By Paul Thomas, Managing Editor Coldstreams 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 Agencys Cincinnati office on each step of the project. FDAs 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 its 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. Its 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
Products & Services
Biotechnology and Pharmaceutical Manufacturing Services
Biotechnology and pharmaceutical manufacturing services active pharmaceutical ingredients, sterilize biomedical components or materials, validate processes or packaging, and formulate drug or medicinal preparations on a contract basis.
Biological materials are biocompatible materials, natural or man-made, that comprise a whole or a part of a living structure or biomedical device that performs, augments, or replaces a natural function
Dust collectors are used in many processes to either recover valuable granular solid or powder from process streams or to remove granular solid pollutants from exhaust gases prior to venting to the atmosphere.
Gate valves and knife valves are linear motion valves in which a flat closure element slides into the media stream to shut off flow.
Pipe fittings cover many components that connect pipe ends for in-line, offset, multi-port, and mounting configurations.
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By Paul Thomas, Managing Editor Whats on drawings is never what ends up on the equipment, says Gilbert. You cant be off even an eighth of an inch. Much to his...
By Paul Thomas, Managing Editor In the summer of 2004, six men met at a Princeton, N.J. hotel to brainstorm a new aseptic filling facility for the University of Kentuckys Center for...
This quick, one-time registration gives you access to members-only site benefits. No doubt the inherent risk and complexity of vaccine manufacturing also led to some of the issues at the facility.
This quick, one-time registration gives you access to members-only site benefits. Another thing that comes into play is the preference of the maintenance people on site, notes Jarvis.
This quick, one-time registration gives you access to members-only site benefits. Those same benefits could make ELNs extremely attractive for manufacturing, especially considering the amount of time...