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