SPMC's FAQs provide guidance for your technical challenges.
Frequently Asked Questions
An Indispensable Industry Resource
Welcome to SPMC's FAQs section, an industry resource used annually by hundreds of packaging professionals and engineers looking for guidance regarding material challenges for their flexible sterilization packaging. Our member companies’ technical experts voluntarily convene on a regular basis to answer your questions and post our answers here. Over the years, we’ve built a virtual library of information for your use. To find the technical guidance you need, please use any of the following search methods or browse the categories below.
Recently Added FAQs
- ISO 11607 and Test Method Validation
- Storage Conditions
- Bond Strength of Cold Seal Packages
- Troubleshooting the Package Sealing Process
- F2096 and F1929: Redundant or Complimentary Tests?
- Whole Package Sterilization Qualification
- Novel Non-Traditional Sterilization Methods
- Testing Integrity after Sterilization
- Packaging Expiration and Sterilization
- Moisture Sensitive Components in EtO Sterilization
- Targeting Package Air Permeability and Breathable Area in EtO
- Using Multiple EO Cycles in Performance and Stability Validations
- Packaging in Non-traditional Sterilization Methods
- E-Beam, Gamma and Product and Process Design
- References for Material Stability in Sterilization
- Penetration and Directional Exposure in E-beam and Gamma Radiation Sterilizations
- Packaging for a Disposable Bioburden Filter Apparatus That Will Be Gamma Sterilized
- Testing Fluid-filled Bags
- Using Dye Penetration for Double Package Testing
- Using Dye Penetration for Whole Package Testing
2008 Webcast-Understanding the Nuances of ISO 11607
General Interest
Materials
Outsource
Package Development
Sterilization
Testing
Validation
2008 Webcast-Understanding the Nuances of ISO 11607
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
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
Testing
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 11607 and Test Method Validation
FAQ Directory
2008 Webcast-Understanding the Nuances of ISO 11607
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
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
Testing
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 11607 and Test Method Validation
To search the FAQs by keyword, use the searchbar at the top of the page.