Bioburden Monitoring Sample Size Increase

S

s.parakos

#1
Hi,

We had a part manufactured in a cleanroom and then sterilized.
It is now no longer possible to manufacture in a cleanroom.
The new manufacture area can not really be classed as "controlled" as there is no air filtration or monitoring of any kind.
Can we increase our bioburden monitoring program and still claim sterility if the monitoring does not show increased bioburden? How would we determine the increase in sample size? Frequency is already per batch.

thanks for any advice
Simon
 
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D

Dudes

#3
Without any kind of control, I think it would be difficult. You can increase your sample size (depending on the batch size), but how do you make sure that this is representative of the worst case?

Maybe doing a risk assessment could be helpful.
 
D

dutch meddev

#4
depending on the product, measurements and the processes you need to perform, maybe there would be a possibility to complete production in a "dirty" environment and only final packaging in a (future) sterilie barrier in a clean environment.

This does not have to be a clean room at all, maybe a laminair airflow cabinet could do the trick too?
 

somashekar

Staff member
Super Moderator
#5
Hi,

We had a part manufactured in a cleanroom and then sterilized.
It is now no longer possible to manufacture in a cleanroom.
The new manufacture area can not really be classed as "controlled" as there is no air filtration or monitoring of any kind.
Can we increase our bioburden monitoring program and still claim sterility if the monitoring does not show increased bioburden? How would we determine the increase in sample size? Frequency is already per batch.

thanks for any advice
Simon
What was the clean-room class you maintained ...
How was your bio-burden monitoring in that room ...
Is there a final cleaning process before sterile packaging ...
What is the part manufactured ...
Based on these considered in my risk management, I would go the dutch meddev way, said in post #4.
The laminar airflow bench will come in good effect, however if the input atmosphere is contaminated by particle of varied sizes, this challenge will fail the laminar flow bench filter pretty fast.
Tell me if you your manufacturing area can be said as Clincally Clean ...
 
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