Effects of 100% ethylene oxide test gas on the resistance of ethylene oxide biological indicators

Effects of 100% ethylene oxide test gas on the resistance of ethylene oxide biological indicators

There have been previous changes to the EtO gas used for Bl testing. A previous version of an HCFC mixture, Oxyfume 2002, which consists of 10% EtO, 63% HCFC-124, and 27% HCFC-22, was eliminated by the Clean Air Act in December of 2009. At the time, many Bl manufacturers were using Oxyfume 2002 as t...

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Veröffentlicht in:Pharmaceutical technology Europe 2014-12, Vol.26 (12), p.40
Hauptverfasser: Krushefski, Garrett, Piotrkowski, Anthony M, Wallace, Craig A, Matzinger, Kellie A
Format: Artikel
Sprache:eng
Schlagworte:
Air cleanliness
Binding sites
Biological indicators
Environmental protection
Ethylene
Ethylene oxide
Federal regulation
Indicator organisms
Laboratories
Pharmaceutical industry
Pharmaceutical research
Tests
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Zusammenfassung:There have been previous changes to the EtO gas used for Bl testing. A previous version of an HCFC mixture, Oxyfume 2002, which consists of 10% EtO, 63% HCFC-124, and 27% HCFC-22, was eliminated by the Clean Air Act in December of 2009. At the time, many Bl manufacturers were using Oxyfume 2002 as the source gas in their resistometers when performing Bl EtO D-value resistance assessments.
ISSN:1753-7967