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.
What We Did for Our Clients
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:Read More about this project
- 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.
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:Read More about this project
- IOQ protocol generation and execution for a loader, buffer, and filler isolator and a STERIS H2O2 generator.
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:Read More about this project
- 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)
Site Acceptance Testing (SAT)
Installation & Operational Qualification (IQ/OQ)
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