Analytics for Chemistry, Biology and Production:

Quality has to be produced, before you can search for!  P. Forster


Why this other additional Site ?:   The author of this page is independent and has no commercial intention ! Diese Seite in Deutsch.


On this pages I will publish and preserve analytical 'know-how' that may help a lot of people involved in production and/or quality-control of chemical, or biological products. I will keep this information as independent as possible and point out all things in both ways - the good one and the bad!.
I just started with this project, please be patient to find all the information I have for you.
Here are my first items:
     
  - System Suitability Test (SST)
- IQ, OQ, PQ, PV, FDA, USP, EP
A new System Suitability Test for Diode Array Spectrometers: By spending only ten seconds every 24 hours for carrying out the new SST, much more is achieved — apart from the paperwork — than what IQ, OQ, PQ, and PV can ever do together, for correct and reliable results in the daily routine work.
  - Dynamic Dilutors:
- DYNAMIX II:
Are you still spending so much time, effort, and manpower as well as so many solvents, and glassware, doing the necessary dilutions for spectroscopy and liquid chromatography by hand? How are you checking the required linearity [1] for your spectrometric methods [2] and the allowed range for it?
But do not mingle “Dynamic” with “Normal/Static” Dilutions. [3]
  - Spectroscopy
   ~ Beer-Lambert Law
   ~ Instruments
      - Photo Diode Arrays
   ~ Linearity
   ~ FAQ's
- Near Near Infrared
- 'Bar-Sipper'
- Dynamic Dilution
- MCA/MLR/PLS
   ~ How to do MCA !!
- Factor Analysis
Are you still filling the cuvettes for your spectrophotometer as it already Mr. A. Beer (1825 - 1863) and Mr. J. H. Lambert (1728 - 1777) did, or even worse, are you using a peristaltic pump or water-jet vacuum pump for filling/cleaning? Then you also didn't gain very much in “celebrating” spectroscopy at all and you are using the first till the fifth derivative on your recorded spectra to evaluate the concentration of your samples. Why are you always running the reference spectrum just before or just behind your sample? Why are you using a spectrophotometer with double monochromator and a linearity up to 4.5 AU or why do you think it is absolutely necessary to have a resolution of 0.1 nm or less?. Then I think, it is high time to learn the spectroscopy again from the basics. There is also a big advantage in learning the new chemometric methods and their correct use [4], then mathematics/statistics is not all.
At the same Time you get SMV [5] and SRI [5] for less then a penny, including instrument/system validation. [6]
  - EPPENDORF Do you require a automation tool for controlling the Eppendorf THERMOMIXER Comfort or controlling the THERMOSTAT Plus, then you have the possibility to download a demo program that really helps you to control your experiments. It is a real tool and not only a radio control program as Eppendorf's demo program . The full version can run up to 20 Temperature profiles (with controlled temperature ramps) and repeat each up to100 times. The demo program shows you already that it helps you to fulfill the '21 CFR part 11' requirements.
  - ARGUS Colour
- System Suitability
- MCA
   ~ How to do MCA !!
- 'PREP-SET'

The automated spectrometer system for production, quality control, and routine analytics. Using it with the "real !! Multi Component Analysis algorithm" (MCA) empowers the production and gives it the possibility to produce a higher quality. The new designed system has not the same amount of features as the old one, but it is still the most powerfully system you can buy at the moment. The next expanded Release is in work and will be available in a short time.
  - ARGUS DISSOLUTION
- MCA

   ~ How to do MCA !!
An automated Dissolution Tester System that knows a 'in situ-' and a 'flow through-', often called 'closed loop-' mode, and fulfills not only the '21 CFR part 11' requirements. It takes even care to meet all the rules given by the FDA. It knows the acronyms IQ, OQ, PQ and allows you to use many different algorithms for calculation and archives all results for you.
The Autor:   Peter Forster


ReferencesReferences:
 
[1] "Spectroscopy: Lesson 2:   8. That's real linearity and how you have to test it !"    [Paragraph 5.), case a.)]
      www.p-forster.com/english/themes/spectroscopy
[2] "Linearity: - maybe a little bit more?
      That's how a real method with linearity has to look!
      www.p-forster.com/english/themes/spectroscopy/Linearity
[3]  I'm sorry:   But nobody is able to change a "static" Dilutor into a "dynamic" Dilutor by any way !
                  Also is nobody able to create a "dynamic" Dilutor, too, if he is using two Dispensers !
      www.p-forster.com/english/themes/DynamicDilutors/DynamicDilutors.htm
[4] "Chemometrics: Forget it once and for all, this papers talking about .... and reports at the same time only an absolutely minor precision and reproducibility !
      www.p-forster.com/english/themes/Chemometrics
[5]  SMV:  Sample Method Validation.         www.p-forster.com/english/themes/spectroscopy
 SRI:    Sample Reference Identification.           www.p-forster.com/english/themes/spectroscopy
[6]  SST: The System Suitability Test of the spectrometer and system.
      www.p-forster.com/english/themes/Suitability





Software Development & Consulting
Peter Forster
Neubadstrasse 88
CH-4054 Basle, Switzerland

Mail to: peter.forster@p-forster.com

         

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