Sterility samples requirements for AAT

Vinu Raghav

Starting to get Involved
#1
Hi,

Can any one please share the requirements of Sterility sample quantity in Accelerated Aging test (AAT).
Currently we are using one sample for Sterility and we received Non compliance from auditor that it can not be only one.
Please share your input and reference if any.

Thanks in advance.
 
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planB

Super Moderator
#2
I presume you aim at demonstrating integrity of your sterile barrier system of a medical device over your claimed shelf life according to ISO11607-1:2019? If yes, have you performed other (physical or microbial) tests as well, in addition to your test of sterility? Have you justified your sample size of N=1 for your test of sterility?
 

Vinu Raghav

Starting to get Involved
#3
Yes, we are following as per ISO 11607-2 as well we done all the other tests includes physical and microbial.
But we didn't have anything to justify that the sample size of N=1.

Could you please suggest me something with reference?
 

planB

Super Moderator
#4
In case you performed seal-integrity testing (e.g. via dye penetration) and whole-package integrity testing (e.g. via bubble emission) with an adequate sample size at the same accelerated-aging time point as the test-of sterility, you could be in a position to argue that your sterility test is purely confirmatory and does not require a greater sample size than you used.

HTH,
 

Vinu Raghav

Starting to get Involved
#5
Thank you,

i need one more clarification.
Does sterility test really required? as we kept the product in stability chamber with 55 degree C? Most of the microorganism gets kiiled by this temperature i believe.
 

planB

Super Moderator
#6
Have a look into ISO/TS 16775:2021, section 5.25.2.1:
[...] the most important acceptance criterion of the packaging system design is retaining/maintaining this sterility. This can be confirmed by testing the integrity of the SBS. Testing for sterility is often considered a less effective method for several reasons:[...]
— risk of false negatives and false positives;
— impossibility of demonstrating the presence of one viable microorganism in one million sterilized products by testing (need to test minimum 1 million negatives);
— sterility result is only the status at a single point in time and depends on several aspects, e.g. if exposure to dry conditions or high temperature was conducted just before testing for sterility, then SBSs could be broken but sterile contents could likely pass sterility testing as typical bacteria would likely not survive the exposures.
Thus, physically testing the integrity of the sterile barrier system (ibid, section 5.25.2.4 lists common methods) is the preferred way over testing for sterility.

HTH,
 

Vinu Raghav

Starting to get Involved
#7
Thank you so much.

So we can conclude that, Sterility not mandatory if we performed packaging integrity test with adequate sample size
 
#10
Hello. For the verification tests of the SBS, Two separate samples are produced (stability-shelf life and transport)First of all we perform double sterilization(ETO), and after that transport and stability tests(accelerated aging) are performed separately. The sample size comes from the design risk file and depends on the testing type. (I mean attribute testing or variable).
 
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