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Sterile Process Development

Your project may range from a small-scale sterility test suite to a large-scale advanced aseptic processing facility. The pharmaceutical manufacturer and equipment vendors can add the experienced group of engineers and scientists at Advanced Barrier Concepts, Inc. to their project team. Together they can identify and resolve the myriad of issues related to development and integration of isolation technology into an advanced aseptic processing environment.

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System Design Review

Advanced Barrier Concepts, Inc. will thoroughly review and comment on system designs prior to construction and, if necessary, suggest changes or alternative new technologies to avoid unnecessary delays in the implementation or validation of the system or costly retrofits to fix an overlooked problem.

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Systems Integration

Advanced Barrier Concepts, Inc. will work closely with the client and equipment manufacturers to select, integrate and validate the equipment required to support specific aseptic processing and sterility testing applications.

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Validation Master Planning

The development of a good manufacturing system requires planning not just for the technical details of the engineering, but also from a regulatory perspective. A validation master plan, which is developed properly during the early phases of project planning, can provide a significant savings in time and resources and lead to faster facility licensing. Advanced Barrier Concepts, Inc. has the experience to integrate key design decisions and important validation strategic decisions into a comprehensive document relating the design rationale to the validation strategy. This seamless approach to validation takes the guesswork out of developing a realistic equipment and process validation schedule.

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Isolation and Barrier System Project Management Assistance

Advanced Barrier Concepts, Inc. can assist in the professional management of isolation and barrier related projects from start to finish. Acting as a customer advocate, we can coordinate complex vendor relationships and ensure that the right scientific, validation, and engineering questions get answered before the equipment arrives on plant site.

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Factory Acceptance Testing Services

Advanced Barrier Concepts, Inc. will test total systems (both mechanical and microbiological parameters) before they leave the factory floor to eliminate unpleasant surprises during start-up and validation. At the same time, equipment vendors entering this market for the first time will become educated on the principles of pharmaceutical processing, isolator system design, sterilization, and current or proposed good manufacturing practices. This will help them to serve their pharmaceutical clients more effectively on future projects.

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Validation Protocol Development, Review, and Execution

The development of good factory acceptance and validation protocols that focus on the critical elements of the system design will lead to a more cost effective implementation and subsequent regulatory approval of the system. Advanced Barrier Concepts, Inc. has the experience to effectively develop and execute protocols for the application of isolation and barrier systems to pharmaceutical manufacturing.

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150 Iowa Lane
Cary, NC  27511-4496
(919) 469-8876
(919) 469-4665 Fax

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