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December 2002


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Mechlerné Bander Marianna <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Wed, 11 Dec 2002 11:59:18 +0100
text/plain (36 lines)
Dear All,

I know this is a very old question, but perhaps I'll get a correct answer.
Total aerobic microbial count Do you agree that total aerobic microbial count mean aerobic bacteria + moulds and yeast?
The method described in the USP (61) Microbial limit test - Procedure  Total aerobic microbial-is able to detect also yeast and moulds. Of course using Sabouraud Dextrose agar (with lower pH) is better to detect yeast and moulds.
What should be the acceptance criteria for a non sterile pharmaceutical product using for oral application?
1.      mot more than 1000 total aerobic count per g using only Soybean-Casein Digest Agar or,
2.      not more than 1000 total bacterial count  per g using Soybean-Casein Digest Agar and 
       not more than 100 yeast and moulds per g using Sabouraud Dextrose agar

Of course we do the test for  specified microbial contaminants (Escherichia  coli, Pseudomonas aeruginosa, Staphylococcus aureus and Salmonella species) and here is an other question.  I think s not important to do all these "BIG4 " test for tablets. Because you can read in the monographs for example Miconazole Nitrate Topical Powder ( which has much more stricter acceptance criteria than an oral product. According its topical use.) Microbial limits(61) -The total count does not exceed 100 microorganisms per g, and tests for Staphylococcus aureus, and Pseudomonas aeruginosa are negative. If I read also the (1111) Microbiological attributes of non sterile pharmaceutical products  
 "...It is suggested that certain categories of products should be tested routinely for total microbial count and for specified microbial contaminants, e.g., natural plant, animal, and some mineral products for Salmonella species, Oral solutions and suspension etc..."
 its not unambiguous what test shall we do for tablets, which contain  e.g. starch ( natural origin). Is it enough to do the  specified test only for E. coli and Salmonella species?

Thank you all in advance

Regards Marianna

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