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Lutetium 177

UniFill 5

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

 


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Beta Boxes Complex

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.


Beta Box

 

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

Isotope Technologies Dresden GmbH
Rossendorfer Ring 42
01328 Dresden

+49 (351) 266 34-0

 

 

 

 

 

 

 

 

 

 

 

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