An Overview of Package Integrity

for Medical Device Manufacturers

Michael Troedel
President
Troedel & Associates, Inc.
ASTM Fellow
Overview

„ What is package integrity?

„ Why test for package integrity?

„ How to test for package integrity.

Overview

„ What’s the right test?

{ Seal Integrity

{ Seal Strength

{ Package Integrity
Overview

„ How do you meet the new requirements of ISO

11607, Part 1 and Part 2?

„ What is TIR 22 and what role does Test Method

Validation play?
What is Package Integrity?

„ As defined in ASTM F-1327-05, Standard

Terminology Relating to Barrier Materials for
Medical Packaging….

{ Package integrity is “the physical capability of a given

package to protect its contents with the desired level of
protection over a defined period of service; for example,
as a barrier to physical, microbiological, or chemical
challenges.”
Why Test for Package Integrity?

„ In ISO 11607, Packaging for terminally sterilized

medical devices - Part 1, Section 6.1.2, the
standard states….

{ “The packaging system shall provide physical protection

and maintain integrity of the sterile barrier system.”
Why Test for Package Integrity?

„ Manufacturers that neglect to follow ISO 11607’s

recommendations do so at the risk of FDA sanction,
insists Nick Fotis of Cardinal Health...

{ “FDA has recognized ISO 11607 as a consensus

standard” he says. “Nevertheless, it’s voluntary. If I as a
packaging engineer get audited by FDA, I can show the
auditor that FDA recognizes my approach is legitimate as
long as I am in full compliance with ISO 11607.”

„ Source: Pharmaceutical & Medical Packaging

News, January 2008
Why Test for Package Integrity?

„ John Spitzley of the Spartan Design Group says in

the February 2008 issue of Healthcare
Packaging….

{ “If you read through the standards (ISO 11607) and

conform to all the ‘shall-statements’[requirements], you
meet the global requirements for your medical device
packaging.”
How to Test for Package Integrity?

„ ASTM F-2097-05, Standard Guide for Design and

Evaluation of Primary Packaging for Medical
Products

„ Figure 1, Summary of Test Methods

„ Section on Package Integrity & Seal Strength

How to Test for Package Integrity?
How to Test for Package Integrity?

„ Table 1, Lists Test, Test Method,

Description and Applicability
How to Test for Package Integrity?
How to Test for Package Integrity?
ISO 11607 - Part 1

„ Requirements for materials, sterile barrier systems

and packaging systems

„ To comply, you should be using the appropriate

tests outlined in F-2097 to insure your package
system is providing and maintaining the sterile
barrier system for the medical device to the point of
use
ISO 11607, Part 2

„ Validation requirements for forming, sealing and

assembly processes

„ This is a subject that will be dealt with in more detail

at our Web Seminar on July 9th, entitled
“Introduction to scientific instrument IQ/OQ/PQ
validations”

„ It will cover the requirements and clarify some of

the common mistakes and myths behind validation
testing
What is TIR 22?

„ AAMI TIR 22:2007

„ Association for the Advancement of Medical

Instrumentation (AAMI)

„ Technical Information Report (TIR)

„ Guidance for ANSI/AAMI/ISO 11607, Packaging for

terminally sterilized medical devices - Part 1 and
Part 2:2006
What is TIR 22?
What is TIR 22?
TIR 22 - Annex B
Test Method Validation
„ If you use a method that has been subjected to an ILS
(Inter-Laboratory Study), or round robin testing, then you
can compare your test method results to the ILS study

„ You need to determine that the test method performs as

intended and measure the repeatability and reproducibility

„ You must also demonstrate that your method falls within

the sensitivity limits of the ILS study

„ Finally, the results of this validation study must be

documented
References

„ ANSI/AAMI/ISO 11607-2:2006 - Packaging for

terminally sterilized medical devices - Part
1:Requirements for materials, sterile barrier
systems, and packaging systems

„ ANSI/AAMI/ISO 11607-2:2006 - Packaging for

terminally sterilized medical devices - Part
2:Validation requirements for forming, sealing, and
assembly processes
References

„ AAMI TIR 22:2007 - Guidance for ANSI/AAMI/ISO

11607, Packaging for terminally sterilized medical
devices-Part 1 and Part 2:2006

„ ASTM F-1327-05, Standard Terminology Relating

to Barrier Materials for Medical Packaging

„ ASTM F-2097-05, Standard Guide for Design and

Evaluation of Primary Packaging for Medical
Products
References

„ Package Testing - Learning the Four R’s, Revised

ISO standard stresses test method validation,
Pharmaceutical & Medical Packaging News,
January 2008, Volume 16, Issue 1

„ Medical Device Packaging - Cost Issues, FDA

inspections seen as key topics, Healthcare
Packaging, February 2008
 Thank you!

Questions please?

For additional questions or a copy of today’s seminar,

please send an email to
webinars@mocon.com
or go to
www.mocon.com
 Join us for next month’s seminar

Understanding ASTM standards for permeation testing - WVTR

Presented By: Michelle Stevens

Wednesday, April 9th, 2008

10:00 am Central