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  • 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.
  • 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. (en)
Title
  • Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation
  • Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation (en)
skos:prefLabel
  • Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation
  • Dry-Swabbing/Image Analysis Technique for the Pharmaceutical Equipment Cleaning Validation (en)
skos:notation
  • RIV/60461373:22310/12:43894833!RIV13-MSM-22310___
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • S
http://linked.open...iv/cisloPeriodika
  • September
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 132250
http://linked.open...ai/riv/idVysledku
  • RIV/60461373:22310/12:43894833
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • Decontamination; Image analysis; Dry-swabbing; Cleaning validation (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • NL - Nizozemsko
http://linked.open...ontrolniKodProRIV
  • [02DD9F2F7CC0]
http://linked.open...i/riv/nazevZdroje
  • Procedia Engineering
http://linked.open...in/vavai/riv/obor
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http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 42
http://linked.open...iv/tvurceVysledku
  • Zámostný, Petr
  • Patera, Jan
  • Bělohlav, Zdeněk
  • Punčochová, Kateřina
  • Vltavský, Zdeněk
issn
  • 1877-7058
number of pages
http://bibframe.org/vocab/doi
  • 10.1016/j.proeng.2012.07.436
http://localhost/t...ganizacniJednotka
  • 22310
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