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
- Bond Strength of Cold Seal Packages
- E-Beam, Gamma and Product and Process Design
- F2096 and F1929: Redundant or Complimentary Tests?
- ISO 11607 and Test Method Validation
- Moisture Sensitive Components in EtO Sterilization
- Novel Non-Traditional Sterilization Methods
- Packaging Expiration and Sterilization
- Packaging for a Disposable Bioburden Filter Apparatus That Will Be Gamma Sterilized
- Packaging in Non-traditional Sterilization Methods
- Penetration and Directional Exposure in E-beam and Gamma Radiation Sterilizations
- References for Material Stability in Sterilization
- Steam Sterilization for PET/cast PP and Medical Grade Papers
- Storage Conditions
- Targeting Package Air Permeability and Breathable Area in EtO
- Testing Fluid-filled Bags
- Testing Integrity after Sterilization
- Troubleshooting the Package Sealing Process
- Using Dye Penetration for Double Package Testing
- Using Multiple EO Cycles in Performance and Stability Validations
- Whole Package Sterilization Qualification
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
- 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
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
Testing
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
- F2096 and F1929: Redundant or Complimentary Tests?
- ISO 11607 and Test Method Validation
- Non-Destructive Integrity Test Methods
- Post Distribution Testing
- Sensitivity of Integrity Test Methods
- Strength and Integrity Testing Difference
- Troubleshooting the Package Sealing Process
- Using Dye Penetration for Double Package Testing
- Using Dye Penetration for Whole Package Testing
FAQ Directory
2008 Webcast-Understanding the Nuances of ISO 11607
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
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
Testing
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
- F2096 and F1929: Redundant or Complimentary Tests?
- ISO 11607 and Test Method Validation
- Non-Destructive Integrity Test Methods
- Post Distribution Testing
- Sensitivity of Integrity Test Methods
- Strength and Integrity Testing Difference
- Troubleshooting the Package Sealing Process
- Using Dye Penetration for Double Package Testing
- Using Dye Penetration for Whole Package Testing
To search the FAQs by keyword, use the searchbar at the top of the page.