Regulatory Open Forum

All - I am learning about EO sterilization validation and had a question around the packaging validation for porous packaging (tyvek and film pouches). There are aging studies to prove shelf life, and ship testing (distribution simulation and environmental conditioning). Are these 2 separate tests, or should they be done together/on the same samples?

If validating new parameters for a EO sterilization process, after running a worst case EO cycle, would you want to run through ship testing (ISTA 3A and ASTM D4169) and then run those same samples through the aging process? Or are ship testing and aging independent tests? 

Is ship testing only required for finished package (in the case of our products we typically test to ISTA 3A)? (for example, would we only need to condition the product in its finished boxed up format and then perform testing on the sterile barrier packages after the conditioning).

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Allyson Swartz
Lead Quality Engineer
Coralville IA
United States
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Hello Allyson,

Welcome to EO sterilisation validation !

You can complete aging studies for shelf life and shipping test separately, but it will be more time consuming and most likely use up more materials.  You can complete them together where you would "simulate" the actual process of shelf life and shipping.  In fact, many would argue the products on shelf life testing should go through a typical process of manufacturing, packaging, sterilisation, distribution, and sale ... mimicking how it the product would be handled through the course.  When I did these studies I made enough samples where i could do shipping studies, and then kept a defined amount later as part of accelerated aging and real time aging.

The samples for aging and shipping would typically go through a normal sterilisation cycle.  A worst case EO cycle is just to confirm the product integrity typically for just the EO cycle, like running twice through if one cycle fails during processes.  The amount of samples needed to run worst case and normal case would be alot, so a well defined protocol with reasoning and justification for the process and samples would be good.  When doing these, again I would try to mimick the actual process for how products are handled.

Yes, ship testing is required just for the finished packaging.  This is just to confirm the product can get from point A to point B thousands of miles away getting there without compromising the performance of the device.  When doing training, I always like to tell people about the ultimate ship test is the Jim Carey method in the beginning of Ace Ventura, watch it, you will see :).

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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 11-Feb-2021 15:54
From: Allyson Swartz
Subject: Sterilization Validation - Ship testing and aging studies

All - I am learning about EO sterilization validation and had a question around the packaging validation for porous packaging (tyvek and film pouches). There are aging studies to prove shelf life, and ship testing (distribution simulation and environmental conditioning). Are these 2 separate tests, or should they be done together/on the same samples?

If validating new parameters for a EO sterilization process, after running a worst case EO cycle, would you want to run through ship testing (ISTA 3A and ASTM D4169) and then run those same samples through the aging process? Or are ship testing and aging independent tests?

Is ship testing only required for finished package (in the case of our products we typically test to ISTA 3A)? (for example, would we only need to condition the product in its finished boxed up format and then perform testing on the sterile barrier packages after the conditioning).

------------------------------
Allyson Swartz
Lead Quality Engineer
Coralville IA
United States
------------------------------

Hey Richard,

Having worked for UPS as a younger man, I can confirm that Ace was actually being gentle ...  But it is a great way to think about ship testing and what the packaging will go through!

-Dan

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Daniel Roberts
Sr Manager
Jenison MI
United States
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Original Message:
Sent: 12-Feb-2021 05:13
From: Richard Vincins
Subject: Sterilization Validation - Ship testing and aging studies

Hello Allyson,

Welcome to EO sterilisation validation !

You can complete aging studies for shelf life and shipping test separately, but it will be more time consuming and most likely use up more materials.  You can complete them together where you would "simulate" the actual process of shelf life and shipping.  In fact, many would argue the products on shelf life testing should go through a typical process of manufacturing, packaging, sterilisation, distribution, and sale ... mimicking how it the product would be handled through the course.  When I did these studies I made enough samples where i could do shipping studies, and then kept a defined amount later as part of accelerated aging and real time aging.

The samples for aging and shipping would typically go through a normal sterilisation cycle.  A worst case EO cycle is just to confirm the product integrity typically for just the EO cycle, like running twice through if one cycle fails during processes.  The amount of samples needed to run worst case and normal case would be alot, so a well defined protocol with reasoning and justification for the process and samples would be good.  When doing these, again I would try to mimick the actual process for how products are handled.

Yes, ship testing is required just for the finished packaging.  This is just to confirm the product can get from point A to point B thousands of miles away getting there without compromising the performance of the device.  When doing training, I always like to tell people about the ultimate ship test is the Jim Carey method in the beginning of Ace Ventura, watch it, you will see :).

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 11-Feb-2021 15:54
From: Allyson Swartz
Subject: Sterilization Validation - Ship testing and aging studies

All - I am learning about EO sterilization validation and had a question around the packaging validation for porous packaging (tyvek and film pouches). There are aging studies to prove shelf life, and ship testing (distribution simulation and environmental conditioning). Are these 2 separate tests, or should they be done together/on the same samples?

If validating new parameters for a EO sterilization process, after running a worst case EO cycle, would you want to run through ship testing (ISTA 3A and ASTM D4169) and then run those same samples through the aging process? Or are ship testing and aging independent tests?

Is ship testing only required for finished package (in the case of our products we typically test to ISTA 3A)? (for example, would we only need to condition the product in its finished boxed up format and then perform testing on the sterile barrier packages after the conditioning).

------------------------------
Allyson Swartz
Lead Quality Engineer
Coralville IA
United States
------------------------------

Good post by Richard.  I'll add that, when grappling with the differences between tasks like "shelf-life", "stability", "transit/ship testing", "package integrity testing", and the like, a great place to start is ISO 11607-1.  Also useful, though not updated yet for the latest version of ISO 11607-1, is AAMI's corresponding guidance document (AAMI TIR22).  ISO 11607 contains key distinctions and testing for sterile packaging materials, the sterile barrier, the packaging system, and the protective packaging.

As a general rule, I consider a worst-case scenario, though not always the case, to be aged materials and/or an aged packaging system that are shipped after aging (as compared to shipping before aging).  ISO 11607-1 can help to sort that out.

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Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 11-Feb-2021 15:54
From: Allyson Swartz
Subject: Sterilization Validation - Ship testing and aging studies

All - I am learning about EO sterilization validation and had a question around the packaging validation for porous packaging (tyvek and film pouches). There are aging studies to prove shelf life, and ship testing (distribution simulation and environmental conditioning). Are these 2 separate tests, or should they be done together/on the same samples?

If validating new parameters for a EO sterilization process, after running a worst case EO cycle, would you want to run through ship testing (ISTA 3A and ASTM D4169) and then run those same samples through the aging process? Or are ship testing and aging independent tests?

Is ship testing only required for finished package (in the case of our products we typically test to ISTA 3A)? (for example, would we only need to condition the product in its finished boxed up format and then perform testing on the sterile barrier packages after the conditioning).

------------------------------
Allyson Swartz
Lead Quality Engineer
Coralville IA
United States
------------------------------

Dear Allyson

For your validation of the safety of the finished medical device in which EO sterilisation is part of the process, I recommend to consider the following standards:

• ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals with its Amendment of 2019 and its corrigenda of 2009
• ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.

More information you will find here: https://www.iso.org/standard/34213.html and https://www.iso.org/standard/56137.html

 

In addition, EO Sterilisation has been under the close scrutiny of the FDA in the past year or so.  

The below website gives hyperlinks to the different themes associated with EO sterilisation.

https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/ethylene-oxide-sterilization-medical-devices

 

Please consider that there are other factors to consider in association with EO sterilisation processing. For instance, your labelling can affect the safety of your finished product.  If the label is too large, sufficient amounts of EO may not expire from your packaging during the processing.   

 
Wish you lots of success.

Best Regards,
Stephanie

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Stephanie Grassmann
Managing Director of MedTechXperts Ltd
Biberstein
Switzerland
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Original Message:
Sent: 11-Feb-2021 15:54
From: Allyson Swartz
Subject: Sterilization Validation - Ship testing and aging studies

All - I am learning about EO sterilization validation and had a question around the packaging validation for porous packaging (tyvek and film pouches). There are aging studies to prove shelf life, and ship testing (distribution simulation and environmental conditioning). Are these 2 separate tests, or should they be done together/on the same samples?

If validating new parameters for a EO sterilization process, after running a worst case EO cycle, would you want to run through ship testing (ISTA 3A and ASTM D4169) and then run those same samples through the aging process? Or are ship testing and aging independent tests?

Is ship testing only required for finished package (in the case of our products we typically test to ISTA 3A)? (for example, would we only need to condition the product in its finished boxed up format and then perform testing on the sterile barrier packages after the conditioning).

------------------------------
Allyson Swartz
Lead Quality Engineer
Coralville IA
United States
------------------------------