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

Resto, Wilfredo; Hernández, Darimar; Rey, Rosamil; Colón, Héctor; Zayas, José

doi:10.1016/j.jpba.2007.01.037

Cited by 13 publications

(4 citation statements)

References 7 publications

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“…Despite having the same pH, observed differences between activities of ProKlenz-One and CIP-100 against PPV highlight that differences in formulation can be important when considering virucidal activity. It should be noted that both formulations have high cleaning efficacy; in addition, specific and nonspecific methods such as high-performance liquid chromatography (HPLC), Total Organic Compounds measurement, and others are available for detecting cleaning agent residues, which is required in the validation process (Resto et al, 2007).…”

Section: Discussionmentioning

confidence: 99%

Virucidal Activity of Disinfectants against Parvoviruses and Reference Viruses

Eterpi¹,

McDonnell

Thomas³

2010

Appl Biosaf.

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Some virus species can resist surprisingly harsh environmental conditions, being able to survive on surfaces for long periods and often presenting high resistance to disinfection. Viruses can be transmitted to susceptible hosts via these contaminated surfaces. This is a major concern not only in healthcare and research but also in manufacturing settings, with recent occurrences reporting viral contamination of non-human cells used to produce therapeutic enzymes in bioreactors. Consequently, a need to validate the virucidal efficacy of products used to clean and decontaminate surfaces in these facilities exists. In this study we tested two alkaline cleaners (CIP-100 and ProKlenz-One), two liquid disinfectants (SporKlenz and a peracetic-based formulation), and a gaseous hydrogen peroxide-based aerial decontamination process for their capacity to inactivate several viruses, including parvoviruses in the presence of organic soils. We demonstrate that these decontamination methods offer virucidal efficacy and can consequently ensure a very high level of protection against viral contamination.

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Section: Discussionmentioning

confidence: 99%

Virucidal Activity of Disinfectants against Parvoviruses and Reference Viruses

Eterpi¹,

McDonnell

Thomas³

2010

Appl Biosaf.

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“…3 Separation and identification of surfactants are challenging due to their diversity, the complex composition of their materials, and the complexity of the sample matrices. Many methods can be used for the qualitative and quantitative analysis of surfactants, including chromatography, capillary 1 Department of Anaesthesiology, 4 Department of Family Medicine, 3 Faculty of Health, Lebanese University, Beirut, Lebanon 2 Department of Emergency Medicine, Lebanese American University, Beirut, Lebanon electrophoresis, and optical sensors. Nevertheless, the spectrophotometric determination of surfactants remains the most commonly used method.…”

Section: Introductionmentioning

confidence: 99%

“…Nevertheless, the spectrophotometric determination of surfactants remains the most commonly used method. 4 Despite beneficial cleaning properties, misuse of detergents can sometimes become toxic to humans. There are numerous studies on the toxicity of pesticides, insecticides and laundry cleaning products.…”

Section: Introductionmentioning

confidence: 99%

Effects of dishwashing detergents residues on redox status and cell proliferation in mice liver and kidney

Chahine

El-Teres²,

Chahine³

et al. 2022

Int J Res Med Sci

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Background: Commonly known for their cleaning and disinfecting properties, dishwashing detergents containing anionic surfactants can be potentially toxic due to misuse. This study aims to investigate the possible harmful effects of detergents residues persisting on utensils after dishwashing.Methods: Residues were collected after cleaning the utensils in 100 mL of water from 100 households in Beirut, Lebanon. After anionic surfactant determination, water with detergent residues (WDR) was added to drinking water of white mice versus tap water as control: G1 (TW for 2 months), G2 (WDR for 2 months), G3 (TW for 3 months) and G4 (WDR for 3 months), N=6 for each group. Animals were then sacrificed. Biopsies from liver and kidneys were taken for histological examination or preserved at -80°C for biochemical analysis of lipid peroxidation, superoxide dismutase activity, and expression of PI3K/AKT/mTOR pathway proteins by western blotting.Results: Our results showed no significant difference in body weight or histological alteration in groups given WDR versus TW groups. An increase of LP (30%) and a decrease of SOD activity (25%) were noted in the liver tissue of G2 and G4 versus G1 and G3 respectively (p<0.05). In addition, p-AKT and p-mTOR proteins expression regulating cell proliferation were significantly increased in the liver of G4 versus G3 (p<0.05).Conclusions: We concluded that traces of detergents on utensils do not cause an acute pathology, but they could cause oxidative stress to the liver and an over-expression of cancer pathway over a relative long period of time.

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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].…”

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

Cited by 13 publications

References 7 publications

Virucidal Activity of Disinfectants against Parvoviruses and Reference Viruses

Virucidal Activity of Disinfectants against Parvoviruses and Reference Viruses

Effects of dishwashing detergents residues on redox status and cell proliferation in mice liver and kidney

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

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