Calibrates and Measures Radiopharmaceutical Dosages

The VDC-606 Touch Screen Dose Calibrator from Comecer combines seamless digital integration with medical certification, making it an ideal solution for nuclear medicine facilities and radiopharmacy centers. This state-of-the-art device utilizes a fully digital ionization chamber, either VIK-202 or VIK-203, ensuring fast and reliable measurements for a range of radiopharmaceutical doses, including Iodine-131 and Technetium-99m preparations. Its intuitive 10″ touch screen interface enhances usability, allowing for easy operation and integration into existing processes such as calibration, testing, and quality control.

The VDC-606 meets both FDA and CE medical device standards, providing confidence in compliance for rigorous medical and pharmaceutical environments. Designed for flexibility, it supports various container geometries from vials to syringes and offers additional accessories like lead shielding and sample dippers to enhance customization. Its compact stand-alone design with a digital output allows integration without the need for additional conversion equipment, optimizing both laboratory and production efficiency. As an in-house producer of ionization chambers, Comecer offers tailored solutions to meet specific customer demands, ensuring precise fit and function for diverse application needs.

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Dispenses and Calibrates Gallium-68 Radiopharmaceutical Doses

The THECLA Shielded Isolator from Comecer is meticulously designed to address the stringent requirements of dispensing Gallium-68 radiopharmaceuticals under sterile conditions. This innovative isolator features a semi-automatic dispensing system for syringes, ensuring precision and safety in radiopharmaceutical production. Equipped with a Comecer IBC Dose Calibrator, it accurately measures and calibrates doses within a range of up to 2 Ci. The isolator operates with laminar airflow to maintain Class A and B air quality, essential for producing sterile 68Ga-labeled compounds like PSMA ligands and DOTATATE. Compact in design, the THECLA integrates seamlessly into existing production lines, even in confined spaces. It employs 50 mm lead shielding and HEPA H14 filtration to guarantee operational safety and contamination control. Additionally, the system’s stainless steel construction provides durability and ease of decontamination, while the option to install a Geiger-Muller probe ensures radiation levels are continuously monitored. Fully compliant with cGMP guidelines, this isolator offers pharmaceutical manufacturers, radiopharmaceutical producers, and hospital pharmacies a dependable solution for efficient and safe radiopharmaceutical dispensing.

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Extracts, Purifies, and Dispenses Lu-177 Radioisotopes

The Lu-177 N.C.A. Semiautomatic Production and Dispensing Plant, offered by Comecer, is a sophisticated system meticulously crafted to meet the demanding needs of radiopharmaceutical manufacturers and nuclear medicine facilities. This system is distinguished by its dual-chamber hot cell configuration—one chamber for extraction and purification, and the other for dispensing and terminal sterilization. It handles the complete workflow from separating Ytterbium-176 from Lutetium-177 to preparing terminally sterilized vials of Lu-177 radioisotope therapy doses.

Equipped with tele-manipulators, robotic dispensers, and semi-automatic dispensing technology, the system ensures precise micro-dose handling while maintaining safety with lead shielding and acid-proof fluoropolymer coatings. Its integration capability with customer-specific modules for automated extraction and purification enhances flexibility. The process automation is complemented by control systems for batch processing and remote handling, all while maintaining rigorous compliance with cGMP standards. Furthermore, the plant features a saturated steam autoclave and supports productivity of 50 vials in 8 hours, optimizing both efficiency and throughput in production. Customization options allow adaptation to specific operational needs, supported by comprehensive engineering support.

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Calibrates and Tests Radiopharmaceutical Doses

The IBC Dose Calibrator from Comecer Netherlands B.V. is a digital, high-precision device designed for radiopharmaceutical dose calibration and testing. It integrates seamlessly into both radiopharmacy and nuclear medicine workflows, supporting applications such as Fludeoxyglucose (18F-FDG) and Technetium-99m dose preparation. Equipped with the VIK-202 or VIK-203 ionisation chamber, it ensures accurate radionuclide purity testing and quality control, including molybdenum breakthrough and background subtraction tests. Its intuitive IBC-LITE software offers touch screen operation and supports full integration with Windows-based systems. CE marked and FDA approved, this calibrator meets stringent compliance standards, making it ideal for industries that demand precision and reliability.

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Handles, Dispenses, and Calibrates Radiopharmaceuticals

The ELIZA Series from Comecer is a shielded laminar flow isolator designed for precise handling of radiopharmaceuticals used in nuclear medicine and metabolic radiotherapy. This equipment is unique for its integration of dose calibrators and fractionation systems, optimizing the dispensing and material transfer of critical isotopes like FDG, Lutetium-177, and Iodine-131. It maintains sterility through a Class A laminar flow workspace, while radiation shielding ensures operator safety. The isolator can be configured for continuous manual operation and supports automatic modules for high-speed processing. Manufactured with AISI 316L stainless steel, it offers robust material integrity and is cGMP-compliant for pharmaceutical environments. Integrated waste collection systems and modulating valve pressure adjustments enhance safety and workflow efficiency, making it ideal for pharmaceutical manufacturers and nuclear medicine departments.

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Dispenses and Calibrates Radiopharmaceutical Syringes

The ALTHEA PC from Comecer is a modular system designed to automate the filling and calibration of radiopharmaceutical syringes, primarily for use in hospital pharmacies and nuclear medicine departments. What sets this system apart is its ability to significantly reduce radiation exposure for operators while ensuring precise dose calibration. The ALTHEA PC seamlessly integrates downstream in your existing production line, directly connecting to synthesis modules or drawing from mother vials in shielded containers. It features a touch screen interface for both the hot cell and dispensing system, and automatic pressure adjustments for optimal operation. Applications include the preparation of FDG doses and customized calibrated syringes using physiological solutions when necessary. With its built-in dose calibrator available in 2 Ci or 20 Ci versions, the system supports continuous operation, contributing to efficient workflow in radiopharmaceutical processing. The equipment complies with GMP standards and offers configurations for both 5 ml and 10 ml syringes with mechanical adjustments. Enhanced by airtight radioactive fluid connections and DOP test features, it ensures contamination-free operations and aligns with safety regulations.

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Dispenses and Calibrates Radiopharmaceutical Vials and Syringes

The BBST Series from Comecer is a state-of-the-art shielded isolator designed for the precise dispensing and calibrating of radiopharmaceuticals in liquid form, such as iodine-131 and technetium-99m vials, as well as fluorodeoxyglucose (FDG) and yttrium-90 syringes. This modular isolator ensures a sterile, Class A environment with a laminar flow system, crucial for maintaining cGMP compliance in production. It integrates seamlessly into radiopharmaceutical production lines, enabling batch or semi-automatic operations tailored to the needs of pharmaceutical manufacturers, hospital pharmacies, and nuclear medicine facilities. Engineered with AISI316L stainless steel for durability and corrosion resistance, it features airtight connections and high sensitivity tele-pliers for safe handling of radioactive materials. The built-in dose calibrator offers precise measurement with touch-screen control, enhancing accuracy and efficiency. Maintenance is streamlined with automated pressure adjustment and optional VPHP connections for sterilization, ensuring minimal downtime and sustained operational efficiency.

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