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Cleaning plastic parts for sterilized medical devices
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Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
Cleaning plastic parts for sterilized medical devices
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Some Related Topic Tags
plastics, sterilization (general)
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  Post Number #9  
Old 11th July 2018, 09:39 AM
chris1price

 
 
Total Posts: 248
Re: Cleaning plastic parts for sterilized medical devices

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.

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  Post Number #10  
Old 11th July 2018, 09:50 PM
kuyakut

 
 
Total Posts: 114
Re: Cleaning plastic parts for sterilized medical devices

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
  Post Number #11  
Old 12th July 2018, 04:06 AM
planB

 
 
Total Posts: 96
Re: Cleaning plastic parts for sterilized medical devices

Arbela,

coming back to your original posting:

Quote:
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?
When you talk about "cleaning" and "dirt", do you aim at reducing your bioburden? Or do you mean by "dirt" other, non-viable contaminations?

And what to you mean by "cleaning [...] good enough"? Have you defined acceptance criteria for your bioburden and/or other contaminations?

Quote:
if there are any standards or guidances regarding cleaning of plastics, i would also appreciate references.
No, there are no general standards or guidance for this purpose, because "plastics" vastly differ in their chemical resistance, and also "cleaning" may depending only vastly different cleanliness requirements. Sources for taking a decision may be technical data sheets that sometimes contain data about chemical resistance, or your materials supplier. Googling "[chemical name / trade name of plastic] resistance IPA" may also return relevant information to substantiate your decision.

HTH, Gerhard
  Post Number #12  
Old 12th July 2018, 05:00 AM
arbela

 
 
Total Posts: 13
Re: Cleaning plastic parts for sterilized medical devices

Hi Gerhard.
Yes, I'm referring to material provided non clean by the plastics manufacturer. the items (several different parts, all plastic) are assembled in a clean room and subsequently sterilized.
While I am aware of all the tests that need to be done to validate the cleaning process, I really wanted, with my question, to "cut corners" and at least get an idea if this could work, since, as i wrote earlier, in the past i used more rigorous cleaning procedures and cleaning just with IPA constitutes looser control.
Since i'm talking about a startup, certain things, such as contamination control, are often less obvious to R&D and management, so before i get into arguments about what needs to be done, i wanted to hear if this is a no-no option or if feasible, based on the experience of others.

BTW - thank you to all who responded.
  Post Number #13  
Old 12th July 2018, 06:26 AM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,356
Re: Cleaning plastic parts for sterilized medical devices

Quote:
In Reply to Parent Post by arbela View Post

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 :-)
IPA wipe will kill the micro organism thus reducing the challenge to the sterilization process. How good it is, you must validate with a defined cleaning process followed by validated sterilization and then testing for the same. When the results meet your requirement, you continue the cleaning by making the defined cleaning as your procedure.
  Post Number #14  
Old 12th July 2018, 06:52 AM
AgnieszkaSz

 
 
Total Posts: 81
Re: Cleaning plastic parts for sterilized medical devices

I just wonder whether you are certain that cleaning of ready product is necessary. This is because I work for producer of injection moulded components for medical devices; we produce parts in cleanrooms (or whiterooms) and generally these details are not manipulated by operators (apart from taking samples, which are then discarded)- sometimes, when a part is fragile, it is evacuated and then packed by robots. We haven't had any bioburden claims for these parts.
  Post Number #15  
Old 13th July 2018, 01:41 PM
NikkiQSM

 
 
Total Posts: 321
Re: Cleaning plastic parts for sterilized medical devices

I see you keep saying "plastic" but you are not explaining what the polymer type is. That is very important information, because different polymers handle different types of sterialization in different ways.

Also is the plastic colored? If so, with what? IPA can cause certain colorants to leach out of the finished part.
  Post Number #16  
Old 17th July 2018, 10:35 AM
arbela

 
 
Total Posts: 13
Re: Cleaning plastic parts for sterilized medical devices

It's black markolon
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