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MEMBERS NEWS RESOURCES FAQs CONTACT MenuFPA Collaboration Members Our News Calendar Advocacy Sterile Packaging Day Learning Tools Industry Resources FAQs Contact Us Request Tech AssistanceFPA Collaboration Our Members Amcor Flexibles Beacon Converters DuPont™ Tyvek® Paxxus PPC Flexible Packaging Printpack Medical Steripax Technipaq Winpak Our News Calendar Advocacy Sterile Packaging Day Learning Tools Industry Resources Contact Us Request Tech Assistance 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 View FAQ Directory Filter By Category Search By Keyword Recently Added FAQs Steam Sterilization for PET/cast PP and Medical Grade Papers 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 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 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 Test Method Validation in a One Person Lab Hiring Someone to Validate Test Methods Which Standards to Validate Creation of Channels for Dye Test Validation Validation of Visual Test Method 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 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 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 Steam Sterilization for PET/cast PP and Medical Grade Papers 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/Steam Visual Appearance After Retort/Autoclave Steam Sterilization for PET/cast PP and Medical Grade Papers Testing Improving Test Methods ISO 11607 and Test Method Validation 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 ISO 11607 and Test Method Validation 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 Equipment Validation of Sealing Process ISO 11607 ISO 11607 and Worst Case 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 FAQ Directory 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...