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Simulated Media Challenge and Environmental Qualification of an Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Jan. 27-28, 2000
 
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission./td>
 
Qualification and Regulatory Issues for a CBER Licensed Isolated Filling Line (Presentation) by Mark W. Diehl, PE and Les Edwards, MSE Oct. 16-17, 2000
 
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>
 
Environmental Qualification and Monitoring within an Isolated Vaccine Filling Line (Presentation) by Les Edwards, MSE June 13-14, 2001
 
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.
 
Implementing the Key Elements of Validating a Production Isolator System (Presentation) by Les Edwards, MSE January 24-25, 2002
 
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.
 
The Effect of VHP® on Testing Devices & Culture Media Used in Sterility Test Isolators (Presentation) by Michelle Stafford October, 2 2001
 
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.
 
Microbiological Monitoring in Isolators (Presentation) by James R. Rickloff, M.S. September 18, 2002
 
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.
 
Performance Comparison of Biotest Sterile Gamma-Irradiated Contact Slides DE-Gamma with Non-Irradiated D/E-Agar by Juergen Horn, Ph.D. September 2002
 
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.
 
Comparative Air Sampling in Isolators Using RCS-Highflow with TCI-gamma Against M-Air Tester With Antiperoxide Cassettes and the MD8 Air Scan With Gelatine Filters by Juergen Horn, Ph.D. December 2002
 
This poster session compares the hydrogen peroxide neutralization capacity of several viable airborne monitoring methods that are currently used in isolator systems.
 
Principles of Microbiological Monitoring in Isolators (Presentation) by Les Edwards, MSE July 2-3, 2003
 
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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