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
General Interest
Material and Sterile Barrier Systems
Sterilization
Test Method Validation
Testing
Validation
Worst Case
Material and Sterile Barrier Systems
- Adhesives for Rapid EtO Cycles
- Aluminum Foil Gauge/Thickness Specification
- Choosing Sterilizable Materials
- Delamination and Breach of Sterile Barrier
- Double Barrier Packaging
- Establishing Minimum Seal Strength
- Explaining Sheet Separation
- Impact on Barrier of Pinholes in Foil Layer of a Lamination
- Incoming Inspection of Packaging Materials
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
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
- ISO 11607 and Test Method Validation
- Test Method Validation in a One Person Lab
- Validating Standard Test Methods
- Validation of Visual Test Method
- Which Standards to Validate
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
Worst Case
- Examples of Worst Case Sterile Barrier Systems
- ISO 11607 and Worst Case
- 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
FAQ Directory
Material and Sterile Barrier Systems
- Adhesives for Rapid EtO Cycles
- Aluminum Foil Gauge/Thickness Specification
- Choosing Sterilizable Materials
- Delamination and Breach of Sterile Barrier
- Double Barrier Packaging
- Establishing Minimum Seal Strength
- Explaining Sheet Separation
- Impact on Barrier of Pinholes in Foil Layer of a Lamination
- Incoming Inspection of Packaging Materials
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
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
- ISO 11607 and Test Method Validation
- Test Method Validation in a One Person Lab
- Validating Standard Test Methods
- Validation of Visual Test Method
- Which Standards to Validate
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
Worst Case
- Examples of Worst Case Sterile Barrier Systems
- ISO 11607 and Worst Case
- 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
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