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 (Presentation) by Richard L. Friedman, MS June 7, 2001
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| The highlights of this presentation by a leading FDA-CDER authority on aseptic processing isolator systems include basic design and validation approaches as well as feedback by FDA inspectors on various isolator applications during pre-approval inspections. |
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by Carmen M. Wagner, Ph.D. and Jennifer Raynor, Pharmaceutical Engineering March/April 2001, pp. 134-140
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| This article presents the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas. |
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by James R. Rickloff, MS, Principal Scientist 5-Mar-01
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| A second identical isolator can be shown equivalent to another through the use of a single test if all critical decontamination cycle parameters can be duplicated. |
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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 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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(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, 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
hydrogen peroxide gas. The microbiological test results on new line of agar plates containing a sterilant neutralizer were also shared with the
attendees. |
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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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