Regulatory Open Forum

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------

Hi Lauren:
Yes such testing is good and generally used ... however the best approach would be to understand your product and supply chain and design your own test program based on the likely challenges your product will face. I see many companies where they have really struggled and spent a lot of money on meeting transit test standards on parameters/tests that are not appropriate for their product. Finding your worst case delivery route and shipping there and back two or three times may be a much cheaper and more realistic test. Like everything these days you need a protocol designed based on a risk-based analysis. So yes, testing to the standards is good, but it may not be right for you, your product, your supply chain and real world testing may show you issues that do not show in lab testing.
Hope that helps
Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom
------------------------------

Original Message:
Sent: 28-Jun-2018 19:34
From: Lauren Combs Viker
Subject: Transit Testing

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------

Agree with what Neil said that you can look at both D4169 which outlines the various tests and then ISTA 2A or 3A which is just test methods like crush, drop, incline, vibration, etc.  But definitely agree you have to look at your entire shipping process, environment, temperature, handling, storage, etc.  We did a nice transport study validation according to D4169 and ISTA 2A with passing information.  Then we had failures in January and February because we did not account for freezing temperatures sitting in the transport - that was a dooh moment (product was below 0degC sensitive).

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

Original Message:
Sent: 29-Jun-2018 03:46
From: Neil Armstrong
Subject: Transit Testing

Hi Lauren:
Yes such testing is good and generally used ... however the best approach would be to understand your product and supply chain and design your own test program based on the likely challenges your product will face. I see many companies where they have really struggled and spent a lot of money on meeting transit test standards on parameters/tests that are not appropriate for their product. Finding your worst case delivery route and shipping there and back two or three times may be a much cheaper and more realistic test. Like everything these days you need a protocol designed based on a risk-based analysis. So yes, testing to the standards is good, but it may not be right for you, your product, your supply chain and real world testing may show you issues that do not show in lab testing.
Hope that helps
Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 28-Jun-2018 19:34
From: Lauren Combs Viker
Subject: Transit Testing

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------

That 0º thing is pretty common - I've run into that oversight a couple of times in my career. Sadly, we all seem to be prone to forget that plastics get brittle, batteries lose charge, liquids freeze etc and that many of our markets/shippers/customers are prone to leaving products for hours in freezing conditions in the winter.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 29-Jun-2018 04:45
From: Richard Vincins
Subject: Transit Testing

Agree with what Neil said that you can look at both D4169 which outlines the various tests and then ISTA 2A or 3A which is just test methods like crush, drop, incline, vibration, etc.  But definitely agree you have to look at your entire shipping process, environment, temperature, handling, storage, etc.  We did a nice transport study validation according to D4169 and ISTA 2A with passing information.  Then we had failures in January and February because we did not account for freezing temperatures sitting in the transport - that was a dooh moment (product was below 0degC sensitive).

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

Original Message:
Sent: 29-Jun-2018 03:46
From: Neil Armstrong
Subject: Transit Testing

Hi Lauren:
Yes such testing is good and generally used ... however the best approach would be to understand your product and supply chain and design your own test program based on the likely challenges your product will face. I see many companies where they have really struggled and spent a lot of money on meeting transit test standards on parameters/tests that are not appropriate for their product. Finding your worst case delivery route and shipping there and back two or three times may be a much cheaper and more realistic test. Like everything these days you need a protocol designed based on a risk-based analysis. So yes, testing to the standards is good, but it may not be right for you, your product, your supply chain and real world testing may show you issues that do not show in lab testing.
Hope that helps
Neil

------------------------------
Neil Armstrong FRAPS
CEO MeddiQuest Limited
Peterborough
United Kingdom

Original Message:
Sent: 28-Jun-2018 19:34
From: Lauren Combs Viker
Subject: Transit Testing

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------

Original Message------

That 0º thing is pretty common - I've run into that oversight a couple of times in my career. Sadly, we all seem to be prone to forget that plastics get brittle, batteries lose charge, liquids freeze etc and that many of our markets/shippers/customers are prone to leaving products for hours in freezing conditions in the winter.

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message------

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------

Westpak has a webinar that compares ASTM to ISTA methods for package distribution simulation. 
Click <g class="gr_ gr_135 gr-alert gr_gramm gr_inline_cards gr_run_anim Grammar only-ins doubleReplace replaceWithoutSep" id="135" data-gr-id="135">link</g> below and scroll down to find that webinar.
ASTM VS ISTA FOR PACKAGE TESTING - WHICH IS BETTER?

------------------------------

Sam Lazzara
Principal Consultant
Fremont CA & Las Vegas NV
United States
https://mdqc.blog/
------------------------------

Original Message:
Sent: 28-Jun-2018 19:34
From: Lauren Combs Viker
Subject: Transit Testing

Hello,

We are conducting transit testing for our class II medical devices. Would you recommend testing against ASTM D4169 or ISTA 3A? Thank you.

------------------------------
Lauren Combs Viker
Quality Assurance Manager
Grover Beach, CA 93433
USA
------------------------------