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Since 2018, the Ammonex20 and BTS systems have been internationally patented. They are designed to efficiently produce 13N Ammonia or Sodium Fluoride NAF.
These next-generation synthesizers are "Setup ready" and enable cardiologists to quickly supply Ammonia or Sodium Fluoride to emergency situations or unscheduled patients at any time.
By running a single QC test per day, multiple sub-batches of doses can be obtained from the same Lot.
The Ammonex20 is specifically designed for sites that require high production output of ammonia or sodium fluoride. With a "minute" one-time setup, this system allows for back-to-back production runs and significantly reduces the time needed between each run.
During active runs, a single-point container collects solids, liquid, and gas waste, ensuring a "cleaned and ready" setup. Additionally, the Ammonex20 system automatically ejects used cartridges to the waste container, which can hold up to 150 runs. The carousel, which holds 20 cartridges, can be reloaded or swapped in seconds for extended runs.
The system is equipped with 24 sensors that report to a log file for each run, providing detailed data on each production cycle.
The Batch Transfer System (BTS) allows for the easy transfer of pre-assembled vial/filters "shuttle" kits and helps dispense the final product in sterile vials or syringes, ensuring the highest level of product quality and safety.
The BTS system comes equipped with a built-in pressure pump that helps dispense the final product from the vial to a syringe, making the process efficient and reliable. Three shuttles are included in the final installation, ensuring a seamless production process.
For sites that require continuous production runs, an optional single tower is available, which can organize up to 10 kits in a small footprint, allowing back-to-back runs without the need to reopen the hot cells doors.
The Ammonex20 and BTS systems are designed for fast production with practically no exposure involved for the lab workers. The unique ergonomic design concept offers easy maintenance for quick response, ensuring minimal downtime and maximum productivity.
The Ammonex20 package includes a PC touch screen laptop and is ready to run right out of the box, making it an easy-to-use and efficient production solution for any lab setting.
The operating software of the Ammonex20 is a fully programmable platform that operates with a single button click, making it simple and user-friendly. It generates complete batch reports, including Cyclotron parameters, production items, sampling process, QC process, biological QC, sterility reports, device log reports, and trend reports, as well as vial, syringe, and shipping labels reports.
All reports are saved in folders with an automatic naming time-stamp concept, and an audit trail keeps track of newly created and edited files. There are four pre-programmed SOP-driven methods involved in the routine production of ammonia: Setup, QC Run, Run Product, and Wash Up.
The inventory control feature allows for the direct transfer of consumable data into the batch record. A QR code tracking label can be printed for any incoming inventory of approved or quarantine items.
To ensure data security, all batch reports can be encrypted and password-protected with a unique picture ID and electronic signature. Batch reports can also be exported in PDF format.
Filter integrity testing is automatically followed through the run method, and the Ammonex20 operating software follows CFR21 part 11 guidelines, ensuring compliance with regulatory standards
The Ammonex20 system includes all necessary SOP documentation templates to help expedite the filing process required by the FDA. These templates cover all aspects of the production process, ensuring that all necessary documentation is complete and accurate.
By including these templates as part of the Ammonex20 system, labs can save time and resources that would otherwise be spent on creating and organizing documentation. This streamlined approach helps to ensure compliance with FDA regulations while also improving overall efficiency and productivity.
Ammonex20 installation Brigham and Women's 2016
Nuclear Medicine Wisconsin university 2017
The advanced operating software of the Ammonex20 offers customers the advantage of a fully customizable platform with unlimited control flexibility.
With SOP-driven controls, the software helps to intuitively operate the fully automated process, making it user-friendly and efficient. At the end of each run, a comprehensive report is generated with minimal user input required.
This flexibility allows labs to tailor the Ammonex20 system to their specific needs, ensuring that it is optimized for their unique production requirements. The software's ease of use and customization options make it an ideal solution for labs looking to streamline their production process while also maintaining a high level of control and flexibility.
The Ammonex20 system's built-in inventory control feature allows for the easy tracking of all consumables, which are directly copied into the batch report.
The inventory control software can be password-protected and keeps track of historical items, providing a comprehensive overview of all items used during production.
Additionally, the system includes an editable built-in library of common items, which helps to efficiently populate the inventory database. This library saves time and ensures accuracy by eliminating the need to manually enter data for commonly used items.
Overall, the inventory control feature streamlines the production process and helps to ensure that all necessary items are on-hand when needed, reducing downtime and improving productivity.
All file reports generated by each Ammonex20 run are automatically classified into timestamp folders with meaningful names, ensuring easy and efficient organization. These files can be saved to the local PC hard drive, thumb drive, or SQL server for easy access and storage.
With each QC run, a single folder is created that allocates all sub-batches, ensuring traceability and efficient record-keeping. Each sub-batch report includes a unique QC ID tracking number, further enhancing traceability and simplifying the reporting process.
Overall, the Ammonex20 system's efficient file reporting and tracking features help to ensure accuracy and traceability throughout the production process, making it an ideal solution for labs looking to streamline their production and record-keeping processes.