Safety Workbench
SWB15 - Safety Workbench
Highlights
Efficient Workflow
- 24”-Wide-Screen inside the workbench for the software of the dose calibrator and additional applications of the customer
- Integrated storage drawer for fast access to all consumables
Best Value for Money
- Customizability Appearance (Customer Corporate Design)
- Use of up to two Tc-99m generators of different types
- Warranty 36 months (for options 12 months)
Ergonmic Design
- Working surface divided into three parts ensuring easy removal for cleaning
- Tilted front panel with 7“-Touch-Screen
User-friendly Operation
- Control of generator safe inside the working area
- Safety interlocks for generator safe and waste storage using optical status detection of functional units (LED)
GMP Compliance
- GMP-compliant base product according current requirements
- Design of the working area ensures safe handling of radiopharmaceuticals
Technical Details
| Basic Configuration | |
| External dimensions (W x D x H) | 1826 x 950 x 2410 mm |
| Internal dimensions (W x D x H) | 1500 x 500 x 615 mm3 (working area) |
| Material | Working area: Stainless steel AISI 316L |
| Air classification | Working area: class A (EG-GMP annex 1) |
| Laminar Flow | 0.45 m/s (±20 %) |
| Laminar flow filter | HEPA14 according EN 1822 |
| Exhaust air filter | HEPA14 according EN 1822 |
| Lighting | >1000 Lux |
| Operating Panel | 7“ touch-screen |
| Covering | Powder-coated steel sheets |
| Shielding side walls, rear wall (600 mm high) and bottom |
10, 30 or 50 mm lead |
| Lead glass window | 10 or 30 mm lead equivalent |
| Waste Safe |
Internal dimensions (W x D x H): 185 x 395 x 320 mm Shielding: 10 or 30 mm lead |
| Capacity: up to two waste containers per waste store | |
| Power supply | 230 V/50 Hz (16 A) |
| Exhaust air flow | 550 m³/h |
| Total weight (SWB15-10Tc) | 2590 kg |
| Options | |
| Dose calibrator |
Integration underneath working surface with lead shielding (Manufacturer independent: MED, Capintec, MecMurphil) |
| Monitor | Integrated 24”-Wide-Screen |
| Heating plate for preparation of Tc-99m radiopharmaceuticals |
Integrated in working surface within working area |
| Holder for label printer | Outside the workbench integrated in covering |
| Particle probe | Integrated in rear wall of working area |
| Laminar flow velocity probe | Integrated in rear wall of working area |
| Connections inside workbench |
USB-/LAN-connections and sockets (splash-proof IP44) |
| Customer Corporate Design |
Color (RAL) of covering according to customer request |
| Generator safe for Tc-99m generators |
For up to two Tc-99m generators (manufacturer independent: GE / Rotop / IBA / Mallinckrodt) Shielding: 50 mm lead |
| Generator safe for Ge/Ga generators |
For all commercially available Ge/Ga generators (e. g. Eckert & Ziegler GalliaPharm) Shielding: 50 mm lead) |
Aspects of the new Product Design
Product and User Protection
The shielded safety workbench SWB15 was developed to ensure optimized product and radiation protection for the preparation of radiopharmaceuticals. The integrated laminar air flow unit generates clean room Class A conditions inside the working area. Additionally, an inward directed air flow guarantees that contaminated particles cannot leave the working area. The ventilation system is monitored and controlled permanently. The various operation modes will be adjusted automatically. The safety workbench is shielded with up to 50 mm lead. A moveable lead glass window which protects the user is installed at the front. Additionally, a lead shielded wall can be installed at the front. The appropriate inward air flow system and lead shielding protect the user all the time while working with radioactive substances.
Features & Equipment
The working area of the safety workbench consists of high- grade stainless steel. The working surface consists of three segments for easy removal to ensure proper cleaning. A dose calibrator can be integrated in the bottom of the working area. The software of the dose calibrator can be displayed on the monitor in the rear wall of the working area. Furthermore this monitor can be used for customer applications. Contaminated waste can be discharged safely through shielded openings in the bottom of the working area. Three LED segments indicate the operation modes of
the ventilation system, the generator and the waste storage. An unshielded drawer is integrated in the covering of the safety workbench at the front underneath the working area. The drawer can be used for the storage of disposables such as gloves and syringes.
Configuration for Tc-99m
The configuration for Tc-99m (SWB15-10Tc) allows to store up to two Tc-99m generators of the same or different types. All commercially available types of Tc-99m generators are supported. The generator safe is positioned underneath the workbench and shielded with 50 mm lead. The generators are automatically lifted to the height of the working area by pushing control buttons inside the working area. There is no need for the user to take the hands out of the working area while eluting the generator.
Configuration for Ga-68
There is a special configuration available for the preparation of radiopharmaceuticals based on Ga-68. The working surface is coated with polyethylene to avoid corrosion of the high-grade stainless steel when using hydrochloric acid. Furthermore, a shielded generator safe for up to two Ge-68/Ga-68 generators is positioned underneath the workbench. Feed- throughs between generator safe and working area allow the installation of lines for the elution of the generators.
Tc-99m-Generatorproduktion
Medium scale facility for aseptic production of 99Mo/99mTc-generators
Methods
The loading of such a sterile chromatographic generator can be carried out in different ways. There is the possibility to apply either aseptic column loading procedures or procedures which include the steam sterilization of the loaded column. The process steps are quite different and require different equipment inside and outside the hot cells, especially in the clean room and sterilization equipment. For the small-medium scale production batches (20-50 pcs.) the aseptic column loading procedure was chosen, instead of a procedure with steam sterilization of the loaded column, which is rather suitable when a large scale production is established. The aseptic loading and washing process with a complete preassembled sterile generator has the advantage that the production personnel have to carry out fewer operations on the radioactive sterile generator and hence there is a significant reduction of the radiation exposure to them. In fig. 1 the main steps of the aseptic procedure are shown. It starts with the preassembly of the inactive generators. In the first hot cell the formulation of the 99Mo solution takes place. After sterile filtration the prepared 99Mo solution is loaded onto the generators in the second hot cell. This is followed by the washing of the loaded generators. In a locally shielded glove box a QC elution of the generators is carried out, for testing of the permeability and a 99Mo breakthrough measurement. After the QC the needles are protected and a cover is added. Outside of the hot cell / glove box unit the produced generators are packed into type A transport packages and the user equipment and manual are added.
The aseptic loading procedure is carried out in an advanced hot cell / glove box arrangement (fig. 2) for full compliance to the current GMP requirements. It has a special design which offers the suitable clean room barriers with adequate pressure gradients maintaining the necessary clean room environment and shielding for radiation safety.
The first hot cell (dispensing box) is located in a room of clean room class “D”. In this hot cell the import of the 99Mo bulk solution and its formulation is carried out under clean room class “C”. The second hot cell (loading box) and the corresponding glove boxes (PMMA box 1-4) are installed in a clean room of class “C”. On a rail system the presterilized generator components entering glove box 1 with clean room class “B” and glove box 2 were the inactive generators are preassembled under clean room class “A” conditions with laminar air flow (LAF). Inside the second hot cell under clean room class “A” conditions with LAF the preassembled generators are loaded with sterile filtered 99Mo solution and washed. The loaded and washed generators are tested for permeability and 99Mo breakthrough in glove box 3 (clean room class “A” with LAF). Via glove box 4 (clean room class “B” with LAF) the produced generators are locked out for packaging.
The shielding of the hot cells is made of 100 mm thick lead for the vertical walls, 70 mm thick lead for the bottom and ceiling walls. This shielding meets the international requirements to keep the radiation exposure to the operators below 5 μSv/h at any time (with max. 2500 GBq of 99Mo). The dispensing and the loading hot cell are separated by a wall with a lead shielding of 50 mm. In fig. 3 an example of the intended hot cell / glove box arrangement installed in a class “C” clean room is shown. There are access doors in order to open the hot cells for maintenance purposes. The windows of the hot cells are made of 230 mm thick lead glass with a density of 5.2 g/cm3. Below the hot cells bottom there is sufficient space for waste collecting containers. The docking unit for 99Mo transport containers is designed for docking of different types of containers.
Results
Among the technical advantages and GMP compliance with special clean room barriers and laminar flow modules this facility design is still cost effective. Even it offers the possibility for an installation at sites were only small areas are available. Furthermore an enhanced radiation protection is realized through abandonment of manual assembly steps at the already loaded generator. However the applied aseptic procedure is more time consuming than a simultaneous loading / sterilizing of multiple columns before their assembly into the generators.
