Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60461373%3A22310%2F12%3A43894833" target="_blank" >RIV/60461373:22310/12:43894833 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.sciencedirect.com/science/article/pii/S1877705812028366" target="_blank" >http://www.sciencedirect.com/science/article/pii/S1877705812028366</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.proeng.2012.07.436" target="_blank" >10.1016/j.proeng.2012.07.436</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation

Popis výsledku v původním jazyce

This paper presents the development of a new technique using the dry-swabbing method for monitoring the contamination of pharmaceutical equipment. Black polyester wipes were used to improve the detection limit of the visual inspection. A standardized method of producing model impurity was used to produce known contamination of the model surface by a variety of compounds ranging from 0 to 500 mýg.dm-2. The sample contaminations were dry swabbed and evaluated by measuring the intensity of contamination using the computer image analysis. The detected intensities of contamination were always proportional to the amount of the impurity applied. The dry-swabbing method has been proven to be at least by one order of magnitude more sensitive than mere visual check.

Název v anglickém jazyce

Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation

Popis výsledku anglicky

This paper presents the development of a new technique using the dry-swabbing method for monitoring the contamination of pharmaceutical equipment. Black polyester wipes were used to improve the detection limit of the visual inspection. A standardized method of producing model impurity was used to produce known contamination of the model surface by a variety of compounds ranging from 0 to 500 mýg.dm-2. The sample contaminations were dry swabbed and evaluated by measuring the intensity of contamination using the computer image analysis. The detected intensities of contamination were always proportional to the amount of the impurity applied. The dry-swabbing method has been proven to be at least by one order of magnitude more sensitive than mere visual check.

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

CI - Průmyslová chemie a chemické inženýrství

OECD FORD obor

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Projekt

—

Návaznosti

S - Specificky vyzkum na vysokych skolach

Rok uplatnění

2012

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Procedia Engineering

ISSN

1877-7058

e-ISSN

—

Svazek periodika

42

Číslo periodika v rámci svazku

September

Stát vydavatele periodika

NL - Nizozemsko

Počet stran výsledku

7

Strana od-do

447-453

Kód UT WoS článku

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EID výsledku v databázi Scopus

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