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 (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Jan. 27-28, 2000
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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 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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(Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Oct. 16-17, 2000
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| The regulatory process for the CBER licensing of an isolated filling line is discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter. |
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(Presentation) by Jeongim Park, Marcia Plese, and Mark Puskar June 2-7, 2001
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(Presentation) by Les Edwards, MSE June 13-14, 2001
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This section discussed the environmental qualification data and established action/alert limits for a vaccine filling system housed within an isolator. A comparison is made to conventional clean room monitoring techniques and limits.
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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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(Presentation) by Les Edwards, MSE January 24-25, 2002
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| An overview of the key aspects of validating a production isolator system is reviewed with an emphasis on relating design documentation to validation plans and protocols. |
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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 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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