نتایج جستجو برای: cleaning validation

تعداد نتایج: 193585  

Journal: :Journal of clinical microbiology 1994
R Roosendaal E J Kuipers A J van den Brule A S Peña A M Uyterlinde J M Walboomers S G Meuwissen J de Graaff

A 16S ribosomal DNA-based PCR appeared to be a sensitive test for the detection of infection by Helicobacter pylori in 31 patients when compared with culturing and histological and serological techniques. For five patients, PCR was the only test with a positive result. H. pylori DNA was also found in gastrointestinal equipment even after standard intensive combined manual and machine cleaning. ...

2013
Magda A Akl Mona A Ahmed Ahmed Ramadan

To ensure that residues of Tirofiban will not carry over and cross contaminate the subsequent product, carefully designed cleaning validation techniques should be investigated. The objective of the present study was to validate simple analytical method for verification of residual Tirofiban in equipments used in the production area and to confirm efficiency of cleaning procedure. An assay metho...

Journal: :Drug development and industrial pharmacy 2011
Zoran Bubnič Uroš Urleb Katjuša Kreft Marjan Veber

The objective of this work was the development and validation of atomic absorption spectrometric (AAS) methods for the determination of residual active pharmaceutical ingredients (API) in rinse samples for cleaning validation. AAS as an indirect method for the determination of API in rinse samples can be applied when it is in the form of salt with metal ions or when the metal ion is a part of t...

2013
R. S. Chandan B. M. Gurupadayya

In Pharmaceutical industries, it is very impo remove drug residues from the equipment and areas used. The cleaning procedure must be validated, so special attention must be devoted to the methods used for analysis of trace amounts of drugs. A rapid, sensitive and specific reverse phase ultra chromatographic (UPLC) method was developed for the quantitative determination of Albendazole in cleanin...

2012
Bahjat Safadi Stéphane Ayache Georges Quénot

In this paper, we have described the active cleaning approach that was used to complement the active learning approach in the TRECVID collaborative annotation. It consists in using a classification system in order to select the most informative samples for multiple annotations, in order to improve the quality and the reliability of the annotations. We have evaluated the actual impact of the act...

پایان نامه :دانشگاه آزاد اسلامی - دانشگاه آزاد اسلامی واحد علوم دارویی - دانشکده داروسازی 1392

دستگاه ها و تجهیزات موجود در صنایع داروسازی، ممکن است برای تولید محصولات دارویی متعددی به کار گرفته شوند، در نتیجه این امکان وجود دارد که فرآورده ها و مواد موثره دارویی توسط دیگر فرآورده ها یا مواد موثره، مواد شوینده، میکروارگانیسم ها و یا دیگر مواد، آلوده شوند، پس ما باید بتوانیم از آلودگی های احتمالی فرآورده جلوگیری نماییم.از این رو استفاده از فرآیند های شستشو اهمیت پیدا می کند و این فرآیند ب...

2014
Tomas Lang Sebastian Staufer Barbara Jennes Peter Gaengler

BACKGROUND Clinical validation of laboratory toothbrushing tests has important advantages. It was, therefore, the aim to demonstrate correlation of tooth cleaning efficiency of a new robot brushing simulation technique with clinical plaque removal. METHODS Clinical programme: 27 subjects received dental cleaning prior to 3-day-plaque-regrowth-interval. Plaque was stained, photographically doc...

2007
Stefan Brüggemann Thomas Aden

Data validation and cleaning are integral processes of the data qualitymanagement cycle. Domain specific knowledge is needed to detect and correct semantic errors. Ontologies can be used to represent valid and invalid attribute value combinations to detect and correct invalid data. We introduce reorganization operations formaintaining such an ontology in the data quality management cycle.

Journal: :International Journal of Pharmaceutical Chemistry and Analysis 2020

Journal: :Journal of Pharmaceutical Negative Results 2022

Cleaning validation is a process used by pharmaceutical manufacturers to ensure that their equipment and facilities are thoroughly cleaned free of any residual contaminants could potentially compromise the quality products. This guided regulatory guidelines set forth FDA European Medicines Agency (EMA) two examples such agencies.
 protocols typically required these guidelines, which outlin...

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