Overview

User Requirement Specifications Consulting & Systems Integration


Accurately define your requirements to set clear client and vendor expectations.

Projects

What We Did for Our Clients

Amgen

Amgen is a biopharmaceutical company headquartered in Thousand Oaks, California. We provided them with a variety of services at their headquarters, as well as at their Rhode Island and Puerto Rico locations. This included:

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  • Validation master plan and User Requirements Specifications development
  • H2O2 Generator User Requirements Specifications development
  • Process equipment and isolator User Requirements Specifications development

SOFIE

SOFIE Biosciences is a healthcare solutions company that serves customers around the world. We provided systems integration services for them at their Totowa, New Jersey location, helping with the design of a hydrogen peroxide decontamination system:

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  • Participated in the design with Decontamination Specialty Equipment (DSE) of a hydrogen peroxide decontamination system that serviced four TEMA hot cells

University of Iowa Pharma. (UIP)

The University of Iowa Pharmaceuticals is a contract development and manufacturing organization that helps clinical and commercial clients in the pharmaceutical industry. We provided them with systems integration services in setting up their hydrogen peroxide vapor decontamination system:

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  • Design, construct, and qualify a fully automated manifold design for the hydrogen peroxide vapor decontamination of a 10-isolator aseptic processing system

User Requirement Specifications Consulting

Advanced Barrier Concepts, Inc. offers user requirement specifications (URS) consulting services, assisting organizations in defining and documenting specific user requirements for isolation and sterilization equipment. Our decades of experience and expertise give us a thorough understanding of how to collaborate with our clients to understand their unique challenges and objectives. We will help you accurately define your requirements in order to improve system performance, set clear client and vendor expectations, minimize change orders, control cost, and maintain schedule.

Systems Integration

We also offer systems integration services to meet the unique needs of our clients. We work closely with our clients and equipment manufacturers to help them select, integrate, and validate the equipment required to support aseptic processing and sterility testing isolation applications.
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