Mobile Isolators Drive Kentucky’s New Aseptic Facility

By Paul Thomas, Managing Editor Coldstream’s core project team has just completed final validation of the facility and is conducting media fills in anticipation of its first products. Just getting to this point is an achievement, especially given the regulatory risk of putting cytotoxic and non-cytotoxic drugs in the same room. Before it put a shovel in the ground, Kentucky contacted FDA and laid out its plans before proceeding. From then on, it has worked closely with the Agency’s Cincinnati office on each step of the project. FDA’s input has been invaluable, says Manella, especially in determining how the facility would be designed and processes validated. Once operational, it will be managed by a Quality Systems Group of five who will oversee QA, QC, document control and other validation and compliance efforts. For process validation, Kentucky will rely upon the practice of concurrent verification, essentially doing the testing necessary to prove the validity of a process and safety of the product with each batch. “Our customers only have enough API to do one batch,” says Manella. “The idea of validation is essentially impossible for a start-up company.” A client may only want 5,000 vials, for example. Once it’s been manufacturered, the site will do a media fill and other testing to ensure sterility, and include everything in detailed batch records — often up to an inch thick, Manella notes. Customers get the high degree of assurance that they expect, and can use the information to simplify validation efforts as they scale up. There are plenty of other issues that the CPST continues to address as it ramps up for production. Training is one. It’s no easy feat getting operators up to speed on such specialized equipment and processes. The plan, says Gilbert, is to do a trial run on a non-sterile