Components of a Successful Packaging Shelf-Life Study

Components of a Successful Packaging Shelf-Life Study

Ed Arscott

Senior Medical Research Manager

NAMSA

1

2

Overview

Packaging Validation Inputs Developed Protocols

3

Determine Packaging Validation Inputs

4

Initial inputs related to the packaging design and packaging materials are key

5

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!

6

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

7

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!

8

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

9

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”

10

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

11

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

12

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

13

Protocol Development

14

Sample preparation Ensure the packaging equipment has been properly

validated for the package/device being tested

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

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

17

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

18

Accelerated Aging Conditions Based on product and package material compatibility,

determine temperatures that will not damage package or device

19

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

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

22

ISO 11607-1 outlines that sampling plans should be based on a statistically valid rationale

23

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?

24

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

25

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

26

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

27

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

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

page For additional information

Contact us at [email protected].