Use of Biological Indicators Designed for Steam or Ethylene Oxide to Monitor a Liquid Chemical Sterilization Process

1993 ◽  
Vol 14 (6) ◽  
pp. 313-319 ◽  
Author(s):  
Raymond C. Kralovic
1993 ◽  
Vol 14 (6) ◽  
pp. 313-319 ◽  
Author(s):  
Raymond C. Kralovic

AbstractObjective:To determine the ability of a commercially available biological indicator (BI), used to monitor steam and ethylene oxide sterilization, to biologically monitor a liquid sterilization process consisting of a sterile processor, a proprietary peracetic acid sterilant, and a sterile rinse system.Design:Analysis of spore survival in BIs tested in STERIS SYSTEM 1™ liquid chemical sterilization processor and in vitro.Setting:STERIS Corp. research laboratory.Methods:In vitro tests were performed in the STERIS SYSTEM 1 Processor using 12-minute and 6-minute sterilant exposure cycles. D values (time to inactivate one log of spores), spore washoff and outgrowth time, and inhibitory effects of the sterilant were determined.Results:Sterilization of the spore-inoculated filter paper strips in the BIs was ascertained in both processor testing and in vitro tests using conditions identical to those in the processor. The extensive washing and dilution during the processor cycle resulted in only 0.2% and 1.8% removal of the spores from Bacillus stearother-mophilus and Bacillus subtilis inoculated spore strips, respectively.Carryover of the diluted sterilant to the culture medium did not inhibit the outgrowth of the spores, and D values could be obtained. B Stearothermophilus was two to three times more resistant to the sterilant than B subtilis. However, either spore meets the performance specifications applicable to BIs for monitoring sterilization processes.Conclusions:The data demonstrate that the commercial Bis evaluated are reproducible and verifiable indicators of the liquid chemical sterilization process. The same kind of performance specifications for producing BIs used to monitor steam or ethylene oxide systems also apply to the evaluated liquid chemical sterilization system.


1993 ◽  
Vol 14 (10) ◽  
pp. 563-566 ◽  
Author(s):  
Paul S. Malchesky ◽  
Walter W. Bond ◽  
Michael D. Decker

1993 ◽  
Vol 12 (6) ◽  
pp. 399-402
Author(s):  
Christopher A. Demitrius ◽  
Anthony P. Duran ◽  
Virginia C. Chamberlain ◽  
Victoria M. Hitchins

2022 ◽  
Vol 23 (1) ◽  
pp. 282-293
Author(s):  
Maryam Poostchi ◽  
Hamed Bagheri

The use of phthalates as a plasticizer in plasticized polyvinyl chloride (PVC) always poses the threat of migration of phthalates into the environment through medical equipment. Phthalates can be used with natural-based plasticizers, such as Epoxidized soybean oil (ESBO) known as phthalate’s scavenger and PVC stabilizers. PVC formulations were characterized by different combinations of di (2-ethylhexyl) phthalate (DEHP) 30-40% with 5% ESBO. PVC flexibility increased significantly in the presence of ESBO, without a change in strength (tensile test). The decrease of the Tg temperature by adding ESBO in Differential Scanning Calorimetry indicated that ESBO preserved DEHP in the polymer. Also, it was shown that the sterilization process with Ethylene Oxide, similar to ESBO, decreased the Tg of polymer. DEHP migration was evaluated at a maximum level to the environment using the Gas Chromatography test. Samples containing ESBO showed less hemolysis. ABSTRAK: Penggunaan phthalates sebagai plasticizer dalam plastik polyvinyl chloride (PVC) selalu menimbulkan ancaman penghijrahan phthalates ke alam sekitar melalui peralatan perubatan. Phthalates boleh digunakan dengan plasticizer berasaskan semula jadi, seperti minyak kacang soya Epoxidized (ESBO) yang dikenali sebagai pemulung phthalate dan penstabil PVC. Formulasi PVC dicirikan oleh kombinasi yang berbeza di (2-ethylhexyl) phthalate (DEHP) 30-40% dengan 5% ESBO. Fleksibiliti PVC meningkat dengan ketara di hadapan ESBO, tanpa perubahan kekuatan (ujian tegangan). Penurunan suhu Tg dengan menambahkan ESBO dalam Calorimetri Pengimbasan Berbeza menunjukkan bahawa ESBO mengekalkan DEHP dalam polimer. Juga, ditunjukkan bahawa proses pensterilan dengan Etilena Oksida, serupa dengan ESBO, menurunkan Tg polimer. Penghijrahan DEHP dinilai pada tahap maksimum ke lingkungan menggunakan uji Kromatografi Gas. Sampel yang mengandungi ESBO menunjukkan kurang hemolisis. 


ASAIO Journal ◽  
1995 ◽  
Vol 41 (2) ◽  
pp. 151-154 ◽  
Author(s):  
C. G. Wallace ◽  
P. M. Agee ◽  
D. D. Demicco

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