Products tagged with GMP
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. DOM: very flexible system It allows to carry out several operations simply and quickly according to the operator needs: add one or several diluents and/or preservatives to a stock solution, fractionate into several vials, rinse the dispensing system. 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.
The DS-75 shielded hot cell is designed to house radiosynthesis robots, for the daily production of radiopharmaceuticals or for research applications. These DS-75 shielded hot cells perfectly comply with statutory requirements for good pharmaceutical practice and those set out in radiation protection standards.
The Accurion-226® dose calibrator is a measuring device designed for the measurement of radioisotope activities of all energies (low, medium and high levels of activity). It can be integrated into manual and automatic preparation equipment such as shielded hot cells, benchtops or L-Block with an adaptable sample dipper and removable lining. Their simple, self-explanatory operation makes it easy to process activity measurements. It conducts check tests and stores essential data on files or labels.
The REP-75 hot cell is perfectly suited for fractionating and placing of products resulting from synthesis in vials, for the daily production of radiopharmaceuticals. REP-75 isolator guarantee complete safety and ease-of-use: With its high-standard 316L stainless steel interior finish, Class A filtration system, Class B passthrough, dose calibrator, vial exit station with an automatic system for placing the vials in a lead container, REP-75 isolator perfectly covers the regulatory requirements set out in radiation protection standards, and for good pharmaceutical practice.
Its performance for the synthesis of [68Ga]- and [177Lu]-labelling-peptides and the production of [18F]-fluoride has been demonstrated in >100 centers worldwide on tenthousands of successful productions.
The GRP 3V module is the fully equipped flagship product in our GRP module family. It was developed for the production of various radiopharmaceuticals in the clinical environment.
HA-DOTATATE (Acetate salt) Precursor for radiometal-labelled HA-DOTATATE High Affinity DOTATATE for imaging & therapy
Precursor for radiometal-labelled PSMA I&T Prostate-specific membrane antigen for imaging & therapy
Widely used in Radiopharmacy networks as well as in the research labs, the cassette based AllinOne is unique in its ability to operate as well in research as in production environments. AllinOne includes semi-preparative radio/UV HPLC and reformulation capabilities to take the hassle out of radiochemistry processes, achieving fully integrated applications that minimize down time.
EASYONE is the most user-friendly synthesizer available for the routine production of tracers labeled with radiometals. The fully automated EasyOne is the most compact and user-friendly theragnostic synthesizer on the market for tracers labeled with radioactive metals.
Trasis hot cell H2000 is designed to host a synthesis module and its accessories for the production of radiopharmaceuticals for research and/or for routine production purposes. The hot-cell with ISO-7 (Class-C) main enclosure can feature one or two side-cabinets with or without laminar flow, for easy recovery of the shielded end-product vial without opening the main door of the hot-cell, and/or for incoming activity from a shielded vial.
The Trasis Hot Cell H600 is an integrated solution, allowing to synthesize and dispense radiopharmaceutical products with a minimal footprint, including molecules labeled with radio-metals such as 68Ga and 177Lu. It consists of one shielded enclosure class ISO 7 “Class C” for synthesis and either one side compartment with laminar flow for dispensing in syringes or one side compartment for the dispensing of the final product in a shielded vial.
