Gentlemen:
We have seen some discussion on leachables from parenteral stoppers, and
have provided an attachment in MS Word which describes a process. This
process is quite common in the European market, but only recently has this
become a concern for the US market. This is process evolved in machines
manufactured by Huber Maschinenfabrik GmbH, who we represent in North
America. If you would like further information, Email or contact us below.
Regards,
Chris Anderson
Victor International Marketing, Inc.
35 Airport Park
Morristown, NJ 07960
1(973)267-8900
1(973)267-0098
vim@ix.netcom.com
>Dear Norm,
>What are your intentions?
>The question is, does the leachable interfere with the drug action or the
>assay or is it toxic?
>Anything will leach: Metal will leach Cr, Cu, Fe. Glass will leach Na,
Si.
>There is nothing that will not leach if you apply the correct assay.
>
>I recommend to state your needs. (if it requires '0' leachables you will
>have to suspend your product in an ion trap - good luck on this).
>
>Gert Eberlein, Ph.D.
>Analytical Method Development
>Santen Inc
>Tel.: (707) 256 2405
>Fax: (707) 254 1760
>Geberlein@Santen-Inc.com
>
>
>
> -----Original Message-----
> From: MODERATOR
> Sent: Wednesday, January 06, 1999 1:58 PM
> To: PharmSciTech
> Subject: Leachables from Elastomers
>
> Dear Forum
> I sent out this question just before Christmas and had only one
>response -
> obviously everyone else was too busy partying!! In the cold hard
>light of
> the New Year, I'm trying a second time in the hope of getting a
>response
> from some of the "Gurus" of the PDA.
> Just about every elastomer we test by TOC shows high levels of
>leachables.
> We simply soak the elastomer overnight in WFI (with a TOC of about
>50ppb)
> then re-test the water for TOC. We consistently see post-soak
>levels in the
> ppm range. Even if you soak the elastomer in several changes of
>water, we
> continue to see leachables coming out (though at gradually reducing
>levels).
> My question is, since most of the materials we tested are USP Class
>VI
> certified, do we need to worry about these leachables?
> Regards,
> Norm Cheale
> Quality Leader, Special Projects Group
> CSL Bioplasma
> 189 - 209 Camp Rd Mobile 0411 401 741
> BROADMEADOWS Tel 61 3 9358 5111
> Vic 3047 Facs 61 3 9358 5107
> Australia Email norm_cheale@cslbio.com.au
>
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