UniFill 5
Automated dispensing system for the filling of open and closed vials
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 both equipped with LAF units and 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 and/or closed vials of different sizes. 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 dropped into the ventilated bottom lock, in which the activity will be determined as well. 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 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 parameters are monitored and logged.
Features dispensing system
Automated dispensing process1
Cycle time closed filling < 1 min/vial
Cycle time open filling < 2 min/vial
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 possible)
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)
Activity probes for the determination of the activity of the vials
Activity range: 10 MBq – 50 GBq (F-18)
Dispensing with sterile filtration in open and/or closed vials
(size between 10 ml and 25 ml)2
Maximum batch size 25 vials (10 ml), 24 vials (20 ml)
Dispensing by volume with an accuracy of } 2%4
Bar code reader to trace the pre-labeled vials
Extraction of the vials after determination of the activity directly
in the lead container
Technical Data
Overall dimensions (W x H x D) [mm] | approx. 2500 x 2600 x 1100 |
Inner dimensions isolator (working area) (W x H x D) [mm] | approx. 995 x 1000 x 495 |
Total weight | approx. 6500 kg |
Shielding, all sides | 75 mm lead |
Covering | Powder-coated steel sheets |
Material inner containment | AISI 304, Ra ≤ 3.2 μm |
Air quality dispensing cell |
Class „A“, LAF in working area LAF velocity: 0.54-0.36 m/s, digitally displayed |
Air quality pre-chamber |
Class „A“, LAF in working area LAF velocity: 0.54-0.36 m/s, digitally displayed |
In-air filter | H13 (DIN EN 1822) |
LAF filter | H14 (DIN EN 1822) |
Exhaust-air filter | H13 (DIN EN 1822) |
Power supply | 230/400 V N/PE 50 Hz 32 A |
Compressed air | min. 6 bar |
Exhaust air | - 500 Pa, 20 m³/h |
synthesis modules
Hot cell for the operation of automated synthesis modules
The mini cell is especially designed for the operation of customary PET synthesis modules or hot cells adapted for research or nuclear medical purposes. The GMP-compliant design ensures the quality of production conditions.
There are four different types, Type I, Type II, Type III and Type IV. The standard model consists of a stainless steel cell and 75 mm lead shielding. A shielded door with an optional lead glass window is implemented at the front side for easy access to the synthesis module.
Customizable design of the mini cell and the thickness of the shielding for customer intended process and/or physical conditions.
Also available are special solutions for the handling of Ga-68 which include coating the inner cell with polyethylene for handling hydrochloric acid.
Technical Data
Dimensions/Weight
Inner dimensions (WxDxH) Outer dimensions (WxD) Height Weight kg
Typ I 700x560x775mm 920x850 mm 3000 mm approx. 3,500
Typ II 700x640x775mm 920x930 mm 3000 mm approx. 3,800
Typ III 850x640x775mm 1070x930 mm 3000 mm approx. 4,500
Typ IV 700x500x610mm 920x770 mm 3000 mm approx. 6,000
Material Inner cell stainless steel (1.4301)
Shielding At all sides 75 mm of lead
Door
Implementation Left or right hinged swinging door
Lead glass window 145 x 145 mm, 75 mm of lead-equivalent
Tightness Inner cell leak rate < 0.25 %/h
Ventilation system
In-air H13 filter, port DN 25
Exhaust-air H13 filter with charcoal, port DN 25 negative pressure
adjustment Manually operated ball valves
Air monitoring system Differential pressure
Electrical / pneumatical specification
Electrical connection 3x230/400 V 50 Hz N/PE, 16 A pre-fuse
Consumption approx. 1 kW
Sockets 2 pcs inside (IP54), external switchable
2 pcs above and underneath the cell
Compressed air > 6 bar
Covering
Material Powder-coated steel plates
Colour Clean white (RAL 9010) or according to customers‘ request
Options
- Customized Dimensions and height of covering
- Slideable tray for synthesis modules
- Fittings and ducts for gas lines
- Double mini cell vertically or horizontally arranged
- Laptop mount
- Shielded feed-through of nuclides
- Storage box for radioactive waste
- Shielded generator storage under the cell with sealed fitting to the inner cell
- Especially for Ga-68: Acid resistant polyethylene coating of the inner cell
research
Hot cell for research on PET-radiopharmaceuticals
This research hot cell is designed for the development of new radiopharmaceuticals based on short-lived positron-emitters. It is used for the implementation of fully- or semi-automated synthesis devices for PET-radiopharmaceuticals. The set up is especially suitable for PET centres which provide daily routine products, like FDG, on the one hand, and on the other hand carry out innovative research activities, for example on 68Ga based radiopharmaceuticals. The cell is offered as a single hot cell or in combination with other hot cells as a functional complex.
We are happy to customize the design and all dimensions of the research cell on request for your intended process and/or physical conditions.
We offer a special solution for the handling of 68Ga featuring acid resistant coating of the inner cell with polyethylene and a shielded generator storage under the hot cell.
Optionen auf Anfrage
- • Anpassung der Abschirmung zw. 20 bis 100 mm und des Strahlenschutzfensters in Größe und Stärke
- • Zusätzliches Hubelement als Rückwand, auch mit Strahlenschutzfenster
- • Schleuse für inaktives Material
- • Bodenschleuse oder Produktcontainerkasten zur Ausschleusung des Radiopharmakons
- • Integriertes Dosisleistungsmesssystem
- • Einbau eines Aktivimeters in den Zellenboden
Technical Data
Dimensions
Outer dimensions (WxDxH) approx. 1400x1400x2600 (±30) mm
Inner dimensions (WxDxH) approx. 1000x1000x800 mm
Weight approx. 9000 kg
Material Inner cell stainless steel (1.4541)
Shielding
Sides, front and back 75 mm of lead
Ceiling and bottom 75 mm of lead
Door / lifting element
Implementation Electromechanical lifting door, at front side
Control Two-hand safety control
Lead glass window 300 x 300 mm, 100 mm lead-equivalent
Tightness
Inner cell Leakage <0.25 %/h acc. to ISO10648-2 class 2
Ventilation system
In-air H13 filter, DNport 50
Exhaust-air H13 filter with charcoal, port DN 50
Negative pressure adjustment Manually operated ball valves
Air monitoring system Differential pressure
Electrical / pneumatical specification
Electrical connection 3x230/400 V 50 Hz TN-S, 16 A pre-fuse
Consumption approx. 1 kW
Sockets 4 pcs. inside (IP54), external switchable
2 pcs. above and below the cell
Compressed air > 6 bar
Covering
Material Powder-coated steel plates
Colour Pure white (RAL 9010) or according to customers‘ request
Options
- Shielding up to 100 mm of lead and customization of lead glass window on request
- Additional lifting element on the back side of the cell, also with lead glass window possible
- Double-door lock for inactive material
- Double-door lock in the bottom or shielded product storage
- under the hot cell to lock out of the radiopharmaceuticals
- Integrated dose rate monitoring and dose calibrator
- Especially for 68Ga: Acid resistant polyethylene coating of the inner cell
Shielded generator storage under the cell with sealed fit to the inner cell