PCD remains valid for new product

#1
Hi, I'm new here and to ISO 13485 and ISO 11135 so go easy on me.

I am new to the company and have been tasked with continuing the work that the company has done with the notified body to resolve the audit findings from the last audit.

One finding has been plaguing them/us...
Product "B" was added to a validated product process and was deemed equivalent to or a lesser challenge than the currently validated product. The protocol used for adoption stated that the candidate part was shorter and wider and did not have a plastic sheath around it before it was put into the heat sealed pouch (sterile barrier). Therefore, the predicate part is still the greater challenge to sterilization. However, the candidate part has a larger shipper container. Therefore, a larger load size was validated using 3 half cycles and 1 full cycle alongside the already validated load size for comparison.

The finding started out that there was no rationale provided that the PCD remains valid for the new maximum load size and has now evolved into the larger product size was not assessed in the rationale for how it was adopted.

The notified body has been given the protocol used for both the original validation that included the fractional cycle to validate the PCD and the new maximum load validation. Both documents state which is the greater challenge to sterility and the second document states why the fractional cycle was not performed for the new maximum load.

I know this is cryptic but this has frustrated the company for way too long and I want to get this resolved. Any assistance would be helpful.

Thank you in advance!
 
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#3
Are you asking what the PCD is or what the results were?
The qualified monitor is PCD 4.7.
The protocol states that in absence of the sublethal cycle (due to the candidate product being a lesser challenge), the half-cycle acceptance criteria includes a requirement that all half-cycle internal product and PCDs must show no growth of the indicator organism after 7 days of incubation. The results showed no growth after 7 days of incubation for the half-cycles and the full cycle.
 

planB

Trusted Information Resource
#6
Heather,

could you please share some more details?
  1. What exact rationale does the second document state why the fractional cycle was not performed for the new maximum load? Did you employ a stanadard for yoru adoption exercise (e.g. AAMI TIR 28)?
  2. What is the exact deficiency regarding the new maximum load stated by your notificed body?
  3. Do you employ iPCDs (internal Process Challenge Devices) or ePCDs (external PCDs) or a combination of both?
  4. 3 half cycles and 1 full cycle: When you compare the physical data of your new PPQ (physical performance qualification) runs with those of your initial validation, did you observe any noticable differences?
Thanks,
Gerhard
 
#7
Gerhard,

Thank you for responding, we are still working on this.

The exact rationale states that "the study did not include a sublethal cycle, as the adoption candidate product was evaluated to be a lesser challenge to the sterility than the currently used master challenge device. Therefore, the half cycle acceptance criteria includes a requirement that all half-cycle internal product and PCDs must show no growth of the indicator organism after 7 days of incubation, since the relative challenge between the "product" internal BI and natural product has not been evaluated."

The study was done in accordance with the ISO 11135-1:2007 and associated technical information reports (and cited AAMI TIR 14, 15, 16 and 28). This adoption study was completed in 2015.

Notified Body Response: The rationale being pointed to in the protocol for adopting this product to the family identifies that the predicate product is longer and narrower with respect to a lumen; however, there's a larger probe on the Uretron (candidate product) so much larger that it requires to validate a new larger load size? It is unclear how this probe size wasn't assessed in this rationale for how it was adopted.

We asked for further clarification as to what they were looking for exactly and the response was as follows: "We found that even though a fractional cycle had been performed, it is not possible to determine if the results of the fractional cycle can represent the existing product in a meaningful way."

We used internal PCDs.

When reviewing the data from both of the studies, I did not see any noticeable differences between the physical data of each. Is there anything that I should be looking for specifically?

Please let me now if you are in need of additional information.

Thank you!
 

planB

Trusted Information Resource
#8
Heather,

from what I understand, you have already experimentally validated that the changed load configuration (i.e. larger containers) can still be reproducibly sterilized with the required SAL of 10exp(-6). The inactivation of all used BIs, plus equivalence of physical data in in your combined MPQ/PPQ study (1 full cycle, 3 half cycles) demonstrates that the varying load configuration has no adverse impact on the cycle efficacy. This should address the NB concern "[...] t requires to validate a new larger load size"., as you have actually done this, if I understood you correctly.

The NB's main concern is that the candidate product may pose a greater challenge to the cycle than the existing PCD. If I understood you correctly, then I see 2 options:

1) Demonstrate bioburden equivalency between candidate and existing products
This approach presumes, that the relevant candidate device's characteristics (geometry, size, packaging etc) do not pose a greater challenge

1.1) Experimentally:
You may try to beef up your rationales why the candidate product's bioburden is not a greater challenge in terms of number and resistance. You may either do this by bioburden enumeration and characterization, compare this result to the existing bioburden data of your existing devices and master product and thus, demonstrate bioburden equivalency.

1.2) Rationales:
In case you manufacture your candidate product from equivalent (raw) materials (including packaging materials), under equivalent manufacturing conditions and equivalent manufacturing processes in terms of bioburden, you might argue that the bioburden characteristics remained unchanged

2) Perform a sub-lethal cycle including the candidate product, as expected by your NB


No matter which route you may chose, seek protocol approval from your NB prior to initiating tests: this might spare you from additional rounds of questions once you submit the related report to your NB.


HTH,
 

levatorsuperioris

Involved In Discussions
#9
This scenario ETO gas would enter the pallet, then enter your external packaging, diffuse through the Tyvek or what ever, then enter the device.

If I understand correctly,

The crux of the issue is that your definition of worst case device relied only on the device itself, the NB correctly argues that the worst case involved also your packaging through which the EO gas must traverse. IFU thickness and placement can also be a consideration. Depending on how large the change to external packaging is you may also encounter issues with EO residuals.

your defenses would be:
1) If you place the packaging post sterilization release
2) You can show the outside packaging does not affect the dynamics of the EO.
 
#10
This scenario ETO gas would enter the pallet, then enter your external packaging, diffuse through the Tyvek or what ever, then enter the device.

If I understand correctly,

The crux of the issue is that your definition of worst case device relied only on the device itself, the NB correctly argues that the worst case involved also your packaging through which the EO gas must traverse. IFU thickness and placement can also be a consideration. Depending on how large the change to external packaging is you may also encounter issues with EO residuals.

your defenses would be:
1) If you place the packaging post sterilization release
2) You can show the outside packaging does not affect the dynamics of the EO.
There were two (2) studies conducted. One of which was the original sterilization validation of the original product family. The second study was to validate a new larger load size as well as adopt the candidate product family into the existing family of products.

We are in need of a range of load sizes due to the difference in packaging of the two different product families. The predicate family is longer in length (150cm) and has a smaller ID (0.5mm). It is packaged as a coil which is then placed in a pouch, sale box and, finally, a shipper box. The candidate family is much shorter (max 5.8cm) and has a larger ID (min 0.6mm). It is packaged straight into a longer pouch, sale box and shipper box. The shipper box is larger due to the increased length of the packaging not to the increased length or size of the product. The candidate product boxes are thinner and therefore can fit more into the shipper box than the square, flat boxes of the predicate part.

The new configuration was validated through the second study. We originally thought the new shipping configuration was the issue but it seems to be the device size now.

Thank you for your help!
 
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