The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Cleaning plastic parts for sterilized medical devices

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
plastics, sterilization (general)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 11th July 2018, 04:58 AM
arbela

 
 
Total Posts: 13
Please Help! Cleaning plastic parts for sterilized medical devices

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 :-)

Sponsored Links
  Post Number #2  
Old 11th July 2018, 06:38 AM
JoshuaFroud

 
 
Total Posts: 22
Re: Cleaning plastic parts for sterilized medical devices

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 by JoshuaFroud; 11th July 2018 at 06:39 AM. Reason: Edited due to my own awful formatting in the first attempt.
  Post Number #3  
Old 11th July 2018, 07:22 AM
arbela

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

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...
  Post Number #4  
Old 11th July 2018, 07:39 AM
JoshuaFroud

 
 
Total Posts: 22
Re: Cleaning plastic parts for sterilized medical devices

That is fair, I apologise, I did not read your post like that. I hope someone else will be able to help!
  Post Number #5  
Old 11th July 2018, 07:58 AM
ScottK's Avatar
ScottK

 
 
Total Posts: 2,760
Re: Cleaning plastic parts for sterilized medical devices

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.
  Post Number #6  
Old 11th July 2018, 08:02 AM
arbela

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

great, thanks!
  Post Number #7  
Old 11th July 2018, 08:13 AM
chris1price

 
 
Total Posts: 259
Re: Cleaning plastic parts for sterilized medical devices

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.
Thanks to chris1price for your informative Post and/or Attachment!
  Post Number #8  
Old 11th July 2018, 08:29 AM
arbela

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

thanks. do you know if there is a difference if used for material sterilized with gamma rather than ETO?
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >

Bookmarks



Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
 
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Emoticons are On
[IMG] code is On
HTML code is Off


Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
Cleaning standards for Medical Devices - Implants - Cleaning Validation ybs80 ISO 13485:2016 - Medical Device Quality Management Systems 14 23rd December 2014 02:00 AM
Plastic Injection Molding - Medical Devices - How to Clean Parts Please gregfish Manufacturing and Related Processes 7 20th September 2011 02:27 PM
Is Risk analysis for plastic parts of medical devices required? Ajit Basrur ISO 13485:2016 - Medical Device Quality Management Systems 9 26th June 2008 05:02 PM
Components Cleaning for Manufacturing Sterilized Medical Device shivaji141 ISO 13485:2016 - Medical Device Quality Management Systems 5 27th February 2008 04:47 AM
Dress Code in ISO Class 8 - Plastic Parts for Medical Devices Ajit Basrur ISO 13485:2016 - Medical Device Quality Management Systems 3 9th September 2006 05:25 PM



The time now is 08:14 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"