UniFill

The automated dispensing system UniFill consists of the lead shielded class A dispensing cell and the directly connected class B pre-chamber. The dispensing system is installed inside the dispensing cell. The shielding at the front side can be lowered for the inactive preparation of the dispensing system through the glove ports. Lead plugs are available to perform the preparation under active conditions. Dispensing cell and pre-chamber are equipped both with LAF units and each have separate ventilation and filter systems. The complex is working under negative pressure. The pressure in the pre-chamber is lower than the pressure in the dispensing cell. The dispensing system enables the filling in open vials. A rotary plate is positioning the vials under each module of the dispensing system. A syringe pump is transferring the product solution through a sterile filter. Afterwards the vials are automatically closed and dropped into the ventilated bottom lock, in which also the activity will be determined. The extraction is done directly into a lead container. The lid of the container will be automatically handled. All vials of a batch are filled consecutively according to a preparation list. The determination of the activity and weight of the bulk solution and the dilution are performed in advance of the dispensing process. Significant events are monitored and logged.

• Automated dispensing process¹ Cycle time < 3 min/vial possible
• Dispensing with sterile filtration in vials (size between 10 ml and 25 ml)² with a maximum batch size of 23 vials (20 ml)
• Solely use of sterile disposable material for all components which get in contact with the product solution; sterile sets are available (customized sets with any sterile filter³)
• Dispensing by volume with an accuracy of ± 3%⁴
• Gravimetric determination of the activity concentration of the bulk solution; dilution of the bulk solution and mixing; diluted product solution with max. 100 ml and max. 590 GBq (F-18)⁵
• Activity probes for the determination of the activity of the vials; Activity range depending on filling volume: ≈10 MBq – 50 GBq (F-18)
• Extraction of the vials after determination of the activity directly in the lead container

1 cycle time depends on the product solution and filled volume; cycle time may differ
2 dispensing system is designed for one specific vial size, other sizes on request
3 sterile filter on request
4 accuracy depends on syringe, filled volume, dispensing parameters and product solution; accuracy may differ
5 bigger volume and activity range on request