> -----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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