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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.
A personal Monitor Employing an Electrochemical Sensor for Assessing Exposure to H2O2 (Presentation) by Jeongim Park, Marcia Plese, and Mark Puskar June 2-7, 2001
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.
Fundamental Principles of Isolator Decontamination by James R. Rickloff, M.S., Principal Scientist 28-Mar-01
The industry consensus on decontamination at the present time is to eliminate detectible levels of microorganisms on non-product contact surfaces within the isolator environment. This can be accomplished by treating a pre-cleaned and properly designed isolator with a sporicidal agent in a quantifiable and reproducible manner with contact points kept to a minimum during the decontamination cycle.
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.





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