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December 2003

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Subject:
From:
Richard Prince <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 4 Dec 2003 07:24:16 -0500
Content-Type:
text/plain
Parts/Attachments:
text/plain (292 lines)
I am looking for a qualified contract lab that can do ALL of the following:

1. Run the AET against bacteria, fungi and viruses
2. Run the GC-FID (alcohol quantitation) as a release test, in-process test,
and stability test

Richard Prince
[log in to unmask]
Tel: 973-564-8565

----- Original Message -----
From: "Booth, Crystal" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Wednesday, December 03, 2003 8:19 AM
Subject: Re: [PMFLIST] Lab set up


> Faizur:
>         It is an instrument we use to Calibrate our Incubators, Autoclave,
> Heat Blocks, etc.  Check out this link.
>
> http://www.kayeinc.com/validationproducts/validator.htm
>
> Good Luck,
> Crystal Booth
> Microbiologist
>
> -----Original Message-----
> From: Faizur Rahman [mailto:[log in to unmask]]
> Sent: Tuesday, November 25, 2003 2:44 PM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Lab set up
>
>
> Dear Crystal Booth,
>          Thanks for your suggestion. I need some more things to know---
>
> 1. What is Kaye Validator 2000??
>
> Regards
> Faizur
>
> At 09:06 AM 11/21/03 -0500, you wrote:
> >Faizur:
> >         The answers you are seeking will vary, depending on the company
> you
> >ask, and the products that are being manufactured.  However, here are
some
> >of my suggestions...
> >
> >1.      Modern Microbiology Lab Set up:  Ideally, you would like to have
> >designated areas for the task at hand.
> >
> >LAL/BET: An area away from moisture and main traffic flow is ideal.  If
you
> >are using the gel-clot method, you'll want to Calibrate the Heat Blocks
> (you
> >may want to think about hooking them up to an alarm system).  For Kinetic
> >LAL, you'll need a separate computer station.
> >
> >EM (Environmental Monitoring):  You would want to designate a hood for
this
> >type of testing (Biological Safety Cabinet/Laminar Flow Class 100).  Open
> >membrane filtration will be preformed in this hood.
> >
> >Specialty Testing:  I consider this testing to include Microbial Ingress,
> BI
> >inoculations, pour plates, etc.  Ideally, this would be a separate hood
for
> >larger organizations, but you may use your EM hood if needed.
> >
> >Microbial Limit Testing:  Your method will depend on where this testing
is
> >preformed.  For instance, if you are using open membrane filtration,
you'll
> >perform this in your EM hood.
> >
> >Identifications/Plate Counting:  This should be a well light isolated
area
> >(such as a corner, to minimize distractions.)  You may want to look into
> >colony counters, and ID systems (such as Vitek, Biolog, or API depending
on
> >your needs.)  You will of course need a microscope in this location.
> >Consider one that can also accommodate particulate testing.
> >
> >Sterility Testing:  This can either be a suite or isolator.  If using a
> >suite, you would want to consider a gowning stage, HEPA filters, a
> >Steri-test System (closed membrane filtration), a Hood designated for
this
> >purpose (Class 100), disinfecting area (for product/equipment), and a
pass
> >through.
> >
> >Bacteriostasis Fungistasis:  Can be preformed using good aseptic
technique
> >in the EM hood.
> >
> >Particulate Testing:  You will need a Laminar Flow Clean Bench (Class
100).
> >Consider having both set ups of HIAC and membrane filtration.
> >
> >Anti-microbial Effectiveness Testing:  This can also be preformed in the
EM
> >hood.
> >
> >Don't forget, you'll need incubators/refrigerators, hot plates, heat
> blocks,
> >water baths, etc.  You could even look into a media maker.
> >
> >2. Working responsibly of Microbiology in a pharmaceutical company
engaged
> >in Sterile manufacturing:  In my opinion, a Microbiology team are the
> >"police" of the clean areas. Instead of sending in your personnel to
sample
> >during filling, you can train your fill room personnel.  However, you
would
> >still send someone in at least weekly to monitor the fill room
personnel's
> >aseptic technique, expiration dates, cleaning procedures, pull samples of
> >their own, etc.  You are responsible for ensuring correct incubation and
> >testing of the samples, making sure all of the samples are present,
> >validating production autoclaves with BI's, validating washers with EI's,
> >keeping sampling supplies stocked for trained fill room monitor's,
training
> >fill room monitor's, etc.  You may also want to think about a small
> >Satellite Lab in the production area for storage of samples and supplies.
> >Of course, your microbiologist would visit this area to retrieve samples
> for
> >testing.
> >
> >3.  Autoclave Validation:  You will need to perform the IQ/OQ/PQ.  The
> >standard is three times.  You will need to qualify your BI's.  The most
> >commonly used BI is G. stearothermophilus.  You will need a Validator of
> >some type.  We use a Kaye Validator 2000.  PDA is a great source.  They
> also
> >offer a great class on Fundamentals of D, F, and z Values.
> >
> >4.  The USP is very specific about re-test specifications of failed
> >sterility tests.  USP <1211> talks about moving to second stage if you
can
> >prove the first stage is invalid (contaminated).  You would want to have
an
> >investigation procedure set in place (interviewing analyst, technique,
> >sample handling, environment, etc.).  I believe most companies test
double
> >the number of the original containers during stage two.
> >
> >5.      I would check into Parametric Release.  PDA has some good
> >references.
> >
> >
> >-----Original Message-----
> >From: Faizur Rahman [mailto:[log in to unmask]]
> >Sent: Tuesday, November 18, 2003 11:50 PM
> >To: [log in to unmask]
> >Subject: [PMFLIST] Lab set up
> >
> >
> >Dear Folks
> >         I would like to introduce as the newest member of this group. At
> >present i
> >am working as Microbiologist in a pharmaceutical company.
> >         Can any one in this group give me details of
> >
> >1. Modern Microbiology Lab Set up
> >2. Working responsibly of Microbiology in a pharmaceutical company
engaged
> >in Sterile manufacturing
> >3. the details of autoclave validation
> >         - Half load
> >         - full load
> >         - empty load
> >4. In what criteria a batch that failed sterility can be re-tested?
> >5. Is the any methods that can be used for rapid screening of Sterile
> >products?
> >
> >         may be most or every questions here seem to be simple to
all/most
> of
> >you.
> >But if anybody helps , that will be nice
> >
> >Regards
> >Faizur Rahman
> >Microbiologist
> >
> >------------------
> >The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
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> >
> >Please take a second to visit our sponsors' web sites and say thank you
for
> >their support of this service.
> >AAI - http://www.aaiintl.com/Micro.htm
> >Accugenix - http://www.accugenix.com/
> >Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
> >Microcheck - http://www.microcheck.com/
> >MIDI, Inc. - http://www.midi-inc.com/
> >Microbial ID, Inc. - http://www.microbialid.com/
> >MicroTest World Class Services - http://www.microtestlabs.com/
> >MIDI Labs, Inc. - http://www.midilabs.com/
> >Millipore - http://www.millipore.com/
> >NovaTek International - http://www.ntint.com
> >Raven Biological Labs - http://www.ravenlabs.com
> >Veltek Associates, Inc - http://www.sterile.com
> >
> >------------------
> >The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> >The Microbiology Network (http://microbiol.org) and supported by
> >our sponsors (http://microbiol.org/sponsor.htm) as a service to
> >the scientific community.
> >
> >Please take a second to visit our sponsors' web sites and say thank you
> >for their support of this service.
> >AAI - http://www.aaiintl.com/Micro.htm
> >Accugenix - http://www.accugenix.com/
> >Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
> >Microcheck - http://www.microcheck.com/
> >MIDI, Inc. - http://www.midi-inc.com/
> >Microbial ID, Inc. - http://www.microbialid.com/
> >MicroTest World Class Services - http://www.microtestlabs.com/
> >MIDI Labs, Inc. - http://www.midilabs.com/
> >Millipore - http://www.millipore.com/
> >NovaTek International - http://www.ntint.com
> >Raven Biological Labs - http://www.ravenlabs.com
> >Veltek Associates, Inc - http://www.sterile.com
>
> ------------------
> The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
> our sponsors (http://microbiol.org/sponsor.htm) as a service to
> the scientific community.
>
> Please take a second to visit our sponsors' web sites and say thank you
for
> their support of this service.
> AAI - http://www.aaiintl.com/Micro.htm
> Accugenix - http://www.accugenix.com/
> Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
> Microcheck - http://www.microcheck.com/
> MIDI, Inc. - http://www.midi-inc.com/
> Microbial ID, Inc. - http://www.microbialid.com/
> MicroTest World Class Services - http://www.microtestlabs.com/
> MIDI Labs, Inc. - http://www.midilabs.com/
> Millipore - http://www.millipore.com/
> NovaTek International - http://www.ntint.com
> Raven Biological Labs - http://www.ravenlabs.com
> Veltek Associates, Inc - http://www.sterile.com
>
> ------------------
> The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
> The Microbiology Network (http://microbiol.org) and supported by
> our sponsors (http://microbiol.org/sponsor.htm) as a service to
> the scientific community.
>
> Please take a second to visit our sponsors' web sites and say thank you
for their support of this service.
> AAI - http://www.aaiintl.com/Micro.htm
> Accugenix - http://www.accugenix.com/
> Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
> Microcheck - http://www.microcheck.com/
> MIDI, Inc. - http://www.midi-inc.com/
> Microbial ID, Inc. - http://www.microbialid.com/
> MicroTest World Class Services - http://www.microtestlabs.com/
> MIDI Labs, Inc. - http://www.midilabs.com/
> Millipore - http://www.millipore.com/
> NovaTek International - http://www.ntint.com
> Raven Biological Labs - http://www.ravenlabs.com
> Veltek Associates, Inc - http://www.sterile.com

------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) as a service to
the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
AAI - http://www.aaiintl.com/Micro.htm
Accugenix - http://www.accugenix.com/
Becton Dickinson Microbiology Systems - http://www.bd.com/industrial
Microcheck - http://www.microcheck.com/
MIDI, Inc. - http://www.midi-inc.com/
Microbial ID, Inc. - http://www.microbialid.com/
MicroTest World Class Services - http://www.microtestlabs.com/
MIDI Labs, Inc. - http://www.midilabs.com/
Millipore - http://www.millipore.com/
NovaTek International - http://www.ntint.com
Raven Biological Labs - http://www.ravenlabs.com
Veltek Associates, Inc - http://www.sterile.com

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