Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hi all,

How did you handle this item in the GSPR?

We ship our devices non-sterile, to be sterilized via autoclave by the end user prior to use. So, what does it matter that there may be microbial contamination during shipping? They are shipping wrapped in plastic and in a box. How can I 'prove' that this is enough? We've done sterilization testing with an outside lab, but there's no documentation on how these parts shipped to the sterilization lab. For all I know, they might have been hand-carried.

Original Message:
Sent: 10/5/2021 9:35:00 AM
From: Anonymous Member
Subject: GSPR 11.7 - how to prove compliance?

This message was posted by a user wishing to remain anonymous

Hi all,

How did you handle this item in the GSPR?

"11.7 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination;  the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer."

We ship our devices non-sterile, to be sterilized via autoclave by the end user prior to use. So, what does it matter that there may be microbial contamination during shipping? They are shipping wrapped in plastic and in a box. How can I 'prove' that this is enough? We've done sterilization testing with an outside lab, but there's no documentation on how these parts shipped to the sterilization lab. For all I know, they might have been hand-carried.

This message was posted by a user wishing to remain anonymous

"11.7 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination;  the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer."

Greetings!  My approach might be different.  I would think the answer would be dependent on the details associated with the cleaning and sterilization instructions in your IFU and the conditions used to validate them.  There are variables to consider such as whether or not your device is reusable and the nature/duration of contact during use. 

If you have a reusable device intended to be cleaned/sterilized between patients that's in contact with blood/bone, I would expect the cleaning and sterilization validation, as long as it specifies to use the same steps prior to first use, to be aggressive enough to rationalize that any packaging sufficient to prevent damaging the device during shipping would be sufficient to satisfy the GSPR. In other words, the process of removing post-surgical deposition of blood/bone/tissue is more challenging than removing incidental microbial contamination that occurred during shipping.

The less aggressive the cleaning and sterilization (or disinfection) instructions, the greater the reliance on the packaging system will be to ensure that the device will be free of microbial contamination at the point of use.  That's why the potential for microbial contamination during shipping matters.  It contributes to your worst-case cleaning and sterilization efficacy determination, which should be built in to your cleaning/sterilization method validation protocol.
Original Message:
Sent: 06-Oct-2021 06:59
From: Lee Leichter
Subject: GSPR 11.7 - how to prove compliance?

Dear Anon,

 

If the "plastic wrap" is intended to be a sterile barrier (after sterilization by the customer) perhaps validating the shipping of the the devices in a shipping simulation such as outlined the ASTM D4169 or ISTA standards, establishing through inspection (or packaging integrity test) that the packaging that ensures that they are clean is still integral and not damaged (allowing contamination onto the device). 

 

If the packaging or "plastic wrap" is perhaps not a intended to be a sterile barrier (after sterilization) perhaps a comparative bioburden test (before or after shipment) or a microbial challenge test of the package before and after shipping is warranted.

 

Lee

Original Message:
Sent: 10/5/2021 9:35:00 AM
From: Anonymous Member
Subject: GSPR 11.7 - how to prove compliance?

This message was posted by a user wishing to remain anonymous

Hi all,

How did you handle this item in the GSPR?

"11.7 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination;  the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer."

We ship our devices non-sterile, to be sterilized via autoclave by the end user prior to use. So, what does it matter that there may be microbial contamination during shipping? They are shipping wrapped in plastic and in a box. How can I 'prove' that this is enough? We've done sterilization testing with an outside lab, but there's no documentation on how these parts shipped to the sterilization lab. For all I know, they might have been hand-carried.

The end user needs to have some knowledge of the bioburden of the device to set the sterilization parameters to achieve an SAL of 6.

The device needs to be clean when shipped. I think of this as a device with a specific microbial state under Annex I(11.3). Then the device packaging should not allow the defined state to get worse. This is Annex I(11.7).

When doing the GS&PR analysis, make both 11.3 and 11.7 applicable. There are standards that can help you determine the microbial state when you put the device in the package. There are also standards to test the packaging system to ensure it is suitable. Conduct the tests, document the results, and include them in your Annex II technical file.

If you have an ISO 13485:2016 QMS you are at least part-way there. Clauses 6.4 and 7.5.2 cover cleanliness of the device. The GS&PR has more specific requirements.

------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------

Original Message:
Sent: 05-Oct-2021 09:34
From: Anonymous Member
Subject: GSPR 11.7 - how to prove compliance?

This message was posted by a user wishing to remain anonymous

Hi all,

How did you handle this item in the GSPR?

"11.7 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination;  the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer."

We ship our devices non-sterile, to be sterilized via autoclave by the end user prior to use. So, what does it matter that there may be microbial contamination during shipping? They are shipping wrapped in plastic and in a box. How can I 'prove' that this is enough? We've done sterilization testing with an outside lab, but there's no documentation on how these parts shipped to the sterilization lab. For all I know, they might have been hand-carried.

This message was posted by a user wishing to remain anonymous

Thanks all!
Original Message:
Sent: 05-Oct-2021 09:34
From: Anonymous Member
Subject: GSPR 11.7 - how to prove compliance?

This message was posted by a user wishing to remain anonymous

Hi all,

How did you handle this item in the GSPR?

"11.7 Packaging systems for non-sterile devices shall maintain the integrity and cleanliness of the product and, where the devices are to be sterilized prior to use, minimize the risk of microbial contamination;  the packaging system shall be suitable taking account of the method of sterilization indicated by the manufacturer."

We ship our devices non-sterile, to be sterilized via autoclave by the end user prior to use. So, what does it matter that there may be microbial contamination during shipping? They are shipping wrapped in plastic and in a box. How can I 'prove' that this is enough? We've done sterilization testing with an outside lab, but there's no documentation on how these parts shipped to the sterilization lab. For all I know, they might have been hand-carried.