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 (Presentation) by James R. Rickloff, MS Oct. 16-17, 2000
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| This presentation discussed the similarities and differences of the current chemical germicides used for isolator decontamination in the pharmaceutical industry with emphasis placed on validation issues and safety considerations. |
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by James R. Rickloff, M.S., Journal of Validation Technology,pp. 61-71 November 1998
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| The purpose of this paper was to revisit some essential validation aspects of sanitizing isolators with H202 gas in order to assist the industry in demonstrating reproducibility of the process under worst-case conditions. |
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(Presentation) by Les Edwards, MSE 14-Apr-01
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| Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission. |
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(Presentation) by James R. Rickloff, MS June 13-14, 2002
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| The second part of the Workshop focused on the Performance Qualification studies that are needed to properly validate the gaseous decontamination method in sterility test isolator systems. Practical examples, a discussion of acceptance criteria, and the demonstration of test methods were included. Key learning objectives included determining a D-value for your BIs, developing and qualifying decontamination cycles, isolator aeration, sterilant ingress methods, and creating a meaningful process simulation (no false negative) study. |
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by James R. Rickloff, M.S., and Paula Orelski, American Sterilizer Company, Erie, PA, Proceedings of the 89th Annual Meeting of the American Society for Microbiology 1989
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| A great deal of information is available in the literature on the relative resistance of microorganisms to aqueous hydrogen peroxide (H202); however, the same cannot be said for H202 in the gaseous state. Bacillus stearothermophilus spores were found to be the most resistant to the sterilant and the presence of organic soil did not affect the ability of H202 gas to sterilize stainless surfaces. |
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by James R. Rickloff, M.S. Advanced Barrier Concepts, Inc. Cary, North Carolina and Donald L. Eddington, Ph.D. AMSCO International, Inc., Proceedings of the PDA/ISPE Advanced Barrier Technology Conference 1995
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Testing was performed on a prototype vial filler isolator at TL Systems Corp. in Minneapolis, MN to determine the feasibility of incorporating hydrogen peroxide gas sterilization into the system. Carrier sterilization, isolator aeration, and water fill residual data were presented.
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by James R. Rickloff, Joseph P. Dalmasso, Ph.D., and Lisa W. Lyhte, American Sterilizer Company, Apex , North Carolina, Proceedings of the PDA Annual Meeting 1992
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| The importance of performing temperature distribution studies, the use of chemical and biological indicators in optimizing and verifying proper gas distribution, a technique to easily perform square-wave D-value determinations, and a means to quantitatively monitor aeration efficiency when using a prototype VHP1000 was reviewed. |
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(Presentation) by Les Edwards, MSE October 3, 2002
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| This presentation provides an overview on the decontamination cycle and regulatory expectations for the process. Past flexible wall data and its' implications are reviewed and how new trends in validation techniques are implemented to reduce them. The benefits of rigid wall isolator construction are also discussed. |
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by Juergen Horn, Ph.D. September 2002
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| This paper compares gamma-irradiation sterilized, modified DE Agar with standard non-irradiated D/E-Agar for recovery of organisms and capacity for neutralizing disinfecting agents. The neutralizing capacity was tested using 4 microorganisms (gram positive coccos, gram positive rod) with a wide range of disinfecting agents neutralized by D/E-Agar including aldehydes, phenol, quaternary agents, chlorine compounds, and hydrogen peroxide. The radiation-sterilized medium neutralized each disinfectant as well as the non-irradiated medium and fertility was equal or better on radiation sterilized DE Agar compared with standard D/E-Agar. |
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(Presentation) by Les Edwards, MSE July 2-3, 2003
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| This session discusses approaches to environment monitoring in isolator systems,including comparisons to conventional cleanroom aseptic process monitoring, measurement methods, alert and action limits, regulatory expectations, and related validation requirements. |
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