A key design attribute of a terminally sterilized medical device is for the device to maintain sterility throughout the labeled shelf-life. This presentation discusses a few of the elements that are necessary for a successful packaging shelf-life.

1. Components of a Successful Packaging Shelf-Life
Study
Ed Arscott
Senior Medical Research Manager
NAMSA
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2. 2
Overview
 Packaging Validation Inputs
 Developed Protocols

3. Determine Packaging Validation Inputs
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4.  Initial inputs related to the packaging design and packaging
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materials are key

5.  Initial inputs related to the packaging design and packaging
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materials are key
 These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!

6.  Initial inputs related to the packaging design and packaging
6
materials are key
 These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!
 Review what method of sterilization is intended to be
chosen for the device and the proposed package
 Certain types of packaging materials are needed for certain
sterilization modes

7.  Initial inputs related to the packaging design and packaging
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materials are key
 These are lengthy studies that have to be re-started form
time 0 if not addressed up front. Time is money!
 Review what method of sterilization is intended to be
chosen for the device and the proposed package
 Certain types of packaging materials are needed for certain
sterilization modes
 Single barrier versus double barrier package design
 Input is essential from users (nurses, doctors). Obtain Voice of
the Customer (VOC) feedback. And don’t forget your marketing
partners!

8.  The decision on how long of a shelf life you would like to
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claim

9.  The decision on how long of a shelf life you would like to
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claim
 The inputs here are:
 Operational – how long do you want this product to be “saleable”

10.  The decision on how long of a shelf life you would like to
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claim
 The inputs here are:
 Operational – how long do you want this product to be “saleable”
 Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor

11.  The decision on how long of a shelf life you would like to
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claim
 The inputs here are:
 Operational – how long do you want this product to be “saleable”
 Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor
 Sealing equipment validations
 Key component PRIOR to starting the Shelf-life study is to
ensure the sealing equipment has been validated

12.  The decision on how long of a shelf life you would like to
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claim
 The inputs here are:
 Operational – how long do you want this product to be “saleable”
 Functional – are there product functionality characteristics that are
part of the product design inputs that are a limiting factor
 Sealing equipment validations
 Key component PRIOR to starting the Shelf-life study is to
ensure the sealing equipment has been validated
 Sample quantities
 Ensure that enough samples have been produced to satisfy
both the Accelerated and Real-Time Testing intervals

13. Protocol Development
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14. 14
 Sample preparation
 Ensure the packaging equipment has been properly
validated for the package/device being tested

15. 15
 Sample preparation
 Ensure the packaging equipment has been properly
validated for the package/device being tested
 Optional – Determine device to represent product family
of devices for this design

16. 16
 Sample preparation
 Ensure the packaging equipment has been properly
validated for the package/device being tested
 Optional – Determine device to represent product family
of devices for this design
 Seal devices within the validated parameters

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 Sample preparation
 Ensure the packaging equipment has been properly
validated for the package/device being tested
 Optional – Determine device to represent product family
of devices for this design
 Seal devices within the validated parameters
 Sterilize at maximum exposure conditions
 Radiation = upper dose or greater
 Ethylene Oxide = double exposure
 Other sterilization processes can use the same logic

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 Accelerated Aging Conditions
 Based on product and package material compatibility,
determine temperatures that will not damage package or
device

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 Accelerated Aging Conditions
 Based on product and package material compatibility,
determine temperatures that will not damage package or
device
 ASTMF1980
 Accelerated aging is based on thermodynamic
dependence on reaction rates

20. 20
 Accelerated Aging Conditions
 Based on product and package material compatibility,
determine temperatures that will not damage package or
device
 ASTMF1980
 Accelerated aging is based on thermodynamic
dependence on reaction rates
 Arrhenius reaction rate function is that, for many
common chemical reactions at room temperature, the
reaction rate doubles for every 10 degree Celsius
increase in temperature (Q10).

21. Protocol Development – Sample Sizes
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22.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale

23.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale
 As stated there is not a standard number of samples
required, so how do you choose?

24.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale
 As stated there is not a standard number of samples
required, so how do you choose?
 Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels

25.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale
 As stated there is not a standard number of samples
required, so how do you choose?
 Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
 Typically it would be Inspection Level II

26.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale
 As stated there is not a standard number of samples
required, so how do you choose?
 Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
 Typically it would be Inspection Level II
 Utilize in-house quality experts for determinations to
satisfy “your” company’s requirements

27.  ISO 11607-1 outlines that sampling plans should be based
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on a statistically valid rationale
 As stated there is not a standard number of samples
required, so how do you choose?
 Utilize ISO 2859 (similar to ANSI/ASQ Z1.4) for inputs
base on lot/batch sizes and inspections levels
 Typically it would be Inspection Level II
 Utilize in-house quality experts for determinations to
satisfy “your” company’s requirements
 Usually NAMSA recommends to send a minimum of 10
samples per test input per time point

28.  To view the complete Remote Training Series on
Components of a Successful Packaging Shelf-Life Study
 Check out NAMSA’s Seminars
 For information about the Packaging Shelf Life services
NAMSA can offer you
 Visit our Packaging Validation and Shelf Life Testing
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page
 For additional information
 Contact us at clientcare@namsa.com.