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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 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 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 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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(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 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 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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