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Radiopharmaceutical Production

Hot Cells for radiopharmaceutical production, labeling and dispensing

The work with radiopharmaceuticals in nuclear medicine requires closest attention to detail, particularly to radiation protection and equipment setup. Eckert & Ziegler offers a wide range of customized hot cell and processing solutions for radiopharmaceutical production, labeling, dispensing, sterile filtration and more.

Key Features

Detail Information

Various Application Areas

ITD’s hot cell solutions can be adapted for processing of almost any radiopharmaceutical and radiochemical product. Whether planning a facility for the production, processing, labeling, dispensing or sterile filtration, whether working with alpha, beta or gamma emitters in Positron Emmission Tomography (PET) or Single Photon Emmission Computed Tomography (SPECT), we provide you with highest quality solutions for different applications. We use the experience from hundreds of projects to offer you the optimal solution with full care from conception via installation to training and a service.

Hot cell for the operation of automated synthesis modules

Our mini cell approach is especially designed for the operation of standard PET synthesis modules. The construction ensures GMP-compliant production under grade C conditions. There are three different types that differ in size. The standard model consists of a stainless steel cell and 75 mm lead shielding, with a shielded door and lead glass window at the front side for easy access to the synthesis module. We also offer special solutions for the handling of Ga-68, with acid resistant coating of the inner cell with polyethylene and the shielded generator storage under the hot cell.

Hot cell with semi or fully automatic dispensing system

The dispensing cell with built-in semi or fullyautomatic dispensing system for sterile filtration is especially set up for the dispensing of short-lived PET radiopharmaceuticals. The automatic dispensing system allows fast dispensing of entered volume or activity into closed vials. The product is transported by a syringe pump which allows high precision filling through a sterile filter. Afterwards, the activity will be determined in a dose calibrator. The measured value is displayed in the software and can be used for further actions. The outward transfer of the filled vial is through a ventilated double lock in the bottom of the cell directly in the shielded container. The slider can be drawn out in the laboratory or at the back of the cell. Laminar air flow generates grade A to the whole dispensing area. The cell is conducted as an isolator which allows working in negative pressure that ensures protection of the operator and the product. All inactive disposables will be prepared under laminar air flow in a dedicated aseptic preparation box with glove ports. The transfer of the disposables into the dispensing cell is by a container (a double-lidded lock transfer system).

References

  • HZDR (Germany) – PET hot cell lines for synthesis, target handling and distribution and dispensing of PET radiopharmaceuticals among GMP conditions
  • Aarhus University Hospital
  • Leipzig University Hospital

Process and Services

Eckert & Ziegler is committed to deliver the best possible solution for your process and project. Therefore, we offer several services for the arrangement of facilities inside new or present premises together with our hot cell equipment. These include consulting and support for the determination of space, clean room, auxiliary and special additional requirements as well as material and personnel flow schemes, effectivity testing, measurement and customization of shielding and lead glass windows for your application.
Furthermore, we provide mock-ups for testing the functional handling and special combined transport and docking solutions for input and output of radioactive material into the hot cell. A dedicated project manager will support you from first contact, via design, installation and training to service and extension of your facility.

Product specific questions?

Isotope Technologies
Dresden GmbH
Rossendorfer Ring 42
01328 Dresden
Germany

+49 35 12 66 34 0
+49 35 12 66 34 10
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