Components of a Successful Packaging Shelf-Life Study
Ed Arscott
Senior Medical Research Manager
NAMSA
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Overview
Packaging Validation Inputs Developed Protocols
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Determine Packaging Validation Inputs
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Initial inputs related to the packaging design and packaging materials are key
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Initial inputs related to the packaging design and packaging materials are key
These are lengthy studies that have to be re-started form time 0 if not addressed up front. Time is money!
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Initial inputs related to the packaging design and packaging 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
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Initial inputs related to the packaging design and packaging 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!
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The decision on how long of a shelf life you would like to claim
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The decision on how long of a shelf life you would like to claim The inputs here are:
Operational – how long do you want this product to be “saleable”
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The decision on how long of a shelf life you would like to 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
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The decision on how long of a shelf life you would like to 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
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The decision on how long of a shelf life you would like to 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
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Protocol Development
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Sample preparation Ensure the packaging equipment has been properly
validated for the package/device being tested
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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
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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
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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
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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 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).
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Protocol Development – Sample Sizes
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ISO 11607-1 outlines that sampling plans should be based on a statistically valid rationale
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ISO 11607-1 outlines that sampling plans should be based on a statistically valid rationale
As stated there is not a standard number of samples required, so how do you choose?
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ISO 11607-1 outlines that sampling plans should be based 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
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ISO 11607-1 outlines that sampling plans should be based 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
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ISO 11607-1 outlines that sampling plans should be based 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
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ISO 11607-1 outlines that sampling plans should be based 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
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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
page For additional information
Contact us at [email protected].