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.

IQ Validation Test Procedure

One of the greatest value added services an equipment qualification protocol can provide is the verification of accurate system and/or equipment drawings. Often contractors and vendors supply ‘as-builts’ as part of a job or project. Unfortunately however, changes are often made even after the as-builts were delivered or errors/omissions occurred in the original drawings. This test procedure can be included in an Installation Qualification as a means of verifying the accuracy of the as-built drawings.The following validation test procedure from our ValPro™ library is submitted for your use and review.

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ISPE, November 1999.

The Sturtevant Sanitary Design Micronizer Still the Only USDA-Dairy-Accepted Jet

ISPE, September 1998 Sturtevant, Inc., manufacturers of the Sanitary Design Micronizer® (SDM) has continued to develop the o­nly USDA-DAIRY accepted jet mill by custom engineering solutions for its customers. By working to solve special application problems, Sturtevant continues to advance the sanitary design features of the SDM to meet the stringent industry needs. Originally, Sturtevant engineered the stainless steel SDM especially for the pharmaceutical industry in response to a customer request.

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ISPE, September 1998 ,

Performance Qualification of a Vial Washer

A vial washer is a relatively simple machine commonly used to clean containers during the manufacture of dosage form drugs. Some drug manufacturers o­nly perform Installation Qualification (IQ) and Operational Qualification (OQ) of the machine as no regulatory requirements clearly state that the performance of the vial washer should be qualified. Although depyrogenation may be achieved using a heating tunnel or oven, if the washing process cannot remove chemical contaminants or particles, they will produce a pyretic response in humans or animals, although there are no pyrogens present.

Journal of Validation Technology Volume 8 Number 2 February 2002 .

Laboratory Equipment Qualification

The main goal in qualifying laboratory equipment is to ensure the validity of data.The current equipment qualification programs and procedures used within the pharmaceutical industry are based o­n regulatory requirements, voluntary standards, vendor practices, and industry practices.The result is considerable variation in the way pharmaceutical companies approach the qualification of laboratory equipment and the way they interpret the often vague requirements.The authors summarize the conclusions of the PhRMA Workshop o­n Acceptable Analytical Practices for the topic “Qualification of Laboratory Equipment.” They describe the areas ofagreement and offer options for areas in which there is variation o­n what is appropriate.

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Pharmaceutical Technology OCTOBER 2001.

Performance Qualification of LC Systems

Chromatographers can use a simple set of tests to check system performance.

Users of liquid chromatography (LC) systems have two compelling reasons to ensure that their systems are working properly. First, good science — why would anyone want to perform LC experiments on a system that isn’t working at its best? Second, the government regulations for the laboratory environments in which many analysts work require testing to confirm that the instruments are doing their jobs.

LC•GC Europe October 2002.