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Required Standard / Validation for the Swabbed Equipment and Surfaces

Started by Miss U, Aug 07 2009 08:34 AM
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Miss U

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Posted 07 August 2009 - 08:34 AM

Hello, anyone in this forum had any idea of the percent rate standard for the total equipment/areas that had been passed in swabbing? For example, if I swabbed several parts in the processing line, and I want to declare it as the total # of areas swabbed (A) - total # of areas that passed in swabbing(B) divided by the total # of areas swabbed (A) x 100, what is the required percent passing rate?


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Posted 07 August 2009 - 10:17 AM

Bump for Miss U.


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Posted 08 August 2009 - 07:08 AM

"U" as in Universe ? :smile: Welcome to the forum ! :welcome:

Have never seen an application of the concept you refer. It's more typically done by prioritising the locations based on a risk assessment IMEX and then assessing the results individually.

Rgds / Charles.C


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Charles.C

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Posted 09 August 2009 - 03:26 AM

Hello, anyone in this forum had any idea of the percent rate standard for the total equipment/areas that had been passed in swabbing? For example, if I swabbed several parts in the processing line, and I want to declare it as the total # of areas swabbed (A) - total # of areas that passed in swabbing(B) divided by the total # of areas swabbed (A) x 100, what is the required percent passing rate?



Hi Miss U

What type of swabbing are you talking about? TVC ? ATP? Y&M?

Regards,

Tony :smile:

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Posted 26 August 2009 - 06:02 AM

Dear Miss U,

Similar with Charles C., IMO you should take samples (as much as possible) on whole equipments/areas, to get impression of microbes quantity on your equipments/areas. After you get the data, analyze it by statistics in order to determine your standard.

So, if your swabbed area is met with the standard, then I guess the whole area should met the standard too. Its the matter of probabilty anyway.


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Posted 27 August 2009 - 01:13 AM

IMEX... I just swab area that most potential to micro growth after cleaning and sanitizing process For example area filling products... so if the result is out of spect.. cleaning and sanitizing process must be repeated...

NOte : i am using ATP to verify the swab test result


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