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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 James R. Rickloff, M.S. , Principal Scientist 12-Jan-01
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| It has been generally recognized for years that conventional aseptic processing has its drawbacks when compared to terminal sterilization of a sterile drug product and there is an FDA mandate to improve upon them. Isolation technology is one available means to help accomplish this. |
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(Presentation) by James R. Rickloff, MS October 29,2000
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| An overview of conventional aseptic processing is presented and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas. |
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by James R. Rickloff, M.S., Principal Scientist 28-Mar-01
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| The industry consensus on decontamination at the present time is to eliminate detectible levels of microorganisms on non-product contact surfaces within the isolator environment. This can be accomplished by treating a pre-cleaned and properly designed isolator with a sporicidal agent in a quantifiable and reproducible manner with contact points kept to a minimum during the decontamination cycle. |
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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 June 13-14, 2002
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| This workshop thoroughly reviewed the overall design process and equipment qualification methodology for isolator systems utilizing gaseous decontamination methods. Key learning objectives included determining your capacity requirements, developing a validation master plan, facility classification requirements, and qualifying your isolators and related process equipment. |
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(Presentation) by James R. Rickloff, MS 10-Mar-98
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| This presentation reviewed the microbial aspects of sterile isolator applications, which a project engineer should consider when the system design and validation requirements are being considered. |
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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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by James R. Rickloff, M.S., Principal Scientist 29-Mar-01
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| This paper reviews some typical sterilant ingress methods and discusses one approach on how to include a variety of test supplies into the study. |
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