Ammonex20 system
Description (Now internationally patented since 2018)
The Patented design Ammonex20 and the BTS system are designed at best for fast production of 13N Ammonia or Sodium Fluoride NAF.
These new generation of "Setup ready" synthesizer offers the ability to supply cardiologist Ammonia or sodium Fluoride to emergency situation or unscheduled patients at any point in time.
A single QC run per day permit multiple sub batches doses originated from the same Lot.
Hardware
The Ammonex20 was developed for sites that require high production output of ammonia or sodium fluoride. This "minute" one time setup offers back to back productions runs and significantly reduced the time setup between each runs. A single point container collects solids, liquid and gas wastes during active runs assuring a "cleaned & ready" setup.
The Ammonex20 system eject used cartridge automatically to the waste container. The waste compartment can hold up to 150 runs. The carousel holds 20 cartridges and can be reloaded or swapped in seconds for extended runs.
Twenty four sensors are reporting to a log file for each run.
The Batch Transfer System BTS allows to drop a pre-assembled vial/filters "shuttle" kit and helps dispense the final product in a sterile vials or syringes.
The BTS builtin pressure pump helps dispense the final product from the vial to a syringe. three Shuttles are included on the final install. An optional single Tower helps organize 10 kits in a small foot print to allow back to back run without re opening the hotcels doors.
The Ammonex20 and the BTS system are designed at best for fast production with practically no exposure involve to the LAB worker.
The unique ergonomic design concept offers easier maintenance for quick response.
The Ammonex20 package include a PC touch screen laptop and ready to run.
Software
The ammonex20 operating software is a one button click operation on a fully programmable methods platform and generate a complete batch reports documentation including Cyclotron params, Items Production, Sampling Process, QC process, Biological QC, sterility reports, device log reports and a trend reports as well as a Vial, syringe and shipping labels reports. All Reports are save in folders with automatic naming time stamp concept. An audit trail keeps track of any newly created files as well as edited files. There are four pre programmed SOP driven method involved in the routine production of ammonia such as Setup, Qc Run, Run Product, Wash up.
An inventory control allows for 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.
All batch reports can be encrypted and password protected with an unique picture ID and electronic signature as well as exporting batch report in a PDF format.
Filter integrity testing are automatically followed through the run method.
The Ammonex20 operating software follow CFR21 part 11 guide lines.
FDA, ANDA and SOP's
The ammonex20 system includes ALL SOP documentation templates to help speed up the filing process require by the FDA.
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
Ammonex20 "Ammonia on demand"
File management and Inventory
Software architecture
The advance operating software offer's to the customer the advantage of flexibility of a full customization platform control without limitation.
The Ammonex20 operating software allows SOP driven to help's intuitively the operation of the fully automated process. A full report with minimum user input is generated at the end of each run.
Embedded Inventory Control
With the built in Inventory control helps the tracking of all consumables and are directly copied into the batch report.
The inventory control software can be password protected and keeps track of history items.
An editable build in library of common item helps populating the inventory data base efficiently.
Automatic file management and audit trail
All file reports generated by each run are classified into time stamp folder with meaningful names and are automatically created. File can be saved in the local PC hard drive, thumb drive or SQL server.
Each QC run create a single folder where all sub batch will be alocated.
A unique QC ID tracking number is copied in each sub batch report for traceability.