Advanced Barrier Concepts: Scientific & Technical Services
Offering barrier isolation, support for aseptic processing and sterility testing, and sterilization system technologies for the pharmaceutical, biotechnology, and medical device industries.
About Advanced Barrier Concepts, Inc.
Leader in the application of isolation technology to advanced aseptic processing and sterility test equipment since 1994.
User Requirement Specifications Consulting & Systems Integration
Advanced Barrier Concepts offers user requirement specifications consulting services in order to accurately define your requirements to improve system performance, set clear client and vendor expectations, minimize change orders, control cost, and maintain schedule. We also provide systems integration, in which we work closely with our clients and equipment manufacturers to select, integrate, and validate the equipment required to support aseptic processing and sterility testing isolation applications.Learn More
Factory & Site Acceptance Testing, Installation & Operational Qualification
Factory acceptance testing assures that the system will operate as intended in the field, thereby facilitating installation, start-up, and validation. Our factory acceptance testing tests total systems, meaning both mechanical and microbiological parameters, before they leave the factory floor to ensure that everything is functional upon arrival. We also offer site acceptance testing, essentially redoing the factory acceptance testing once the system has been assembled on site. Finally, we will provide and execute the installation qualification and the operational qualification of the isolator system. We can address individual equipment validation issues as well as system-wide interface challenges.Learn More
Cycle Development & Performance Qualification
Advanced Barrier Concepts offers cycle development and performance qualification services. We will provide a robust documentation cycle, or optimize the decontamination cycle of the qualified equipment in order to provide the most efficient turnaround times or the decontamination cycle can be tuned to achieve certain process specific goals.Learn More
Standard Operator Procedures (SOP) & Operator Training
In-house procedures may need to be adapted to isolated equipment. Additionally, you may need guidance in writing new documents. We offer standard operating procedure development, helping clients generate documents so that they can properly operate the equipment on their own. Advanced Barrier Concepts provides very detailed documentation, leaning on our broad range of experience in the best industry practices. We also offer operator training, providing proper documentation and hands-on teaching to ensure that your operators are thoroughly trained in the new technologies that they will be working with daily.Learn More
BI Resistance Testing, Sterilant Intrusion & Residue Effects Testing (SIRE)
Advanced Barrier Concepts offers biological indicator resistance testing for Geobacillus stearothermophilus spores, as well as sterilant intrusion and residue effects testing for the sterility testing process. We provide sterilant intrusion and residue effects (SIRE) protocol generation and execution to determine if hydrogen peroxide can penetrate into product containers and environmental monitoring supplies at levels that could lead to false negatives.Learn More
We know how to set up and execute an annual requalification program to keep your system in compliance while maximizing efficiency to keep you up and running. In general, the FDA will look for a minimum of an annual requalification of the decontamination cycle, so this is a service we happily provide for our clients.Learn More