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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./td>
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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./td>
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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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(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 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 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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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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(Presentation) by Les Edwards, MSE July 2-3, 2003
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| This session discusses approaches to environment monitoring in isolator systems, including comparisons to conventional cleanroom aseptic process monitoring, measurement methods, alert and action limits, regulatory expectations, and related validation requirements. |
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