Cleaning validation 1: Development and validation of a chromatographic method for the detection of traces of LpHse detergent

Zayas, José; Colón, Héctor; Garced, Omar; Ramos, Leyda M.

doi:10.1016/j.jpba.2005.10.049

Cited by 6 publications

(6 citation statements)

References 5 publications

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“…The swabbing process has been represented schematically elsewhere. (Zayas, Colón, Garced, et al 2006) The swab was returned to a vial with 2.00 mL of mobile phase. The vials were shaken mechanically for 10 minutes and each of them analyzed by IC.…”

Section: Methodsmentioning

confidence: 99%

The Use of Ion Chromatography for the Determination of Clean-In-Place-200 (CIP-200) Detergent Traces

et al. 2006

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Anion chromatography with conductivity detection was chosen as the analytical technique for the development of a cleaning validation method for clean-in-place (CIP) detergents. The method was developed and validated for the determination of traces of the detergent CIP-200. It was shown to be linear with a squared correlation coefficient (r2) of 0.9999 and the accuracy experiments presented average recoveries of 88.2% (area response factor) from stainless steel surfaces. The repeatability was found to be 1.6% and an intermediate precision of 1.9% across the range. The method was also shown to be sensitive with an average Detection Limit (DL) of 0.23 ppm and a Quantitation Limit (QL) of 0.70 ppm based on the amount of phosphate in the detergent sample. The phosphate signal was well resolved from typical ions encountered in water samples or any other interference presented from swabs and surfaces. The method was applied to cleaning validation samples and proved to be suitable for rapid and reliable quality control.

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Section: Methodsmentioning

confidence: 99%

The Use of Ion Chromatography for the Determination of Clean-In-Place-200 (CIP-200) Detergent Traces

et al. 2006

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“…For each deposited aliquot, a wet swab was passed over the surface of the plate, one side of the swab was passed horizontally and the other vertically. The swabbing process has been represented schematically elsewhere [10]. The swab was returned to a vial with 2.00 mL of purified water.…”

Section: Preparation For the Recovery Of Cip-100 From Stainless Steelmentioning

confidence: 99%

“…It is common to find reports on cleaning validation of drug residues [4][5][6][7][8]. However, reports on cleaning validation of detergents used for the cleaning process are limited [9,10]. The detection of traces of detergents is a difficult task in cleaning validation programs.…”

Section: Introductionmentioning

confidence: 99%

“…Therefore, a complete disclosure from a detergent manufacturer as to what the components of the detergent are, their ratios and possibly reference materials are not readily available unless secrecy agreements are made between the industry and the manufacturer. A previous report from our research group presented a cleaning validation protocol for the determination of residues of LpHse detergent using HPLC [10]. This article, presents an ion chromatography (IC) approach for the determination of CIP-100 Industrial detergent.…”

Section: Introductionmentioning

confidence: 99%

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Cleaning validation 2: Development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent

Resto

Hernández

Rey³

et al. 2007

Journal of Pharmaceutical and Biomedical Analysis

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“…Several different analytical methods have been used in the analyses of surfactants, including reversed-phase chromatography with UV detection [6], ion chromatographic method with conductivity detection [7], total organic carbon analysis, pH, visual detection [8][9][10][11][12][13][14][15]. These analytical methods, along with others, are often used in the validation of cleaning validation procedures according to the demands of the Food and Drug Administration (FDA) [16].…”

mentioning

confidence: 99%

Non-specific methods for detecting residues of cleaning agents during cleaning validation

Milenović¹,

Pešić²,

Mitić³

2011

CI&CEQ

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Cleaning validation procedures are carried out in order to assure that residues of cleaning agents are within acceptable limits after the cleaning process. Cleaning agents often consist of a mixture of various surfactants which are in a highly diluted state after the water rinsing procedure has been completed. This makes it difficult to find appropriate analytical methods that are sensitive enough to detect the cleaning agents. In addition, it is advantageous for the analytical methods to be simple to perform and to give results quickly. In this study, three different non-specific analytical methods are compared: visual detection of foam, pH and conductivity measurements. The analyses were performed on different dilutions of the cleaning agents Bactericidal Hydroclean and Tickopur R33. The results demonstrated that the most appropriate method for these detergents are conductivity measurements, by which it is possible to detect concentrations of cleaning agents down to 10 µg/ml. In this case, pH is an inadequate method (non-linear) and visual detection of foam is a semi--quantitative method. All these methods are easy to perform, gives a quick results, and requires no expensive instrumentation.The main objective of cleaning validation procedures is to provide documented evidence that the equipment is safe for the manufacture of the next product. For this purpose, cleaning agents are used for removal of the previously manufactured product and also for the removal microorganisms. Because cleaning agents often consist of a mixture of various surfactants, often very diluted, it may be difficult to find appropriate analytical methods that are sensitive enough for detection of the compounds.The first step in cleaning equipment is the selection of an appropriate cleaning product for the type of residue to be removed. Once this is done, an analytical strategy must be devised to determine the amount of cleaning agent residue left on surface that has been cleaned. This determination is important because if a cleaning agent effectively removes the drug--product residue but leaves behind its own residue, then one type of contamination has been exchanged for another, and the equipment has not been cleaned effectively. Detergent selection is a critical step in the Correspondening author: D. Milenović, "Zdravlje-Actavis" Company, 199 Vlajkova St.,

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Cleaning validation 1: Development and validation of a chromatographic method for the detection of traces of LpHse detergent

Cited by 6 publications

References 5 publications

The Use of Ion Chromatography for the Determination of Clean-In-Place-200 (CIP-200) Detergent Traces

The Use of Ion Chromatography for the Determination of Clean-In-Place-200 (CIP-200) Detergent Traces

Cleaning validation 2: Development and validation of an ion chromatographic method for the detection of traces of CIP-100 detergent

Non-specific methods for detecting residues of cleaning agents during cleaning validation

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