Hello Everyone,
I have a client that has a piece of plastic (PA-46) that will be attached to a surgical tray. The client (hospital clinical nurse) would like us to prove 1. the plastic can be sterilized and 2. the plastic will not harbor bioburden after sterilization. We talked to a lab who quoted us several tests at 100 cycles per test. This seems like overkill provided we were told industry standard is cycle of 1.
My questions are:
1. Does anybody have a recommended lab to perform sterility and bioburden testing?
2. For sterilization/sterile processing of med dev in the hospital setting, which authority or body sets the acceptable level of bioburden after steam sterilization?
Thank you for all of your help in advance!
L
I have a client that has a piece of plastic (PA-46) that will be attached to a surgical tray. The client (hospital clinical nurse) would like us to prove 1. the plastic can be sterilized and 2. the plastic will not harbor bioburden after sterilization. We talked to a lab who quoted us several tests at 100 cycles per test. This seems like overkill provided we were told industry standard is cycle of 1.
My questions are:
1. Does anybody have a recommended lab to perform sterility and bioburden testing?
2. For sterilization/sterile processing of med dev in the hospital setting, which authority or body sets the acceptable level of bioburden after steam sterilization?
Thank you for all of your help in advance!
L