Very small batch validation ISO 11137 (VDmax25)

K

Kees Fremery

#1
Does anyone has experience with very small batches for validation according to ISO 11137 (VDmax25)?

We are an independent microbiological testing lab and receive occasionally this question from (small) companies. They manufacture expensive devices in very small batches (in the range of 30 - 40).
The value of product loss for validation, which requires at least 20 samples, depending on the type of validation, is something they can not carry.
I am thinking of Bioburden n=5 and the verification experiment also n=5.
Some additional criteria can be applicable like a minimal variation in Bioburden and no failures in the test of sterility.
I want to start making a rationale for this but would like to know any other possible experience and acceptance for this.

Thanks in advance,
Kees
 
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Statistical Steven

Statistician
Staff member
Super Moderator
#2
Re: Very small batch validation ISO 11137

Kees, this is an issue I am dealing with currently. There are several concepts that can be applied including minimal variation in the response. Another think to do is become creative with the idea of sample size. Why does a sampling unit have to be a an individual device? Sometimes you can "mimic" different devices and take multiple samples from the same device. For example, a large laboratory instrument. You can test it in the morning, shut down and restart for a testing in the afternoon. Do that for 3 days and get a sample size of 6. Just a thought.
 

RDSally

Starting to get Involved
#4
Hi all,

I'm currently trying to find a solution to this same issue with an AIMD. Since this topic was discussed some time ago, does anyone have new ideas or experience concerning the required sample size for bioburden determination and sterility testing?

Thank you!
 

Kees Fremerij

Starting to get Involved
#5
In the meantime I had to register again, I did not have access to my previous e-mail address. I have made a rationale for it. It saves a lot of products for testing and several Notified Bodies already approved the solution!
 
N

NicoleinFlorida

#6
Question: Do you mean dose verification? Or Sterilization Validation (Clause 9 in ISO11137-1)?

If you mean the dose veirication, I had a similar question. But the good thing is that we finally decide to use the sample sizes in the standard even though it is costly.

According to ISO11137, VDmax25 requires at least 40 devices for dose verification. 30 of the devices are used to measure the bioburden level of the finished devices. And then the left 10 devices are used for the sterility test.

So I am thinking whether you can figure out some way to use similar device or similar components that have same manufacturing process with your test device. Look forward to other comments.
 

Kees Fremerij

Starting to get Involved
#7
Hi Nicolein,

Here you find something in ISO11137-2 which might help:

5.3.2 ..... Product items may be selected from product rejected during the manufacturing process, provided that they have been subjected to the same processing and conditions as the remainder of production.

So if in production rejected products follow the same route you may pick them for validation purposes. I hope this helps you, otherwise I can try to help you further..
 
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