THEODORICO 2 Robotic Dispenser for Radiopharmaceuticals
The Comecer Theodorico 2 is an automatic shielded dispensing system for open or closed vials which are used in radiopharmaceuticals. Due to the flexibility in the system configuration it is possible to meet the customer productive requirements. A robot in the dispensing chamber is handling the vials in all stages of the dispensing process. This makes sure that the exposure of radiation for the operator is significantly reduced. The robotic dispenser is cGMP compliant and available with different shielding Pb 75- or 100 mm shielding. It is possible in the dispenser to pre-arrange dynamic air sampling, particle counting, VPHP cycle.
BBS Series Shielded Cells for Synthesis Modules
The Comecer BBS shielded cells series for synthesis modules, is especially designed to host specific automatic synthesis modules. This to produce radiopharmaceuticals for experimental purpose or production in cGMP radio pharmacy daily.
The Comecer BBS shielded cell comes in different variants, single or double (lined horizontally or vertically), triple and quadruple. It is possible to make different configurations for the overall dimensions, shielding and various accessories which means a modular design and flexible configuration. The BBS cell is Available in Pb 75- or 100-mm shielding. It has air quality in the work chamber that complies with Class B “At rest” (EEC-cGMP). It is possible to Set-up it up to the Geiger probes for measurement of the radioactivity present inside the cell. It comes with air inlet filtration system made with HEPA absolute filtering cartridge with 99.995% efficiency.
MIP Shielded Cell for Synthesis Modules and Research Activities
The Comecer MIP series of shielded Cell for Synthesis modules and research activities has been designed to host automatic modules for routine, or research equipment of radioisotopes and radiopharmaceuticals for experimental use production. This MIP Serie is made to guarantee the radioprotection of the operator. It also guarantees and secures the decontamination and cleaning procedures being most effective. The design of the work chamber is made so it is sealed, shielded on every side and kept under negative pressure. Some of the remarkable features is that the right side has tele-pliers to handle the vial from the work area to the extraction system and dose calibrator. It has preparation and installation of two tele-manipulators and installation of the side autoclave (which can be reached with the tele-manipulator). The Cell has set up for side material passage chamber (side airlock), shielded or non-shielded, with air quality complying with Class B ’’At rest’’ (EEC-cGMP) and equipped with manipulation gloves.
MUSA 68Ga Shielded Isolator for Gallium-68 Synthesis and Dispensing
The Comecer MUSA 68Ga isolator is designed to secure the optimal use of the Gallium-68 processes (synthesis and dispensing) which is extracted from generator 68Ga/68Ge. This Isolator is shielded (50 mm Pb) with laminar flow with the possibility of handling beta and gamma emitting radiopharmaceuticals in an aseptic environment. This in accordance to the Good Radiopharmacy Practice Standards. Here due to the standard regarding the Preparation of Radiopharmaceuticals in Nuclear Medicine (simple preparations and extemporaneous preparations).
The Comecer MUSA 68Ga isolator can be used for labelling, due to the compact synthesis modules. The Isolator is also suitable for fractioning different radioisotopes, including beta-emitters, such as 177Lu and 90Y. The MUSA 68Ga comes with a dose calibrator (available in the versions 2 Ci or 20 Ci) with touch screen console and cGMP compliant.
TIMO 2 Syringes Dispensing System
The Comecer TIMO 2, a semi-automatic dispensing system which utilize the components and software, that has been developed and adopted by COMECER on ALTHEA PC automatic fractionators. This compact dispensing system makes it possible to do the fractionation of radiopharmaceuticals in single-dose syringes of PET and SPECT isotopes and for radiotherapy. This small sized dispenser makes it possible to install it in cells with small working area. The TIMO 2 dispenser has recipe management, automation and workflow control which is in accordance with cGAMP regulation and the best operator interface.
FEBO Series Syringe Dispensing System
The Comecer FEBO Series which is a Syringe Dispensing System are mainly designed to secure a safe and accurate fractionation of radiopharmaceuticals in syringes. This FEBO Syringe dispenser system has been designed in compliance with Eudralex requirements as well as – Volume 4 Good Manufacturing Practice (GMP) Guidelines. The objective of this system is to introduce a fast and efficient dose preparation process in Nuclear Medicine and Radio pharmacy departments.
The FEBO dispensing system are a reliable dose calibrator which can measure the radioactivity of the dispensed dose through an integrated ionizing chamber. It is possible for the FEBO to receive radiopharmaceuticals from a multidose vial. It is also designed to be installed inside laminar flow cells, isolators or hoods. Some of the main features of the Dispensing system is that is can dispense in 5- and 10-ml syringes and Letho Cartridge. FEBO has Recipe management, automation and workflow control by means of operator interface developed in accordance with GAMP regulation and compliant with 21 CFR Part 11. It is very suitable for Nuclear Medicine-, production and Radio pharmacy departments.
ARGO-T Closed Vial Dispensing System
The Comecer ARGO-T Closed Vial Dispensing System is dispensing in closed vials and with a complete filling cycle completed in 30 seconds. The Comecer Argo T is very precise in the dispensed volume with a disposable sterile KIT. The dispensing system is GMP compliant fulfilling the guidelines for filling closed vials. The system is a part of the ARGO dispenser family with the feature which allows automatic perforation with a needle. In the disposable kit there is an integrated pumping syringe which controlled the volume being dispensed. It has a designed piecing needle which allows filling together with an integrated vent needle with 0.22 sterile filtration.
CLIO Volumetric Dispensing System for Radiopharmaceuticals
The Comecer automatic volumetric dispensing system CLIO is a standalone unit which is compliant with cGMP guidelines for radiopharmaceuticals. The CLIO Dispenser systems main purpose is to dispense FDG like radiotracer, however it can also be used for different tracer isotope or molecules after a technical evaluation. The system is dispensing in open vials and is also transseptal in dispensing in closed vials aswell as in syringes. It has an accurate dispensed monodose. CLIO has automatic vials open/close system and comes with pre-assembled, compact, easy-to-install consumables kit. In order secure the process there is many sensors and diagnostic tools to supervise the operation cycle (i.e. consumable kit installation, vial cap presence, vial crimping check).