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At Advanced Barrier Concepts, we recognize that the critical assistance we provide will have a significant impact on the quality, performance, regulatory and economic outcomes of your specific project. The case studies presented are the tip of the iceberg of our knowledge, experience and capabilities. Yet they offer an excellent starting point for discussions about how we can help answer your precise needs.
 
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Isolated Sterility Testing Facility for a Contract Laboratory

The isolator system at Lancaster Labs is used as a contract sterility testing facility in Lancaster, Pennsylvania (USA). It features two transfer isolators and one dual, half-suit workstation isolator. Advanced Barrier Concepts, Inc. provided consultation and assistance with initial room specification and design, as well as validation, start-up, operator training, and SOP development.


 
 
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Isolated Vial Filling Facility for a Vaccine Manufacturer

The isolated filling system at Aventis Pasteur is used for high-speed vial filling. Advanced Barrier Concepts, Inc. initially performed validation testing on the VHP surface sterilization cycle and UV transfer tunnel. Later, we joined the core project team to complete environmental qualification testing, media fills, and to spearhead the FDA-CBER license application process. The facility is located in Swiftwater, Pennsylvania (USA).


 
 
 
 
 

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