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Go Back   The Elsmar Cove Forum > National and International Business Standards and Requirements > Food and Drug (Pharmaceuticals) related Regulations > Qualification and Validation (including 21 CFR Part 11)
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EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation


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  Post Number #1  
Old 9th August 2009, 03:13 AM
karthic

 
 
Total Posts: 1
Please Help! EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

I would like to know about ETO Validation Protocol as in EN 550 Standard

Last edited by Ajit Basrur; 9th August 2009 at 01:17 PM. Reason: Rephrased the sentence and changed from all capitals to regular sentence

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  Post Number #2  
Old 9th August 2009, 03:59 AM
bio_subbu's Avatar
bio_subbu

 
 
Total Posts: 601
Re: En550

Quote:
In Reply to Parent Post by karthic View Post

I WHOULD LIKE TO KNOW ABOUT ETO VALIDATION PROTOCOL AS IN EN 550 STANDERDS
Dear Mr. Karthic

FYI

EN 550 is replaced by ISO 11135-1:2007 (Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices) and Part 2: Guidance on the application of ANSI/AAMI/ISO 11135-1 (TIR11135-2:2008) please use revised one.

Regards
S. Subramaniam
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  Post Number #3  
Old 9th August 2009, 06:14 AM
harry

 
 
Total Posts: 6,278
Re: EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

Welcome to the Cove,

Scroll down to the 'Similar Discussion Threads' box below for a few threads on the same subject.
  Post Number #4  
Old 9th August 2009, 01:18 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

Quote:
In Reply to Parent Post by karthic View Post

I would like to know about ETO Validation Protocol as in EN 550 Standard
Welcome Karthic.

I have changed your text from all capital letters to a regular sentence and also corrected typo errors.

My friend moderator have posted your question in the appropriate forum
  Post Number #5  
Old 9th August 2009, 04:33 PM
MIREGMGR

 
 
Total Posts: 3,475
Re: EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

Quote:
In Reply to Parent Post by karthic View Post

I would like to know about ETO Validation Protocol as in EN 550 Standard
We're not so good at telling people the entire extent of what a regulatory/quality professional should know and do to meet appropriate compliance requirements for topics as big as "EtO validation".

We can answer specific questions, though. Do you have such a question?
  Post Number #6  
Old 10th August 2009, 09:02 AM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 5,757
Re: EN550 (ISO 11135-1:2007) - ETO (Ethylene Oxide) Validation

MIREGMGR is absolutely right

Karthic, if you are working with some employer, you would already have this, isnt it ? In that document, if you are looking for soemthing very specific or are unsure of anyhting, pl come back without any hesitations
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Similar Discussion Threads
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ETO Sterilizer Validation (ISO 11135:2007) ISO MAN Other Medical Device Related Standards 23 8th August 2011 09:03 AM
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