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Principles of Microbiological Monitoring in Isolators
Barnett International Environmental Monitoring Conference, Brussels, Belgium, 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.
 

Implementing Validation Strategies for Isolator-Based Systems
Barnett International's 4th Annual Isolator Conference, Januray 27-28, 2003

This workshop thoroughly reviewed the overall strategies and basic validation methodologies for isolator system validation utilizing gaseous decontamination methods. Facility design and qualification, equipment qualification, performance qualification, and process simulation testing was reviewed, with practical examples and demonstrations of key methods and techniques.
 
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H2O2 Gas Decontamination Cycle Comparisons Between Rigid and Flexible Wall Isolators
la Calhene AUDITS 101 Conference, October 3-4, 2002

This presentation provides an overview on the decontamination cycle and regulatory expectations for the process. Past flexible wall data and its' implications are reviewed and how new trends in validation techniques are implemented to reduce them. The benefits of rigid wall isolator construction are also discussed.
 
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Microbiological Monitoring in Isolators
bioMerieux Industrial Microbiology Seminar, 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.
 
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Practical Validation Strategies for Isolated Sterility Testing Labs - Part I
Barnett Isolator Conference, 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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Practical Validation Strategies for Isolated Sterility Testing Labs - Part II
Barnett Isolator Conference, 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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Implementing the Key Elements of Validating a Production Isolator System
Barnett Isolator Conference, 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 general regulatory steps in obtaining a license for a biologic product filling facility upgrade are outlined, then some details of the validation methods for equipment and sanitization system qualification are reviewed. Finally, a case study of a filling line project is presented, showing the initial approach followed by a project restructuring and successful regulatory feedback and ultimate licensure.
 
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The effect of VHP® on Testing Devices & Culture Media Used in Sterility Test Isolators
PDA SE Chapter Isolator Interest Group Meeting, October 2, 2001.

This presentation reviewed the physical and microbiological testing performed by Millipore on Steritest canisters following their exposure to hydrogen peroxide gas. The microbiological test results on a new line of agar plates containing a sterilant neutralizer were also shared with the attendees.
 
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Case Study: Environmental Qualification and Monitoring within an Isolated Vaccine Filling Line
Barnett Environmental Monitoring Conference, June 13-14, 2001

This session 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.
 
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A Personal Monitor Employing an Electrochemical Sensor for Assessing Exposure to H2O2
American Industrial Hygiene Conference, June 2-7, 2001

A Dräger Pac III hand-held sensor was evaluated in terms of accuracy, response time, and interferences to determine if it could be used in place of OSHA's impinger method for personal monitoring.
 
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Aseptic Processing Isolators
ISPE Barrier Technology Forum, 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.
 
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Current Trends in Controlled Environments
AAPS Annual Meeting, October 29, 2000.

An overview of conventional aseptic processing was presented, and it addresses the key issues that corporate decision makers are faced with when implementing isolation technology, such as regulatory requirements and equipment validation focus areas.
 
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Qualification and Regulatory Issues for a CBER Licensed Isolated Filling Line
PDA Conference, October 16-17, 2000.

The regulatory process for the CBER licensing of an isolated filling line was discussed, including media fill data and FDA feedback from the pre-approval inspection (PAI) and FDA response letter.
 
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Isolator Sterilants: Common Issues and Differences
PDAConference, October 16-17, 2000.

This presentation discussed the similarities and differences of the current chemical germicides used for isolator decontamination in the pharmaceutical industry with emphasis placed on validation issues and safety considerations.
 
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Sterility Testing Isolators: Current Status and Trends
ISPE Zurich Conference, September 2000

This presentation given by Dr. Carmen Wagner reviewed the current results of an ongoing survey assessing the implementation status of sterility test isolator systems worldwide. The results from the survey, coordinated with the assistance of Ms. Jennifer Raynor of Serentec, 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.
 
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Current Trends and Concepts in Validating Sterility Testing Isolators
Serentec Workshop for Sterility Testing, May 25-26, 2000.

Past practices and current trends in validating sterility testing isolators were reviewed with an emphasis on productivity. Although the key validation criteria remain the same, i.e. no false negatives, improvements to the overall system design have permitted the optimization of the decontamination cycle.
 
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Facility Design Considerations for Sterility Testing Isolators
Barnett International Conference on Sterility Testing, May 15-16, 2000.

Examples of sterility testing suites were discussed, highlighting the design of the Lancaster Laboratories contract sterility test system, including the sterilant manifold and exhaust systems.
 
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Simulated Media Challenge and Environmental Qualification for an Isolated Filling Line
Barnett International Conference on Isolation Technology, January 27-28, 2000.

Media fill and environmental qualification data were reviewed for an isolated filling line approximately two months prior to license application submission.
 
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Isolator Microbiology Issues of Interest to the Project Engineer
ISPE Carolina Chapter Program on Barrier Isolation Systems, March 10, 1998.

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.
 
 
 
 

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