Overview
Annual Requalification
Annual requalification services ensure that your system remains in compliance, keeping your business up and running.
Projects
What We Did for Our Clients
Amgen
Amgen is a biopharmaceutical company headquartered in Thousand Oaks, California. We provided them with a variety of services at their headquarters, as well as at their Rhode Island and Puerto Rico locations.
- Validation master plan and User Requirements Specifications development
- H2O2 Generator User Requirements Specifications development
- Process equipment and isolator User Requirements Specifications development
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.
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.
Annual Requalification
Advanced Barrier Concepts offers annual requalification services to ensure that your system remains in compliance. We will set up and execute an annual requalification program that keeps your system in line with regulatory requirements and maximizes its efficiency, helping to keep you up and running. The FDA recommends a minimum of an annual requalification of the decontamination cycle. For companies that do not have the necessary resources to perform annual requalification, we will happily provide this service for all of our clients.
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