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 |
Beta Boxes Complex
Beta Boxes Complex
Glove box complex for the handling of radiopharmaceuticals based on beta-emitters
The Beta Boxes Complex is for the handling of Y-90-compounds and other high-energy beta-emitter. It is designed for the GMP-compliant preparation, process and dispensing of Y-90-radiopharmaceuticals up to 30 GBq. The Beta Boxes Complex consists of three interconnected acrylic glass boxes with glove ports. Inward/outward transfer and transfer between the boxes are realised by double locks. Laminar air flow ensures grade A respectively B conditions inside the complex for all the critical process stages.
The operator is supported by local shieldings and manipulation equipment to optimize handling and to essentially reduce radiation exposure, especially to the hands.
We will customize the design and all dimensions of the Beta Boxes Complex on your request regarding your intended process and/or your physical conditions.
Technical Data
Dimensions
Outer dimensions (WxDxH) ca. 1200x1500x3000 (±30) mm
Inner dimensions Box 1 (WxDxH) ca. 1200x900x600 mm
Inner dimensions Box 2/3 (WxDxH) ca. 900x900x600 mm
Weight ca. 1000 kg
Material
Boxes PMMA, glued
Thickness 20 mm
Shielding
On all sides 20 mm PMMA gegen b--Strahlung
Tightness
Inner cell leak rate < 0.25 %/h according DIN 25412-2
Ventilation system
In-air H13 filter, port DN 50
Exhaust-air H13 filter with charcoal, port DN 50
Laminar air flow Fan, H14 filter, laminator, perforated plates
Negative pressure adjustment manually operated ball valves
Air monitoring system differential pressure, LAF velocity
Transfer system / sluices
Inward/outward transfer double locks made of stainless steel
Between boxes double lock made of stainless steel
Glove ports
Box 1 4 pcs / 4 blank flanges
Box 2/3 2 pcs / 2 blank flanges
Electrical / pneumatical specification
Electrical connection 3x230/400 V 50 Hz N/PE, 16 A pre-fuse
Consumption approx. 1 kW
sockets 4 pcs each box (IP54), external switchable
2 pcs above and underneath the boxes
Compressed air > 6 bar
Covering
Material powder-coated steel plates
Colour clean white (RAL 9010) or according to customers‘ request
Optional
Customised dimensions
Integrated dose rate monitoring system
Integrated dose calibrator
Local shieldings made of lead, acrylic glass or lead glass
