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 (Presentation) by Les Edwards, MSE May 15-16, 2000
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| Examples of sterility testing suites are discussed, highlighting the design of the Lancaster Laboratories contract sterilty test system, including the sterilant manifold and exhaust systems. |
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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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(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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(Presentation) by Carmen M. Wagner, Ph.D. September 2000
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| This presentation given by Dr. Carmen Wagner reviewed the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey, coordinated with the assistance of Ms. Jennifer Raynor of Serentec, 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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(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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(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 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 James R. Rickloff, M.S. September 18, 2002
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| This presentation reviews the principles of microbial monitoring in isolators, current US and European regulatory requirements for monitoring, and the means to achieve and maintain a germ free environment. The current means to monitor the air and surfaces in isolators is also touched upon. |
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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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