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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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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Handles, Weighs, and Dispenses Pharmaceutical Powders

Comecer’s Production Isolator is designed specifically for the pharmaceutical and radiopharmaceutical industries, delivering precise powder preparation, weighing, and dispensing within a controlled environment. Operating at a negative pressure in comparison to its surroundings, it protects operators and materials from contamination. The isolator includes an integrated water washing system, drainage system, and compressed air drying system, ensuring comprehensive cleaning and maintenance. Its versatile application range supports dermatological and chemotherapeutic drug production, radiolabeled isotopes, and cell and gene therapy products like CAR-T cells and gene editing materials. Adhering to stringent GMP guidelines, it offers seamless integration into existing production lines and is engineered to accommodate manual and continuous operations with advanced containment features. The system is configurable to meet the specific needs of pharmaceutical manufacturers, radiopharmaceutical producers, and cell and gene therapy facilities.

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Ensures Safe Dispensing and Weighing of Hazardous Compounds

The MDWI Modular Dispensing and Weighing Isolator from Comecer is engineered for pharmaceutical and biotech companies needing high containment during handling of hazardous compounds. This isolator offers a disciplined approach to dispensing and weighing with its fully PLC-controlled operation, ensuring precise and safe processing of active pharmaceutical ingredients (APIs). It employs a glove box system with OEB5-level containment, ideal for tasks like sampling and manual operations without contamination. Designed to handle cytotoxic drugs, monoclonal antibodies, and vaccines, this isolator ensures compliance with stringent industry standards. Its construction features high-grade stainless steel and optional rapid transfer ports for seamless integration with existing lab systems. Maintenance is simplified with internal washing systems and paperless recording, keeping operations efficient and compliant with GAMP 5 and CFR21 part 11. Customizable configurations and additional upgrades, such as continuous liners and glove leak tests, cater to specific process requirements, making it adaptable to diverse pharmaceutical settings.

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Secures HAPI Transfer and Dispensing Processes

The HAPI Transfer and Dispensing Isolator from Comecer offers a reliable solution tailored for the secure handling of highly active product ingredients. Designed to address the stringent safety and containment requirements in pharmaceutical and radiopharmaceutical contexts, its dual-chamber system ensures seamless transfer and dispensing operations. Ideal for producing anticancer drugs, radiolabeled compounds, and other specialty chemical compositions, these isolators integrate smoothly into existing production lines.

Featuring integrated automation with manual overrides, the isolator’s construction includes pressure control systems and adjustable ventilation, ensuring precise environmental management. Polypropylene glove flanges and nitrile gloves enhance operator safety during operations. The isolator complies with GMP standards, supporting pharmaceutical manufacturers, radiopharmaceutical producers, and hospital pharmacies in adhering to regulatory requirements.

Built with materials ensuring chemical resistance, this isolator supports both productivity and safety, including components like JUMO manometers and DPTE transfer doors. Easy-to-maintain, it offers optional CIP systems for efficient cleaning, crucial for minimizing downtime and contamination risk in sensitive production environments.

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Ensures Safe Dispensing and Isolation

The Dispensing Isolator Glove Box from Comecer is expertly designed for environments demanding precision and safety in material handling, particularly within the pharmaceutical, radiopharmaceutical, and cell & gene therapy sectors. Specially engineered to maintain separation between operators and hazardous materials, this system utilizes negative pressure and turbulent air flow to ensure containment. Ideal for applications in dispensing, containment, and isolation, it’s widely employed in the production of radiopharmaceuticals like Fluorodeoxyglucose (FDG), Iodine-131, and Technetium-99m, as well as chemotherapy drugs and monoclonal antibodies.

This glove box system boasts a fully PLC-controlled operation, which allows for both automated and manual processes, offering flexibility in various pharmaceutical settings. It features a bag-in/bag-out filter replacement method, ensuring minimal exposure during maintenance. Compliant with GMP standards, it supports stringent contamination control required in laboratory departments focusing on safety and environmental conditions.

Notably, the system accommodates a wide range of materials—solid, liquid, and powder—making it versatile for various production requirements. Comecer provides engineering support to customize configurations to meet specific operational needs, thereby integrating seamlessly into existing production lines.

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Dispenses and Weighs Micronized Pharmaceutical Substances

The Dispensing and Weighing Isolator from Comecer is a vital solution for managing micronized, high-potency pharmaceutical substances. It offers a fully PLC-controlled environment, ensuring precision and safety throughout the dispensing and weighing processes. This isolator features dual chambers for material inlet and dispensing operations, equipped with multi-stage filtration to maintain air purity. Its integrated CIP system, comprising spray balls and guns, facilitates efficient cleaning and drying in place. A continuous liner port aids in the secure transfer of products, while the Hycoflex® system in the main chamber streamlines product removal. Designed for pharmaceutical, biotech, and nuclear medicine applications, it supports compliance with stringent GMP standards. The isolator’s material options and robust monitoring system, including temperature and humidity sensors, ensure operational excellence and product integrity.

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Ensures Safe Transfer and Weighing of Explosive Powders

The ATEX Isolator from Comecer is an engineered solution designed for the safe handling of pharmaceutical powders and explosive substances. This isolator features a highly controlled chamber ideal for activities such as weighing and powder transfer. Equipped with a fully PLC-controlled interface, it integrates seamlessly into existing batch or semi-automatic operations, allowing for precise process control and monitoring.

The equipment is particularly effective in manufacturing settings dealing with pharmaceutical tablets, fine chemical powders, and energetic materials. It supports a range of industries, including pharmaceutical, chemical, and biotech, by ensuring compliance with ATEX ZONE 22 Ex II3D requirements for working with hazardous materials.

Inside the isolator, the inclusion of Magnehelic and Photohelic manometers ensures accurate pressure control and air filter monitoring, respectively. A unique RTP system facilitates the safe discharge of materials, optimizing workflow and reducing contamination risk.

Constructed with stainless steel AISI 316L, the isolator offers excellent resistance to corrosion, crucial for maintaining integrity in chemically aggressive environments. The adoption of GAMP 5 compliant software and optional 21 CFR Part 11 availability highlights its suitability for regulated industries.

Furthermore, the isolator incorporates features for efficient cleaning and maintenance, such as spray balls and spray guns, streamlining the decontamination process. Customization options are available to meet specific operational needs, backed by comprehensive engineering support from Comecer.

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