Regulatory Open Forum

Dear Community,

In our planning for testing according to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems, we have to take into consideration the multiple shipping to-and-from the patient for use and subsequent re-use of the device, within the same country. Originally, the device was intended for multiple use/re-use but within a HCP's environment. The new approach of shipping to-and-from the patient is the BD's proposal.

Has anyone had this challenge of defining the environmental conditions for the multi-cycle of the device?

Exposing the device to the temperature and humidity conditioning + shocks/vibration/drop for the duration which is the sum of all shipping cycles may be too aggressive if done at once? (After all, the device has to pass its performance/functional tests afterwards)

Would a HALT test be appropriate on the device in its final design?

Any ideas, comments, suggestions are highly appreciated!

Dear Community,

In our planning for testing according to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems, we have to take into consideration the multiple shipping to-and-from the patient for use and subsequent re-use of the device, within the same country. Originally, the device was intended for multiple use/re-use but within a HCP's environment. The new approach of shipping to-and-from the patient is the BD's proposal.

Has anyone had this challenge of defining the environmental conditions for the multi-cycle of the device?

Exposing the device to the temperature and humidity conditioning + shocks/vibration/drop for the duration which is the sum of all shipping cycles may be too aggressive if done at once? (After all, the device has to pass its performance/functional tests afterwards)

Would a HALT test be appropriate on the device in its final design?

Any ideas, comments, suggestions are highly appreciated!

Follow ASTM D4169 for each iteration of the shipping routine. The standard tests the packaging so you need to define it for each iteration.<o:p></o:p>

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Typically, the packaging from the manufacturer to the customer is well defined. The packaging from the customer to the manufacturer may not be.<o:p></o:p>

<o:p> </o:p>

Assume that the same packaging is used in both directions. This means the customer saved the packaging and reuses it. Determine the number of iterations.<o:p></o:p>

<o:p> </o:p>

For each iteration determine the D4169 distribution cycle such as DC13 Air (intercity) and motor freight (local, single package up to 150 lb (61.8 kg). Follow the schedules for each iteration.<o:p></o:p>

<o:p> </o:p>

Determine if you need to unpack and repack the product between iterations to better simulate the actual condition. Then, the packaging must meet the acceptance criteria after all the iterations.<o:p></o:p>

Dear Community,

In our planning for testing according to ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems, we have to take into consideration the multiple shipping to-and-from the patient for use and subsequent re-use of the device, within the same country. Originally, the device was intended for multiple use/re-use but within a HCP's environment. The new approach of shipping to-and-from the patient is the BD's proposal.

Has anyone had this challenge of defining the environmental conditions for the multi-cycle of the device?

Exposing the device to the temperature and humidity conditioning + shocks/vibration/drop for the duration which is the sum of all shipping cycles may be too aggressive if done at once? (After all, the device has to pass its performance/functional tests afterwards)

Would a HALT test be appropriate on the device in its final design?

Any ideas, comments, suggestions are highly appreciated!