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USP 61 - Interpretation of the Results

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ReadyForLiftoff

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Posted 20 October 2022 - 12:59 PM

While looking at USP 61, Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, the Interpretation of the Results section. It states the following:

 

When an acceptance criterion for microbiological quality is prescribed, it is interpreted as follows:
 
101 cfu: maximum acceptable count = 20;
102 cfu: maximum acceptable count = 200;
103 cfu: maximum acceptable count = 2000;
 
and so forth.
 
How is 101 CFU maximum acceptable count interpreted as 20? Shouldn't it be 10? The same goes for 102 and 103. Shouldn't they be 100 and 1,000?
 
Thank you in advance.
 


Charles.C

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Posted 20 October 2022 - 05:48 PM

 

While looking at USP 61, Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests, the Interpretation of the Results section. It states the following:

 

When an acceptance criterion for microbiological quality is prescribed, it is interpreted as follows:
 
101 cfu: maximum acceptable count = 20;
102 cfu: maximum acceptable count = 200;
103 cfu: maximum acceptable count = 2000;
 
and so forth.
 
How is 101 CFU maximum acceptable count interpreted as 20? Shouldn't it be 10? The same goes for 102 and 103. Shouldn't they be 100 and 1,000?
 
Thank you in advance.

 

Hi RFL,

 

The answer (if any) likely relates to the context of the data quoted which is unfortunately unknown.

 

Offhand, I note the word "interpreted" which can have a zillion meanings. :smile:


Kind Regards,

 

Charles.C




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