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December 2002

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Subject:
From:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 17 Dec 2002 12:06:25 -0600
Content-Type:
text/plain
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text/plain (154 lines)
Art,
 
Could you please send me copies of the articles you have written?
 
Thanks.
 
Scott Sutton
Mail Code R0-15
Alcon Laboratories
6201 South Freeway
76134

-----Original Message-----
From: Art Vellutato, Jr. [mailto:[log in to unmask]]
Sent: Monday, December 16, 2002 7:49 PM
To: [log in to unmask]
Subject: Re: [PMFLIST] Regs Governing Sterilization of Disinfectants in
Cleanrooms


Hi Scott,

There are actually a few recent references for sterilizing the disinfecting
agents prior to entry to the aseptic area.  

First an most notably from the FDA would be the verbiage in FDA's Sterile
Drug Products Produced by Aseptic Processing Concept Paper 9/26/02: 

"Upon preparation, disinfectants should be rendered sterile, and used for a
limited time, as specified by written procedures" Line 1047

Second, Look at USP 1072:

"Typically, disinfectants used in aseptic processing areas are diluted with
Water for Injection and are prepared aseptically." P. 151

ISO 14698 also mentions this in its content.

I've done a lot of work with the levels of bioburden that could exist in
disinfectants and sporicides.  Most tests during validations I have
performed show disinfectants like phenol, quaternary ammonium, peroxides (at
low concentrations) and others can harbor resistant spores.  With the
sporicides it is less likely but during some testing I did notice it in one
or two tests (of 100's performed).  One of our main concerns with sporicides
would be the sporicide in a container with head space.  The head space could
harbor a resistant spore that may not be contacted to the solution.  When
poured, it may be rinsed out, go to the surface and not have enough contact
time before the sporicide dries to kill it.  Again, this is a remote chance
but one most may not want to test in our operations and fail.

I've published several papers, book chapters, and wrote many technical
support articles that included information on this subject.  I have just
completed another book chapter on disinfectants for Jeanne Moldenhauer's new
book she is editing that may be of value.

I think it is common knowledge that spores can harbor in disinfectants and
so in our attempt to control what enters the environment, we choose to
sterilize a possible source of contamination that we will wipe or spray all
over our walls.  It's a good control.  

One of our greatest concerns in disinfection is the water we dilute such
agents with.  This seems always to be a problem if not controlled. 

Please let me know if I can help[.

Art Vellutato, Jr.
V.P. Technical Support Operations
Veltek Associates, Inc.
1039 West Bridge Street
Phoenixville, PA 19460-4218
Tel: (610) 983-4949 X 110
Fax: (610) 983-9494
http://www.sterile.com <http://www.sterile.com/> 
[log in to unmask]



At 03:53 PM 12/16/2002 -0600, Scott Sutton wrote:


All,

It is obviously a good idea to sterilize disinfectants going into a
cleanroom environment, but for the life of me I cannot remember if I have
read this as a requirement or a suggestion in any regulatory document (aside
from posted 483s).

Two questions:

        1.  Is this a written in any guidance document?

        2.  What are some good references on contamination of disinfecting
solutions relevant to this topic?

Thanks for the help.

Scott


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