To answer that question: If the particulate count only increases, that will not usually affect the sterilization validation. If the bioburden load increases then additional verification / testing will be required. I doubt that the addition of another piece of equipment will increase bioburden, though it will increase particulate (and possibly oil vapor if any compressed air escapes into the controlled environment (should be plumbed out)). If the equipment also requires additional human handling of the product, then there could be increased product bioburden.
After the implementation of the new equipment, If there is increased product bioburden, then at the very least a half cycle should be run on the product, and then test sterility of some product / PCDs in the most difficult to sterilize locations in the load at a half cycle. Then either complete the cycle or do a full cycle on the load if that was a production run (with data to prove that additional sterilization runs do not negatively affect product function).
Generally the addition of some additional equipment into a controlled environment does not create a serious challenge to the sterilization cycle. Of course, consideration of any potential disruption in the air flow in the clean room by the equipment addition must also be addressed.
Of course document all the above. Could be an addendum to the last sterilization validation test report.
jel@jelincoln.com
updated 10/20/21
Note: The above response mostly assumes EO sterilization. - JEL 09/20/2023
