Kevin FernandezPresenter

Eric LauPresenter

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Greg SchwinghammerModerator

Sterile Barrier System: Common Failure Modes & Design Recommendations

March 2013

• 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

Agenda

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Per ISO 11607

Combination of sterile barrier system and

protective packaging

Packaging System

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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)

Packaging System

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• 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

Sterile Barrier System Integrity Testing

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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

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Gross Leak DetectionFailure Mode #1: Stress Cracking

Possible Causes

1. Compound folding

2. Excessive pouch length

3. Universal package configurations

Stress Cracking Gross Leak Detected

Recommendations

1. Always aim to use the proper pouch size

2. Use a stronger/more flexible laminate material (i.e. nylon)

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Gross Leak DetectionFailure 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 Objects8

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

Gross Leak DetectionFailure Mode #3: Tray Cracking

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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

Gross Leak DetectionFailure Mode #4: Sealing Issues

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

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Dye Penetration FailureChannel 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

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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

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Seal Strength (Peel) Testing

• ASTM F88/F88M-09

• Measuring the strength

of the seals

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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

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

Seal Strength TestingFailure Mode #1: Less than 1.0 lbf/in

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Seal Strength TestingFailure Mode #2: Cohesive Failure

COHESIVE FAILURE: Torn Tyvek®(Result of over sealing)

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ADHESIVE PEEL: Separated at adhesive

Seal Strength TestingFailure Mode #2: Cohesive Failure

When is this an issue?

Cohesive Failure on Tray(Recommendation to adjust sealing parameters)

Opening a Poly/Tyvek® Pouch(Aseptic Technique)

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Burst Test

• ASTM F1140-07 and F2054-07

• Evaluating tendencies for package failure when

exposed to pressure differentials – from sterilization

or transportation

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Failure

1. Low burst values

2. Consistent failure

location

Recommendations

1. Adjust sealing

parameters for optimal

seals

2. Check sealing

equipment for uneven

sealing

Burst Test

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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

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Questions

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Thank You

Please feel free to contact us with any additional

questions or assistance with your medical device

package validation needs.

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Kevin Fernandezkevin@westpak.com

Eric Laueric@westpak.com

Two Locations

San Jose83 Great Oaks Boulevard

San Jose, CA 95119

408.224.1300

San Diego10326 Roselle Street

San Diego, CA 92121

858.623.8100

www.westpak.com

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