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Ammonex20 system
Ammonia N13 on demand
Since 2018, the Ammonex20 and BTS systems have been internationally patented to efficiently produce 13N Ammonia or Sodium Fluoride (NaF). These next-generation synthesizers are "setup ready," allowing labs to quickly supply cardiologists Ammonia or Sodium Fluoride for emergencies or unscheduled patients at any time. With just one daily QC test, multiple sub-batches of doses can be produced from a single lot.
Hardware
The Ammonex20 is optimized for high-output production of ammonia or sodium fluoride, with a swift one-time setup that supports continuous, back-to-back runs with minimal downtime. During each run, a single waste container collects solid, liquid, and gas waste, ensuring the system remains “cleaned and ready.” The Ammonex20 uses FDA-compliant single-use Waters ion exchange CM cartridges, which are automatically ejected after each use into a waste container with a capacity for up to 150 runs. A 20-cartridge carousel enables quick reloading or swapping to facilitate extended production runs.
Outfitted with 24 sensors, the Ammonex20 logs comprehensive data for each production cycle, providing valuable real-time insights. The Batch Transfer System (BTS) streamlines the transfer of pre-assembled vial/filter “shuttle” kits and dispenses the final product in sterile vials or syringes, ensuring the highest product quality and safety.
The BTS includes a built-in pressure pump for efficient, reliable transfer from vial to syringe, along with three shuttles to ensure smooth production. For sites requiring continuous production, an optional single tower organizes up to 10 kits within a compact footprint, enabling uninterrupted runs without reopening hot cell doors.
Prioritizing high-speed, low-exposure production, the Ammonex20 and BTS are designed with safety and ergonomic efficiency in mind, making maintenance easy and minimizing downtime. The Ammonex20 package also includes a PC touch-screen laptop, arriving fully configured for immediate use—an ideal, user-friendly solution for any laboratory setting.
Software
The Ammonex20’s operating software is a fully programmable, user-friendly platform that operates with a single click. It automatically generates comprehensive batch reports, covering Cyclotron parameters, production items, sampling and QC processes, biological QC, sterility, device logs, trend analyses, and labels for vials, syringes, and shipping.
Reports are saved in folders with a time-stamped naming system, and an audit trail records all new and modified files. Routine ammonia production includes four pre-programmed SOP-driven methods: Setup, QC Run, Run Product, and Wash Up.
The software’s inventory control feature enables direct transfer of consumable data into batch records, and QR code tracking labels can be printed for any incoming inventory of approved or quarantined items.
For data security, batch reports can be encrypted and protected with a password, unique picture ID, and electronic signature. Reports can also be exported in PDF format. Filter integrity testing is automatically integrated within the run method, and the software adheres to CFR21 Part 11 guidelines, ensuring compliance with regulatory standards.
FDA, ANDA and SOP's
The Ammonex20 system provides comprehensive SOP documentation templates to streamline the FDA filing process. These templates cover every aspect of the production process, ensuring all required documentation is thorough and accurate.
By integrating these templates into the Ammonex20 system, laboratories can save time and resources that would otherwise be dedicated to developing and managing documentation. This efficient approach supports FDA compliance while enhancing overall productivity and operational efficiency.
Ammonia 13N and Sodium Fluoride NAF Literature
Announce up coming and past events
Ammonex20 installation Brigham and Women's 2016
Nuclear Medicine Wisconsin university 2017
File management and Inventory
Software architecture
Automatic file management and audit trail
Embedded Inventory Control
The Ammonex20’s advanced operating software provides a fully customizable platform, offering customers extensive control flexibility. SOP-driven controls make the automated process intuitive and user-friendly, requiring minimal input to generate comprehensive reports at the end of each run.
This flexibility enables labs to tailor the Ammonex20 system to meet their specific production needs, optimizing it for unique requirements. The software’s ease of use and customization options make it an ideal solution for labs aiming to streamline their production processes while maintaining high levels of control and adaptability.
Embedded Inventory Control
Automatic file management and audit trail
Embedded Inventory Control
The Ammonex20 system's integrated inventory control feature simplifies tracking of all consumables by automatically incorporating them into batch reports. This password-protected software maintains a historical log, offering a complete overview of items used during production.
An editable built-in library of commonly used items further enhances efficiency, allowing easy database population without manual data entry, saving time and improving accuracy. Overall, this inventory control feature streamlines production, ensures essential items are readily available, reduces downtime, and boosts productivity.
Automatic file management and audit trail
Automatic file management and audit trail
Automatic file management and audit trail
All reports generated by each Ammonex20 run are automatically organized into timestamped folders with clear, descriptive names, allowing for efficient and easy file management. Files can be stored on the local PC hard drive, or thumb drive for convenient access and backup.
Each QC run generates a dedicated folder to house all sub-batches, supporting traceability and efficient record-keeping. Each sub-batch report includes a unique QC ID tracking number, enhancing traceability and simplifying the reporting process.
The Ammonex20 system’s streamlined file management and tracking features ensure accuracy and traceability throughout production, making it an ideal solution for labs focused on efficient production and record-keeping.