Regulatory Open Forum

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey

Hello Aubrey,

True, ISO 11607 gives plenty of examples because there are many different types of packaging materials and packaging configurations.  In my experience, for typical paper/Tyvek/plastic type of pouches would be burst test, bubble leak, dye penetration, and peel test.  These all have ASTM standards associated with them for testing methods.  This does usually depend on the type of packaging and configuration such as a Tyvek pouch versus a thermo-formed package with heat-sealed top.  Usually you can get some advice from packaging engineers and others working with similar packaging materials.

For the second question, the answer is yes would be expected.  Typically there would be accelerated aging performed on the packaging, then packaging validation testing.  There is usually two sets of packaging ... well three sets ... packaging validation of baseline, testing after accelerated aging, and then testing after normal aging.  The sample sizes are usually determined and fairly common amounts.  All of this testing does need to be included in the Design History File (DHF).  In my experience, for the 510(k) submission we included the initial packaging validation which was often just summarised.  Then we included the validation testing after the accelerated testing.  Submitted the 510(k) application with those data.  Then some time in the future, the real time testing would be included in the DHF for any subsequent inspection or review.

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey

We do this testing in house and I agree with what Richard said. I have received feedback from FDA that they prefer the burst or bubble test over dye penetration since those two tests are considered "whole package" tests whereas dye penetration only tests the seal. Most of our customers perform seal strength and bubble emissions. 

Hello Aubrey,

True, ISO 11607 gives plenty of examples because there are many different types of packaging materials and packaging configurations.  In my experience, for typical paper/Tyvek/plastic type of pouches would be burst test, bubble leak, dye penetration, and peel test.  These all have ASTM standards associated with them for testing methods.  This does usually depend on the type of packaging and configuration such as a Tyvek pouch versus a thermo-formed package with heat-sealed top.  Usually you can get some advice from packaging engineers and others working with similar packaging materials.

For the second question, the answer is yes would be expected.  Typically there would be accelerated aging performed on the packaging, then packaging validation testing.  There is usually two sets of packaging ... well three sets ... packaging validation of baseline, testing after accelerated aging, and then testing after normal aging.  The sample sizes are usually determined and fairly common amounts.  All of this testing does need to be included in the Design History File (DHF).  In my experience, for the 510(k) submission we included the initial packaging validation which was often just summarised.  Then we included the validation testing after the accelerated testing.  Submitted the 510(k) application with those data.  Then some time in the future, the real time testing would be included in the DHF for any subsequent inspection or review.

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey

Hello Aubrey,

True, ISO 11607 gives plenty of examples because there are many different types of packaging materials and packaging configurations.  In my experience, for typical paper/Tyvek/plastic type of pouches would be burst test, bubble leak, dye penetration, and peel test.  These all have ASTM standards associated with them for testing methods.  This does usually depend on the type of packaging and configuration such as a Tyvek pouch versus a thermo-formed package with heat-sealed top.  Usually you can get some advice from packaging engineers and others working with similar packaging materials.

For the second question, the answer is yes would be expected.  Typically there would be accelerated aging performed on the packaging, then packaging validation testing.  There is usually two sets of packaging ... well three sets ... packaging validation of baseline, testing after accelerated aging, and then testing after normal aging.  The sample sizes are usually determined and fairly common amounts.  All of this testing does need to be included in the Design History File (DHF).  In my experience, for the 510(k) submission we included the initial packaging validation which was often just summarised.  Then we included the validation testing after the accelerated testing.  Submitted the 510(k) application with those data.  Then some time in the future, the real time testing would be included in the DHF for any subsequent inspection or review.

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey

There are a few issues here. I recently worked with a client who received a request from FDA for an accelerated life test as well as a packaging study. The request was for a packaging study following ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems. After the packaging study they asked for tests of the integrity of the sterile barrier which include a peel strength test, a dye penetration test, and a bubble test.

The basic idea is to pick those tests that simulate the shipping conditions of the device such as drop tests, etc. Examine the packaging and the sealed device for damage. Then check that the shipping simulation didn't affect the integrity of the sterile barrier.

For accelerated aging, you need to test some units before the start to establish a baseline. Then sterilize and seal the units for the accelerated aging. Since the devices are in a sealed sterile barrier, you may not have many options for the acceleration. At the end of the accelerated test, test the units again to show they are still in specification.<o:p></o:p>

Hello,
I am working with a client on performing shelf life/packaging testing for a sterile product and have a couple of questions.
1) ISO 11607 gives plenty of examples of types of tests that can be conducted, but it's unclear to me if there is a standard for how many different tests are conducted and why certain test methods are selected over others.  I see burst testing and dye penetration a lot, so I had assumed they were the standard, but I'm hoping you all can provide some thoughts on which test methods to use.
2) I saw a post related to this in the forum, but wanted to continue the conversation a bit.  If performance testing is required to be conducted after an accelerated aging study is conducted to validate performance, is that required for a 510K submission? Or does that just need to be included in a design history file? I have also seen  performance testing that does not state that the device had been through accelerated aging or other shelf life/packaging validation testing.

Thank you for the input!
Aubrey