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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.
 
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.
 
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.
 
Facility Design Considerations for Sterility Testing Isolators (Presentation) by Les Edwards, MSE May 15-16, 2000
 
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.
 
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.
 
Isolated Sterility Testing System Lancaster Labs, Lancaster, PA (Presentation) by Les Edwards, MSE 14-Apr-01
 
Media fill and environmental qualification data is reviewed for an isolated filling line approximately two months prior to license application submission.
 
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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