Review and Updates on Standardized Test Methods of ISO 11607

Katie TranPresenter

©2014, Westpak, Inc. 1

Greg SchwinghammerModerator

Review and Updates on Standardized Test Methods of

ISO 11607

Herb SchuenemanPresenter

May 2014

• ISO 11607

• Popular Test Methods (ISO 11607 Part 1 – Annex B)

• Future Test Method Change

• FDA Recognition

• Conclusions

Agenda


• Guidance document for validating terminally sterilized

medical devices

• FDA recognized

What is ISO 11607?


If you have a sterilized medical device, which must

perform efficiently, safely, and effectively in the hands of

the users.

Do I need to use ISO 11607?


• Previous revision

• ISO 11607:2003

• Current revision

• Technically revised and divided into 2 parts

• ISO 11607-1:2006 and ISO 11607-2:2006

ISO 11607 Revision


• Packaging for terminally sterilized medical devices

• Part 1

Requirements for materials, sterile barrier systems and

packaging systems

• Part 2

Validation requirements for forming, sealing and assembly

processes

ISO 11607 document


• Specifies the basic attributes required of materials and

pre-formed systems intended for use in packaging

systems for terminally sterilized medical devices

• Sterile barrier system

• Allow sterilization

• Provide physical protection

• Maintain sterility up to the point of use

• Allow aseptic presentation

ISO 11607 Part 1


• Applicable to industry, to health care facilities, and

wherever medical devices are placed in sterile barrier

systems and sterilized

• Does NOT cover all requirements for sterile barrier

systems and packaging systems for medical devices that

are manufactured aseptically

ISO 11607 Part 1 (cont.)


• NOT part of this webinar

• Describes the validation requirements for forming,

sealing and assembly processes

ISO 11607 Part 2


• Not intended to be all-inclusive

• Current revision is 2006

ISO 11607 Part 1 – Annex B


Annex B

Accelerated Aging

Conditioning

Integrity

Internal Pressure

Performance Testing

Puncture

Seal Strength

Visual Inspections

Title Standard Guide for Accelerated Aging of Sterile Barrier Systems for

Medical Devices

Standard ASTM F1980

Scope Provide information for developing accelerated aging protocols to

rapidly determine the effects, if any, due to the passage of time on the

sterile integrity of the sterile barrier system (SBS).

Current Revision 2007

Previous Revision 2002

Changes 1. Removed package shelf life test plan flow chart.

2. Clarify no need to use actual product.

3. Clarify that aging/stability testing and performance testing are

separate entities.

Accelerated Aging


Accelerated Aging (cont.)


2002

Accelerated Aging (cont.)


Change Removed Flow Chart

2007

Conditioning


Title Standard Practice for Conditioning Containers, Packages, or Packaging

Components for Testing

Standard ASTM D4332

Scope Describe procedures for conditioning these containers, packages, or

packaging components so that they may reach equilibrium with the

atmosphere to which they may be exposed.



Changes NO changes to testing procedure

Conditioning (cont.)


Change Added Extreme Cold -30°C, uncontrolled RH to Table 1

2001

2013



Change Removed Table 2



Change Removed Table 2



Integrity


Title Standard Test Method for Detecting Seal Leaks in Porous Medical

Packaging by Dye Penetration

Standard ASTM F1929

Scope Detect and locate a leak equal to or greater than a channel formed by

a 50 μm (0.002 in.) wire in package edge seals formed between a

transparent material and a porous sheet material.



Changes 1. Added 2 more test methods (edge dip and eyedropper)

2. The method in 1998 is now called injection

Integrity (cont.)


InjectionVideo on Westpak

site

Integrity (cont.)


Edge Dip

Integrity (cont.)


Title Standard Test Method for Detecting Leaks in Nonporous Packaging or

Flexible Barrier Materials by Dye Penetration

Standard ASTM F3039

Scope Detect and locate a leak equal to or greater than a channel formed by

a 50 μm [0.002 in.] wire in the edge seals of a nonporous package.


Previous Revision n/a

Procedure Inject dye penetrant into package at a volume of 0.25 ml per inch of

seal length (minimum)

Internal Pressure


Title Standard Test Method for Detecting Gross Leaks in Packaging by

Internal Pressurization (Bubble Test)

Standard ASTM F2096

Scope Detection of gross leaks in packaging (tray and pouch packages) with

method sensitivity is down to 250 μm (0.010 in.) with an 81%

probability.



Changes 1. No need to place airflow in center of the package

2. Changes to testing procedure

3. Added “rotating the package 180°” (this does not affect Westpak™)

Internal Pressure (cont.)


Video on Westpak

site

Performance Testing


Title Standard Practice for Performance Testing of Shipping Containers and

Systems

Standard ASTM D4169

Scope This practice provides a uniform basis of evaluating, in a laboratory,

the ability of shipping units to withstand the distribution environment.



Changes 1. Change verbiage to consider the use of ASTM D7386 for single

parcel shipments

2. Increased the weight limit for DC 12 and 13 from 100 lb to 150 lb

3. Clarify what is a long, narrow shipping unit (length ≥36”, width and

height ≤20% of length) such that if bridge impact testing is

required

4. NO changes to testing procedure

Test Input Standards Current Revision

Handling (Manual) ASTM D5276 1998

Vehicle Stacking (Compression) ASTM D642 2000

Loose Load Vibration ASTM D999 2008

Low Pressure (Altitude) ASTM D6653 2013

Vehicle Vibration ASTM D4728 2006

Concentrated Impact ASTM D6344 2004

ASTM D4169


This webinar will not cover these standards in details but if you have questions

please contact Katie at [email protected]

Performance Testing (cont.)


Title Standard Practice for Performance Testing of Packages for Single

Parcel Delivery Systems

Standard ASTM D7386

Scope This practice provides a uniform basis of evaluating, in a laboratory,

the ability of shipping units, weighing up to but not exceeding 150 lb

(68 kg), intended for the single parcel delivery system to withstand the

hazards associated with the distribution environment.


Previous Revision 2008 (Initial Release)

Changes 1. Bibliography and reference updates


ISTA Series Title

1 (A, B, C, D, E, G, and H) Non-Simulation Integrity Performance Testing

2 (A, B, and C) Partial Simulation Performance Testing

3 (A, B, E, F, H, and K) General Simulation Performance Testing

Performance Testing (cont.)


These standards get updated on a yearly basis.

Puncture


Title Standard Test Method for Slow Rate Penetration Resistance of

Flexible Barrier Films and Laminates

Standard ASTM F1306

Scope Permits flexible barrier films and laminates to be characterized for

slow rate penetration resistance to a driven probe.


Previous Revision n/a

Seal Strength


Title Standard Test Method for Seal Strength of Flexible Barrier Materials

Standard ASTM F88/F88M

Scope Measures the force required to separate a test strip of material

containing the seal and identifies the mode of specimen failure.



Changes 1. Added “M” to the standard meaning the whole document has the

primary units as “metric”


Seal Strength (cont.)


UnsupportedVideo on Westpak

site



Title Standard Test Methods for Internal Pressurization Failure Resistance

of Unrestrained Packages


Scope Determine the ability of packages to withstand internal pressurization.



Changes 1. NO changes to testing procedure

2. Added “M” to the standard meaning the whole document has the




Closed PackageVideo on Westpak

site



Title Standard Test Method for Burst Testing of Flexible Package Seals

Using Internal Air Pressurization Within Restraining Plates


Scope Determine the minimum burst strength of a seal placed around the

perimeter of a flexible package as it is internally pressurized and

enclosed within restraining plates.



Changes 1. NO changes to testing procedure

2. Added “M” to the standard meaning the whole document has the


Visual Inspection


Title Standard Test Method for Determining Integrity of Seals for Flexible

Packaging by Visual Inspection


Scope This test method covers the determination of channels in the package

seal down to a width of 75 μm [0.003 in.] with a 60–100 % probability.



Changes 1. Added “M” to the standard meaning the whole document has the


2. Replaced “medical packaging” with “flexible packaging”


• Performance testing - ASTM D4169

• Truck and/or air vibration spectrum and duration

• Anticipated time frame 1-3 years from now

Future Test Method Change


• Currently, ISTA test procedures not recognized on their

website but we have customers who do use them and

do get FDA approval.

• We anticipate they will be recognized in the near future.

FDA Recognition (cont.)


ISTA



ASTM D7386



Conclusions


Questions?



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About WESTPAK, Inc.

Thank You !

Please feel free to contact us with any questions or

assistance with your testing needs.


Katie [email protected]

Herb [email protected]

[email protected]

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Review and Updates on Standardized Test Methods of ISO 11607