In addition to a full array of traditional radiopharmaceutical products and preparations, Triad Isotopes, Inc. is proud to support the Positron Emission Tomography (PET) needs of hospitals and clinics within the communities we serve. Our dedicated team serves as your partner and trusted advisor for all your PET radiopharmaceutical needs.
In 2015, Triad Isotopes earned approval by the U.S. Food and Drug Administration (FDA) of our Abbreviated New Drug Applications (ANDA) for two PET radiopharmaceuticals: Sodium Fluoride F-18 Injection for Intravenous Use, which is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging bone to define areas of altered osteogenic activity (ISI for Sodium Fluoride); and Fludeoxyglucose F-18 Injection for Intravenous Use, which is indicated for PET imaging in Oncology, Cardiology and Neurology (ISI for FDG).
These approvals, which are the result of a rigorous and extensive review process, reflect our company's compliance to the highest standards of PET radiopharmaceutical manufacturing. Triad Isotopes' PET manufacturing facilities — located in Atlanta, GA; Macon, GA; and Mobile, AL — serve our PET customers' needs throughout the southeastern United States.
The PET manufacturing Quality System established at Triad Isotopes is designed to ensure that the PET radiopharmaceuticals we manufacture meet or exceed the standards established by 21 CFR Part 212.
Triad Isotopes' PET facilities perform drug manufacturing operations in controlled clean-room environments, which exceed current requirements for PET radiopharmaceutical manufacturers. Further, our clean rooms are routinely certified by an independent National Clean Room certification organization.
Team members with expertise in PET radiopharmaceutical manufacturing and compliance provide regulatory oversight of our programs. This ensures that our cGMP program not only meets the standards established by the FDA for PET manufacturing, but also anticipates changes in the regulatory environment to continuously update and improve our Quality System.
Triad Isotopes utilizes a state-of-the-art computerized batch record system that employs the latest technology to trace materials and components used in the drug manufacturing process. This electronic system ensures that all materials, components and quality control information used in the manufacture of your PET doses are compliant with cGMP requirements.
Triad Isotopes provides both live and on-demand Continuing Education opportunities to ensure that you and your staff stay current on the latest trends in the industry.
Our electronic pharmacy management system provides fast and easy dose tracking information, along with detailed reports that allow your department to track patient indications and referring physician information.
Triad Isotopes participates in several PET radiopharmaceutical clinical trials, demonstrating the strength of our program and our commitment to the on-going development of new PET radiopharmaceuticals and the use of PET In diagnostic imaging.
Carl Riley, III, R.Ph., BCNP
VP – PET Operations