S
s.parakos
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
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