Overview
Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation & Operational Qualification (IQ/OQ)
Assure that all systems will operate as intended in the field, and ensure that all equipment is properly installed and qualified on-site.
Projects
What We Did for Our Clients
Merck
Merck is a pharmaceutical company specializing in the development of innovative healthcare solutions, including prescription medications, vaccines, and other consumer health products. We provided them with factory acceptance testing, and installation and operational qualification services at their Elkton, VA and West Point, PA locations in the United States, as well as internationally at their location in France:
- Factory Acceptance Testing and IQ/OQ protocol development and execution of an isolated (Despatch Industries isolator system integrated with a Peroxide Plus sterilization process) high speed TL filling system that consisted of a vial washer, depyrogenation tunnel, filler, stoppering and capping systems. NOTE: This was one of the initial isolated aseptic filling line installations (1997) in the USA.
- Factory Acceptance Test for three rigid wall filling line isolators at la Calhène (France) and IMA (Italy). IQ/OQ protocol development and execution at the Merck Sharpe & Dohme’s (MSD) France facility. NOTE: This was la Calhene’s first production isolator system.
- IQ/OQ protocol development and execution for MSD’s second isolated filling line consisting of filling/lyophilization/capping isolator system, two support transfer isolator systems, a sterility test isolator system, and the twelve STERIS H2O2 generators.
MilliporeSigma
MillporeSigma is a company in the life sciences space that offers a range of products and services for research and pharmaceutical manufacturing. We provided them with installation and operational qualification services at their Kankakee, IL and Rockville, MD locations:
- IOQ protocol generation and execution for a loader, buffer, and filler isolator and a STERIS H2O2 generator.
Samsung Biotech
Samsung Biotech is a company that develops and manufactures innovative biopharmaceutical products and solutions. We provided them with installation and operational qualification services at their Incheon, Korea location. These services included:
- IQ/OQ protocol development and execution for a STERIS H2O2 Biodecontamination system integrated with Comecer rigid wall 4-glove isolator with an airlock.
Factory Acceptance Testing (FAT)
Advanced Barrier Concepts offers factory acceptance testing (FAT) services. Factory acceptance testing plays a crucial role in ensuring the proper functioning of a system in the field, thereby facilitating installation, start-up, and validation. This testing covers all aspects of the system, meaning it tests both mechanical and microbiological parameters. Testing is done before the system leaves the factory floor, ensuring that every component is fully functional upon arrival. Our factory acceptance testing guarantees that your system will be ready to perform as intended, allowing for a smooth transition from installation to operation.
Site Acceptance Testing (SAT)
We also provide site acceptance testing, which essentially involves reperforming the factory acceptance testing once the system has been assembled and installed on-site. This meticulous testing process ensures that the system operates as intended in its actual installation environment. By conducting site acceptance testing, we verify that all components and functionalities of the system are functioning optimally and meet all specified requirements.
Installation & Operational Qualification (IQ/OQ)
Advanced Barrier Concepts will take care of the installation qualification (IO) and operational qualification (OQ) of your isolator system. Our experienced team will provide and execute these qualifications to ensure that your system is properly installed and functions as intended. We are also equipped to address any individual equipment validation issues that may arise during the qualification process, as well as any system-wide interface challenges. With our comprehensive approach, you can trust us to validate your isolator system that meets all of your specific requirements.
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