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bashir01219
Commentator

Join Date: Oct 2010
Location: Bangladesh
Posts: 91
Good Answers: 2

HVAC

10/28/2010 9:44 AM

Hi, I am working with a Pharmaceuticals company, at present we want to develop a new floor for solid dosage product. The floor should comply U.S. FDA pharmaceuticals regulation for solid dosage product. We are little confused as we have Licensee of F.Hoffman-La Roche Ltd. and their requirements for HVAC, air change rate is not less then 6.

Can anyone give me the U.S FDA guideline for HVAC system (specially air change rate) solid dosage product or any suggestion?

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 Experiance will come with time, but you have to manage quality time. Bad management always leads us bad experiance.
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lyn
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Join Date: Oct 2008
Posts: 42355
Good Answers: 1693
#1

Re: HVAC

10/28/2010 8:45 PM

Yes, I can.

Contact the U.S FDA and ask them.

Or, hire a qualified engineer with the appropriate experience.
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bashir01219
Commentator

Join Date: Oct 2010
Location: Bangladesh
Posts: 91
Good Answers: 2
#2
In reply to #1

Re: HVAC

10/30/2010 12:24 AM

Thanks!

ACR as per U.S. FDA 20, so our problem is solved.

We have qualified engineer I just want to check myself.

__________________
 Experiance will come with time, but you have to manage quality time. Bad management always leads us bad experiance.
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