    • Post Validation Changes in Breathable Area
  • Process
    • Seal Validation and Seal Strength Testing
  • Sample Size
    • Determining Sample Size
  • Seal Strength
    • Round Robin Testing on F88 Seal Strength Testing
  • Sterilization
    • Shift in Burst Values for Seal Strength from Pre- to Post- Sterilization
  • Worst Case
    • ISO 11607 and Worst Case