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December 2002

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Subject:
From:
Edward Fitzgerald <[log in to unmask]>
Reply To:
Date:
Mon, 9 Dec 2002 09:36:30 -0500
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Steven Richter wrote:
>
> Michelle,
>
>
>
> At my lab, we perform spike recovery studies that allow one to
> determine repeatability and accuracy of the test method.  Robustness
> is determined by using different analyst and comparing the data to
> spiked recovery studies.
>
> Sporeformer Bioburden is very important aspect of a raw material used
> in medical devices and drugs.  Many times a method development process
> is required to determine the best extraction and enumeration method.
> If you would like a copy of a paper I published on this very subject,
> then please email me at [log in to unmask]
>
>
>
> Steven Richter Ph.D.
>
> President and Scientific Director
>
> Microtest World Class Testing Services
>
>
>
>
>
> -----Original Message-----
> From: The Pharmaceutical Microbiology Mail List
> [mailto:[log in to unmask]] On Behalf Of Michelle Wheeler
> Sent: Tuesday, October 15, 2002 10:09 AM
> To: [log in to unmask]
> Subject: Re: [PMFLIST] Raw Material Bioburden
>
>
>
> Good question, Mike! The reason we are doing bioburden on resin (which
> is typically heated to 200  degrees C) is because it was requested by
> the FDA.
>
> I discovered this difference in results when doing training with a new
> analyst. Her results differed vastly from mine, so I retested several
> time and got a large variation in results. The reason for the question
> is that typically we set a % difference limit between trainee and
> trainer's results. What can I do about that?
>
> Michelle
>
>
>
>      ----- Original Message -----
>
>      From: Villa, Mike
>
>      To: [log in to unmask]
>
>      Sent: Tuesday, October 15, 2002 7:41 AM
>
>      Subject: Re: [PMFLIST] Raw Material Bioburden
>
>
>
>      Michelle (and all),
>
>          Microbiological contamination in any raw material,
>      finished good, etc., will rarely be evenly distributed.
>      That is one of the quirks of microbiological testing.  In
>      the grand scheme of things, and statistics of distribution,
>      there is little difference between the testing results you
>      mention.  I would not get bogged down into increasing the
>      number of samples, as you're never going to be able to get
>      consistent results between samples. However, increasing the
>      sample size may give you a bit more confidence in the amount
>      of bioburden.
>
>          Also, I'm no expert in blow-fill-seal technology of
>      resins, but my guess is that the resin will need to be
>      heated/melted to some temperature....if so, wouldn't that
>      tend to control the bioburden?  If so, why worry about the
>      bioburden to begin with?
>
>
>
>      Michael R. Villa
>
>      Manager - Lab Services
>
>      Bath & Body Works
>
>      p- 614-856-3773
>
>      f- 614-856-6563
>
>
>
>           -----Original Message-----
>           From: Michelle Wheeler
>           [mailto:[log in to unmask]]
>           Sent: Monday, October 14, 2002 7:26 PM
>           To: [log in to unmask]
>           Subject: [PMFLIST] Raw Material Bioburden
>
>           Dear Group,
>
>           What should you do if the bioburden in a raw
>           material is not evenly distributed? If you tested
>           a sample from the same lot 10 times, you might get
>           results ranging from 2 cfu/10 grams all the way up
>           to 110 cfu/10 grams. The raw material in question
>           is polyethylene resin pellets, used in forming
>           ampoules with Blow-FIll-Seal technology.
>
>           I have been following the 10 gram sample size, as
>           recommended by USP. Would increasing the sample
>           size (and diluting to compensate) help?
>
>           I have validated the method and I really don't
>           think the problem lies there.
>
>
>
>           Any suggestions would be greatly appreciated.
>
>           Thank you,
>
>
>
>           Michelle Wheeler
>           Finished Products Supervisor
>           Holopack International
>           1 Technology Circle
>           Columbia, SC 29203
>           [log in to unmask]
>
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> 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
> Chemunex - http://www.chemunex.com/ Microcheck -
> http://www.microcheck.com/ MIDI - http://www.midi-inc.com/ MIDI
> Microbial ID - http://www.microbialid.com/ MIDI Labs -
> http://www.midilabs.com/ Millipore - http://www.millipore.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
> Chemunex - http://www.chemunex.com/ Microcheck -
> http://www.microcheck.com/ MIDI - http://www.midi-inc.com/ MIDI
> Microbial ID - http://www.microbialid.com/ MIDI Labs -
> http://www.midilabs.com/ Millipore - http://www.millipore.com/

Dr. Richter:

Please send me a copy of the paper on extraction and enumeration of
sporeformer bioburden as per your E-mail response to Michelle Wheeler.
My address is: 3 Owens Court
               Rockville, MD 20850
Thanks in advance for the courtesy.

Ed Fitzgerald
Fitzgerald Consulting


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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
Chemunex - http://www.chemunex.com/
Microcheck - http://www.microcheck.com/
MIDI - http://www.midi-inc.com/
MIDI Microbial ID - http://www.microbialid.com/
MIDI Labs - http://www.midilabs.com/
Millipore - http://www.millipore.com/

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