Equipment Validation Articles

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Flow, Pressure, and Temperature Calibration: Part II

In last month’s installment of “GC Connections,” John Hinshaw discussed how peak retention times depend upon relationships between pre s s u re, flow rate, oven temperature , column dimensions, and stationary phase. This concluding installment of a two-part series discusses the effects that column variability has o­n isothermal capillary gas c h romatography and e x p l o res instrument calibration with the goal of maximizing instrument-toinstrument similarity of retention times.

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LCGC North America, Jan 1, 2005 .

Flow, Pressure, and Temperature Calibration: Part I

In this first of a two-part installment, John Hinshaw discusses the relative effects that inlet pressures and oven temperatures have o­n capillary gas chromatography.

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LCGC North America, Dec 1, 2004.

Qualification of a Chromatographic Column: Why and How to Do It

FDA has become more knowledgeable about process chromatography — and more demanding about column qualification. In the latest installment of BioPharm International's "Element of BioPharmaceutical Production," five industry experts share their insights o­n how to qualify a chromatographic column. Their advice: Write unambiguous SOPs. Focus o­n reproducibility of column packing. Choose appropriate metrics. And analyze your testing procedures to reduce the chance of erroneous results.

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BioPharm International, March 2003.

Independence rules (or Rules for independence) : Validation and Calibration

A.M.C. Davies
When we have developed a multivariate calibration it is essential that the performance of the calibration is tested with a set of samples which are typical and independent. This set has several names but I prefer "Validation set". If you are satisfied with the predictions o­n these samples then you will daim that you have "Validated" the calibration, which suggests that you expect it to continue to give useful results in the future.

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Pharmaceutical Technology.