Dispenses, Calibrates, and Shields Radiopharmaceuticals

The TALIA Series, from Comecer, offers a state-of-the-art solution for radiopharmaceutical dispensing and shielding, with a focus on safety and compliance. This isolator features a laminar flow Class A chamber and up to 100mm lead shielding to protect operators. Ideal for radiopharmaceuticals, it efficiently handles dispensing, filling, calibrating, and fractioning with integrated automation and monitoring via a 17” touch-screen panel. The TALIA Series is specifically designed for operations involving fluorodeoxyglucose (FDG) doses, Lutetium-177, and Technetium-99m radiotracers, supporting sterile vial and syringe fills up to 30 vials or 10 syringes per batch. With internal monitoring of critical parameters and compliance with cGMP protocols, it ensures product quality and operator safety. This isolator integrates seamlessly into both manual and automated production lines, offering energy efficiency through optimized filtration and shielding, and is supported by Comecer’s engineering for customization and maintenance.

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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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Processes and Dispenses Radiopharmaceutical Compounds

The Ra-223 Dichloride Production and Dispensing Suite from Comecer is a sophisticated solution designed to streamline radiopharmaceutical production processes. This suite is distinguished by its ability to manage the complete cycle from 227Ac generator loading to the dispensing and packaging of Ra-223 Dichloride, ensuring precise handling of radiopharma and pharmaceutical compounds. Its workflow encompasses critical operations such as semi-automatic processing, separation, purification, and sterilization, emphasizing both high precision and safety.

Ideal for use in nuclear medicine and radiopharmaceutical industries, it supports pharmaceutical manufacturers and radiopharmaceutical producers in generating end-products like alpha-emitter radiopharmaceuticals and therapeutic compounds. The suite’s automated crimping units and shielded isolators are all integrated into a laminar air flow environment, compliant with Class A – ISO5 standards. The vial filling line, equipped with a Flexicon® peristaltic pump and WIPOTEC high precision scales, facilitates accurate volume dispensing with weight control feedback.

Designed for easy integration, this system offers both positive and negative pressure settings relative to laboratory conditions, enhancing its application flexibility. Constructed from durable stainless steel AISI 316L, the equipment supports robust and reliable operation while meeting stringent GMP standards. It is engineered for seamless incorporation into existing production lines, offering compatibility and efficiency across diverse environments.

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Manufactures Aseptic Rb-82 Generators

The Rb-82 Generators Production Plant by Comecer is engineered to streamline the production of radiopharmaceuticals and comply with GMP and FDA standards. This plant features a series of shielded isolators and hot cells, facilitating aseptic operations from formulation through to quality control. Equipped with telemanipulators and automated systems, the plant handles Sr-82/Rb-82 generator column production efficiently, ensuring consistency and sterility of radiopharmaceuticals. With a capacity to produce 100 generators in an 8-hour shift, it integrates automation from filling to washing and assembly. The facility leverages automated sterilization, using vaporized H2O2, for quick turnaround while maintaining aseptic conditions. Flexible conveyor systems and assembly stations support in-line QC and sterility testing, meeting the rigorous demands of nuclear medicine and pharmaceutical industries. Comecer also offers customization options and engineering support to adapt the plant to specific production needs.

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Dispenses and Calibrates Radiopharmaceuticals Safely

The Radiopharmaceutical Dispensing Isolator PHAEDRA from Comecer offers a specialized solution for handling and dispensing sensitive radiopharmaceutical compounds. PHAEDRA stands out for its dual-stage dispensing and calibration system that maintains sterility and safety, making it ideal for producing Fluorodeoxyglucose (FDG), Gallium-68 radiotracers, and more. Equipped with a Class A chamber, it supports a laminar flow environment crucial for contamination control. This isolator is optimized for batch and continuous operations, featuring both manual and high-speed processes. Integration with GMP lines is seamless, with a user-friendly touch panel for precise control. Fabricated with 316L stainless steel, it offers excellent corrosion resistance, catering to the demanding environments of nuclear medicine and pharmaceutical compounding. Fully compliant with GMP standards, PHAEDRA ensures minimal downtime through its efficient waste management and swift decontamination capabilities, including an optional VPHP system for thorough sterilization. Whether you’re in medical research or a hospital pharmacy, PHAEDRA provides comprehensive solutions for radiopharmaceutical applications.

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Synthesizes and Dispenses Radiopharmaceuticals Safely

The PHAEDRA COMBO Series from Comecer is a versatile shielded isolator specifically designed for the synthesis and dispensing of radiopharmaceuticals and aseptic pharmaceutical products. What sets this equipment apart is its combination of modular design and strict adherence to cGMP standards. The system seamlessly integrates a synthesis and dispensing chamber, allowing for precise production and containment of various isotopes such as FDG, Iodine-123, and more. With a synthesis capacity maintained under Class B conditions and dispensing under Class A laminar airflow, it ensures the highest purity levels. The isolator’s compact design is ideal for small laboratory spaces, while its ergonomic features and the tele-plier handling system provide safe, efficient operations. Certified with advanced decontamination features and designed for ease of cleaning, the PHAEDRA COMBO Series offers a reliable solution for pharmaceutical manufacturers, nuclear medicine facilities, and hospital pharmacies seeking state-of-the-art radioprotection and operational excellence.

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Ensures Aseptic Handling of Radiopharmaceuticals

The MIP LAF Series by Comecer is a series of specialized Laminar Flow Shielded Cells designed for radiopharmacy and nuclear medicine applications. These units are essential for aseptic handling and dispensing of radiochemicals and radiopharmaceuticals, such as FDG and Technetium-99m. Featuring a full laminar air flow working area and modular design, these cells integrate seamlessly into lab environments, offering advanced fluid handling and dose calibration through airtight connections and automated pressure adjustments using modulating valves. Built with AISI 316L stainless steel, they offer exceptional corrosion resistance and comply with cGMP standards. Equipped with high sensitivity tele-pliers and a touch-screen interface, they enable precise manual operation and monitoring. Designed for integration into a wider processing line, these cells offer compatibility with radiochemistry modules and provide flexible configurations, including options for telemanipulators and shielded pre-chambers. This series is optimized for safe, continuous operations, offering robust solutions for product and vial extraction while maintaining necessary shielding with 75 mm lead walls.

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Synthesizes and Dispenses Gallium-68 Radiopharmaceuticals

The MUSA 68Ga Shielded Isolator from Comecer is designed to streamline the synthesis and dispensing of Gallium-68 radiopharmaceuticals. Featuring a modular design, it allows for flexible configuration to meet the specific needs of nuclear medicine and pharmaceutical applications. The isolator operates under aseptic conditions, aligning with cGMP standards for handling beta and gamma-emitting radiopharmaceuticals, including Lutetium-177 and Yttrium-90. It integrates seamlessly through its multi-functional compartments for synthesis, calibration, and fractioning processes, all of which are protected by 50 mm Pb shielding for superior radiation safety. Automation is achieved via a touch-screen console and dose calibrator, ensuring precise dispensing. The isolator is compliant with Good Radiopharmacy Practices, enhancing safety and efficiency in complex radiopharmaceutical operations while offering custom engineering support for specialized applications.

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Synthesizes and Aseptically Fills Ioflupane I-123 Vials

The Automated Ioflupane I-123 Injection Dispensing Plant from Comecer is an advanced solution for radiopharmaceutical production that excels in the aseptic filling of Ioflupane I-123 vials. This system uniquely integrates automated synthesis, HPLC purification, and vial filling, ensuring precise weight control and sterility. It features multiple lead-shielded isolators that facilitate process integrity from synthesis to inspection, making it ideal for use in nuclear medicine and pharmaceutical industries. Capable of dispensing and filling at a rate of 360 vials per hour, this system reduces operator exposure through robotic buffering and decontamination with VPHP. It seamlessly combines into existing production lines, offering automated operation with semi-automatic visual inspection to ensure quality control. Designed with compliance in mind, it adheres to stringent GMP and aseptic standards, meeting the highest industry requirements while offering customization options to fit specific production needs.

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Synthesizes and Dispenses Radiopharmaceutical Doses

The BBST COMBO Series by Comecer seamlessly integrates synthesis and dispensing in a single shielded hot cell, designed to streamline the preparation of radiopharmaceuticals under sterile, cGMP-compliant conditions. Specially engineered for radiopharmaceutical manufacturers and nuclear medicine facilities, this equipment combines synthesis modules and fractionation systems, facilitating efficient production of doses such as Fludeoxyglucose (18F-FDG) and Lutetium-177 therapies.

The BBST COMBO Series operates using a multi-chamber design, featuring a main shielded dispensing area with air-tight and laminar flow systems for critical class “A LAF” environments, and additional class “B” zones for synthesis and material transfer. This ensures high containment and purity levels crucial for nuclear medicine applications.

With automation options, the hot cell supports both batch and continuous operations, maintaining precise pressure adjustments and airtight connections for processing radioactive fluids. Made from AISI 316L stainless steel, it offers high corrosion resistance, vital for handling aggressive chemicals. The integrated dose calibrator, available in 2 Ci or 20 Ci versions, provides accurate dose measurements, crucial for regulatory compliance.

Compliance with cGMP standards is built-in, with features like VPHP connections and semi-automatic bubble point testing. This focus on safety and efficiency is further enhanced with the optional integration of the Illuminate™ Manufacturing Intelligence platform, offering real-time data analytics for optimizing production throughput, quality, and sustainability.

For ease of maintenance, the BBST COMBO Series includes a waste collection system, both solid and liquid, and supports CIP capabilities, reducing downtime and ensuring contamination-free operations. Comecer also provides customization options to adapt the system to specific operational needs, supported by comprehensive engineering support.

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