Dispenser/Sterilizer

Dispenser/Sterilizer

The Dispenser/Sterilizer is suitable to dilute and dispense all liquid PET tracers under aseptic conditions into sterile, evacuated vials according to GMP guidelines. The process includes aseptic dispensing under laminar flow and terminal sterilization of the PET tracer in the final containment.

The system integrates the needs of pharmaceutical, clean room and radiation safety requirements. Dispensing is done in a lead shielded isolator to separate the process from laboratory atmosphere.

Process Description

At the beginning, the operator defines a number of sample vials with activity or volume for each single vial at a preferred reference time. Each vial can be assigned to a customer who can be selected out of the database of the system. Backup probes and QC samples can be generated automatically. The labeled vials are then introduced into the Dispenser/Sterilizer.

From a manifold of supplying synthesizers, one is selected, which sends the PET tracer to the Dispenser/Sterilizer. Total activity, activity concentration, and volume of the product are determined automatically. If needed, the tracer is diluted with sterile saline to a predefined concentration. This PET tracer is then aseptically dispensed through a sterile filter into evacuated vials in a laminar flow class 100 environment (PIC class A).

After filling the desired number of vials, an automated sterilization process can start: The tracer solution is terminally sterilized in a temperature range between 132 and 138 °C. Sterilization effectiveness is calculated continuously and the sterilization process is automatically controlled according to the F0 concept. Up to 17 vials are sterilized in one cycle.

Finally, the activity of the PET tracer in each vial is determined with an ionization chamber before ejection into the lead transport container. The container is moved through an air lock into laboratory atmosphere. An automated and documented cleaning cycle (CIP) keeps the Dispenser/Sterilizer clean.

Documentation and GMP

Each dispensing and sterilization process is documented according to GMP guidelines. Process conditions are recorded throughout the whole dispensing procedure, displayed graphically in a live display, and stored permanently. They are printed out with each batch.

A label, which is printed for each vial, contains name and address of the manufacturer, name of the product, dispensed activity, volume, and concentration of active ingredients, reference time, and other important information. The user can select the data displayed on the label. The same information can be used to generate a delivery note and a daily report.