Quarterly Dose Audit Medical Device VDmax

alonFAI

Involved In Discussions
#1
Hello All,

Dear All, I have a number of question regarding VDmax quarterly dose audit:

1. Why do I need ,technically speaking to perform a quarterly dose audit?
if I perform a Bioburden routinely and my CFU<X then wouldn't it mean that my product is sterile? why a dose audit is still required?

2. is it possible that the level of CFU on my product is still within acceptable limits (CFU<X) but the sterility of the product would be compromised some how? maybe due to a change in the type of microbes? (gram stain, maldi tof)?

3. lets say I manufacture a certain product in 2 different contract manufacturers.
these products are then sterilized in 2 different sterilizers.
sterilization dose is the same.
would I need to perform a quarterly dose audit for "both products" (i.e. perform a dose audit on items produced by Contract manufacturer 1 and on items produced by contract manufacturer 2 as well?) (these are identical products just manufactured by 2 different contract manufacturer according 3. to same spec)?

4. Where should I perform the quarterly dose audit? must it be done by the sterilizer itself? or I can work with any other lab capable of doing sterility test?

THANKS!!!:applause::bigwave:
 
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pkost

Trusted Information Resource
#2
I'm not an expert on this, but will add my thoughts

1. Why do I need ,technically speaking to perform a quarterly dose audit?
if I perform a Bioburden routinely and my CFU<X then wouldn't it mean that my product is sterile? why a dose audit is still required?
I believe this demonstrates that the process (both manufacture and sterilisation) is repeatable and stable;. from recollection, after a year you can justify droping down the dose audits to annual


2. is it possible that the level of CFU on my product is still within acceptable limits (CFU<X) but the sterility of the product would be compromised some how? maybe due to a change in the type of microbes? (gram stain, maldi tof)?
VDmax validates against your bioburden type, if it changes significantly, your valdiation is no longer valid


3. lets say I manufacture a certain product in 2 different contract manufacturers.
these products are then sterilized in 2 different sterilizers.
sterilization dose is the same.
would I need to perform a quarterly dose audit for "both products" (i.e. perform a dose audit on items produced by Contract manufacturer 1 and on items produced by contract manufacturer 2 as well?) (these are identical products just manufactured by 2 different contract manufacturer according 3. to same spec)?
the different sites will have different handling/bioburden etc...from recollection the standard includes parameters that impact the validation...site, bioburden, process etc...

Both sites should probably be validated seperately


4. Where should I perform the quarterly dose audit? must it be done by the sterilizer itself? or I can work with any other lab capable of doing sterility test?
I believe the work can be done anywhere
 

Kees Fremerij

Starting to get Involved
#3
This is called ¨maintaining process effectiveness¨. Is everything still under control like bioburden, production environment, product handling, packaging and so on. That is why it is required to check this periodically, every 3 months. Historically this period was to eliminate seasonal influences. Nowadays this is not such a big issue anymore in most production environments.
Once all appear to be stable and under control you can lower the frequency to maximum once a year. You can write a rationale which covers all the actions required. (I wrote several of these, it is not very complicated if you know where to look at).

If you have a stable and low Bioburden the change of failure in a Dose Audit is very small. But the purpose of this Dose Audit is exactly to cover that. For the Bioburden it is not only in numbers but also the types of bacteria which is relevant.

Production at different locations automatically implicates different validation studies as the external risks are not equal. Again, after proven stability a rationale can be a solution to reduce this.

Any accredited Microbiological Lab (preferable ISO 13485 certified) should be able to perform the tests.

So I completely agree with the previous comments...
 
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