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Quality has to be produced, before you can search for! P. Forster |
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| 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: |
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- 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. | ||
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- 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] |
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- Spectroscopy: ~ Beer-Lambert Law ~ Instruments - Photo Diode Arrays - Inverted Optics - Diode Array Quiz ~ Linearity ~ FAQ's - Near Near Infrared - 'Bar-Sipper' - Dynamic Dilution |
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[4] them?
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 it's also absolute no problem for you to still believe that monochromatic Light must be used for all reliable measurements according to the true Beer-Lambert Law,
and that the Law only holds till a little above 1.0 Absorption and otherwise fails anyway, but you own and use daily a Instrument till 4.5 AU. |
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- Chemometrics: ~ MCA/MLR/PLS - How to do MCA !! ~ Factor Analysis |
There is also a big advantage in learning the new adequater chemometric methods and their correct use [5],
then mathematics/statistics, and all other such "number crunching" alone is by far not all! At the same Time you get SMV[6] and SRI [6] for less then a penny, including instrument/system validation [7], which beats all others like IQ, OQ, PQ, and PV together! Real reliably and validated Chemometrics can do this all for you, and saves much more then only time [7, 8]. |
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| - 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. | ||
| - HELIOS++ | The Expert-System in Colorimetrics/Color-Matching/Quality-Control! - includes Quality-Control, Shading, Recipe-Calculation, Dye-Calbration, Gamut-Control, Consitency-Checks, and a lot more (Whiteness, High Visability Dyes, etc.). COLPOCA++ The Expert-Workhorse for your daily Recipes in Dye-Kitchen und Production, also for Shading, and so on. ARGUS++ Your Expert to PRODUCE & Control all the Dyestuffs in the equired Quality to be used in Helios++ and Colpoca++, or other Colorimetric Systems. |
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- ARGUS/ARGUS++ - System Suitability - MCA ~ How to do MCA !! - 'PREP-SET' |
The automated spectrometer system for Labratories, Production, Quality Control, and Routine Analytics
for Pharmaceuticals, Dyes, Food, and so on, does also all what's required for USP, EP, GMP, etc., and '21 CFR part 11'. 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. |
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- 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. Combined with the Relative Fit Error (RFE), MultiComponent Analysis (MCA) is certainly one of the most powerful tools a spectroscopist can use today. |
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| The Autor: Peter Forster | |||
References:| [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/Diluter into a "dynamic" Dilutor
by any way ! Also is nobody able to create a "dynamic" Dilutor/Diluter, too, if he is using two Dispensers ! www.p-forster.com/english/themes/DynamicDilutors/DynamicDilutors.htm |
| [4] | "For filling Cuvettes see: The 'Bar-Sipper' "For cleaning Cuvettes see: FAQ: 'How can I clean my cuvettes?' |
| [5] | "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 |
| [6] | SMV: Sample Method Validation.
www.p-forster.com/english/themes/spectroscopy SRI: Sample Reference Identification. www.p-forster.com/english/themes/spectroscopy |
| [7] | SST: The System Suitability Test of the spectrometer and system. www.p-forster.com/english/themes/Suitability |
| [8] | "MCA: Combined with the RFE (Relative Fit Error), MCA is certainly one of the most powerful tools a spectroscopist can use today!: Multi Component Analysis (MCA/MKA) |
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Software Development & Consulting Peter Forster Neubadstrasse 88 CH-4054 Basle, Switzerland Mail to: peter.forster@p-forster.com |
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