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venkatarman (venkynir)
Senior Member
Username: venkynir

Post Number: 26
Registered: 3-2004
Posted on Tuesday, December 26, 2006 - 1:22 am:   

Garvriel Levin,
You message is very impressive.Please send the copy of your effective work on PAT. Through web and literature the question of PAT was raised by INDIAN guy. There is nodoubt about the service of BRIMROSE to NIRS .My wish is any development work should reach to root of the society than only it will be helpful.In the view of Globalazation the developing coutries like INDIA ready to work in collbrative mode to share their knowldege and other activitis to benefit to the society .I request you please avoid "I" .Kindly remember RAMAN,RAMANUJAM,CHANDRA SHEKAR and MAHALANO are from..
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Gavriel Levin (levin)
Senior Member
Username: levin

Post Number: 28
Registered: 1-2006
Posted on Friday, December 22, 2006 - 7:02 am:   

Hi Venkat,

Thanks. Point is - we at Brimrose have been promoting PAT in collaboration with Dr. Ali Afnan (then AZ, now FDA) as early as 1998. In fact, Ajaz has invited me to give a short presentation in the Science and Board Advisory Meeting of the FDA in November 2001, I then predicted that the Pharma will have to go PAT just as much as the aircraft Engine industry (also Federally regulated industry) went from testing parts to controlling the process between 1975 to 1981 (I worked as a metallurugist with Ph.D. at GE aircraft then)- I said the industry will go this way because it has no choice but to go this way. Few people told me I am a fool to think the FDA will embrace the concept. In July 2002 the FDA anounced the PAT initiative!, not even a year after I predicted it.
If you wish I can send you a short copy of my presentation.

Speaking about lyophilization - we have our analyzers doing high speed - 300 vials per minute!! moisture measurements while vials are moving in three major pharma - I will name only Roche Basel, where a Ph.D. dissertation was published describing the work and why they chose Brimrose. I can send you scanned copy.

Anything you wish to hear from me about PAT and NIR please write to me.

Many thanks,

Gabi Levin
Brimrose
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Ian Michael (admin)
Board Administrator
Username: admin

Post Number: 9
Registered: 1-2006
Posted on Friday, December 22, 2006 - 5:52 am:   

In case anyone has not seen Erik's Spectroscopy Europe article, it is available from http://www.spectroscopyeurope.com/articles.html#NIR_18_5
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venkatarman (venkynir)
Advanced Member
Username: venkynir

Post Number: 25
Registered: 3-2004
Posted on Friday, December 22, 2006 - 5:06 am:   

Garvriel Levin,
Thanks for your Greetings,Hope coming year to be the Year of NIR . I do accept your statement approved method and nothing called as APPROVED in PAT.But NIR is the working horse in the PAT tool box and NIR a multifaceted analyzer. The use of NIR as a PAT tool in the lyophilisation process and as a monitoring and control tool in fermentation process. As Mr.Erik Skibsted mentioned in his article Spectroscopy vol2 no4 2006 ,the future looks bright for NIRS as PAT tool . We NIR Guy should join in hands do our best for the global community . I hope my NIRS friends agree for it. Your work will help not only developed countries , it should penetrate to the developing and under developing countries too.That is way the NIR Guys has to work for the coming year
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Gavriel Levin (levin)
Senior Member
Username: levin

Post Number: 27
Registered: 1-2006
Posted on Friday, December 22, 2006 - 2:54 am:   

Hi Guys,

First let me wish everyone happy seasons greetings, celebrate whatever you may, I wish you all the happiest holiday and new year.

One small remark - as some one who has been doing PAT in numerous pharma companies - big ones as well as small ones, from RM ID to blend, to FBD to tablet analysis, API applications, to you name it -

there is no such thing as an "approved" method - NIR was never "approved" - a method with good validation data - including proof of the required challenges, specifity (when required) is approved - if NIR is the best tool to deliver the goods, use it, if some other method delivers better goods, use it.
And I am an NIR guy.

If anyone wishes more details, applications that work well, examples, etc. you are invited to write to me

[email protected]
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venkatarman (venkynir)
Advanced Member
Username: venkynir

Post Number: 23
Registered: 3-2004
Posted on Friday, December 22, 2006 - 12:10 am:   

Nuno , Kindly specify where you are going to apply PAT in SDF . Is it granulation or Blending or tablet.
I have read quit good number of paper in Blending and tablet .NIRS is one of vital and approved tool in PAT.
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hlmark (Unregistered Guest)
Unregistered guest
Posted on Tuesday, May 02, 2006 - 8:50 am:   

Anita - you might want to check out the article in Spectroscopy, 9(1), p.27-32 (1994), some of the spectra you're looking for might be in that. If those are not detailed enough then contact me privately, off the discussion group, and I may be able to help you out.

Howard

\o/
/_\
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anita sure (Anitasure)
New member
Username: Anitasure

Post Number: 1
Registered: 5-2006
Posted on Tuesday, May 02, 2006 - 8:23 am:   

Dear all,
Can any one suggest books which have the near infrared spectrum of the paints, lacquers and polymers like polyethylene, surlyn, acrylic etc.,
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hlmark (Unregistered Guest)
Unregistered guest
Posted on Tuesday, March 07, 2006 - 10:02 pm:   

Katherine - so it finally came out? Congratulations!

\o/
/_\
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Katherine A. Bakeev (Unregistered Guest)
Unregistered guest
Posted on Tuesday, March 07, 2006 - 9:03 pm:   

Dear Nuno,
A recent book that may interest you:

Process Analytical Chemistry: Spectroscopic tools and implementation strategies for the chemical and pharmaceutical industries, Katherine A. Bakeev, Editor, Blackwell Publishing, Oxford, UK, 2005.
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Nuno Matos (Nmatos)
Posted on Thursday, May 12, 2005 - 4:39 am:   

Dear All

I'm in the process of jumping to PAT. Please, could anyone indicate me some good references (books, articles, etc...)?

Thank you in advance

Nuno

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