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November 1998

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Subject:
From:
Fausto Silva <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 3 Nov 1998 10:01:04 +0100
Content-Type:
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Hi All

I have a specific question for the Forum.

I was asked for specific limits for microbiological testing of hygiene levels
(cleaning) of bulk containers used for different products.

My question is seeing that most products have a bacterial count limits of < 1000
cfu's p/ml or p/g, and < 100 cfu's p/ml or p/g of fungi/yeasts ,what should be
the cleaning level that should be accomplished?

What type of method should I use RODACs or swabs?

Cleaning is done by high pressure water at Temperatures +/- 70 deg. C, plus
TEEPOL which is but a soap, or should I rather call it "CHEAPOL", I suggested
that a disinfectant soap would straight off be a better choice but motivation
would obviously be required.

Should there be a difference in the type of soap/disinfectant used for more
difficult product (i.E. ointments/creams)?

Please let me know your valued opinions soon.

Thank you all for all the help so far provided.

My E-mail [log in to unmask]

Fausto Silva - Lennon pharmaceuticals microbiology Section Head.


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