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Aseptic Processing Isolators (Presentation) by Richard L. Friedman, MS June 7, 2001
 
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.
 
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.
 
Practical Validation Strategies for Isolated Sterility Testing Labs - Part I (Presentation) by Les Edwards, MSE June 13-14, 2002
 
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.
 
Isolator Microbiology Issues of Interest to the Project Engineer (Presentation) by James R. Rickloff, MS 10-Mar-98
 
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.
 
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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