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Presentations
 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.
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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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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