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]
>
> ------------------ 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/
>
> ------------------ 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/
>
> ------------------ 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/
>
> ------------------ 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
------------------
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/
|
