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October 1999

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Subject:
FW: Endotoxin on production machine parts
From:
"Dalmaso, Gilberto" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Mon, 11 Oct 1999 08:31:04 +0100
Content-Type:
text/plain
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> -----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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