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October 1999

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Subject:
From:
Simon Rusmin <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 12 Oct 1999 09:43:34 -0400
Content-Type:
text/plain
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text/plain (79 lines)
Gilberto:

You mentioned 'production machine parts'.
I am wondering about ...........

a) What kind of processing do you do with the machine?
Unless you are fermenting gram negative bacteria, I do
not see why any machine parts should have have
detectable endotoxin.
OR
b) What are the products made using this is machine.
If they are solid dosage forms (not injectable),
endotoxin is not usually a concern.

I am personally afraid of our industry's tendency to put
efforts for product quality without looking into the cost-
benefit aspect on a scientific bases.

Simon Rusmin, Ph.D.
Consultant
[log in to unmask]


----- Original Message -----
From: Dalmaso, Gilberto <[log in to unmask]>
To: <[log in to unmask]>
Sent: Monday, October 11, 1999 3:31 am
Subject: [PMFLIST] FW: Endotoxin on production machine parts


> > -----Original Message-----
> > From: Dalmaso, Gilberto
> > Sent: Monday, October 11, 1999 9:24 AM
> > To:   'Gruppo, Microbiologia'
> > Subject:      Endotoxin on production machine parts
> >
> >
> > A question for our group:
> >
> > We have to determinate the pyroburden on our production machine parts as
validation program. Is there any internationals procedure/methods or
requirements for this porpose? is there any regulatory requirements?
> > Have we to contaminate (recovery determinations) the piece?
> > What is the rinsing method? How much LRW I have to use?
> >
> > As you know production pieces are quite big.
> >
> > Thank you in advantage
> >
> Gilberto Dalmaso
> Microbiological Lab. - Q.A.
> GlaxoWellcome Italy
> tel.:            +39 045 9218735
> fax:             +39 045 9218178
> e-mail:    [log in to unmask]
> address:  via A.Fleming, 2 - 37135 Verona, ITALY
> >
> >
> >
>
>
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