Cycle Development & Performance Qualification
Enhancing cycle development and performance qualification for optimal efficiency.
What We Did for Our Clients
Eyenovia
Eyenovia is a pharmaceutical company specializing in the development of innovative ophthalmic products and medications for various eye conditions. We provided them with cycle development and performance qualification services at their Redwood, CA location for their 4-glove production isolator.
Read More about this projectGenentech
Genentech is a leader in the biotechnology industry, pioneering the development of groundbreaking therapies for a variety of medical needs in the oncology, immunology, and neuroscience spaces. We provided them with cycle development and performance qualification services at their Hillsboro, OR location. Services included CD/PQ protocol development and execution for the two SKAN ARIS sterility testing isolator systems and two SKAN aseptic processing isolator systems.
Read More about this projectLantheus
Lantheus is a healthcare company that specializes in the field of medical imaging, and develops and provides innovative diagnostic imaging products. We provided them with cycle development and performance qualification services for two TEMA hot cell chambers at their Somerset, NJ location.
Read More about this projectCycle Development & Performance Qualification
Advanced Barrier Concepts provides its clients with cycle development and performance qualification services. Leveraging our extensive experience and expertise, we provide a robust decontamination cycle that supports annual revalidation, or optimize the decontamination cycle of the qualified equipment in order to provide the most efficient turnaround times. Alternatively, the decontamination cycle can be tuned to achieve certain process specific goals, tailoring it to your unique requirements.
Biological indicators for the decontamination process are located at representative locations to ensure that all exposed surfaces of the isolator and its contents (production or sterility testing) have been decontaminated. One, two, or three biological indicators can be located at each challenge site.
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