The chemical precursors are no less critical than O-18 water in determining the yield and quality of FDG. Rotem’s production of Mannose Triflate, Cryptand 222 (Kryptofix) and full reagent kits is designed to ensure the highest quality and batch-to-batch uniformity available, allowing users to derive the maximum from their own synthesis operations.
The production takes place in Rotem’s state-of-the art facilities at Rotem Industrial Park and with dispensing a Class 7 (10,000) clean room under Class 5 (100) conditions. The highly qualified production staff is specially trained for organic synthesis under cGMP Q7A standards.
Mannose triflate and kryptofix are supplied in a range of vial sizes, from 1000 mg for user dispensing, down to quantities ca. 15 mg for dose use. Both crimp and screw-top vials are available, with color-coded caps and/or labels according to customer preference, to assist in quick differentiation among materials.
Full reagent kits for all the commercial synthesis modules are also supplied, with close attention paid to the quality of the inactive ingredients as well.
All chemical precursors are doubly packaged in a closed plastic tray within a compact carton box. This allows for acceptable introduction of the materials into clean rooms, where the carton is discarded in the transfer area and the plastic tray disinfected according to local standards.
FDG Precursor Quality Information
The entire production process takes place in Rotem’s facilities at Rotem Industrial Park. Dispensing is performed under Class 5 conditions in Class 7 clean rooms. The clean rooms are regularly tested for presence of particles and sterility and found to meet the requirements for production of active pharmaceutical ingredients.
The production staff is specially trained for organic synthesis with an emphasis on adherence to work instructions, maintenance of the aseptic atmosphere and the utmost attention to issues of quality. The staff is concerned only with production of FDG precursors and does not engage in other duties for Rotem.
· All materials are supplied by approved suppliers. Technical specifications are clearly defined and materials are supplied with a certificate of conformance.
· Comprehensive in-process control is performed throughout the multiple production steps in order to ensure final product adhering to specifications.
· The entire production process is documented in a “batch record” coinciding with normal cGMP procedures. This record ensures full traceability of the materials used, process steps, personnel and testing results pertaining to the lot.
· Dispensing takes place in Class 7 (10,000) clean rooms. The clean rooms are regularly tested for presence of particles and sterility and found to meet the requirements for production of active pharmaceutical ingredients.
A Certificate of Analysis accompanies each shipment.
All production and quality records as well as samples from each lot are retained for a minimum of two years from product release.
Rotem Industries is committed to supplying high quality materials produced under tightly controlled conditions. Highest priority is placed on training of production staff and operation according to SOP’s. Comprehensive lot documentation, in-process controls and final product testing ensure the supply of uniform product adhering to defined specification.
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