Webinar - Standards 051514

May 2014
Review and Updates on

Standardized Test Methods of
ISO 11607
Katie Tran Herb Schueneman Greg Schwinghammer

Presenter Presenter Moderator
2014, Westpak, Inc. 1

Agenda
ISO 11607
Popular Test Methods (ISO 11607 Part 1 Annex B)
Future Test Method Change
FDA Recognition
Conclusions

What is ISO 11607?
Guidance document for validating terminally sterilized

medical devices
FDA recognized

Do I need to use ISO 11607?
If you have a sterilized medical device, which must

perform efficiently, safely, and effectively in the hands of
the users.

ISO 11607 Revision
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 document
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 Part 1
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 (cont.)
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 2
NOT part of this webinar
Describes the validation requirements for forming,

sealing and assembly processes

ISO 11607 Part 1 Annex B
Not intended to be all-inclusive

Current revision is 2006
Annex B
Accelerated Aging
Conditioning
Integrity
Internal Pressure
Performance Testing
Puncture
Seal Strength
Visual Inspections
Accelerated Aging
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 (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 -30C, 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 m (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.)
Video on
Injection
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 m [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 m (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
ASTM D4169
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
This webinar will not cover these standards in details but if you have questions
please contact Katie at katie@westpak.com

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

Performance Testing (cont.)
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
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.)
Video on
Westpak
site
Unsupported
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

Video on
Closed Package
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 m [0.003 in.] with a 60100 % probability.
Changes 1. Added M to the standard meaning the whole document has the
2. Replaced medical packaging with flexible packaging

Future Test Method Change
Performance testing - ASTM D4169

Truck and/or air vibration spectrum and duration
Anticipated time frame 1-3 years from now

FDA Recognition (cont.)
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.

ISTA

ASTM D7386

Conclusions

Questions?

About WESTPAK, Inc.
Two Locations:
San Jose Laboratory San Diego Laboratory

83 Great Oaks Boulevard 10326 Roselle Street
San Jose, CA 95119 San Diego, CA 92121
408-224-1300 858-623-8100
www.westpak.com
projects@westpak.com

Thank You !
Please feel free to contact us with any questions or

assistance with your testing needs.
Katie Tran Herb Schueneman

katie@westpak.com herb@westpak.com
webinar@westpak.com

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May 2014

Review and Updates on

Katie Tran Herb Schueneman Greg Schwinghammer

2014, Westpak, Inc. 1

2014, Westpak, Inc. 2

Guidance document for validating terminally sterilized

2014, Westpak, Inc. 3

If you have a sterilized medical device, which must

2014, Westpak, Inc. 4

2014, Westpak, Inc. 5

Packaging for terminally sterilized medical devices

2014, Westpak, Inc. 6

Specifies the basic attributes required of materials and

Sterile barrier system

Applicable to industry, to health care facilities, and

Does NOT cover all requirements for sterile barrier

2014, Westpak, Inc. 8

NOT part of this webinar

Describes the validation requirements for forming,

2014, Westpak, Inc. 9

Not intended to be all-inclusive

2014, Westpak, Inc. 11

2014, Westpak, Inc. 12

Change Removed Flow Chart

2014, Westpak, Inc. 13

Title Standard Practice for Conditioning Containers, Packages, or Packaging

2014, Westpak, Inc. 14

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

2014, Westpak, Inc. 15

Change Removed Table 2

2014, Westpak, Inc. 16

Change Removed Table 2

2014, Westpak, Inc. 17

2014, Westpak, Inc. 18

2014, Westpak, Inc. 19

Title Standard Test Method for Detecting Leaks in Nonporous Packaging or

2014, Westpak, Inc. 22

Title Standard Test Method for Detecting Gross Leaks in Packaging by

2014, Westpak, Inc. 23

Title Standard Practice for Performance Testing of Shipping Containers and

Test Input Standards Current Revision

2014, Westpak, Inc. 26

Title Standard Practice for Performance Testing of Packages for Single

2014, Westpak, Inc. 27

ISTA Series Title

These standards get updated on a yearly basis.

2014, Westpak, Inc. 28

Title Standard Test Method for Slow Rate Penetration Resistance of

2014, Westpak, Inc. 29

2014, Westpak, Inc. 30

Title Standard Test Methods for Internal Pressurization Failure Resistance

2014, Westpak, Inc. 32

2014, Westpak, Inc. 34

2014, Westpak, Inc. 35

Performance testing - ASTM D4169

2014, Westpak, Inc. 36

Currently, ISTA test procedures not recognized on their

We anticipate they will be recognized in the near future.

2014, Westpak, Inc. 37

2014, Westpak, Inc. 38

2014, Westpak, Inc. 39

2014, Westpak, Inc. 40

2014, Westpak, Inc. 41

San Jose Laboratory San Diego Laboratory