Cleaning plastic parts for sterilized medical devices

arbela

Starting to get Involved
#1
Hi all.
Does anyone know if using IPA 70% for cleaning a plastic, non-implantable device assembled in a class 8 clean room, a good enough? that is, can it remove dirt to a sufficient level that will allow sterilizing it, or should ultrasonic cleaning be applied? if there are any standards or guidances regarding cleaning of plastics, i would also appreciate references.
thank you :)
 

JoshuaFroud

Involved In Discussions
#2
Hi Arbela

I do not have much experience working with Clean rooms, however, I would suggest a question like that is only going to be able to be answered by some R&D/Validation work.

A 70% IPA solution may well be suitable but without the validation/verification work to demonstrate this, it will be hard/impossible to justify why the choice was made.

The background to why the selection was made and supporting evidence is almost more important than the final choice made (assuming the selection is fit for purpose).
 
Last edited:

arbela

Starting to get Involved
#3
thank you Joshua - that was precisely the point of my question. I do actually have experience both with plastics cleaning and with clean rooms, however cleaning processes I used previously involved more extensive cleaning than just IPA and I was wondering if others had experience or scientific-based knowledge that in some cases IPA would suffice. I prefer to know up front rather than enter a long and expensive process validation only to find out that it doesn't work...
so, if there's anybody out there...
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#5
I have used IPA in cleaning new sterilization trays prior to shipping to the customer in a non-clean room atmosphere. I was always acceptable to our customers - orthopedic mostly.
We did not use ultrasonic cleaning.
 

chris1price

Trusted Information Resource
Trusted
#7
Hi, In principle yes, IPA should be suitable and is commonly used; I have done so on numerous devices. IPA is only considered a low-level disinfectant, so will only give a few log reduction in bioburden. You should look at your bioburden before and after cleaning and if you are relying on the IPA, perform suitable validation.
 

chris1price

Trusted Information Resource
Trusted
#9
If you are going for Gamma and using VDmax25, the bioburden should be below 1000cfu, for VDmax15 is has to be below 1.5cfu. If you are higher than this, you have to use another method. There are no set limits for EtO, but you need to track it over time and show it is stable.

Other than reducing bioburden, IPA shouldn't have any interaction with the sterilisation method.
 

kuyakut

Involved In Discussions
#10
We use 70 % IPA / 30 % water mixture to clean our equipment ( EOAT / Molds) before doing swab. We've been doing this for quiet sometimes and no issue with it
 

Top