The DOM, Lemer Pax dose dispensing system is designed to prepare, fractionate and dose radioactive solutions in aseptic conditions. These solutions can include radiopharmaceutical preparations with marketing authorisation or experimental radiopharmaceutical drugs for biomedical research.
It allows to carry out several operations simply and quickly according to the operator needs:
The DOM must be used in a class A shielded hot cell to meet the necessary aseptic conditions required for injectable preparations as well as regulatory requirements such as GMP, GPP, or EuGMP.
The filling is performed in open vials, which are afterwards crimped on the dedicated module of the DOM.
All the DOM functions are electronically controlled:
Users can independently configure their preparations. The information relative to the isotopes, the type of preparations and the production batches, can be easily modified. Therefore, the DOM can be perfectly adapted to the changes in radiopharmaceutical preparations.
The labels for the vials and the shielding are directly printed using the machine. The page layouts can
be customised based on the types of pots and vials (quality control, production vial, waste), for maximum flexibility.
It allows to reach a volumic activity and activity in each vial at the required time.
The kit contains one sterilising filter
This filter has a PVDF hydrophilic filtering membrane to ensure the sterility of most of the radiopharmaceutical preparations. The filter integrity can be checked directly on the DOM, by measuring the bubble point pressure, integrated function.
Production information is archived and can be easily exported. This archive contains the data concerning the drug, the batch and each vial produced for maximum traceability.