Biological indicators

GOOD DOCUMENTATION PRACTICE (GDocP) PQ (PERFORMANCE QUALIFICATION)
1

Hi all,

I would like to know if when we use certificated biological indicators, it would be enough with the supplier certificated of population or it is required to make the recovery assay.

Thank you very much in advance!

2

I never heard any one recovering the certified Biological Indicators at the user sites.
Even FDA auditors will go with the certificates.
There are seperate guidelines for Biological Indicator manufacturers to perform the lot uniformity test for number of spores or species from time to time.
Its only adding a Microbial agony to the existing pressure and qualifying all materials.

3

http://www.sordellini.com/articles/article6.htm

4

[quote=anukitakataka]Hi all,

I would like to know if when we use certificated biological indicators, it would be enough with the supplier certificated of population or it is required to make the recovery assay.

Thank you very much in advance![/quote]

Dear Anuk,
COA of BI is enough for tracebility and reference. No need to perform recovery tests on BIs.

Thanks

5

Hi,

A couple points to the discussion.

Currently, there is no regulatory requirement that the population on a BI be independently verified against the BI manufacture’s certificate. It is a good practice, however, to verify BI population and survival/kill times (or D-value) for the assurance that the population/resistance are within an expected range. A requirement that the BI population can not be below a label claim is ludicrous since it is known that different types of recovery media and different lots of a culturing medium as well as time to recovery, incubation temperature, etc. effect spore outgrowth. Therefore, it should be a given that an in-house determination of spore population may not equal the manufacturer’s BI certificate.

Rejecting lots of BIs due to say a population below 1 x 10^6 (1E6) is absolutely not necessary. It appears some regulatory/representative bodies are implying validation of sterilization processes can not be performed with BIs containing less than 1E6 spores. This notion most likely comes from the misconception that to demonstrate a PNSU of 10^-6 the BI population must be at least 1E6 and there must be no survivors.

Regards,

6

Hi,

Reviving an old thread in case it is useful to anyone…

The USP does state it as a requirement that the user verifies the purity, identity and spore count of the BI:

USP <1035> : " Upon initial receipt of the biological indicator from a commercial supplier, the user should verify the purity and morphology of the purchased biological indicator microorganisms. Verification of at least the proper genus is desirable. Also, a microbial count to determine the mean count per biological indicator unit should be conducted."

What’s your opinion? Is this standard practice in the US?