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
- 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
- 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
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
Sterilization
ETO
- Determining LDPE Suitability for ETO Sterilization
- Heat Seal Coatings for Rapid ETO Cycle
- Moisture Sensitive Components in EtO Sterilization
- Porous Area Needed for EtO Sterilization
- SBS Paperboard and EtO Sterilization
- Targeting Package Air Permeability and Breathable Area in EtO
- Use of Water-Based Coatings in ETO Sterilization
- Using Multiple EO Cycles in Performance and Stability Validations
Testing
- Bond Strength of Cold Seal Packages
- Calculating Burst Values
- Effect of Humidity on Accelerated Aging
- F2096 and F1929: Redundant or Complimentary Tests?
- Obtaining the Max T and RH from Environmental Challenging Tests
- Round Robin Testing on F88 Seal Strength Testing
- Test Equipment and ASTM Standards
- Testing Fluid-filled Bags
Validation
- Determining Sample Size
- Developing Climatic Stressing Protocols
- ISO 11607 Section 8.3
- Post Validation Changes in Breathable Area
- Pre-Validated Packages
- Seal Area Validation
- Seal Validation and Seal Strength Testing
- Selecting ISTA Conditioning Methods
- Shift in Burst Values for Seal Strength from Pre- to Post- Sterilization
- Validating Multiple Sealers
- Validating Package Sealing Equipment
- Validation of Sealing Process
FAQ Directory
2008 Webcast-Understanding the Nuances of ISO 11607
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
Sterilization
ETO
- Determining LDPE Suitability for ETO Sterilization
- Heat Seal Coatings for Rapid ETO Cycle
- Moisture Sensitive Components in EtO Sterilization
- Porous Area Needed for EtO Sterilization
- SBS Paperboard and EtO Sterilization
- Targeting Package Air Permeability and Breathable Area in EtO
- Use of Water-Based Coatings in ETO Sterilization
- Using Multiple EO Cycles in Performance and Stability Validations
Testing
- Bond Strength of Cold Seal Packages
- Calculating Burst Values
- Effect of Humidity on Accelerated Aging
- F2096 and F1929: Redundant or Complimentary Tests?
- Obtaining the Max T and RH from Environmental Challenging Tests
- Round Robin Testing on F88 Seal Strength Testing
- Test Equipment and ASTM Standards
- Testing Fluid-filled Bags
Validation
- Determining Sample Size
- Developing Climatic Stressing Protocols
- ISO 11607 Section 8.3
- Post Validation Changes in Breathable Area
- Pre-Validated Packages
- Seal Area Validation
- Seal Validation and Seal Strength Testing
- Selecting ISTA Conditioning Methods
- Shift in Burst Values for Seal Strength from Pre- to Post- Sterilization
- Validating Multiple Sealers
- Validating Package Sealing Equipment
- Validation of Sealing Process
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