LAL Testing Frequency

We manufacture single use syringes mainly used for orthopedic surgeries for administration of anaesthetic agents. We claimed supplied devices as sterile and non-pyorogenic. Sterility of the device is routinely verified as part of the gamma dose audit. However for the endotoxin claim we have performed LAL testing once only and meets the LAL acceptance criteria.


During our regulatory audit we have been questioned for not conducting LAL testing for every batch (2-3 batches per year). I am just wondering whether it is mandatory for LAL testing to be performed for every batch for medical devices?


· Our manufacturing process / environmental conditions are same for every batch i.e. same bio-burden

· No changes in product and packaging material

 

I personally have not read the attached - but it seems to talk about the process you describe.

 

Thanks Nikki,

Thanks for your reply, feels like I am on elsmar forum.
I have read your supplied document and relevant information published on http://www.mddionline.com/article/using-fmea-develop-alternatives-batch-testing however, beside this not able to get any constructive information. I am in process of creating a rationale that could support LAL testing frequency, its very expensive to perform LAL testing for every batch considering the batch quantity that we supply is very less.

 

Hi Nash,

FWIW, the FDA's stance is:

"The sampling plan should be considered dynamic; firms should begin with maximum coverage and adjust their sampling plans as they gain confidence in the prevention of endotoxins in their manufacturing processes."

http://www.fda.gov/Drugs/GuidanceCo...rmation/Guidances/ucm314718.htm#_Toc315937925

From what I've seen, for a new process at least the first three batches should be tested. Then a gradual relaxing may begin if it can be justified, the details depending on circumstances.

Cheers,
Ronen.

 

Good day Ronen, you always rescued me when at elsmar forum and looks like again rescued me like a super hero....thanks a lot.

I agree, I should take this path of initial testing say 3 batches or until establish a substantial history.