User Requirement Specifications Consulting & Systems Integration

At Advanced Barrier Concepts, we provide consulting services for user requirement specifications to accurately define your requirements in order to improve system performance, establish transparent client and vendor expectations, minimize change orders, control costs, and maintain schedules. Additionally, we offer systems integration services, where we collaborate closely with clients and equipment manufacturers to carefully select, integrate, and validate the necessary equipment for aseptic processing and sterility testing isolation applications.

Decontamination skid servicing 3 TEMA hot cells

Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation & Operational Qualification (IQ/OQ)

Advanced Barrier Concepts provides factory acceptance testing (FAT), site acceptance testing (SAT), and installation and operational qualification (IQ/OQ). Factory acceptance testing ensures that systems will operate as intended in the field, facilitating installation, start-up, and validation. We assess total systems before they leave the factory floor to ensure that everything is functional upon arrival. This means that both mechanical and microbiological parameters are tested in advance of delivery.

Our site acceptance testing essentially redoes the factory acceptance testing once the system has been installed and assembled on site. Lastly, we will provide and execute the installation qualification and the operational qualification of the isolator system, and can address individual equipment validation issues and system-wide interface challenges as needed.

Cycle Development & Performance Qualification

We offer comprehensive services for cycle development and performance qualification. Our expertise allows us to develop a robust decontamination cycle that supports annual revalidation for qualified equipment. Additionally, we specialize in optimizing the decontamination cycle to meet specific process goals, tailoring it for maximum efficiency and effectiveness. With our dedicated focus on cycle development and performance qualification, we strive to deliver reliable and customized solutions that meet your unique requirements.

gloves hanging from a rack on the ceiling

Standard Operator Procedures (SOP) & Operator Training

Advanced Barrier Concepts offers standard operator procedures (SOP) development and operator training to assist clients with operating the equipment on their own. In-house procedures may need to be adapted to isolated equipment, and you may need guidance in writing new documents, and our standard operating procedure development helps clients do just that. We provide clients with very detailed documentation, leveraging our extensive experience and knowledge in the best industry practices.

Our operator training includes hands-on teaching to ensure that your operators are fully trained in utilizing the new technologies they will be working with on a daily basis.

BI Resistance Testing, Sterilant Intrusion & Residue Effects Testing (SIRE)

We offer biological indicator resistance testing and sterilant intrusion and reside effects testing (SIRE) for the sterility testing process. SIRE testing determines if hydrogen peroxide can penetrate into product containers and environmental monitoring supplies. These services include the generation of detailed test protocols

biological indicators being held in a spring

Annual Requalification

Lastly, Advanced Barrier Concepts offers annual requalification services to keep your system in compliance. We know how to set up and execute an annual requalification program to keep your system compliant while maximizing its efficiency, helping to keep you up and running. This is a service that we happily provide for our clients as the FDA will look for a minimum of an annual requalification of the decontamination cycle.