FAQ Directory

• 2008 WEBCAST-UNDERSTANDING THE NUANCES OF ISO 11607
  • GENERAL INTEREST
    • Global Use of ISO and ASTM Standards
    • Involving the Packaging Manufacturer in the Design Process
    • Sterile Fluid Pathway Products and ISO 11607
    • Using Webcast Presentations in Developing Rationale
  • 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
  • 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
    • "Pre-Validated" Packages
    • Seal Area Validation
    • Selecting ISTA Conditioning Methods
    • Validating Multiple Sealers
    • Validating Package Sealing Equipment
  • 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
  • SUSTAINABILITY
    • Sustainability in Healthcare Packaging
• MATERIALS
  • BARRIER PROPERTIES
    • Pinholes and Microbial Barrier
  • COATINGS
  • FOIL
    • Aluminum Foil Gauge/Thickness Specification
    • Impact on Barrier of Pinholes in Foil Layer of a Lamination
  • MATERIAL PROPERTIES
  • PRINTING
    • Printing on Sterilization Packaging
  • STERILIZATION
    • PVC Films and Gamma Radiation
• 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
  • ETO
    • Determining LDPE Suitability for ETO Sterilization
  • RETORT/AUTOCLAVE
    • Visual Appearance After Retort/Autoclave
• TESTING
  • INTEGRITY TESTING
    • Bubble Emission Testing of Packages to Evaluate Package Integrity
    • Dye Testing of Packages to Evaluate Seal Integrity
  • SEAL INTEGRITY
    • Evaluating Seal Integrity of a Tyvek®/Tyvek® Pouch
  • SEAL STRENGTH
    • Round Robin Testing on F88 Seal Strength Testing
  • TEST METHOD VALIDATION
    • Requirements for Test Method Validation
• VALIDATION
  • AGING
    • Effect of Humidity on Accelerated Aging
  • 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