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 (Presentation) by James R. Rickloff, MS May 25-26, 2000
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| Past practices and current trends in validating sterility testing isolators was reviewed with an emphasis now being placed on productivity. Although, the key validation criteria remain the same, i.e. no false negatives, improvements to the overall system design have permitted the optimization of the decontamination cycle. |
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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 Michelle Stafford October, 2 2001
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| This presentation reviewed the physical and microbiological testing performed by Millipore on Steritest canisters following their exposure to hydorgen peroxide gas. The microbiological test results on new line of agar plates containing a sterilant neutralizer were also shared with the attendess. |
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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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(Presentation) by Leslie M. Edwards, MSE and James R. Rickloff, MS January 27-28, 2003
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| This presentation thoroughly reviewed the overall strategies and basic validation methodologies for isolator system validation utilizing gaseous decontamination methods. Facility design and qualification, equipment qualification, performance qualification, and process simulation testing was reviewed, with practical examples and demonstrations of key methods and techniques. |
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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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by Juergen Horn, Ph.D. December 2002
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| This poster session compares the hydrogen peroxide neutralization capacity of several viable airborne monitoring methods that are currently used in isolator systems. |
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