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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
Validation of Visual Test Method
Hiring Someone to Validate Test Methods
Test Method Validation in a One Person Lab
Which Standards to Validate
Creation of Channels for Dye Test Validation
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
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
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
Filter by category
2008 Webcast-Understanding the Nuances of ISO 11607
» General Interest
» Material and Sterile Barrier Systems
» Test Method Validation
» Validation
» Worst Case
General Interest
» Sustainability
Materials
» Barrier Properties
» Coatings
» Extrusions
» Foil
» Material Properties
» Printing
» Sterilization
Outsource
» Consultant
Package Development
» ISO 11607
» Printing
» Product Data Sheets
» Specifications
» Sustainability
Sterilization
» ETO
» Non-Traditional Methods
» Other Considerations in Sterilization
» Radiation
» Retort/Autoclave
Testing
» Inflation Burst
» Integrity Testing
» Leaks
» Seal Integrity
» Seal Strength
» Test Method Validation
Validation
» Aging
» Climatic Stressing
» Developing Rationales
» Equipment
» ISO 11607
» Package
» Post Initial Validation
» Process
» Sample Size
» Seal Strength
» Sterilization
» Worst Case
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