Sterile Barrier System: Common Failure Modes & Design Recommendations Kevin Fernandez Presenter Greg Schwinghammer Moderator Eric Lau Presenter March 2013 1
Agenda Packaging System Protective package Sterile barrier system (SBS) Tests Gross Leak Detection (Bubble Test) Dye Penetration Test Seal Strength (Peel Test) Burst Test Common Failures Design Recommendations Conclusions Questions 2
Packaging System Per ISO 11607 Combination of sterile barrier system and protective packaging 3
Packaging System Protective Packaging Shipper (i.e. corrugated fiberboard box) Secondary, tertiary package, etc. (i.e. folding carton) Sterile Barrier System (SBS) Primary package Sterile Barrier System (i.e. pouch or tray) 4
Sterile Barrier System Integrity Testing Integrity testing determine if the sterile barrier is maintained to ensure the product is free from viable microorganisms Typically conducted after distribution simulation testing on the entire package system to ensure the SBS is maintained 5
Gross Leak Detection (Bubble) Testing ASTM F 2096-11 Detecting gross leaks in medical packaging by means of internal pressurization Finding leaks as small as 125-250 µm 6
Gross Leak Detection Failure Mode #1: Stress Cracking Possible Causes 1. Compound folding 2. Excessive pouch length 3. Universal package configurations Recommendations 1. Always aim to use the proper pouch size 2. Use a stronger/more flexible laminate material (i.e. nylon) Stress Cracking Gross Leak Detected 7
Gross Leak Detection Failure Mode #2: Punctured Surfaces Possible Causes 1. Protruding objects 2. Abrasion Recommendations 1. Use a device card 2. Apply plastic cover(s) 3. Use a thermoformed tray (not pouch) Pouch Punctures Caused by Protruding Objects 8
Gross Leak Detection Failure Mode #3: Tray Cracking Possible Causes 1. Impact testing 2. Material/incorrect bend radii 3. Extreme aging temperatures Recommendations 1. Tray redesign (i.e. geometry of tray, use more less brittle/more ductile material ) 2. Lower aging temperature 9
Gross Leak Detection Failure Mode #4: Sealing Issues Possible Causes 1. Bad sealing procedure 2. Protruding package contents 3. Equipment setup issues Recommendations 1. Ensure proper sealing by performing a design of experiments (DOE) 2. Check sealing equipment Folding During In-House Sealing Voids During Sealing Process 10
Dye Penetration Testing ASTM F 1929-12 Detecting channel leaks in the seals of the SBS Method A Injection Method Method B Edge Dip Method Method C Eye Dropper Method 11
Dye Penetration Failure Channel leak within the seal (material separation) Possible Causes 1. Fold or crease along the seal causing a channel 2. Material defect 3. Uneven sealing along the length of the seal Recommendations 1. Minimize folding by using the proper pouch length 2. Inspect the material for consistency 3. Check sealing equipment for proper function and consistency 12
Dye Penetration Failure Material folded over within the seal Possible Causes 1. Material defect crease or fold along the length of the roll stock 2. Improper sealing process Recommendations 1. Inspect the roll stock for consistency 2. Observe the sealing process workers properly trained 3. Add a brief inspection after sealing per ASTM F1886/F1886M-09 13
Seal Strength (Peel) Testing ASTM F88/F88M-09 Measuring the strength of the seals Method A Unsupported Commonly used Consistent data Method B 90 Supported Least requested Human factor involved Method C 180 Supported Commonly used Vendor suggested Higher seal values than Method A 14
Seal Strength Testing Failure Mode #1: Less than 1.0 lbf/in Failure 1. Seal strength of peel sample less than 1.0 lbf/in Recommendations 1. 1.0 lbf/in not an industry standard 2. Change sealing parameters if necessary 15
Seal Strength Testing Failure Mode #2: Cohesive Failure ADHESIVE PEEL: Separated at adhesive COHESIVE FAILURE: Torn Tyvek (Result of over sealing) 16
Seal Strength Testing Failure Mode #2: Cohesive Failure When is this an issue? Opening a Poly/Tyvek Pouch (Aseptic Technique) Cohesive Failure on Tray (Recommendation to adjust sealing parameters) 17
Burst Test ASTM F1140-07 and F2054-07 Evaluating tendencies for package failure when exposed to pressure differentials from sterilization or transportation 18
Burst Test Failure 1. Low burst values 2. Consistent failure location Recommendations 1. Adjust sealing parameters for optimal seals 2. Check sealing equipment for uneven sealing 19
Conclusions These are some of the common failures we observe during testing The proper material, sealing parameters and sealing method are key in designing a good SBS Westpak provides recommendations if failures are found during testing Always consult with your supplier for different material and packaging options 20
Questions 21
Thank You Please feel free to contact us with any additional questions or assistance with your medical device package validation needs. Kevin Fernandez kevin@westpak.com Eric Lau eric@westpak.com 22
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