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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.
 
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.
 
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.
 
Industry Survey on Sterility Testing Isolators: Current Status and Trends by Carmen M. Wagner, Ph.D. and Jennifer Raynor, Pharmaceutical Engineering March/April 2001, pp. 134-140
 
This article presents the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey confirmed that sterility testing in isolators is now the "norm" vs. being a novelty. One key finding of the survey was that these systems have been predominantly placed in unclassified, although controlled access, areas.
 
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.
 
Practical Validation Strategies for Isolated Sterility Testing Labs - Part II (Presentation) by James R. Rickloff, MS June 13-14, 2002
 
The second part of the Workshop focused on the Performance Qualification studies that are needed to properly validate the gaseous decontamination method in sterility test isolator systems. Practical examples, a discussion of acceptance criteria, and the demonstration of test methods were included. Key learning objectives included determining a D-value for your BIs, developing and qualifying decontamination cycles, isolator aeration, sterilant ingress methods, and creating a meaningful process simulation (no false negative) study.
 
 

 

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