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 |
Kapselabfüllung
Hot Cell, Glove Box and Auxiliary Equipment
Dedicated for the production of 131I-capsules with the CapFill dispensing unit
The unit for 131I-capsules production consists of the following hot cells, boxes and auxiliary equipment:
- Hot cell (for CapFill gelatine capsule loading)
- Glove box (for the inactive preparation work)
- In-cell equipment (for gelatine capsule loading)
Hot Cell
- Dedicated for gelatine capsule loading in the iodine-therapy capsule production.
- Supporting frame: robust welded construction of stable hollow steel squares for mounting the lead shielding and the inner cell box
- Covering on all sides with powder-coated steel sheets
- All side lead shielding: 50 mm Pb
- Vertically movable rear shielding door with electric driving unit and two hand safety operation or swing door on the operator side
- Hermetically closed inner cell box made of stainless steel
- Dimensions: (w x h x d): 1000 x 1000 x 800 mm
- Bottom port for input active material
- Bottom airlock for output of active material
- Air lock on the left side wall connected to the glove box with tray and pull-out rail
- Lead-glass window in the stationary front wall, dimensions (w x h x d): 300 x 300 x 115 mm
- Two manipulators, stainless steel shaft, diameter ½“
- HEPA filter unit combined with charcoal filter for the in-air and for the exhaust-air
Glove Box
- For inactive preparation work. Connected to the therapeutic– capsule production-hot cell.
- Hermetically closable box
- Made of 20mm acrylic glass or of stainless steel
- Dimensions approx. (w x h x d): 700 x 1000 x 600/700mm
- Front side with removable and airtight acrylic glass panel, with two glove ports and two gloves
- Supporting frame: robust welded construction of stable hollow steel squares and powder coated surface
- Covering above the box with powder-coated steel sheets
- Interlock signal connections for the existing lock system Standard flanges on the top of the cell for in-air and exhaust-air equipment or with path-through ducts for cables and tubing to pass gases and liquids into the cell
- Airlocks for input and output of materials on the left side and on the right side connected to the hot cell
Auxiliary Equipment
- Dose calibrator (Interconnected with dispenser touch screen unit, printer, ionization measuring chamber and connection flange with frame and lead shielded)
- Dose rate measuring system for monitoring the dose rate with up to three probes, optical signal lights and acoustical alarm
- Vial decapper, size 20 mm (remote controlled)
- Vial crimper, size 20 mm (remote controlled)
- Different grip tongs including tongs-changing fixture
- Lead-shielded solid waste container
- Lifter trolley for container docking
CapFill dispensing unit for 131I-capsules
In cell equipment for iodine 131I-capsules production
The proposed capsulation technology is designed for producing 131I-capsules for diagnosis and therapy under semi-automated conditions. The unit is designed to operate inside a hot cell and is suitable for an automated capsule filling process for 25 capsules per pallet (unlimited batch size by using an appropriate amount of palletes). The gelatine capsules are inserted into a special holder, opened, filled with a special composed filling material and then loaded with the required 131I-solution. The capsules are then closed and sealed.
In cell equipment CapFill
- 1x remote controlled dispensing unit consisting of high precision automated pipetting device
- holder unit vertical and horizontal movable
- control unit with PC and touchscreen monitor
- CapFill software, outer dimension: 420 x 460 x 250 mm (W x H x D)
- weight: approx. 23 kg
- materials: Stainless steel 1.4301, Stainless steel A2 and A4, Aluminum AlMg3, PMMA, PVC (cables and leads)
Dispenser specification
- Pipetting range < 1 – 1000 μl
- Resolution 0.1 μl / increment
- Tip size 300 μl
Pipetting performance
- Pipetting volume 10 μl 50 μl 300 μl
- Accuracy 5.0 % 2.0 % 1.0 %
- Precision 2.0 % 0.75 % 0.75 %
- 10x Production palettes for capsule bodies (for 25 capsules each, capsules size 0)
- Capsule closing device
- 1x transport tray
- 1x special capsule tweezers
- Lead container for intermediate storage of the bulk solution (dimension of bulk flask required), shielding thickness 15 mm (can be customized)
- 1x Vacuum grabber for capsules (remote controlled per manipulator and touch screen monitor)
- Electrically and pneumatic control cabinet, dimension: 500 x 500 x 250 mm, connection: 220V/50Hz
- Set of consumable materials included (1000 pcs. gelantine capsules size 0,96 pcs. pipetting tips)
Documentation and quality requirements
- One hard- and one softcopy of technical documentation
- User/servicing manuals in English language
- Overview drawings in English language
- PC software in English language
- Isotope Technologies Dresden GmbH is certified according to ISO 9001 and complies with the regulations to the quality management system.
Optional (upon request)
- Dose calibrator (consisting of ionization measuring chamber and connection flange with frame and lead shielding) interconnected with the capsule dispenser and dispenser control unit
- Vial decapper, size 20 mm (remote controlled)
- Vial crimper, size 20 mm (remote controlled)
Consumables / spare parts
- 1x dispenser (easy exchangeable)
- Pipetting tips, size 300μl
- Gelantine capsules, size 0
