Sterility and BioBurden Testing for Plastics

davishont02

Starting to get Involved
#1
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
 
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Ronen E

Problem Solver
Staff member
Moderator
#4
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
Hi,

"1. the plastic can be sterilized" can have two meanings:
(a) Sterility of that piece is achievable
(b) The plastic piece will not be harmed (get out of spec) by the cycle necessary for achieving sterility

(a) is thoroughly covered by published standards, and you definitely don't need 100 cycles for that. (b) might require repeated cycles, the number of which depends on the intended use (how many cycles the part is intended for).

"2. the plastic will not harbor bioburden after sterilization" is mostly a function of how they package it for sterilisation and how they handle it afterwards. It's a part of the reprocessing validation, which is also throughly covered by published standards.

The "authority or body that sets the acceptable level of bioburden after steam sterilization" would be the hospital itself, and that level is also supported by published standards.
 

Ajit Basrur

Staff member
Admin
#5
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 am unclear on your question as sterility and bioburden are different concepts.

When you "sterilize" an article, it has to be "free from viable micro-organisms" and proved by a sterility test so there is no "bioburden". Typically all articles intended to be used as sterile undergo this sterilization process and should not have any microbial load.

You can refer the following thread for more info:

Sterility Testing vs Bioburden Testing - Differences
 
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